Download Minutes of 260th meeting of Registration Board

Minutes for 260th Meeting Registration Board held on 28-29th June, 2016.
Item No.
Detail of Item
Page No(s)
Item No.I
Confirmation for minutes of 259th Registration Board meeting
04
Item No.II
Pharmaceutical Evaluation & Registration Division
05 - 375
Item No.III
Biological Drugs Division
376 - 483
Item No.IV
Quality Assurance & Laboratory Testing Division
484 – 490
Item No.V
Additional cases
491 - 493
Minutes for 260th Meeting Registration Board
1
260th meeting of Registration Board was held on 28-29th June, 2016 in the Committee
Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by
Mr. Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration Division,
DRAP. The meeting started with recitation of the Holy Verses. The meeting was attended by the
following:1.
Lt General (R) Karamat Ahmed Karamat.
Member
2.
Brig (R). Dr. Muzammil Hasan Najmi,
Associate Dean, Basic Sciences Division,
Foundation University Medical College, Rawalpindi
Mr.A.Q.Javed Iqbal
Member
4.
Sheikh Sarfraz Ahmad
Additional Draftsman, M/o Law and Justice
Member
5.
Mr.Ghulam Mujtaba, Assistant Director
Representative of IPO
Member
6.
Dr.Muhammad Arshad
President, Pakistan Veterinary Medical Council
Member
7.
Dr.Amanullah Khan
Director Drugs Testing Laboratory
Government of Baluchistan, Quetta
Dr.Muhammad Khalid Khan
Director Drugs Testing Laboratory
Government of Khyber Pakhtunkhwa, Peshawar
Mr.Abdus Salam Shah
Director Drugs Testing Laboratory
Government of Sindh, Karachi
Mr.Saleem Butt
Director Drugs Testing Laboratory
Government of Punjab, Rawalpindi
Shaikh Ansar Ahmad,
Director Biological Drugs Division, DRAP
Member
12.
Dr.Noor Muhammad Shah
Director Medical Device Division, DRAP
Member
13.
Dr.Abdur Rasheed
Chairman, Quality Control
QA&LT Division, DRAP
Member
3.
8.
9.
10.
11.
Minutes for 260th Meeting Registration Board
Member
Member
Member
Member
Member
2
14.
Dr. Obaidullah, Deputy Director General (Reg.I)
Secretary
Dr.Muhammad Khalid Khan attended the meeting on 28.06.2016 while Dr.Muhammad
Arshad and Mr.Abdus Salam Shah participated on 29.06.2016 only.
Dr.Masud-ur-Rehman (DDG Biological), Zaheer-ud-Din M Babar (DDC R.I/R IV),
Muhammad Akhter Abbas (DDC/Incharge, PEC), Dr.Hafsa Karam Elahi (DDC,PEC),
Muhammad Amin (DDC R.V / DDC,PEC), Tehreem Sara (DDC RRR), Adnan Faisal Saim
(DDC,QC), Babar Khan (ADC R.II/RIII), Dr.Ghazanfar Ali Khan (ADC RRR), Salateen
Waseem Phillips (ADC,PEC), Muhammad Ansar (ADC,PEC) and Muneeb Cheema
(ADC,Biological) assisted relevant Directors and Secretary of the Board with agenda.
Shafiq Ahmad Abbasi, Ayub Siddique, Nadeem Alamgeer and Abuzar Faizi Rattu
attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA respectively.
In addition to routine agenda, following was also discussed and decided:

Registration Board deliberated that only those drugs will be registered for import from
India, which are as allowed / permissible as per Import Policy Order, 2016 (Ministry of
Commerce).
Minutes for 260th Meeting Registration Board
3
Item No. I: Confirmation of minutes of 259th meeting Registration Board.
259th meeting of Registration Board was held on 30-31st May, 2016. Draft minutes were
circulated to all members (who attended the meeting) on 15.06.2016 through e-mail with the
request to forward their comments (if any) within 05 days. 02 members forwarded their
comments / observations, as follows:

Dr.Amanullah Khan, Director DTL, Quetta:
Item No.III, Case No.01:
It may be decided as per decision of Registration Board.

Dr.Noor Muhammad Shah, Director Medical Device, DRAP:
While discussing observation of Dr.Amanullah regarding registration of Injection Ropegra, the
members were informed that the Board endorsed the statement of registration of the product in
parawise comments submitted before the court and change in source was accordingly approved.
Member including the undersigned stated that Board has its own wisdom and procedure for
registration of drugs instead of endorsing of parawise comments. It was also submitted that as
necessary requirements were fulfilled, registration should have been granted for the new source
instead of change of source.
Keeping in view comments of Dr.Amanullah Khan, Director DTL, Quetta, respective
case is again placed as agenda item (Item No.II, Case No.01).
Decision:
Registration Board deliberated that points observed by Director Medical
Device, DRAP has already been discussed in previous meetings. Hence
Registration Board confirmed minutes of 259th meeting Registration Board.
Minutes for 260th Meeting Registration Board
4
Item No. II: Pharmaceutical Evaluation & Registration Division.
Case No.01: New committee(s) for on-site inspection of stability data or any other
assignments.
Registration Board in 258th meeting considered following proposal of Dr.Muhammad
Khalid Khan, Director DTL, Peshawar forwarded in response to draft minutes of 257th
Registration Board meeting. Dr.Amanullah Khan, Director DTL, Quetta has also endorsed these
observations.
As per decision of the Registration Board to verify stability data as per site and in this
connection already one committee was constituted which is working. However as a member
of Registration Board I do feel that only one committee is not sufficient to look after the
entire Pharma of the country therefore to avoid unnecessary delay for onsite verification of the
data the board may constitute new committee(s) in the public interest compromising of members
of the Registration Board only. Registration Board may also develop rationalized check list for
onsite verification of the data with clear, time Bound Terms of Reference.
Registration Board after deliberation deferred the case and advised Pharmaceutical
Evaluation Cell to bring complete details / data of stability datas submitted by the manufacturers
in forthcoming meeting. Accordingly, following data is submitted for consideration of
Registration Board.
S.No
1.
2.
3.
4.
5.
Name of Drug & Composition
No of applicants / manufacturers
Capsule Dex-Lansoprazole 30mg, 60mg
02
Tablet Sofosbuvir 400mg
03
Tablets Cinacalcet 30 mg, 60 mg
01
Tablet Mirabegron 25mg, 50mg
01
Tablet Sitagliptin+Metformin XR 50/500,
01
50/1000, 100/1000
In 259th meeting, Registration Board decided as follows:
Registration Board deliberated the matter in detail and decided that already constituted panel
(Brig (R) Muazmmil Najmi, Dr.Obaidullah and Dr.Saif-ur-Rehman Khattak) will continue to
inspect pharmaceutical units for onsite investigation to confirm genuineness/ authenticity of
stability data and associated documents, import of API, quality, specification, test analysis,
Minutes for 260th Meeting Registration Board
5
facilities for Anti-retroviral drugs. For rest of formulations, following panels are constituted for
aforementioned purposes.

Sind and Balochistan:
Director DTL Karachi; Director DTL Quetta and area
FID, DRAP.

Punjab:
Director DTL Lahore; Director DTL Peshawar and
area FID, DRAP.

Islamabad, AJK and KPK:
Director DTL Rawalpindi; Director DTL Peshawar and
area FID, DRAP.
Registration Board also approved above panels for confirmation genuineness/
authenticity of stability data and associated documents, import of API, quality, specification, test
analysis, facilities for various applications.
Decision:
Registration Board deliberated the matter and decided that already
constituted panel (Brig (R) Muazmmil Najmi, Dr.Obaidullah and Dr.Saif-ur-Rehman
Khattak) will continue to inspect pharmaceutical units for onsite investigation to confirm
genuineness/ authenticity of stability data and associated documents, import of API,
quality, specification, test analysis, facilities for Anti-retroviral drugs. For rest of
formulations, following panels are constituted for aforementioned purposes.
 Sind and Balochistan:


Director DTL Quetta (Chairman), Director DTL
Karachi (Member); and area FID, DRAP
(Member / Convener).
Punjab:
Director DTL Peshawar (Chairman), Director DTL
Lahore; and area FID, DRAP (Member/Convener).
Islamabad, AJK and KPK: Director DTL Peshawar (Chairman), Director DTL
Rawalpindi and area FID, DRAP (Member/Convener).
Case No.02: Price fixation under the Drug Pricing Policy-2015.
Drug Pricing Committee referred the under mentioned five cases of price fixation for
policy guidelines from the Policy Board of the Authority for price fixation of drugs whose plain
formulations or injections in vials/ampoules are available in the market at much lower prices and
the companies have applied for price fixation of sustained release formulations or injections in
prefilled syrings or modification in dosage administration / drug delivery device respectively.
These formulations are not new chemical entities and DPC could not find any guideline in the
Drug Pricing Policy -2015 to fix prices of these formulations at much higher prices. Therefore,
Minutes for 260th Meeting Registration Board
6
DPC decided to refer the following cases of price fixation to the Policy Board of the Authority
for policy guideline whose prcice fixation is not covered under the Drug Pricing Policy –2015.
S.
No.
1.
Drugs / Composition
Reasons for referring to the Policy Board for policy guideline
Panadol Joint Tablets
Each modified release tablet
contains:Paracetamol
Ph
Eur….665mg
Plain tablets of Panadol 500mg of the same company are available
@ Rs.180.00/200’s (Rs.0.90/- per tablet) and the company is
demading Rs.200.00/20’s (Rs.10.00/- per tablet) for modified
release of 665mg tablets.
M/s GSK, Karachi
(M-243)
2.
Sayana Press Injection PFS
104mg/0.65ml
(Medroxyprogesterone
acetate)
Pre-filled injection system
contains
Depomedroxyprogesterone acetate
(DMPA) 104mg/0.65ml

Imported by Pfizer
Pakistan
Limited,
Karachi
 Imported
from
Manufacturer: Pfizer
Manufacturing
Belgium
NV,
Rijksweg 12, 2870
Puurs, Belgium.
Main indications:
Contraceptive,
depot
effective for at least 13
weeks.
Demanded price of 665mg modified release tablets @ Rs.10/- per
tablet is much high in comparison to price of 500mg plain tablet of
the same company available @ Rs.0.90/- per tablet.
It is not a new chemical entity. Reference price is neither available
nor applicable. DPC decided to refer the matter to Policy Boar for
policy guideline.
The
company
is
already
marketing
injection
of
Medroxyprogesterone acetate 150mg per 1ml in vial dosage form @
Rs.153.16/1ml x 1’s under the brand name “Depo-Provera”.
Now the company has applied for price fixation of same drug
(Medroxyprogesterone acetate) for 104mg per 0.65ml under the
brand name “Sayana Press Injection PFS” and demaned maximum
retail price of Rs.1078/- per injection in Pre-filled syringe.
Demanded price of Sayana Press Injection @ Rs.1078/- per
injection is much higher in comparison to already available brand
“Depo-Provera” of the same company @ Rs.153.16 per injection
(vial).
It is not a new chemical entity. Reference price is neither available
nor applicable. DPC decided to refer the matter to Policy Boar for
policy guideline.
Minutes for 260th Meeting Registration Board
7
S.
No.
3.
4.
Drugs / Composition
Reasons for referring to the Policy Board for policy guideline
Ritalin LA Capsules 20mg
Each capsule contains:Methyphenidate
hydrochloride…..20mg
(M-245)
 Imported by M/s.
Novartis
Pharma
(Pakistan)
Ltd.
Karachi/
 Imported from M/s.
Elan Holdings Inc,
Georgiam, USA.
The company is already marketing Methyphenidate hydrochloride
10mg Tablets in plain tablet dosage form @ Rs.140.00 per pack of
10 tablets under the same brand name “Ritalin Tablets”.
Ritalin LA Capsules 30mg
Each capsule contains:Methyphenidate
hydrochloride….320mg
(M-245)
 Imported by M/s.
Novartis
Pharma
(Pakistan)
Ltd.
Karachi/
 Imported from M/s.
Elan Holdings Inc,
Georgiam, USA.
Now the company has applied for price fixation of same drug
(Methyphenidate hydrochloride) for 20mg per capsule under the
brand name “Ritalin LA Capsules 20mg ” and demaned maximum
retail price of Rs.2400.00/- for a pack of 30 capsules (Rs.80/- per
capsule).
Demanded price of Ritalin LA Capsules 20mg @ Rs.2400.00/- for
a pack of 30 capsules (Rs.80/- per capsule) is much higher in
comparison to already available brand “Ritalin Tablets 10mg” of
the same company @ Rs.140.00 per pack of 10 tablets (plain)
(Rs.14/- per tablet).
It is not a new chemical entity. Reference price is neither available
nor applicable. DPC decided to refer the matter to Policy Boar for
policy guideline.
The company is already marketing Methyphenidate hydrochloride
10mg Tablets in plain tablet dosage form @ Rs.140.00 per pack of
10 tablets under the same brand name “Ritalin Tablets”.
Now the company has applied for price fixation of same drug
(Methyphenidate hydrochloride) for 20mg per capsule under the
brand name “Ritalin LA Capsules 30mg ” and demaned maximum
retail price of Rs.3200.00/- for a pack of 30 capsules (Rs.106.67/per capsule).
Demanded price of Ritalin LA Capsules 30mg @ Rs.3200.00/- for
a pack of 30 capsules (Rs.106.67/- per capsule) is much higher in
comparison to already available brand “Ritalin Tablets 10mg” of
the same company @ Rs.140.00 per pack of 10 tablets (plain)
(Rs.14/- per tablet).
It is not a new chemical entity. Reference price is neither available
nor applicable. DPC decided to refer the matter to Policy Boar for
policy guideline.
Minutes for 260th Meeting Registration Board
8
S.
No.
5.
Drugs / Composition
Reasons for referring to the Policy Board for policy guideline
Ritalin LA Capsules 40mg
Each capsule contains:Methyphenidate
hydrochloride…..40mg
(M-245)
 Imported by M/s.
Novartis
Pharma
(Pakistan)
Ltd.
Karachi/
 Imported from M/s.
Elan Holdings Inc,
Georgiam, USA.
The company is already marketing Methyphenidate hydrochloride
10mg Tablets in plain tablet dosage form @ Rs.140.00 per pack of
10 tablets under the same brand name “Ritalin Tablets”.
Now the company has applied for price fixation of same drug
(Methyphenidate hydrochloride) for 20mg per capsule under the
brand name “Ritalin LA Capsules 40mg ” and demaned maximum
retail price of Rs.3900.00/- for a pack of 30 capsules (Rs.130/- per
capsule).
Demanded price of Ritalin LA Capsules 40mg @ Rs.3900.00/- for
a pack of 30 capsules (Rs.130/- per capsule) is much high in
comparison to already available brand “Ritalin Tablets 10mg” of
the same company @ Rs.140.00 per pack of 10 tablets (plain)
(Rs.14/- per tablet).
It is not a new chemical entity. Reference price is neither available
nor applicable. DPC decided to refer the matter to Policy Boar for
policy guideline.
Policy Board of the Authority in its 14th meeting held on 10th & 11th September, 2015 had
referred the matter to the Drug Registration Board to decide a specialized dosage form whether it
is a new drug or not and its price is to be granted. Accordingly as a new product or a same
product but different strength / different pack size as both are separately mentioned in the Drug
Pricing Policy-2015.
Decision:
Mr.Abdul Ghaffar, DDC (Pricing) apprised Registration Board about the
case. The Board deferred the case for decision of DRAP’s Policy Board in
instant case for further deliberation.
Minutes for 260th Meeting Registration Board
9
RRR Division
Case No.03: Renewal of registered drug and Post-registration variation approval.
In 243rd Meeting of the Registration Board a following decision was made postregistration variation was made and the extract is as under:
“Registration Board deliberated that transfer from one importer to another (with no change in
manufacturing site), change of brand name and change of name of manufacturer will be
considered as post-registration variation. Moreover, this approval will not be considered as
renewal of the product and firm will apply for renewal of product as per procedure and will be
processed as per import policy for finished drugs.”
Although decision was made as above but notification to this effect for not considering
post-registration variations towards renewal products was not issued and the firms are still
considering/applying renewal of registration from their date of post-registration variations.
Case was deliberated in 259th Registration Board meeting and decided to bring the issue
as agenda in the forthcoming meeting for discussion.
Decision:
Registration Board deliberated on the matter at length and decided postregistration variations shall not be considered towards renewal of products
w.e.f 01-10-2016. However, it was observed that renewal applications already
submitted or to be submitted till 30.09.2016 shall be considered from post
registration varioation, if appled by the firm.
Case No.04: Renewal of Registered drugs.
Number of applications submitted for renewal of drugs which are incomplete or have
shortcoming especially with reference to the submitted prescribed renewal fees. The following
applications for renewal of drugs are submitted on Form 5-B after the expiry of validity of the
certificate of registration but within sixty days after validity of certificate of registration. The
applications for renewal are incomplete with reference to renewal application fee or having some other
deficiency.
Rule 27 Drug (Licensing, Registering & Advertising) Rules, 1976 (Duration of certificate of
registration). A certificate of registration under this chapter, [shall unless earlier suspended or
cancelled, be in force for a period of five years from the date of [Registration of the drug] and may
thereafter be renewed for period not exceeding five years and a certificate to this effect shall be
issued within one month] at a time.
Minutes for 260th Meeting Registration Board
10
Provided that an application for the renewal of registration shall not be entertained unless it has
been made within sixty days after the expiry of the registration and when an application has been
made aforesaid the registration shall subject to the orders passed on the application for the renewal
continue in force for the next period of five years and a certificate to this effect shall be issued within
one month].
Provided further that in case of an imported drug, the renewal may be granted and a renewal
certificate shall be issued, if in the opinion of the Registration Board it is necessary to do so in the
public interest.
Following cases are placed below for the consideration of Registration Board.
a.
M/s Prix Pharma Lahore.
S.
No
Reg/No
Products/Name
1
014568
Farbenda Oral Suspension
Each ml contains
Albendazole…. 100 mg
Decision:
b.
22-2-1994
Application receiving
date
and fee submitted date/
and due date
Due date (21-2-2014)
17-3-2014
Fee of Rs. 40,000/deposited on 17-03-2014
Firm submitted renewal application within 60 days of expiry period of
registration time i.e; 17-03-2014 with fee of Rs. 40000/-, therefore
Registration Board decided to grant renewal of above product till 21-02-2019
subject to adherence to the Import Policy for Finished Drugs.
M/s Navegal Laboratories Rawalpinid.
S.
No
Reg/No
Products/Name
1
015732
Naveten 1 mg tablet
Each tablet contains
Ketotifen Fumerate.. 1 mg
2
015731
Piram 20 mg capsule
Each capsule contains
Piroxicam…..20 mg
Zantidon 150 mg tablets
Each tablet contains
Ranitidine HCl… 150 mg
3
Initial Date of
Registration
018979
Minutes for 260th Meeting Registration Board
Date of
transfer of
Reg.
21-1-2008
Application receiving date
and fee submitted date/
and due date
Due date (20-1-2013)
19-2-2013
Fee of Rs. 60,000/deposited on 19-02-2013
do
do
do
do
11
Decision:
c.
Firm submitted renewal application within 60 days of expiry period of
registration time i.e. 19-02-2013 with full fee, therefore Registration Board
decided to grant renewal of above products at serial No. 1 to 3 till 20-01-2018.
M/s Nabiqasim Industries (Pvt) Ltd Karachi.
S.
No
Reg/No
Products/Name
1
053139
2
053135
Deplat-AP Tablet
Each tablet contains
Clopidogrel
(as bisulphate)…. 75 mg
Aspirin BP….. 75 mg
(Manufacturer’s Specification)
Lungair 4 mg tablet
Each chewable tablet contains
Montelukast Acid (as
sodium)………. 4 mg
(Manufacturer’s Specification)
Valset 250 mg tablet
Each tablet contains
Valproic Acid (as
sodium)………. 250 mg
(Manufacturer’s Specification)
Ordiab 5/500 tablet
Each tablet contains
Glipizide……. 5.00 mg
Metformin Hydrochloride…
500 mg
(Manufacturer’s Specification)
Clarithro 125mg/5ml Oral
Drops
Each 5ml contains
Clarithromycin …….. 125 mg
(Manufacturer’s Specification)
Lumether tablet
Each tablet contains
Artemether ……… 20.00 mg
Lumefantrine…… 120.00 mg
(Manufacturer’s Specification)
Lungair 4 mg Sachet
Each chewable tablet contains
Montelukast Acid (as
sodium)………. 4 mg
(Manufacturer’s Specification)
3
053142
4
053133
5
053138
6
053140
7
053136
Minutes for 260th Meeting Registration Board
Initial Date
of
Registratio
n
1-12-2008
Application receiving date
and fee submitted date/ and
due date
Due date (30-11-2013)
10-12-2013
Fee of Rs. 20,000/- deposited
on 10-12-2013
do
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Decision:
d.
Firm submitted renewal application within 60 days of expiry period of
registration time i.e; 10-12-2013 with full fee, therefore Registration Board
decided to grant renewal of above products at serial No. 1 to 7 till 30-11-2018.
M/s Mediate Pharmaceuticals (Pvt) Ltd Karachi.
S.
No
Reg/No
Products/Name
1
006919
Mefenemic tablet
Each tablet contains
Mefenamic Acid……. 250 mg
9-3-2004
2
012123
do
3
012449
do
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4
012451
5
006920
6
004327
7
011342
8
010526
Tr.Iodine Solution
Each contains
Iodine……… 5 gm
Potaqssium Iodide……. 10 gm
Benephal Capsule
Each Capsule contains
Cephalexin……….. 250 mg
Lakenine Capsule
Each capsule contains
Ampicillin Trihydrate eq.to
Ampicillin Base…..250 mg
Seladrine tablet
Each tablet contains
Chloroquine Phosphate eq.to
Chloroquine base……. 80 mg
Seladrine tablet
Each tablet contains
Chloroquine Phosphate250 mg
Frusemide tablet
Each tablet contains
Frusemide……….. 40 mg
Trupentine Liniment
Contains
Soft Soap……….. 75 gm
Turpentine Oil…… 650 ml
Purified water…….. 225 ml
(Fresh boiled& cooled
Camphor……….. 50 gm
Application receiving
date
and fee submitted
date/ and due date
Due date (8-3-2014)
11-3-2014
Fee of Rs. 10,000/deposited on 11-32014. Remaining fee of
Rs/ 10,000 deposited
on 18-5-2016
do
Minutes for 260th Meeting Registration Board
Initial Date
of Reg.
do
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13
9
010287
10
004488
11
009043
12
010289
13
011180
14
012125
15
012124
16
006917
17
010286
18
012448
19
009352
20
009042
Polter past Ointment
Each 400 gm contains
Heavy Kaolin……..52.7 gm
Boric Acid………….04.5 gm
Methylsalicylate…….. 00. 2ml
Thymol…………….. 50.0 mg
Pepermint Oil…… 0.05 ml
Glycerol………….. 42.5 gm
Aspera-Co tablet
Each tablet contains
Aspirin…………… 300 mg
Paracetamol……….. 200 mg
Caffeine…………. 30 mg
Feverol Suspension
Each 5ml contains
Paracetamol………… 120 mg
Decmasil tablet
Each tablet contains
Magnesium Trisilicate.. 500 mg
Duocarte Solution
Contains
Salicylic Acid…….. 16.7%
Lactic Acid………. 16.7%
Decsazone tablet
Each tablet contains
Dexamethasone……… 0.5 mg
Aminophylline tablet
Each tablet contains
Aminophylline………. 100 mg
Dep-Roll tablet
Each tablet contains
Aspirin…………. 300 mg
Inchthazmol Glycerin
Each contains
Inchthazmol Glycerin….10%/w/w
Benaphal Capsule
Each capsule contains
Cephalexin………… 500 mg
Cetadrine tablet
Each tablet contains
Ephedrine………….. 30 mg
Anatrate Syrup
Each 5ml contains
Sodium Citrate……. 37.625 Kgs
Citric Acid………. 14.200 Kgs
Minutes for 260th Meeting Registration Board
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14
21
004489
Predamenium tablet 4 mg
Each tablet contains
Chlorpheniramine Maleate…. 4mg
Freshmasil Syrup
Each 5ml contains
Ammonium Chloride….. 100 mg
Sodium Citrate…… 60 mg
Chlorpheniramine Maleate…… 2mg
Ephedrine HCL….. 7 mg
Menthol…………. 1 mg
Mercurochrone Solution
Contains
Mercurochrone Solution….1%/w/w
Clean Skin Lotion
Contains
Calamine………….. 15%
Ascorbic Acid tablet
Each tablet contains
Ascorbic Acid……… 50 mg
Cake-Sea 500 tablet
Each tablet contains
Ascorbic Acid……. 500 mg
Paracetamol tablet
Each tablet contains
Paracetamol ………. 500 mg
Gentian Violate Paint
Contains
Crystal Violet in water…. 0.5%/w/w
Mad folic tablet
Each tablet contains
Folic Acid………. 5 mg
do
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22
009044
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23
010525
do
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24
004601
do
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25
007032
do
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26
006918
do
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27
010524
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28
007033
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29
009353
Kotria tablet
Each tablet contains
Trimethoprim………. 80 mg
Sulphamethoxazole……. 400 mg
do
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30
004328
Paracambind tablet
Each tablet contains
Paracetmol ………..300 mg
Aspirin……….. 200 mg
do
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31
010577
Clean Skin Solution
Contains
Calamine………..15%
do
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Minutes for 260th Meeting Registration Board
15
32
012450
33
006921
34
004602
35
004603
Decision:
e.
Lakcine Capsule
Each capsule contains
Ampicillin Thydrate eq.to
Ampicillin Base ……500 mg
Sodamint tablet
Each tablet contains
Sodium Bi Carbonate… 300 mg
Kaleup tablet
Each tablet contains
Calcium Lactate…… 300 mg
Sulphadiazine tablet
Each tablet contains
Sulphadiazine……. 500 mg
do
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Firm submitted renewal application within 60 days of expiry period of
registration time i.e; 11-03-2014 with full fee, therefore Registration Board
decided to grant renewal of above products at serial No. 1-35 till 08-03-2019.
M/s Shaheen Pharmaceuticals Swat.
S.
No
Reg/No
Products/Name
1
068418
Butone Elixir
Each 5ml contains
Phenobarbitone…….20 mg
(shaheen Specification)
Decision:
Initial Date of
Registration
2-12-2010
Application receiving
date
and fee submitted date/
and due date
Due date (1-12-2015)
3-12-2015
Fee
of
Rs/10,000 deposited on
3-12-2015 remaining fee
of Rs 10,000/- deposited
on 15-2-2016
Firm submitted renewal application within 60 days of expiry period of
registration time i.e. 03-12-2015 with full fee, therefore Registration Board
decided to grant renewal of above product till 01-12-2020.
Minutes for 260th Meeting Registration Board
16
Registration-I
Case No.05: Request for change of manufacturer of Kefei ® Injection (Reg.No.059054) by
M/S. RG Pharmaceutical (Pvt.) Ltd, Karachi.
M/s. RG Pharmaceutical (Pvt) Ltd., Karachi had applied for change of
manufacturer/manufacturing site for their following already registered imported human product
from M/s. Guangzhou Lifetech Phrmaceutical Co. Ltd., China to M/s. Reyoung Pharmaceutical
Co., Ltd No. 06 Erlangshan Road, Yiyuan County, Shandong Province, P.R China:S. No.
1.
Reg. No.
059054
Name of Products.
KeFei ® Injection
Each vial contains:Levocarnitine for injection 1.0gm.
The firm have deposited required fee Rs.100,000/- and submitted following supporting
documents:i)
Application on Form 5A.
ii)
Copies of initial registration letters & renewal status.
iii)
Original & legalized CoPP & GMP from China regarding new manufacturing facility.
iv)
Site master plan of the manufacturer.
In 259th meeting The Registration Board observed that following points needs to be
clarified before taking decision:i.
ii.
iii.
iv.
The firm has
Brand name owner.
Sole agency agreement from the new proposed manufacturer.
NOC from previous manufacturer for the proposed change.
Approval status by reference regulatory authorities.
submitted sole agency agreement from the new proposed manufacturer and
NOC from previous manufacturer mentioning that change of manufacturer of Kefei ® Injection
as requested above.
The availability of the drug as lypolized powder could not be confirmed in reference
countries like USA, EMA etc. Moreover, the Board observed that there is need to establish the
product license holder as in the CoPP given by the firm product license holder is mentioned for
generic name and brand name Kefei is not mentioned.
Decision:
Registration Board advised to provide evidence of approval of the drug
(lyophilized form) by regulatory authorities of reference countries and also to
Minutes for 260th Meeting Registration Board
17
Case No.06
clarify the product license holder, who is authorized to make such request
alongwith supporting document.
Application for registration of drug of M/S. ICI, Karachi - remanded back
by Drug Appellate Board in its 144th Sitting.
The Appellate Board in its 144th sitting held on 22-12-2015 has, interalia, decided
to remand back the case filed by M/s. ICI, Karachi regarding rejection of transfer of registration
applications of following products:S. No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
Reg. No.
063792
075666
026563
063787
069607
059134
059153
059129
063798
035082
059165
059161
063559
063549
075663
059113
075671
059144
059130
063800
058800
063790
059124
059143
063556
059109
075656
075667
002821-E
075665
075669
075670
059107
Brand Name
Alba 10 Plus Suspension
Alba 10 suspension
Alba-25 suspension
Albasan Plus 2.5 Suspension
Alpro Suspension
Bendol 2.5 Suspension
Bendol 10 Suspension
Clobendol 2.5 Suspension
Cypercid Liquid
Creezan suspension
Cypermet Liquid
Darsul Liquid
Devotyl Liquid
Enrolac 10 Liquid
Enrocam Liquid
Levanil Drench
Motil Liquid
Noworm Plus Suspension
Oxanil Drench
Oxfenox Plus Suspension
Oxyfen S.C Drench
Oxypro Drench
Paranil Plus Suspension
Paranil Gold Suspension
Pulmopro Liquid
Disulf Liquid
Resporal Liquid
Solvita-S Solution
Sist-Mix Drench
Tryton suspension
Tolzur Plus Liquid
TY-Dox Plus Liquid
Tenex Plus 8.75 Drench
Minutes for 260th Meeting Registration Board
18
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
057131
063791
058780
063563
059141
059110
059103
059155
059150
075662
075677
063555
059154
063548
059181
059131
075668
063796
059115
059166
063799
063788
059159
075673
059146
075659
075660
063797
057126
057130
075658
075672
059119
075657
057129
059160
049532
059157
063553
059117
052371
063564
063551
059135
063550
Toltrox Oral Solution
Triclev 8.75 Drench
Trisole S.C Drench
Vorcid Suspension
Wantox Drench
Wantox Plus Drench
Wantonil Plus Suspension
Zurox Oral Solution
Alincospectin Water Soluble Powder
Almoxin-C Water Soluble Powder
Avicox Water Soluble Powder
Clarinal Powder
Colicid Water Soluble Powder
Colint Water Soluble Powder
Comox Water Soluble Powder
Cyclo-Mix 20 Premix
Coxikil Water Soluble Powder
Diurex Powder
Doxityl WSP
Doxi-Mix 50 Powder
Etholon Powder
Lincamox-S Water Soluble Powder
Linco-Mix II Premix
Macrodox Water Soluble Powder
Neo-Stin Water Soluble Powder
NCO-60 Water Soluble Powder
Rapid-TD Water Soluble Powder
Somcox Powder
Sulfa-Vito Water Soluble Powder
Sulzin Powder
Super Leva Water Soluble Powder
Super Flush Water Soluble Powder
Trifon Powder
Triclofon Powder
Tydox Water Soluble Powder
TY-Mix 10 Premix
Ventilax Water Soluble Powder
Vitavit-Adek Feed Premix
Voladol Premix
ZPS-100 Powder
Almoxin 15% L.A Injection
Amivit Injection
Amcolox L.A Injection
Amoxicure L.A Injection
Amoxilist LA Injection
Minutes for 260th Meeting Registration Board
19
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
002820-E
002819-E
057146
063552
059175
063557
059174
071050
063786
075654
059156
059132
059138
063795
059182
059147
059106
057142
069606
059178
059125
059126
059136
075664
063558
059151
059148
059133
059152
059127
063554
075652
063794
059142
057147
063547
059114
075653
059137
059128
059149
075661
059145
057095
063561
Bi-Sel E Injection
Bi-Strep Injection
Biosign Injection
Cal.D Lyte Injection
Cefpro Injection
Ceftron Injection
Coligent Injection
Control-CRD Injection
Dayfos Injection
Dimox Injection
Diaminac Granules for Injection
Diclonac Plus Inj.
Dimenol Injection
Dipyrene Plus Injection
Dectron Injection
Distilled Water for Injection
Disulf Injection
Dorvet Injection.
Enrolac-10 Injection
Enro-Pro10 Injection
Flunix Injection.
Fostel Injection
Genton Injection 10%
Genton 5% Injection
Gentamix Injection
Gencotyl Injection
Gentrax Injection
HIT-CRD Injection
Ivoron Injection
Ivoron Super Injection
Melonac Injection
Melonac Plus Injection
Megaflux Injection.
Mectin Plus Injection
Metagen Injection
Moxin Injection
Onyx 50 Injection
Oxytron LA Injection
Onyx 100 Injection
Onyx LA Injection
Orasone Injection
Oxytron 100 Injection
OTC Forte LA Injection
Pred Gold Injection
Progent Injection
Minutes for 260th Meeting Registration Board
20
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
178
159
160
161
059162
075676
075674
075675
059120
059158
059176
059180
059123
057135
057137
002822-Ex
059108
063789
059163
059173
059177
063793
075655
059179
059164
057128
063560
044980
059104
069605
059111
059139
059105
063562
044978
059112
059116
059118
002378-EX
059140
044979
059122
Provet 40 Lac Dry Injection
Pyraminol Injection
Solodex Injection
Supernova Infusion
Spectral Injection
Strepciben 5gm powder for Inj.
Strepcin Injection
Top-Vet Injection
Triben Injection
Triface Injection
Tylo 2DHS Powder for Injection
Tri-Vit+ Injection
Tylogent Injection
Tylox-P Injection
Tycolimet Injection
Tylo-Pro 10 Injection
Tylo-Pro 20 Injection
Tryton Injection
Tylox-20 Injection
VAD3 Injection
V-Sel Injection
Variax Injection
Vigorin Injection
Albenda 250 Bolus
Benvet Plus 250 Bolus
Bendol 250 Bolus
Bendol 500 Bolus
Bengral Granules
Benvet 600 Bolus
Clovet Bolus
Dart 350Bolus
Deworm Bolus
Fendamax Plus Bolus
Nitron Bolus
Oxyclozanide Super 750mg Bolus
Paranil Bolus
Zanisol Bolus
Incramilk Granulated Powder
The Brief of the case presented in Registration Board meeting No. 245th held on 29-30th
September, 2014, is as under:M/s. ICI Pakistan Limited, Karachi had applied jointly with M/s. Breeze Pharma (Pvt)
Limited, Islamabad to the Central Licensing Board for acquisition of their license
Minutes for 260th Meeting Registration Board
21
premises situated at 125, 126, 127-A, Industrial Triangle, Kahuta Road, Islamabad, on
the basis of a registered Lease agreement, they have applied for transfer of
registrations of above mentioned 161 products from M/s. Breeze Pharma (Pvt)
Limited, Islamabad to their name and deposited an amount of Rs.3,320,000/-, as the
required fee in the DRAP account.
M/s. ICI Pakistan Limited, Karachi later informed that as the Central Licensing Board
vide its orders communicated under letter dated 4th February, 2014, decided that
instead of transfer of DML No.000659 (Formulation) M/s. ICI Pakistan Limited shall
apply for grant of fresh DML after surrendering of Licence and Inspection Book issued
to M/s. Breeze Pharma (Pvt) Limited, Islamabad, so their application for transfer of
registration has been rendered redundant and stands effectively aborted, as neither of
the parties agrees to such terms and the same would cause a drastic shortage of the
concerned drugs in the market against the spirit and requirements of the law and
relevant rules. They have therefore requested that the amount of Rs.3,320,000/deposited as above be refunded and returned to them to foreclose the issue.
The applications for the grant of registrations are submitted under rule 26 of the Drugs
(Licensing, Registering & Advertising) Rules, 1976. The fee is deposited under subrule 3 of the rule 26. The Rule 26 (6) stats “Any Fee deposited under sub-rule (3) shall
not be refunded”.
Moreover, the applications were submitted for transfer of
registration which can not be approved as the central licensing Board has not acceded
to their request.
Registration Board in its 245th meeting held on 29-30th September, 2014, after detailed
deliberations and keeping in view decision of the Central Licensing Board rejected the
applications of M/s. ICI Pakistan Limited, Karachi for transfer of registrations of 161
products from M/s. Breeze Pharma (Pvt) Limited, Islamabad to their name.
The proceedings, observation and decision of the Appellate Board is as under:The appellant submitted the following arguments, as already stated in their appeal that:
i.
They never applied for transfer of registration. They applied for grant of
registration.
ii.
Against their request for refund of fee, they received letter that the Registration
Board has rejected their applications for transfer of registration of 161 products.
Minutes for 260th Meeting Registration Board
22
iii.
iv.
They were trying to acquire a running business.
Sub-Rule (3) of rule 26 of the Drugs (Licensing, Registration & Advertising)
Rules, 1976, which stipulates that the fee deposited in no case be refunded, stood
omitted by SRO 662(I)/2005 dated 25-06-2005.
v.
Why their application submitted in 2013 were considered while applications for
registration of January, 2011, were pending.
b.
The respondents stated that the firm applied for the transfer registrations to the 161
products, which were registered in the name of Breeze Pharma (Pvt.) Ltd; to their name. Refund
is not allowed under rule 26 (6) of the Drugs (Licensing, Registration and Advertising) Rules,
1976.
c.
The Board observed that:
i.
No explicit decision was made by the Registration Board on the specific of the
Appellant for refund of the fee.
ii.
The Appellant prematurely applied for transfer of grant of registration, as the case
may be, before the final decision on their request by the Central Licensing Board.
iii.
Appeal was applied based on a decision communicated vide letter No.F.3-4/2014Reg-I(M-245) dated 06-11-2014, wherein their request for transfer of registration
of 161 products from M/s. Breeze Pharma (Pvt.) Ltd; Islamabad to their name was
rejected. But the Appellant was contesting their request of refund instead of
rejection of their request for transfer.
Decision of Appellate Board:In light of the above, the Board decided to remand back the case to Registration Board
for precise and specific decision on the request of the Appellant for refund of their fee. The
Registration Board in its 259th meeting deferred the case for having clear rule positions
particularly with reference to issue of refund of registration fee.
The applications for the grant of registrations are submitted under Rule 26 of the Drugs
(Licensing, Registering & Advertising) Rules, 1976. Earlier, the fee was deposited under Subrule 3 of the Rule 26 which specify registration fees to be submitted. The Sub-rule 3, however,
was omitted vide SRO 662(I)/2005 dated 25-06-2005, while the Sub-rule 6 of Rule 26, which
states that “Any Fee deposited under sub-rule (3) shall not be refunded”, is intact.
Decision:
Registration Board observed that sub-rule 3 of Rule 26 of Drugs (Licensing,
Registering & Advertising) Rule 1976 can not be read in isolation. Sub-rule 3
is an integral part of Rule 26 and also referred in sub-rule 3(b). When subrule 3 was omitted, a consequential amendment was to be made in sub-rule 6
where the reference of sub-rule 3 should have been substituted with the
reference to sub-rule 3(b). This consequentianal amendment was not carried
out which is very nominal consequential omission and does not render the
contents of sub-rule(6) in-effective. Therefore, the fee is not to be refunded as
the applications have already been rejected by Registration Board.
Minutes for 260th Meeting Registration Board
23
Case No.07: Show cause notices issued to the firms having registration of products
containing Ciprofloxacin for veterinary use.
The Registration Board in its 249th meeting had decided to issue show cause
notices for cancellation of all the drug formulation having Ciprofloxacin for veterinary use for
the reason of development of resistance in human. Accordingly show cause notices were issued
to the firms having registrations of aforementioned drug formulations. A number of firms have
responded with their point of view including request for personal hearings.
The case was placed before the Registration Board in its 257th meeting and the Board
directed to place comments of all firms / stake holders before the Board in its next meeting.
Accordingly the responses of the firms are being placed before the Board. The salient points, of
the responses received are summarized as under:i)
ii)
iii)
iv)
v)
vi)
vii)
The Board may considered taking legal measures to avert unnecessary use and
ensuring compliance of withdrawal period after treatment.
Opinion of technical expert/veterinary expert committee may be taken before
making any decision in this regard.
Transfer of drug resistance from animal bacteria to human bacteria is not reported
strongly.
Putting ban on over the counter sale of such antibiotic.
Under Section 7 (11) of Drugs Act, 1976, detail of the, information or enquiry
conducted or comprehensive data/record/documents, on the basis of which the
decision was taken, may be communicated for response.
A few firms also agreed to withdraw and requested for grant of registration of
other products.
Most of the firm requested for opportunity for personal hearing.
Registration Board deferred the case in its 258th meeting due to paucity of time. The case
was again taken by in its 259th meeting held on 30th -31st May, 2016 and the Board decided to
call the firm's having registration of such products for personal hearing.
Notices for personal hearing to the firms have been issued.
Decision:
Representatives of M/s. Tarobina Corporation, SB Pharma, Bio Labs,
Vetcon Pharmaceuticals, Attabak Pharmaceuticals, Cheris Pharma, and
Grand Pharma appeared before the Board. The firm representatives were of
the view that there is need together credible scientific data for establishing
the claim of development of resistance in human due to veterinary use of
ciprofloxacin. However, firm’s representatives agreed to proposal of de-
Minutes for 260th Meeting Registration Board
24
registration as the drug is not used in veterinary practices in reference
countries. They further requested that in order to save from financial losses
may be given sufficient time to liquidate the existing stocks and substitute
registration of another product may be given to them on priority. Keepining
in view above discussion, the Board in princiale agreed to de-register all the
products having Ciprofloxacin for veterinary use. However modalities for
implementation to this effect will be further deliberated in forthcoming
meeting.
Case No.08: Request for Registration of Drug(s) under Drug Act, 1976 by M/s. Unicare
Enterprises, Faisalabad.
The Registration Board in its 237th meeting held on 26-02-2013 constituted a subcommittee for evaluation of applications of veterinary product for ensuring completion of codal
formalities. The Board further authorized Chairman, Registration Board for taking decision on
recommendations of the committee.
The sub-committee in its meeting held on 25-04-2013 approved the following products of
M/s. Unicare Enterprises, Faisalabad, manufactured by M/s. Laboratorios Karizoo S.A. Caldes
De Montbui, Barcelona, Spain, subject to inspection of manufacturer abroad, verification of
storage facilities as per policy:S. No.
Name of Drug(s)
1.
Lincosol 40% Oral Powder
Each gm contains:Lincomycin (as lincomycin
hydrochloride)…………400mg
(Antimicrobial).
2.
Kariflox 10% Oral Solution
Each ml contains:Enrofloxacin…100mg/ml solution
(Antimicrobial).
3.
Amoxicilina 500 Karizoo
Each gm contains:Amoxicillin Trihydrate….500mg
(Antimicrobial).
Minutes for 260th Meeting Registration Board
Demanded
Pack sizes
Decontrolled
100gm
500gm
1 Kg
2.5 Kg
5 Kg
10 Kg
Decontrolled
1 Liter
5 Liter
10 Liter
25 Liter
Decontrolled
200gm
400gm
1 Kg
2.5 Kg
5 Kg
10 Kg
Demanded
Shelf life
03 years
03 years
02 years
25
The firm has deposited fee of Rs. 1,00,000/- per product. The storage facility of the
importer has already been verified by the Area FID and as per new Import Policy of Medicine,
the product approved by regulatory authorities of Western European counties including Spain
may be exempted from inspection of manufacturing facilities.
While processing M/s. Unicare Enterprises, Faisalabad request for issuance of registration letter
of above drugs, it was noted that the pack sizes mentioned on CoPP are as under:Lincosol 40% Oral Powder 100gm, 1Kg
Kariflox 10% Oral Solution No pack size mentioned
Amoxicilina 500 Karizoo
200gm, 400gm & 1Kg
While the firm has demanded no of pack sizes which are not included in the CoPP of
exporting country.
The case was considered in 259th meeting of the Registration Board and the Board
decided as under:a. Approved the pack size of the products which are already mentioned in their CoPP.
b. For pack sizes not mentioned in the CoPP, the Board deferred the case for further
deliberation.
With reference to Kariflox 10% Oral Solution the firm has now submitted a copy of
Summary of Products Characteristics (SPC) which it claims to be part of CoPP. As per clause 6
of SPC the packs sizes of 250ml, 1 Liter 5 Liter are mentioned. The firm has requested to grant
them the same packing.
Decision:
Registration Board decided as under:i.
For the product Kariflox 10% Oral Solution, the pack size mentioned
in SMPC i.e. 250ml, 1 liter and 5 liters is approved.
ii.
It was also decided that in future the pack size approved by the
reference regulatory authority, or those approved by the regulatory
authority of exporting country as mentioned in CoPP, SMPC shall be
considered for approval.
Minutes for 260th Meeting Registration Board
26
Case No.09:
Request for Registration of Surgical Sutures by M/S. Zenith
International, Karachi.
Registration Board in its 243rd meeting deferred following products for expert opinion.
1.
M/s. Zenith
International,
Karachi. /
Manufactured by
M/s. Sutures
India (Pvt) Ltd.
Bangalore, India.
“Trugut” Chromic Catgut
(Absorbable Surgical Suture
U.S.P) (With or Without
Needle) (All sizes)
As per PRC
05
years
Rs.15000 +
Rs.85000 =
Rs.100000/-
(Surgical Suture).
The product, however, was not sent for expert opinion as the firm did not provide the EC
certificate. The firm subsequently claimed that EC Authority do not issue CE certificate to any
manufacturer for Chromic Catgut since several years. They further claimed that their principal is
exporting this product to USA. The Board in 254th meeting, while considering the case, advised
that the firm should provide an appropriate certificate from the concerned regulatory authority as
evidence of it’s free sale.
The firm later provided a legalized and attested free sale certificate issued by Indian
authorities. The case was considered in the 259th meeting the Registration Board and the Board
deferred the case for confirmation of importability from India as per Import Policy Order, 2106.
The product is not included in the list of items not importable from India.
Decision:
Registration Board decided to defer the case for ascertaining the approval
status by reference regulatory authorities. Moreover, the sizes also need to be
specified and clarification is required with regards to differentiation of the
sutures with needle and without needle.
Case No.10: Deferred drugs for expert opinion regarding for the use of formulation of
phenylbutazone.
Registration Board in its 257th meeting held on 24-25th March, 2016 deferred following
case for taking expert opinion of veterinary experts regarding use of the formulation in veterinary
practice.
Minutes for 260th Meeting Registration Board
27
S.
1.
Name of
N
Manufacturer
o
M/s
Prix
Pharmaceutica
(Pvt) Ltd. Plot #
5 Pharmacity, 30Km
Multan
Road, Lahore.
Name of Drug (s)
Composition &
Therapeutic Group.
Pri-Phen 20 Injection
Demanded
Price &
Pack Size.
50ml
Each ml injection contains:Phenylbutazone.…….200mg
Shelf
Life
02
years
(NSAID)
The opinion of the experts is as under:Prof. Dr. M. Shoaib Akhtar,
Professor of Pharmacology,
Faculty of Pharmacy,
University of Sargodha.
Prof. Dr. Muhammad Ashraf
(T.I),
Brig (R). Dr.
Muzammil Hasan
Najmi,
Professor of Emeritus,
Associate Dean,
Basic Sciences
Department of Pharmacology
Division, Foundation
and Toxicology,
University Medical
College, Rawalpindi.
University of Veterinary
Animal Sciences, Lahore.
According to the published
literature Phenylbutazone has
been one of the earliest
NSAIDS approved for use in
horses and dogs for the relief of
the relief of inflammatory
conditions associated with the
musculoskeletal system. It is
available in the form of tablet,
paste gel and parenteral
(injectable)
formulations.
However,
there
is
no
Phenylbutazone product for
approved use in food animals in
USA. But it can be used as
extra label drug in dairy cattle
as well in less than 20 months
old animals.
Therefore, keeping in view the
literature attached, I feel like
recommending the use of this
i)
Phenylbutazone is a Awaited.
nonsteroidal
antiinflammatory drug with
same indications as
other NSAIDs.
ii) In veterinary practice it
is quite effective and is
commonly
used
in
horses.
iii) FDA also has approved
its preparations for use
in Horses and Dogs.
iv) The drug is not for use
in cattle/buffalo/sheep/
goat as zero tolerance
policy in meat/milk/eggs
due to chances/ problem
of lethal idiosyncrative
agranulocytosis
by
Phenylbutazone reported
in human.
Minutes for 260th Meeting Registration Board
28
drug formulation (Pri-Phen 20 v) Phenylbutazone
is
Injection) use in veterinary
banned for use in any
practice, especially in equines,
animal intended for
cats and dogs. However, when
human
consumption
used in food producing species,
because it causes serious
the withdrawal time periods
and lethal idiosyncratic
must be taken care due to the
adverse
effects
in
toxicity problems associated
human.
vi) Effect
of
with the drug residues.
Phenylbutazone is bonemarrow toxicity, leading
to agranulocytosis.
vii) Product "Pri-Phen 20
Injection"
may be
approved for use in
equines and dogs only.
The Registration Board deferred the case in its 259th meeting for confirmation of
approval status by reference regulatory authorities.
As per information available on the website Phenylbutazone is not permitted for use in
food producing animals by USFDA and EMA.
Decision:
Registration Board, in view of the expert opinion and status of use of
phenylbutazone in reference regulatories authorities decided as under:i.
Rejected the application of Pri-Phen 20 Injection as drug is not
recommended for use in food producing animals.
ii.
Issue show cause notices to all registered veterinary drug formulation
containing phenylbutazone.
Case No.11: Import of Phenylbutazone by M/S. International Pharma Labs. Lahore for
manufacturing of already registered drugs.
M/s. International Pharma Labs. Lahore has informed that their imported consignment of
Phenylbutazone raw material for manufacturer of their registered drug Phenylbutazone Injection
(Registration No.041231) has been withheld by the Assistant Drugs Controller, Lahore office
with the advise to get clarification from DRAP on whether use of Phenylbutazone in veterinary
product has been discontinued or not. The firm has requested for necessary clarification.
Minutes for 260th Meeting Registration Board
29
As per record of this office no formal instruction has been issued for discontinuation of
Phenylbutazone for veterinary use. However, the product is under review by the Registration
Board alongwith number of other veterinary drugs but, so far, no decision has been taken.
Since 218th meeting held 2009, the Registration Board used to refer the cases of
combinations, containing Phenylbutazone, to the Veterinary Expert Committee. As per available
record of VEC meetings (74th to 76th meeting) no recommendations were finalized.
The Registration Board in its 259th meeting deferred the case till decision of preceding case.
Decision:-
Registration Board decided to defer the case till finalization of under
consideration issue of the registration of phenylbutazone containing
products.
Case No.12: Lack of interest for getting registration of approved oncology products by
M/S. Novartis Pharma, Karachi.
The Registration Board in its 236th meeting held on 20th November, 2012
approved the registration of following imported drugs in the name of M/s. Novartis Pharma
(Pakista) Limited, Karachi Manufactured by firm as mentioned in column II subject to inspection
of manufacturer abroad, verification of storage facilities and price fixation / calculation etc, as
per policy:S. No. Name of applicant & Name of Drug(s)
Manufacturer
1. M/s. Novartis Pharma Oxaliplatin “Ebewe”
(Pakistan) Limited, 150mg Injection
Karachi. /
Each vial contains:M/s. Ebewe Pharma Oxaliplatin…150mg
Ges.m.b.H. Nfg. KG (Anticancer).
MondseestraBe
Unterach, Austria.
Minutes for 260th Meeting Registration Board
Demanded
Price
Rs.30000/ Per
vial
Shelf
Remarks
life
03 Rs.28,500/ Per vial
years
7th DPC (DRAP)
Complete address
of the manufacturer
has been mentioned
on registration letter
as per CoPP.
30
M/s. Novartis Pharma Neoflubin 50mg/2ml
Rs.13262.70/1’ 03
Rs.9280.00/1’s
(Pakistan) Limited, injection
s
years
Karachi./
Each vial contains:14th DPC
M/s. Ebewe Pharma Fludarabine
Complete address
Ges.m.b.H. Nfg KG Phosphate……50mg/2ml
of the manufacturer
Unterach, Austria.
(Anticancer).
has been mentioned
on registration letter
as per CoPP.
3. M/s. Novartis Pharma Ebetrexat 2.5mg Tablets Rs.403.43/Per
03
The firm is not
(Pakistan) Limited, Each tablet contains:30’s
years interested in the
Karachi./
Methotrexate
registration.
M/s. Salutas Pharma Disodium….2.75mg
GmbH, Otto-von(equivalent to 2.5mg
Guericke, Germany. Methotrexate)
(Anticancer Specialty)
License Holder:M/s. Hexal AG,
Holzkirchen,
Germany.
2.
4.
M/s. Novartis Pharma Folcium 50mg/5ml
Rs.1171.98/1’s 02
(Pakistan) Ltd,
Injection
years
Karachi. /
Each 5ml ampoule
M/s. Ebewe Pharma contains: Ges.m.b.H Nfg. KG Folinic Acid as Calcium
MondseestraBe 11
Folinate......50mg.
AT-4866 Unterach
Austria.
(Anticancer) not by FDA
& EMA
-do-
5.
M/s. Novartis Pharma Folcium 100mg/10ml
Rs.2343.96/1’s 02
(Pakistan) Ltd,
Injection
years
Karachi. /
Each 10ml vial contains: M/s. Ebewe Pharma Folinic Acid as Calcium
Ges.m.b.H Nfg. KG Folinate......100mg.
MondseestraBe 11
(Anticancer Adjuvants)
AT-4866 Unterach
Austria.
-do-
Minutes for 260th Meeting Registration Board
31
6.
M/s. Novartis Pharma Folcium 300mg/30ml
Rs.7031.88/1’s 02
(Pakistan) Ltd,
Injection
years
Karachi. /
Each 30ml vial contains: M/s. Ebewe Pharma Folinic Acid as Calcium
Ges.m.b.H Nfg. KG Folinate......300mg.
MondseestraBe 11
(Anticancer)
AT-4866 Unterach
Austria.
-do-
The firm later informed that they are only interested in registration of products at Sr. 1 &
2 above, and are not interested in the rest of the products.
Accordingly the registration letter of above 02 products have been issued, while the firms
intention for not getting registration of rest of the above products is submitted for consideration
of the Registration Board.
Decision:-
As the product are important anti-cancer drugs, so the Board decided to ask
firm the reason / clarification for withdrawing registration of these products.
Case No.13: Request For Change Of Manufacturer Of Clipper Tablet (Reg.No.066104) By
M/S. Chiesi Pharmaceutical (Pvt.) Ltd, Lahore.
M/s. Chiesi Pharmaceuticals (Pvt.) Ltd; Lahore has applied for change of
manufacturer/manufacturing site for their following already registered imported human products,
as per details given below:S.
No.
1.
Reg. No.
Name of Products.
066104
Clipper Tablets
Each tablet contains:Beclomethasone
Dipropionate ………. 5mg
Existing Approved
sites
M/s. Chiesi
Farmaceutici S.p.A,
Italy.
New proposed site
M/s. DOPPLE
FARMACEUTICI
S.R.L. con
stabilimento sito in
VIA MARTIRI
DELLE FOIBE, 129016
CORTEMAGGIORE
(PC) ITALIA.
The firm have deposited required fee of Rs.100, 000/- (Pages 60-61 & 83-84/Corr) and
submitted following supporting documents:i)
ii)
Application on Form 5A.
Copies of initial registration letter and the firm had applied within the validity of
registration on 21-06-2011.
Minutes for 260th Meeting Registration Board
32
iii)
iv)
Fresh original & legalized CoPP from authorities of Italy for proposed
manufacturing site (Pages 100-102/Corr).
Site master plan of the manufacturer.
The firm have deposited required fee of Rs.100, 000/- and submitted following supporting
documents:i)
Application on Form 5A.
ii)
Copies of initial registration letter and the firm had applied within the validity of
registration on 21-06-2011.
iii)
Fresh original & legalized CoPP from authorities of Italy for proposed
manufacturing site.
iv)
Site master plan of the manufacturer.
Decision:
Registration Board deferred for confirmation of approval status in of
formulation by regulatory authorities of reference countries.
Case No.14
Request for change of manufacturer of Seroxat Tablet 20mg (Reg.No.
019501) by M/s. GlaxoSmithKline Pakistan Limited, Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi has applied for change of
manufacturer/manufacturing site for their following already registered imported human products,
as per details given below:S. No. Reg. No.
Name of Products.
1.
Seroxat Tablet 20mg
Each tablet contains:Paroxetine HCl …… 20mg
019501
Minutes for 260th Meeting Registration Board
Existing
Approved
sites
M/s.
S.C.
Europharma
S.A.
Brasov Romania.
New proposed site
Product
License
holder / marketing
authorization
holder:
M/s.
Smithkline
Beecham Limited,
980 Great West
Road,
Brentford,
Middlesex, TW8
9GS,
United
Kingdom.
Manufacturer
/Packagers:
M/s.
Glaxosmithkline
Pharmaceuticals
S.A.
Ulica
Grunwaldzka 189,
Poznan,
PL-60322, Poland.
33
The firm have deposited required fee of Rs.100, 000/- and submitted following
supporting documents:i)
Application on Form 5A.
ii)
Copies of initial registration letters & renewal status. (265-270/Corr).
iii)
Original & legalized CoPP from Medicine and Healthcare Products Regulatory
Agency of UK for proposed manufacturing site (Pages 272-297/Corr).
iv)
Site master plan of the manufacturer.
The firm have deposited required fee of Rs.100, 000/- and submitted following supporting
documents:i)
Application on Form 5A.
ii)
Copies of initial registration letters & renewal status.
iii)
Original & legalized CoPP from Medicine and Healthcare Products Regulatory
Agency of UK for proposed manufacturing site.
iv)
Site master plan of the manufacturer.
Decision:-
Registration Board approved change of manufacturing site and product
license holder of Seroxat Tablet 20mg (Reg.No. 019501) as under:Product License holder:
M/s. Smithkline Beecham Limited, 980 Great West Road, Brentford,
Middlesex, TW8 9GS, United Kingdom.
Manufacturer & Packagers:
M/s. Glaxosmithkline Pharmaceuticals S.A. Ulica Grunwaldzka 189, Poznan,
PL-60-322, Poland.
Case No. 15. Request of M/S. CCL Pharmaceuticals (Pvt.) Ltd., Lahore for change of
manufacturing sites of their registered drug(s).
M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore have requested to approve the change of
manufacturing site of their following registered imported anti-cancer
products form M/s.
Laboratorios IMA S.A.I.C (Palpa 2870, CABA) Argentina to M/s. Glenmark Generics S.A.
Calle 9 Ing Meyer Oks N° 593 (B1629MAX) Parque Industrial Pilar, Buenos Aires, Argentina:S. No.
1.
Reg. No.
044851
2.
044852
3.
052286
Name of drug(s) & Composition.
Toxiplatin 150mg Injection
Each vial contains:Carboplatin ……….150mg
Toxiplatin 450mg Injection
Each vial contains:Carboplatin ……….450mg
Cytotecan Injection 40mg
Each 2ml vial contains:Irinotecan Hydrochloride Trihydrate 40mg
Minutes for 260th Meeting Registration Board
34
M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore have deposited fee Rs.50,000 + 50,000 =
3,00,000/- and submitted following supporting documents:i)
ii)
iii)
iv)
v)
vi)
vii)
viii)
ix)
x)
Copies of initial registration letters.
Copy of change of manufacturer name from M/s. Servycal S.A., Argentina to
M/s. Glenmark Generics S.A., Argentina.
Copies of last renewal.
Original and legalized approval from regulatory authority of Argentina.
Copy of GMP Certificate.
Original & Legalized Certificate of Pharmaceutical Products.
Applications on Form 5-A.
Credentials of the Manufacturer.
Site Master File.
Copy of NOC for CRF.
M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore initially submitted Rs.50, 000/ per
products claiming that these are not available locally. However, later the firm has submitted the
balance fee Rs.50, 000/- per products also.
Decision:
As the proposed change has been approved by the regulatory authority of
exporting countries, so the Board approved change of manufacturing site of
above products from M/s. Laboratorios IMA S.A.I.C (Palpa 2870, CABA)
Argentina to M/s. Glenmark Generics S.A. Calle 9 Ing Meyer Oks N° 593
(B1629MAX) Parque Industrial Pilar, Buenos Aires, Argentina subject to
inspection of manufacturer abroad as per policy on same terms & condition.
Case No.16: Request of M/s. Ghazi Brothers, Karachi for change of name of
manufacturer/manufacturing sites of their registered drug(s).
M/s. Ghazi Brothers, Karachi has applied for change of name of manufacturers for their
following already registered products as under:S.
No.
1.
Reg.
No.
046647
Name
of
Drugs/Composition
Neomix 325 Soluble
Powder
Each gm contains:Neomycin
Sulphate…….715mg
(equivalent
to
Neomycin
base
500mg)
Minutes for 260th Meeting Registration Board
Existing Name
Requested changes
M/s. Pfizer Suzhou
Animal
Health
Products Co. Ltd.,
China.
M/s. Zoetis Suzhou
Manufacturing Co.
Ltd., No.180 Zhu
Yuan Road, Suzhou
New
District,
Jiangsu, China.
35
2.
044992
Excede Injectable
Each ml contains:Ceftiofur crystalline
free acid equivalent
to 200mcg Ceftiofur
in a Miglyol and
cottonseed oil based
suspension
M/s. Pharmacia &
Upjohn
Company,
Subsidiary of Pfizer
Inc. USA.
M/s. Zoetis Inc.
2605 East Kilgore
Road, Kalamazoo,
Michigan,
49007,
USA.
The firm has further requested for change of manufacturing site of their registered
products Draxxin Injection as per following details:S.
No.
1.
Reg.
No.
044919
Name
of
Drugs/Composition
Draxxin Injection
Each ml contains:Tulathromycin….100mg
Monothioglycerol…5mg
Existing Source
Requested/proposed
changes
M/s. Pfizer Global M/s.
Laboratorios
Manufacturing,
Pfizer
Ltda
France.
Guarulhos, Avenida
Presidente Tancredo
de Almeida Neves,
1555 Guarulhos, SP
P.P. Box 017112070 Brazil.
The firm have deposited required fee Rs.100,000 x 3 = Rs.300,000/- and submitted following
supporting documents:i)
ii)
iii)
iv)
v)
vi)
vii)
Application on Form-5A.
Copies of initial registration letters.
Copies to renewal status.
Original & Legalized CoPP's for Neomix 325 Soluble Powder (China), for Excede
Injectable (USA) for Draxxin 100mg injection (Brazil)
Copy of GMP Certificate for Neomix 325 Soluble Powder) for Excede Injectable &
for Draxxin 100mg injection.
NOC for (Draxxin 100mg Injection).
Site master plans of concerned firms (Draxxin 100mg injection).
Decision: Registration Board decided as under:i. For Neomix 325 Soluble (Reg.No.046647), approved change of the name of
manufacturer from M/s. Pfizer Suzhou Animal Health Products Co. Ltd.,
China to M/s. Zoetis Suzhou Manufacturing Co. Ltd., No.180 Zhu Yuan
Road, Suzhou New District, Jiangsu, China on same terms & conditions.
ii. For Excede Injectable (Reg.No. 044992), approved change of the name of
manufacturer from M/s. Pharmacia & Upjohn Company, Subsidiary of
Minutes for 260th Meeting Registration Board
36
Pfizer Inc. USA to M/s. Zoetis Inc. 2605 East Kilgore Road, Kalamazoo,
Michigan, 49007, USA on same terms & conditions.
iii. For Draxxin Injection (Reg.No. 044919), approved the change of
manufacturing site from M/s. Pfizer Global Manufacturing, France to
M/s. Laboratorios Pfizer Ltda Guarulhos, Avenida Presidente Tancredo
de Almeida Neves, 1555 Guarulhos, SP P.P. Box 017112-070 Brazil
subject to inspection of manufacturer abroad on same terms &
conditions.
Minutes for 260th Meeting Registration Board
37
Registration-IV
Case No.17:
Registration of Drugs For Export Purpose.
The following firm has applied for registration of drugs for the purpose of export only:S. #
1
Name of
Manufacturer
M/s. Fassgen
Pharmaceuticals,
Hattar
Name of Drug (s)/Composition.
Valdis Tablets
Each film coated tablet contains:Ledipasvir…………………90mg
Sofosbuvir……………….400mg
The firm submitted all the relevant documents along with the fee of Rs.20,000/- per
product and requested for registration of drugs for export purpose only.
Decision:
Registration Board approved above product for export registration.
However firm will deposit remaining balance Fee of Rs. 30,000/- and
Chairman, Registration Board will permit issuance of registration letter.
Registration is subject to following conditions:
 Manufacturer will export the product after complying all the
requirements as required under Drug Act, 1976 and relevant rules
including No objection certificate from concerned DRAP office.
 Manufacturer will also furnish export documents endorsed from custom
authorities (if required for any query) in order to ensure the export of the
product.
Case No.18: Request of M/s. Welmed Pharmaceuticals Gadoon for extension in contract
manufacturing permission.
Registration Board in 254th meeting deferred following application of M/s. Welmed
Pharmaceuticals Gadoon Swabi for extension of contract manufacturing period (where contract
manufacturer was also changed) for confirmation of already extended contract manufacturing
permissions.
Minutes for 260th Meeting Registration Board
38
S.No
Name of
Applicant
Existing
manufacturer
Reg.No Name of Product
Date of
applicatio
ns/Fee
056233 W-Pime 500mg Injection 30-06-2015
Each vial contains:Dy No.66
Cefipime….500 mg
Rs.50,000/(USP Specification)
Remarks
1.
M/s. Welmed
Pharmaceutical
Gadoon Swabi.
M/s.
Welmark
Hattar
2.
-do-
-do-
056234 W-Pime 1 gm Injection
Each vial contains:Cefipime…………1 gm
(USP Specification)
30-06-2015
Dy No.69
Rs.50,000/-
-do-
3.
-do-
-do-
056238 Mectrum 1gm Injection 30-06-2015
Each vial contains:Dy No.68
Cefoperazone Sodium
Rs.50,000/≡ Cefoperazone.500 mg
Sulbactam …….500mg
(Welmark Specification)
-do-
4.
-do-
-do-
056239 Mectrum 2 gm Injection 30-06-2015
Each vial contains:Dy No.67
Cefoperazone Sodium
Rs.50,000/≡ Cefoperazone.1000 mg
Sulbactam ….1000mg
(Welmark Specification)
-do-
30-06-2015
Firm has
requested
for
change of
contract
manufacturer
to Bio-Lab
(Pvt) Ltd.,
Islamabad
The firm subsequently requested that they would like to exclude the products Medifotax
Injection 500mg & 1gm, contract manufacturing permission for which has already been given
from M/s. Mediate Pharmaceuticals, Karachi and they may be granted extension/change of
manufacturer permission of above products instead. The case was considered in 258th meeting
and deferred on the ground that the firm has not made any specific request for withdrawal /
cancellation of their products Medifotax Injection (500mg & 1gm), so matter needs to be
clarified from the firm. The case is accordingly deferred.
Now the firm stated to cancel the registration of Medfotax Injection (Cefotaxime 500mg,
Minutes for 260th Meeting Registration Board
39
1gm) (Reg.No. 056228, 056229) and issue the extension letter of above mentioned drugs.
The firm has only two Sections and it, therefore, entitles to contract manufacturing of 10
products as per policy of 5 products per section. So far the firm has been granted registration of 8
products.
Decision:
Registration Board did not agree to the firm’s proposal for withdrawal /
cancellation of their already registered two products for making way to get
the approval of fresh one as replacement. The Board further decided to allow
permission for extension of contract manufacturing alongwith change of
manufacturer (from M/s. Wnsfeild Pharmaceuticals Hattar to M/s. Bio-Labs,
Islamabad) for only two of the above mentioned products of firm choice till
30.06.2020. The Chairman Board was authorized to allow issuance of
permission letter after taking firm’s choice for the products.
Case No.19:
Registration of Frodine Syrup.
Registration Board in 243rd meeting held on 9th May, 2014 deferred following drug of
M/s. Wisdom Pharmaceuticals, Peshawar for confirmation of controlled drug section and
international availability of the product
M/s. Wisdom
1 Pharmaceuticals,
Peshawar
Frodine Syrup
Each 5ml contains:Pholcodine……………….….5mg
Chlorpheniramine Maleate…..2mg
Registration Board in 250th meeting considered the comments of review committee and
decided as under:International availability
BRONCALENE ADULTES
chlorphénamine (maléate de) ;
pholcodine
0,01300g/100 ml (0.65mg/5ml);
0,08g/100ml (4mg/5ml)
Oral Syrup
Minutes for 260th Meeting Registration Board
Remarks
Chlorphénamine (maléate de) ;
pholcodine
Adults:
Dose: 0.01300g/100 ml (0.65mg/5ml);
0.08g/100ml (4mg/5ml)
0.0133gm/100ml (0.665mg/5ml);
0.08g/100ml (4mg/5ml) (sugar free
sweetened with saccharine sodium)
Children: 0.01gm/100ml (0.5mg/5ml);
0.05g/100ml (2.5mg/5ml)
(Ref: ANSM France)
40
Decision of 250th Registration Board meeting :
i. Applicants shall shift their formulation as per formulation approved in ANSM France (new
registration application with complete fee) if manufacturing facility is approved by CLB.
ii. For already registered drugs, same procedure as mentioned above (at Sr. No. i) shall be
adopted.Otherwise show cause notices shall be issued for deregistration of drugs in this
formulation.
iii. All such application shall be processed on priority basis.
Now M/s. Wisdom Pharmaceuticals Peshawar has made an application with the revised
formulation alongwith complete fee of Rs.20000/- . The revised formulation is as under:1
M/s. Wisdom
Pharmaceuticals,
Peshawar
Frodine Syrup
Each 5ml contains:Pholcodine……………….….4mg
Chlorpheniramine Maleate…..0.65mg
Decision:
Registration Board decided to approve the change in formulation of Frodine
Syrup in accordance with the revised standard formulation.
Case No.20:
Request of firms for issuance of registration of deferred drugs.
The following registration applications of various firms were deferred by Registration
Board meetings in its 234th meeting for the reason mentioned against each.
1.
M/s. Winbrain
Research
Laboratories,
Hattar
1. Tablet General
2. Caps General,
3. Dry powder
Susp General
Razole 20mg Tablets
Each tablet contains:Omeprazole…….20mg
(Proton Pump Inhibitor)
2.
-do-
Diclo-K 50mg Tablets
Each tablet contains:Diclofenac
Minutes for 260th Meeting Registration Board
10’s
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
2x10’
s
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section (product is
41
Potassium……50mg
(Analgesic)
recommended by the me-too
committee)
3.
-do-
Diclo-K 75mg Tablets
Each tablet contains:Diclofenac
Potassium……75mg
2x10’
s
As Per
SRO
4.
-do-
Pepzole 40mg Tablets
Each tablet contains:Pantoprazole (as
Sodium
Sesquihydrate)…40mg
14’s
As Per
SRO
5.
-do-
10’s
As Per
SRO
6.
-do-
Lodepress 20mg Tablets
Each tablet contains:Paroxetine as
HCl…..20mg
(Antidepressant)
Am-Telma 5/40mg
tablets
Each tablet contains:Amlodipine………5mg
Telmisartan……..40mg
(Antihypertensive)
14’s
As Per
SRO
7.
-do-
Loxit 60mg Capsules
Each capsule contains:Duloxetine as
HCl….60mg
(Antidepressant)
8. -doGabapen 300mg
Capsules
Each capsule contains:Gabapentin……100mg
(Anticonvulsant)
9. M/s.
Weather G-Pentin 300mg Capsule
Folds
Each capsule contains: Pharmaceuticals, Gabapentin …… 300mg
Hattar
(Analgesic)
1. Dry powder
Susp General,
2. Caps, General
10. -doEffexor 75mg Capsule
Each capsule contains:Venlafaxine HCl 75mg
10’s
14’s
As Per
SRO
10’s
As Per
SRO
10’s
-do-
10’s
-do-
Minutes for 260th Meeting Registration Board
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
42
(Psychotherapeutic)
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
11. -do-
Tizadine 6mg Capsule
Each capsule contains:Tizanidine …….. 6mg
(Muscle relaxants)
10’s
-do-
12. -do-
Helcobal 500mcg
Capsule
Each capsule contains:Mecobalamine. 500mcg
(Coenzyme-type vitamin
B12)
10’s
10x1
0’s
-do-`
13. -do-
Floxapen 250mg Capsule 10’s
Each capsule contains:Flucloxacilline .. 250mg
(Pencillin)
-do-
14. -do-
D-Lox 30mg Capsules
Each capsule contains:Duloxetine as
HCl.30mg
(Antidepressant)
D-Lox 60mg Capsules
Each capsule contains:Duloxetine as
HCl.60mg
(Antidepressant)
14’s
As Per
SRO
10’s
14’s
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section. (product is
recommended by the me-too
committee)
Artham DS Capsule
Each capsule contains:Artemether …… 40mg
Lumefantrine ….. 240mg
(Anti-malarial)
Ciprofold 250mg Capsule
Each capsule contains:Ciprofloxacin as HCl.
250mg
(Anti infective
Quinolones)
Tranxam 500mg Capsule
Each capsule contains:Tranexamic acid.. 500mg
8’s
-do-
10’s
-do-
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Not
menti
oned
-do-
15. -do-
16. -do-
17. -do-
18. -do-
Minutes for 260th Meeting Registration Board
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Approved
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
43
19. -do-
Tranxam 250mg Capsule Not
Each capsule contains:- menti
Tranexamic acid.. 250mg oned
(Antifibrinolytic)
-do-
20. -do-
P-Zole 40mg Capsule
Each capsule contains:Pantoprazole…… 40mg
(Antipeptic ulcerants)
14’s
-do-
21. M/s.
Welwrd
Pharmaceuticals,
Hattar
1. Dry Powder
Inj. Sterile
2. Tablet General
3.
Capsule
General
4. Dry Powder
Suspension
General
5. Sachet General
Artiwel 280mg Tablets
Each tablet contains:Artemether……….40mg
Lumefantrine……240mg
(Antimalarial)
8’s
As Per
SRO
22. -do-
Estowel 10mg Tablets
Each tablet contains:Escitalopram (as
oxalate).10mg
(Anti Psychotic)
10’s
14’s
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me
23. -do-
Weldiclof 100mg SR
Tablets
Each film coated tablet
contains:Diclofenac SR
…..100mg
(NSAID)
2x10’
s
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
24. -do-
Lansowel 30mg Capsules 14’s
Each capsule contains:Lansoprazole Pellets
equivalent to
Lansoprazole…30mg
(Proton Pump Inhibitor
As Per
SRO
Approved with fulfillment of
requirements of source, GMP
certificate, stability data and
Fee. Rs.15000/-
25. -do-
W-Pentone Injection
Each vial contains:Thiopentone Sodium
As Per
SRO
Highly
sensitive
product.
Product specific inspection is
recommended by the experts.
Minutes for 260th Meeting Registration Board
Per
vial
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
44
26. -do-
..5.00mg
(Anesthetic agent)
Zimtac 250mg Injection
I.V
Each vial contains:Cefotaxime sodium
equivalent to
Cefotaxime……..250mg
(Cephalosporin)
Per
vial
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
27. -do-
Zimtac 500mg Injection
I.V
Each vial contains:Cefotaxime sodium
equivalent to
Cefotaxime……..500mg
(Cephalosporin)
Per
vial
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
28. -do-
Zimtac 1gm Injection I.V
Each vial contains:Cefotaxime sodium
equivalent to
Cefotaxime……..1gm
(Cephalosporin)
Per
vial
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
29. -do-
Weltraxone 250mg
Injection IV
Each vial contains:Ceftriaxone Sodium
equivalent to
Ceftriaxone ……250mg
(Cephalosporin)
Weltraxone 500mg
Injection IV
Each vial contains:Ceftriaxone Sodium
equivalent to
Ceftriaxone ……500mg
(Cephalosporin)
Per
vial
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Per
vial
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
Weltraxone 1gm
Injection IV
Each vial contains:Ceftriaxone Sodium
equivalent to
Ceftriaxone …1gm
Per
vial
As Per
SRO
Deferred as per policy of 5
products per section for new
license/new section (product is
recommended by the me-too
committee)
30. -do-
31. -do-
Minutes for 260th Meeting Registration Board
45
(Cephalosporin)
In 234th meeting the Board adopted 5 products per section policy and 5 products per section of
each firm were accordingly approved while rest of the applications were deferred. Subsequently
in 236th meeting 5 more products per section per firm were approved among the products
deferred in 234th meeting. The above products are the remaining applications which were left
after the approval of 10 products (in 234 & 236th meeting) as mentioned above paras.
The firms have requested for issuance of registration letters for the products at S.No.1-25
while for the products at S.No.26-31, the applicant M/s. Welwrd has not made any request.
As per record of the section number of registration granted to various sections of the
above firms is as under:Name of Firms
Section
M/s. Winbrain Reserch Labs Capsules
Decision:
Already registered
8 products
M/s. Weather Fold
Capsule
10 products
M/s. Welwrd
Pharmaceuticals,
Tablets
10 products
Liquid Injectable
10 products
Capsule
8 products
Registration Board in principal agreed to allow two products in Capsule
Section of M/s. Welwrd Pharmaceuticals, Hattar from among their above
applications. The choices for the products are to be taken from the firm
before placing the case for consideration of the Board for final decision.
Remaining products will be taken up as per their turn.
The case of applications of M/s. Winbrain Research Laboratories, Hattar
was discussed alongwith following case No.21 and decision is recorded there
in.
Minutes for 260th Meeting Registration Board
46
Case No.21
Request of M/s. Winbrain Research Laboratories, Hattar for issuance of
registration letter.
M/s. Winbrain Research Laboratories, Hattar has requested for issuance of registration
letters of their following product approved in 234th meeting of Registration Board with
conditions mentioned against each .
S.No
Name
of Name of Products
Manufacturer
Pack
size
Demand
ed MRP
Dated
1.
Brainzole 30mg
Capsules
Each capsule contains:Lansoprazole Pellets
equivalent to
Lansoprazole…..30mg
(Proton Pump Inhibitor)
14’s
As Per
SRO
2-62011
2.
M/s. Winbrain
Research
Laboratories,
Hattar
1.
Tablet
General
2.
Caps
General,
3. Dry powder
Susp General
-do-
Esobrain 20mg Capsules
Each capsule contains:Esomeprazole Pellets
equivalent to
Esomeprazole….20mg
(Proton Pump Inhibitor)
14’s
As Per
SRO
-do-
3.
-do-
14’s
As Per
SRO
-do-
4.
-do-
Omebrain 40mg
Capsules
Each capsule contains:Omeprazole Pellets
equivalent to
Omeprazole……..40mg
(Proton Pump Inhibitor)
Loxit 30mg Capsules
Each capsule contains:Duloxetine as
HCl….30mg
(Antidepressant)
Minutes for 260th Meeting Registration Board
14’s
As Per
SRO
-do-
Decision
of
Registration
Board
Approved
with
fulfillment
of
requirements of
source,
GMP
certificate,
stability data and
Fee. Rs.15000/-
Approved
with
fulfillment
of
requirements of
source,
GMP
certificate,
stability data and
Fee. Rs.15000/Approved
with
fulfillment
of
requirements of
source,
GMP
certificate,
stability data and
Fee. Rs.15000/Approved
47
The registration letter was not issued as the firm has not fulfillment the requirements while the
product as S.No.4 was referred for price fixation. The firm has now requested to issue registration
letter by providing the documents referred in the minutes. Moreover the price of product as S.No. 4
has also been fixed.
The firm already has registration of 8 products in the capsule section.
Decision:
Registration Board in principal agreed to allow two products in capsule
section of M/s. Winbrain Research Laboratoire, Hattar from among their
above applications (referred in the instant case and case No.20). The choices
for the products are to be taken from the firm before placing the case for
consideration of the Board for final decision. Remaining products will be
taken up as per their turn.
Minutes for 260th Meeting Registration Board
48
Registration-V
Case No.22:
Export of Non Me-Too Product
a. M/s. Highnoon Laboratories Ltd, Lahore
M/s. Highnoon Laboratories Ltd, Lahore has requested for registration of following
product for export purpose only:S. No
Name of Products
1.
Daploz 5mg Tablets
Each film coated tablet contains:
Dapagliflozin propanediol monohydrate equ to;
Dapagliflozin…………..5mg
2.
Daploz 10mg Tablets
Each film coated tablet contains:
Dapagliflozin propanediol monohydrate equ to;
Dapagliflozin……….…..10mg
3.
Cana 300mg Tablets
Each film coated tablet contains:
Canagliflozin hemihydrates equivalent to;
Canagliflozin…..……….300mg
4.
Cana 100mg Tablets
Each film coated tablet contains:
Canagliflozin hemihydrates equivalent to;
Canagliflozin…..……….100mg
5.
Daclata 60mg tablets
Daclatasvir dihydrochloride equ to:Daclatasvir……………...60mg
6.
Daclata 30mg tablets
Daclatasvir dihydrochloride equ to:Daclatasvir……………..30mg
The firm has submitted the following documents.
a.
Fee of Rs. 50000/- each product for this purpose.
b.
Form-5.
c.
Copy of GMP inspection.
d.
Export orders.
c.
NOC for CRF.
e.
Approval of section by CLB.
Minutes for 260th Meeting Registration Board
49
Decision:
Registration Board approved grant of above registrations exclusively for
export purpose. Registration is subject to following conditions:
 Manufacturer will export the product after complying all the
requirements as required under Drug Act, 1976 and relevant rules
including No objection certificate from concerned DRAP office.
 Manufacturer will also furnish export documents endorsed from custom
authorities (if required for any query) in order to ensure the export of the
product
b. M/s. CCL Pharmaceuticals (Pvt) Ltd , Lahore
M/s. CCL Pharmaceuticals (Pvt) Ltd , Lahore has requested for registration of following
product for export purpose only:S. No
Name of Products
1.
Carci Suspension 500mg/5ml
Each 5ml contains:
Carbocisteine…………..500mg
Carci Suspension 200mg/5ml
Each 5ml contains:
Carbocisteine…………..200mg
Carci Capsule 500mg
Each Capsule contains:
Carbocisteine…………..500mg
2.
3.
The firm has submitted the following documents.
a.
Fee of Rs. 50000/- each product for this purpose.
b.
Form-5.
c.
Copy of GMP inspection.
d.
Export orders.
c.
NOC for CRF.
e.
Approval of section by CLB.
Decision:
Registration Board approved grant of above registrations exclusively for
export purpose. Registration is subject to following conditions:
 Manufacturer will export the product after complying all the
requirements as required under Drug Act, 1976 and relevant rules
including No objection certificate from concerned DRAP office.
 Manufacturer will also furnish export documents endorsed from custom
authorities (if required for any query) in order to ensure the export of the
product
Minutes for 260th Meeting Registration Board
50
Case No.23
Registration applications of M/S Gallop Water Sciences, Lahore deferred in
253rd meeting of Registration Board.
Following applications of M/s Gallop Water Sciences, Lahore were deferred in 253rd
meeting of registration board
1.
2.
3.
G-SOL PAEDS
IV Infusion
Each 100ml contains:
Dextrose
anhydrous….4.3g
Sodium
Chloride……..0.18g
Caloric & Electrolytic
solution
G-Lyte M
IV Infusion
Each 100ml contains:
Sodium
Chloride……..0.216gm
Potassium
Chloride…..1.5gm
Calcium Chloride 2 H2O
…..…0.022
Sodium Acetate 3 H2O
…0.313gm
Dextrose………..5.0gm
Electrolytic & Caloric
solution
Mannitol
IV Infusion
Each 100ml contains:
Mannitol…….17.5gm
Sorbitol…….2.5gm
Osmotic diuetic
Form-5
• Int availability
Dy. No: 3472
not confirmed.
dated
18-05-  Me-too: Macsol
Paeds of M/s Mac
2015
& Rains Lahore.
20,000/Rs.50/- Rs.40/500ml, 200ml
Deferred
for
confirmation of
approval
by
reference
regulatory
authority.
Form-5
Dy. No: 3473
dated
18-052015
20,000/Rs.100/Rs.70/1000ml, 500ml,
 Internationally,
not available in
this strength.
 Me-too:
Plabolyte-M of
M/s
Otsuka,
Karachi
Deferred
for
confirmation of
approval
by
reference
regulatory
authority.
Form-5
Dy. No: 3458
dated
18-052015
20,000/Rs.200/- 500ml
 Internationally
Not available in
this strength
 Me-too: Mactol
of M/s Mac &
Rains, Lahore
Deferred
for
confirmation of
approval
by
reference
regulatory
authority.
Subsequently the firm requested for replacement of above applications with the following
new ones which were presented in 255th meeting of the board. Case was decided as follows:
Minutes for 260th Meeting Registration Board
51
566 G-SOL 10%
Form 5
Each 100 ml contains
Dextrose anhydrous 10gm
Rs. 20,000/vide Dy. No.
1140 dated 0611-2015
Pack size of
1000ml / 70
PKR
Caloric solution
(Manufacture
Specification)
FDA
approved
Dextrose
10%
The Board deferred the
application
for
clarification whether the
firm wants to withdraw
their previously deferred
application in view of the
newly
submitted
applications or otherwise.
Medisol
10%
(Medipak)
567 G-SOL 5%
Form 5
Each 100 ml contains
Dextrose anhydrous 5gm
Rs. 20,000/vide Dy. No.
1140 dated 0611-2015
Pack size of
500ml / 55
PKR
Caloric solution
(Manufacture
Specification)
Otsuka
Japan
formulation
(Pladix)
FDA
approved
Dextrose
5%
The Board deferred the
application
for
clarification whether the
firm wants to withdraw
their previously deferred
application in view of the
newly
submitted
applications or otherwise.
Medisol 5%
(Medipak)
568 G-Sol RL 500 ml
Form 5
Each 100 ml contains
Rs. 20,000/vide Dy. No.
Sodium Chloride 0.60gm
1141 dated 06Potassium
Chloride 11-2015
0.04gm
Calcium
0.027gm
Otsuka
Japan
formulation
(Pladix)
Chloride Pack size of
500ml / 56
Minutes for 260th Meeting Registration Board
MHRA
approved
Medisol
Hartmann
IV infusion
The Board deferred the
application
for
clarification whether the
firm wants to withdraw
their previously deferred
application in view of the
newly
submitted
applications or otherwise.
52
Sodium lactate 0.32 gm
PKR
(Medisol )
Electrolyte Solution
(Manufacture
Specification)
The firm has requested that the registration of the products deferred in 253 rd meeting may
be considered in routine as per DRAP Policy and two products may be processed on priority
basis against the quota of ten products per section. This request of the firm was considered in
257th meeting of registration board and following decision was taken:Decision: Registration Board acceded to the request of the firm and approved products at
serial no. 559 and 560 whereas product at serial no 558 was deferred for clarification
whether the firm wants to withdraw their previously deferred application in view of the
newly submitted applications or otherwise.
It is submitted that a typographic error was made in the minutes of 257th registration
board meeting and products at Sr no. 559 and 560 was mentioned inadvertently instead of
product at Sr. No 567 & 568. The firm has been issued registration letter with correction in
minutes.
Decision: Registration Board noted the information and endorsed the action taken.
Case No.24: Pending registration of Vinqo 500mg & 1gm Injection of M/s Wilshire
Laboratories (Pvt) Ltd, Lahore.
Registration Board in 258th meeting discussed the following case of M/s. Wilshire
Laboratories (Pvt) Ltd, Lahore. Following products of M/s Wilshire Laboratories (Pvt) Ltd,
Lahore were discussed in 236th meeting of Drug Registration Board but deferred for further
clarification about manufacturing facility. Then the case was included in 243rd meeting of the
board again deferred for further clarification about the manufacturing facility.
Minutes for 260th Meeting Registration Board
53
S.No
Product Name
Generic Name
1
Vinqo 500mg inj
2
Vinqo 1gm inj
Vancomycin
Hydrochloride 500mg
Vancomycin
Hydrochloride 1gm
Date
Submission
04.06.2011
04.06.2011
of Remarks
Applied as a new
section product
Applied as a new
section product
Registration Board its 243rd meeting discussed the case and for further deliberation on
manufacturing area requirements.. Registration Board in its 248th meeting decided the
manufacturing Area requirement for Vancomycin:
“As it is not a Penicillin Derivative, hence manufacturers, having in-house lyophilization
facilities, may be allowed to produce it in General Injectable Area”
Decision:
Registration Board deferred the case for getting details of manufacturing
process of the applicant and to decide the case in the light of decision taken by the board
in 248th meeting.
The above decision needs to be reconsidered as Registration Board in 257th meeting has
granted the same registration to M/s. Fynk Pharma, Lahore and referred decision of 248 th
meeting of the board is not the same as depicted in 258th meeting of the board. Rather, board in
2418th meeting had deferred the product for further deliberations.
Decision: Regsitration Board approved the above drugs in favour of M/s Wishire
Laboratories (Pvt) Ltd, Lahore.
Case No.25: Change of brand name for Epinol CF tablet of M/s. CCL Pharmaceuticals
(Pvt) Ltd; Lahore
M/s. CCL Pharmaceuticals (Pvt) Ltd: Lahore has requested for change of brand name of
their following product and they have informed that the proposed brand name already in syrup
form:S. No.
Names of Drug(s) with
formulation
Reg. No.
New proposed names
1.
Epinol CF Tablet
Each tablet contains:
Paracetamol……………500mg
Pseudoephedrine HCl….60mg
023982
Pulmonol CF Tablet
Minutes for 260th Meeting Registration Board
54
Chlorpheniramine
Maleate……….4mg
The management of the firm has submitted following documents:
i.
Fee of Rs. 20,000/- for each product.
ii.
Undertaking on stamp paper.
iii.
Copies of initial letter of registration & renewal status.
iv.
CRF clearance certificate.
It is submitted that the composition of Epinal tablets as mentioned above is different form
pulmonol syrup. Composition of pulmoul is as under.
Decision:
S.No. Reg. No
Name of Product with composition
1
Pulmonol Syrup
Each 5ml Contains:Chlorpheniramine maleate B.P……5mg
Terpin Hydrate USP……………….10mg
Potassium Bicarbonate B.P………...0.1mg
Ammonium Chloride B.P…………..25mg
Menthol B.P………………………...1mg
Aminophylline Ph.Eur………………32mg
Potassium guaiacol sulfonate U.S.P…...5mg
Potassium citrate B.P………………..0.1mg
Tr. Senega B.P……………………….0.05ml
Tr. Ipecac B.P………………………...0.025ml
Extract Glycyrrhiza b.P………………..0.1ml
Flavor & Base……………..q.s
000874
Registration Board considered the request of the firm in the light of SOPs /
guidelines for change of brand name of the drugs and did not accede to the
request as composition of formulation of the drug (Epinol CF Tablet) was
different from the composition of Pumonol Syrup.
Case No.26: Registration of M/S N.B.S Pharma, Lahore
Following products of M/s N.B.S Pharma, Lahore were considering 215th meeting of
registration board and decided as follows.
Sr.No
1.
Name of Drug
Povidone-1 Solution
Each 100ml contains:Povidone Iodine USP 7.5gm equivalent to
0.75% available iodine (USP)
Minutes for 260th Meeting Registration Board
Decision
Approved subject to the submission of
the last Inspection report.
55
It is submitted that the above cases were discussed in 215th meeting of registration board
and decision of the board has been reflected in the above table. The firm has now submitted the
differential free of Rs. 12000 and submitted the inspection report dated 12.11.2014. which
shows details of the section as under:External Preparation Section:This section comprised of preparation and filling rooms, equipped with preparation
vessels of different sizes. Silver san mixer and filling machines was installed HVAC
system was provided in this area and was functional at the time of inspection. Re-packing
area was equipped with filling machine and different size vessels. HVAC system was
installed production area furnish with epoxy.
Decision:
Registration Board deferred the case for GMP status of the firm and
confirmation of section either from Licensing division or from panel /
renewal inspection report.
Case No.27: Registration of M/s Chishti Pharma ; Sahiwal
M/s Chishti Pharmaceuticals Industries, Sahiwal has requested to issue following
registration approved in 206th meeting.
Sr.No
1.
Name of Drug
Imperial Crepe Bandage.
Contains:Crepe Bandage BPC.
Decision
Approved.
The firm has submitted following documents :i.
ii.
iii.
Decision:
Copy inspection report (GMP)
Copy of Bank challan of Rs. 8000/Differential fee of Rs. 12000/-as balance fee.
Registration Board deferred the case for submission of new Form-5 and
verification of record regarding issuance of registeration letter, as product
was considered by Registration Board in 2007.
Minutes for 260th Meeting Registration Board
56
Case No.28: Registration Of M/S Schazoo Pharma, Lahore.
M/s the Schazoo Pharmaceuticals Laboratories (Pvt) Ltd, Sheikhupura had requested for
permission to export drugs containing precursor Chemical Ephedrine to M/s. Rahullah Nasrat
Limited, Afghanistan as detail below:S.No
Name and composition
1.
Rhinosone-P Nasal Spray
040892
Each 100ml Contains:Naphazoline
Nitrate…..125mg
Ephedrine HCl…..500mg
Prednisolone
Acetate….2.5mg
Rhinosone-P Nasal Spray
000834
Each 100ml Contains:Naphazoline
Nitrate…..125mg
Ephedrine HCl…..500mg
9
alphaFluoro
Prenisolone
21Acetate….2.5mg
2.
Reg. No
Pack Size
15ml
15ml
Quantity
Quantity
requested to Ephedrine
export
50000 Bottles 3.75-kg
100000
Bottles
7.5-kg
The firm was asked for the clarification of the both compounds of Prednisolone . They
have replied with official reference i.e. The USP monograph of 9 Alpha-Floropredinsolone
Acetate shows it is an veterinary drugs but the ear drops applied by the firm are for human
consumption.Moreover, the subject formulation is not available in reference regulatory
authorities as specified by the board in 249th meeting.
Decision:
Registration Board deferred the case for further deliberation and
presentation by the firm before Registration Board.
Minutes for 260th Meeting Registration Board
57
of
Case No. 29: Registration of M/S Dyson, Lahore
M/s. Dyson Pharma, Lahore has requested to issue following registration considered in
236th meeting.
Sr.No
1
Name of Drug
Dyprog Tablets 5mg
Each tablet contains:Norethisterone….5mg
B.P Specs
Decision
Approved subject to submission of
comparative dissolution profile and
related documents. The firm shall be
granted non-anabolic steroids in this
section.
-do-
2
Dyston Tablets 10mg
Each film coated tablet contains:Dydrogesterone….10mg
USP Specs
3
Dyestro Tablets 0.625mg
Each film coated tablet contains:Conjugated Estrogens …..0.625mg
USP Specs
-do-
4.
Dyestadiol Tablets
Each film coated tablet contains:Cyproterone acetate….2mg
Ethinylestradiol….35mcg
-do-
The firm has submitted following documents:i.
ii.
iii.
Decision:
Differential Fee of Rs. 12000/per product
Comparative dissolution profile
Undertaking as per decision of Registration Board in 251st meeting.
Registration Board deferred the case for further deliberation in next
meeting.
Minutes for 260th Meeting Registration Board
58
Case No.30: Registration application of M/s. English Pharmaceutical, Lahore deferred in
241st meeting.
Registration Board in 241st meeting discussed the case of M/s English Pharma, Lahore
and decided as follows:M/s. English Pharmaceuticals Industries, Lahore were deferred in its 237th meeting for
verification of complete formulation with originator (Detrusitol Capsule SR 4 mg by Pfizer) and
Comparative Dissolution profile with originator.
Name of products & Composition
Terol 4mg SR Capsules
Each capsule contains:Tolterodine HCl equiv. to
Tolterodine SR…4mg
Pack
size
Demanded
price
3×10’s
Rs.2300/-
The firm has provided following documents:1. Comparative dissolution profile.
2. Sample of Detrusitol Capsule SR 4 mg by Pfizer confirming that product is I pellet
form
3. GMP certificate of manufacturer.
4. Stability studies.
5. Certificate of analysis.
Decision (241 meeting): - Registration Board deferred the submitted data to following experts for
evaluation and authorized its Chairman for decision on recommendation of experts:
I.
II.
III.
Prof.Dr.mehmood Ahmad, Islamia university, Bahawalpur
Prof.Dr.Zafar Iqbal, University of Peshawar.
Director DTL, Lahore.
In view of above, experts have furnished comments as under:S.NO
1.
Name of the drugs with
composition
Mr. Jamil Anwar Director,
Drugs Testing Laboratory,
Lahore
Minutes for 260th Meeting Registration Board
Comments of the experts
As per information/ data provided by M/s.
English Pharmaceutical industries Lahore for
registration of the product Terol (Tolterodine
HCl to Tolterodine 4mg) SR Capsule, the
59
3.
standard Analytical Procedures for the finished
product has been studies. The stability data foe
accelerated stability program (6 Months) and
long term stability program (12 months) has
been performed for 1,3 and after 7 hours
dissolution profile. The study has been carried
out by M/s. Heterol, India.
The comparative study with the brand leader
i.e. M/s Pgizer’s product- Detrusitol 4mg SR
capsules, Bach No A..1566F, carried out by
M/s. English Pharmaceutical Industries, Lahore
with the comparable results at 01,1 and after 7
hours.
The Good Manufacturing Practices (GMP),
dated 22.08.2012 for M/s. Heterol, India is
attached with information/ data provided by
M/s. English Pharmaceuticals industries,
Lahore.
In the light of above and as per data/
information provided, the registration of
“Terol 4mg SR Capsule” is recommended
subject to the provision of Good
Manufacturing Practices of M/s English
Pharmaceutical, Lahore, and the firm may be
directed to submit the dissolution profile of
Terol 4mg SR Capsules before marketing.
Dr. Mehmood Ahmad, Granules with white to off white colour were
Islamia
University seen in enclosed gelatin shells upon physical
Bahwalpur.
examination.
Dissolution
studies
were
conducted in USP type-1 basket with rotation
speed of 100 ± 4rpm at 37± 2°C. Standard
solution was made in mobile phase comprising
of buffer solution and acetonitrile. Stability
studies i.e real time at 30°± 75% RH for 2
years and accelerated at 40°C ± 75% RH for 06
month were conducted. During stability testing
various parameters were evaluated like
physical description, identification via HPLC
chromatogram, dissolution testing and assay.
Product passed all aforementioned parameters
and remained stable during the stability period.
Therefore, based on the presented results it is
recommended that the capsule Terol 4mg can
be registered.
Dr Zafar Iqbal
Reply Awaited
Minutes for 260th Meeting Registration Board
60
Decision:
Registration Board deliberated the reports and deferred the case for opinion
of Prof.Dr.Mehmood Ahmad regarding use of basket system for performing
dissolution studies instead of paddle system and to issue reminder to Dr.
Zafar Iqbal for furnishing expert opinion.
Case No.31: M/s Feroza International Lahore- Extension of contract manufacturing.
M/s Feroza International Lahore has informed that their below mentioned products were
approved in 212th meeting of registration board but letter was not issued. The firm has requested
to grant extension.
Sr Name of Drug
No.
1
Leetab Infusion 500mg
Each vial contains:Levofloxacin…………………….500gm
2
Haemofer 200mg Injection
Each 5ml Contains:Iron as iron sucrose……………..200mg
3
Neuramin 500mcg injection
Each ml contains:Mecobalamine…………..500mcg
Following documents have been submitted.
 Fee of Rs: 50,000 per product.
 Form -5 with contract agreement with M/s English Pharma, Lahore.
 Copy of contract agreement between two parties.
 GMP certificate of M/s English Pharma, Lahore.
It is submitted that the above products of the firm were approved in 212 meeting and extension
was granted till 30.6.2010. However, the form did not apply for extension for the further period.
Now the firm has requested to grant approval for extension under new toll policy for the period
of five years.
Decision:
Registration Board deferred for confirmation of composition of applied
products at S.No.02 and confirmatuion from record regarding non-issuance
of
registration
letters
as
claimed
by
the
firm.
Minutes for 260th Meeting Registration Board
61
Pharmaceutical Evaluation Cell
Out of Queue Applications for New Molecule, Anticancer, HIV Aids and other life saving drugs.
Registration Board in 257th meeting decided to consider registration applications of
various classes of drugs on priority. Decision is as follows:
“Registration Board deliberated that drugs for treatment of chronic ailments and drugs which
are in short availability should have priority review process and consideration by the Board to
ensure their free availability. The Board decided that drugs for treatment of cancer, viral
diseases, thalaesemia, immunosuppresants, vaccine and sera, new molecules / formulations,
blood factors and bags will be given priority consideration.”
Registration Board considered (out of queue) following registration applications as
evaluated by Pharmaceutiacl Evaluation Cell. However the Board advised to inform DRAP’s
Policy Board regarding above mentioned decision.
List of human imported drugs Anticancer, Immunosuppressant, New molecules and Blood
bags applications with complete fee.
Muhammad Ansar Evaluator-I (PEC)
S/N Name
and
address
of
manufacturer /
Applicant
1.
Brand Name
(Proprietary name +
Dosage
Form
+
Strength)
Composition
Pharmacological
Group
Finished
product
Specification
M/s. AJ Mirza Emeset
Type
of
Form
Initial
date, diary
Fee
including
differential
fee
Demanded
Price
/
Pack size
4mg/2ml Form -5-A
Minutes for 260th Meeting Registration Board
Remarks on
the
formulation
(if
any)
including
International
status
in
stringent
drug
regulatory
agencies
/
authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
MHRA.Ondan
Remark
s of the
Evaluat
or.
COPP
Decision
Approved
62
Pharma
(Pvt) Injection
Ltd., Karachi. /
Each ml contains:Ondansetron
Manufactured
Hydrochloride
USP
By
M/s Cipla Ltd Equivalent
to
D.P
Pally Ondansetron…2mg
(Narsapur
Water for Injection
Road).
Near BP……..q.s.
Gandimaisamma
X
Road, Anti
emetic
for
Hydarabad India chemotherapy induced
emesis.
Manufacturer’s
Specifications
2.
36 months
M/s. AJ Mirza Emeset 4mg Tablets
Pharma
(Pvt)
Ltd., Karachi.
Each film coated tablets
contains:Manufactured
Ondansetron
by
M/s. Cipla Ltd., Hydrochloride
USP
L-147 to L0147- Equivalent
to
1,
Verna Ondansetron……4mg
Industrial Estate,
Verna
Goa, Anti
emetic
for
India.
chemotherapy induced
emesis.
setron 2mg/ml valid
as
per
Diary No. by
M/s upto 13- Import
136/ R&I
Hameln
12-2013. Policy for
Dated 15GMP
Finished
06-2011
complian Drugs.
Rs.15000
Local. Zofran t as per Firm will
& 350000 by M/s GSK.
COPP.
provide
dated 15GMP
valid
10-2012 dy
valid
legalized
No.951.
upto 30- CoPP and
As
per
12-2016. Chairman
PRC.
Registratio
n Board
will permit
further
processing
of case.
Form 5A
Dy.No 79
15-06-2011
Rs.15000/
15-10-2012
Rs.35000/-
MHRA.Ondan
setron
4mg
tablet by M/s
Accord
COPP
issued on
12-062008 by
India.
Local. Zofran GMP
4mg by M/s complian
As per PRC GSK.
t as per
COPP.
GMP 2906-2017.
Deferred
for
the
submissio
n of valid
legalized
COPP, as
it
was
expired at
time
of
submissio
n
of
registratio
n
applicatio
n.
Form 5A
Dy.
No.
261 Dated
27-07-2011
Rs. 15000/09-12-2014
Rs. 85000/dy No. 225.
MHRA.
Capecitabine
500mg f/c by
M/s Accord.
Approved
as
per
Import
Policy for
Finished
Drugs
Manufacturer’s
Specifications
3.
36 months
M/s.
Merixil Capecitabine
Pharma
Labosuan/Mericap
Office No 28, 500mg Tablet
2nd Floor, Rose
Plaza
I-8 Each film coated tablet
Markaz,
contains:Islamabad.
Capecitabine….500mg
Manufactured
By
adjuant treatment of
M/s.
patients
following
Minutes for 260th Meeting Registration Board
COPP
issued by
Spain
dated 1201-2016.
Local. Xeloda Brand
500mg by M/s Name for
Roche.
Pakisatn
Mericap
Tablet.
63
4.
5.
Laboratorios
Normon, S.A.
Ronda
De
Valdecarrizo, 6,
Tres
Cantos,
28760, Madrid,
Spain.
surgery of stage III As per PRC
colon cancer, metastatic
colo-rectal
cancer
M/s.
Merixil
Pharma
Office No 28,
2nd Floor, Rose
Plaza
I-8
Markaz,
Islamabad.
Product
License Holder
M/s Fair-Med
Healthcare
GmbH
Planckstrasse
13,
22765
Hamburg,
Germany.
Manufactured
by
M/s.
Eirgen
Pharma
Ltd.
64/65 Westside
Business Park
Old Kilmeaden
Road,
Waterford,
Ireland.
Temoeirgen
Capsules
USP Specifications
100mg Form 5A
MHRA.
Temodal 5mg,
Dy.
No. 20mg, 100mg,
Each capsule contains:- 721 dated 140mg, 180mg
Temozolomide…100mg 18-08-2011 & 250mg by
Rs. 15000/- M/s Merck
For newly diagnosed 08-12-2014
Rs 85,000/- Local.
Glioblastoma
dy No. 226. Temoside
multiforme
20mg, 100mg
concomitantly
with
As
per & 250mg by
radiotherapy.
SRO
M/s AJ. Mirza.
Manufacturer’s
Specifications
24 Months
M/s. Oncogene Anaskebir 1mg Coated
Pharmaceuticals Tablet
, Karachi
Each film coated tablet
Product License contains:Holder
Anastrozole……1mg
M/s.
Laboratorios
Manufacturer’s
Aspen
S.A. Specifications
Remedios
Minutes for 260th Meeting Registration Board
Form 5A
MHRA.
Anastrozole
Dy
No. 1mg f/c by
1198 dated M/s consilent.
28-11-2012
Rs.100,000 Local.
/Anastrozole
1mg by M/s
Rs.3300/Pa Pfizer
ck
GMP
complian
t as per
COPP.
GMP
issued
13-062014.
COPP
issued on
04-022015 by
HPRA
Ireland.
GMP
complian
t as per
COPP.
GMP
issued
dated 2802-2014
by Irish
Medicine
Board.
COPP
issued on
29-082012 and
valid
upto 2808-2013.
GMP
complian
t as per
64
Approved
as
per
Import
Policy for
Finished
Drugs
Deferred
for
the
submissio
n
of
following:
a. valid
legalized
COPP, as
already it
was valid
3439/43,
C1407HJC,
Buenos Aires,
Argentina.
Manufactured
by
M/s
Laboratorios
Eczane Pharma
S.A. Laprida 43
Localidad
Avellaneda.
Prov. Bs. As
Craveri S.A.I.CArengreen 830,
CABA Blipack
S.A-Av. Juan B.
Justo
7669,
Caba.
6.
(Treatment
of
harmone
recpotor
positive
advanced
breast cancer in post
menopausal women)
M/s. Oncogene Kebirzol 2.5mg Coated
Pharmaceuticals Tablets
, Karachi
Each tablet contains:Product License Letrozole……2.5mg
Holder
M/s.
(Adjuant treatment of
Laboratorios
post-menopausal
Aspen
S.A. women with harmone
Remedios
recpotor
positive
3439/43,
invasive early breast
C1407HJC,
cancer).
Buenos Aires,
Argentina.
USP Specifications
Manufactured
by
M/s
Laboratorios
Eczane Pharma
S.A. Laprida 43
Localidad
Avellaneda.
Prov. Bs. As
Craveri S.A.I.CMinutes for 260th Meeting Registration Board
CoPP.
Stability
data as
per
condition
s of Zone
IV-A not
attached.
DSL is
not
attached.
Clarificat
ion
regardin
g
the
place of
manufact
ure.
Form 5A
MHRA. Femra
2.5mg
f/c
Dy
No. tablet by M/s
1197 dated Novartis.
28-11-2012
Rs.100,000 Local. Femra
/2.5mg by M/s
Novartis.
Rs.5000/pa
ck
The
product
is
not
actually
in
the
market
of
country
of origin
as
mentione
d
in
COPP.
DSL is
not
attached.
GMP
certificat
e is not
attached.
Complet
e
descripti
on of the
65
upto 2808-2013.
b. Stability
data as per
conditions
of
Zone
IV-A.
Druds
c.
Sales
License.
d.
Clarificati
on
regarding
the
manufactu
ring site as
it
is
different
in
Form5A
and CoPP.
Deferred
for
the
submissio
n
/
clarificatio
n
of
following
a.
The
product is
not
actually in
the market
of country
of origin
as
mentioned
in COPP.
b.
Drug
Sales
License.
c.
Complete
descriptio
n of the
Arengreen 830,
CABA Blipack
S.A-Av. Juan B.
Justo N 7.669,
CABA.
7.
M/s. Amgomed,
Office # 5, 1st
Floor Rose 1,
Plaza
I-8
Markaz,
Islamabad.
Farmatide 50mg Tablets Form 5A
Manufactured
by
M/s.
West
Pharma,
Producoes
de
Especialiaes
Farmaceuticas,
SA Rua Joao de
Deus, n. 11,
Amadora, 2700-
Adjuant
to
radial
prostectomy or radiotherapy in patients with
locally
advanced
prostate cancer
Each
film coated
tablets contains:Bicalutamide
………….50mg
USP Specifications
MHRA.
Bicalutamide
Dy No.510 50mg f/c by
dated
M/s
Sun
09-06-2014 pharma.
Rs.100,000
/Local.
Calutide 50mg
As
per by M/s AJ.
SRO
Mirza.
tablet is
not
provided
as film
coated.
Clarificat
ion
is
required
for
manufact
urer and
market
authoriza
tion
holder.
Stability
data as
per
condition
s of Zone
IV-A not
attached.
Clarificat
ion
regardin
g
the
place of
manufact
ure.
Photocop
y
of
legalized
COPP
issued
dated 3001-2014
(Photoco
py)
GMP
complian
t as per
COPP.
(Photoco
py)
03 years
Minutes for 260th Meeting Registration Board
66
tablet.
d.
Clarificati
on
is
required
for
manufactu
rer
and
market
authorizati
on holder.
e. Stability
data as per
conditions
of
Zone
IV-A.
f.
Clarificati
on
regarding
the
manufactu
ring site as
it
is
different
in
Form5A
and CoPP
Deferred
for
the
submissio
n of valid
legalized
COPP.
486, Portugal.
8.
9.
M/s. Lundbeck
Pakistan (Pvt)
Ltd., 40 T/4,
Blessing Street,
Block
6,
P.E.C.H.S,
Karacki. Market
Authorization
Holder.
M/s.
H.
Lundbeck A/S,
Ottiliavej
9,
2500
Valby,
Denmark.
Manufacturer
also responsible
for batch release
QC, Primary &
Secondary
Packaging.
M/s.
H.
Lundbeck A/S,
Ottiliavej
9,
2500
Valby,
Denmark.
Site Responsible
for
Quality
Control
M/s
Eurofins
Pharma
A/S,
Ornebjergvej 1,
2600 Glostrup,
Denmark.
Site for Primary
&
Secondary
Packaging.
M/s Elaiapharm,
2881, route des
Cretes, Z.I. Les
Bouillides,
Sophia
Antipolis,
06560, France.
M/s. Lundbeck
Brintellix 10mg Tablets
Form 5-A
Each film coated tablet
contains:Vortioxetine
hydrobromide …10mg
equivalent to 10mg
Vortioxetine
Dy No.569
30-06-2014
Rs.50,000/-
MHRA.
Brintellix
5,
10 & 20mg f/c
tablet by M/s
Lundbeck.
Orignal
legalized
COPP
issued by
EMA on
dated 0402-2014
GMP
complian
t as per
CoPP.
Approved
as
per
Import
Policy for
Finished
Drugs
MHRA.
Orignal
Approved
Rs.265/tabl
et
(Receptor Antagonist).
New Molecule
Manufacturer’s
Specifications
30 months
Brintellix 20mg Tablets
Minutes for 260th Meeting Registration Board
Form 5-A
67
Pakistan (Pvt)
Ltd., 40 T/4,
Blessing Street,
Block
6,
P.E.C.H.S,
Karacki.
10.
Authorization
Holder.
M/s.
H.
Lundbeck A/S,
Ottiliavej
9,
2500
Valby,
Denmark.
Manufacturer
also responsible
for batch release
QC, Primary &
Secondary
Packaging.
M/s.
H.
Lundbeck A/S,
Ottiliavej
9,
2500
Valby,
Denmark.
Site Responsible
for
Quality
Control
M/s
Eurofins
Pharma
A/S,
Ornebjergvej 1,
2600 Glostrup,
Denmark.
Site for Primary
&
Secondary
Packaging.
M/s Elaiapharm,
2881, route des
Cretes, Z.I. Les
Bouillides,
Sophia
Antipolis,
06560, France.
M/s.
CCL
Pharmaceuticals
(Pvt) Ltd., 65-
Each film coated tablet
contains:Vortioxetine
hydrobromide …20mg
equivalent to 20mg
Vortioxetine
Dy No.570
30-06-2014
Rs.50,000/Rs.398/tabl
et.
(Receptor Antagonist).
New Molecule
Brintellix
5,
10 & 20mg f/c
tablet by M/s
Lundbeck.
legalized
COPP
issued by
EMA on
dated 0302-2014
GMP
complian
t as per
CoPP.
as
per
Import
Policy for
Finished
Drugs
Manufacturer’s
Specifications
30 months
Praxed Injection 100mg
Each vial contains:-
Minutes for 260th Meeting Registration Board
Form 5A
MHRA.
Dossier
Deferred
Alimta 100mg is
a for
the
Dy No.Nil &
500mg photocop submissio
68
Industrial Estate, Pemetrexed
(as dated 30- powder
for
Kot
Lakhpat, disodium)………..100
06-2014
conc.
For
Lahore
mg
Rs.50,000/- infusion
by
M/s Eli Lilly.
M/s. Glenmark (Malignant
pleural As
per
Generics S.A. mesothelioma
Local. Alimta
non- Brand
Calle 9 Ing. small cell lung cancer) leader
100mg
&
Meyer Oks No
500mg by M/s
593
Pilar Manufacturer’s
Eli Lilly.
(B1629 MAX), Specifications
Buenos Aires,
Argentina.
03 years
11.
M/s.
CCL
Pharmaceuticals
(Pvt) Ltd., 65Industrial Estate,
Kot
Lakhpat,
Lahore
M/s. Glenmark
Generics S.A.
Calle 9 Ing.
Meyer Oks No
593
Pilar
(B1629 MAX),
Buenos Aires,
Argentina.
Praxed Injection 500mg
MHRA.
Alimta 100mg
Each vial contains:Dy No.Nil &
500mg
Pemetrexed
(as dated 30- powder
for
disodium)………..500
06-2014
conc.
For
mg
Rs.50,000/- infusion
by
M/s Eli Lilly.
per
(Malignant
pleural As
Local. Alimta
mesothelioma
non- Brand
leader
100mg
&
small cell lung cancer)
500mg by M/s
Manufacturer’s
Eli Lilly.
Specifications
Minutes for 260th Meeting Registration Board
Form 5A
y.
Fee
Rs.50,00
0 is a
photocop
y.
Different
ial
fee
not
provided.
Photocop
y
of
COPP
issued
dated 0612-2013.
(valid for
12
months)
Brand
Name
Proxed.
GMP
complian
t as per
CoPP.
Stability
data for
one
batch is
attached.
Dossier
is
a
photocop
y.
Fee
Rs.50,00
0 is a
photocop
y.
Different
ial
fee
not
provided.
Photocop
y
of
69
n
of
following.
a.
Verificatio
n of Fee
Rs.50,000
as it is a
photocopy
.
b.
Differentia
l fee as
molecule
is me too.
c. Valid
legalized
COPP
d. Stability
data as per
conditions
of
Zone
IV A.
Deferred
for
the
submissio
n
of
following.
a.Verificat
ion of Fee
Rs.50,000
as it is a
photocopy
.
b.Different
ial fee as
molecule
is me too.
03 years
12.
M/s.
Revive
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Manufactured
By
M/s.
United
Biotech (P) Ltd.,
Village
Bagbania,
Baddi-Nalagarh
Road, DistrictSolan
(H.P)
174101, India.
13.
M/s.
Revive
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Pemex Injection 500mg
COPP
issued
dated 0612-2013.
(valid for
12
months)
Brand
Name
Proxed.
Form 5A
MHRA.
Alimta 100mg
Each vial contains:Dy no 24 &
500mg
Pemetrexed
(As dated 04- powder
for
Pemetrexed
07-2014
conc.
For
Disodium)…….500mg Rs.100,000 infusion
by
Excipients…….q.s
/M/s Eli Lilly.
(Malignant
pleural As
mesothelioma
non- SRO.
small cell lung cancer)
Manufacturer’s
Specifications
GMP
complian
t as per
CoPP.
Stability
data for
one
batch is
attached.
COPP
valid
upto 1005-2017.
GMP
complian
t as per
COPP.
c. Valid
legalized
COPP
d. Stability
data as per
conditions
of
Zone
IV A.
Approved
as
per
Import
Policy for
Finished
Drugs
per Local. Alimta
100mg
& Free
500mg by M/s sales
Eli Lilly.
certificat
e issued
dated 2602-2016.
24 months
Cagin 50mg Injection
MHRA.
Cancidas
Each vial contains:Dy No.26 powder
Caspofungin
Acetate dated 04- conc.
eq.
to 07-2014
infusion
Caspofungin…….50mg Rs.50,000/- M/s MSD.
Minutes for 260th Meeting Registration Board
Form 5A
50
for
For
by
GMP
valid
upto 1709-2017.
Free
sales
certificat
e issued
dated 2602-2016.
70
Deferred
as Antifungal
drugs are
not
importable
14.
M/s.
United
Biotech (P) Ltd.,
Village
Bagbania,
Baddi-Nalagarh
Road, DistrictSolan
(H.P)
174101, India.
M/s.
Revive
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Manufactured
by
M/s.
United
Biotech (P) Ltd.,
Village
Bagbania,
Baddi-Nalagarh
Road, DistrictSolan
(H.P)
174101, India.
(Antifungal/Supportive
cancer therapy)
New Molecule
As per PRC
Manufacturer’s
Specifications.
24 months
Doxulip 20mg Injection
Form 5A
MHRA.
Caelyx
Each ml contains:Dy. No. 27 2mg/ml
Doxorubicin
dated 04- (10ml) by M/s
Hydrochloride
07-2014
Janssen.
USP..2mg
Rs.100,000
(As
pegylated /Local.
Liposomal)
Doxopeg
As
per 20mg/10ml by
M/s
Alone for meta-static PRC.
Ferozsons.
breast
cancer,
advanced
ovarian
cancer.
In
combination
with
Bortezomide
for
treatment
of
progressive multiple
myeloma.
Manufacturer’s
Specifications
15.
24 months
M/s.
Revive Temotec
100mg
Health Care,
Capsules
Office 503, 5th
Floor, 6 Main Each capsules contains:Gulberg,
Jail Temozolomide
Road, Lahore.
USP…………..100mg
MHRA.
Temodal 5mg,
Dy. No 28 20mg, 100mg,
dated 04- 140mg, 180mg
07-2014
& 250mg by
Rs.100,000 M/s Merck
/Local.
Manufactured
For newly diagnosed
As
per Temoside
by
Glioblastoma
M/s.
United multiforme
SRO
20mg, 100mg
Biotech (P) Ltd., concomitantly
& 250mg by
with
Village
M/s AJ. Mirza.
radiotherapy
Bagbania,
Baddi-Nalagarh Manufacturer’s
Minutes for 260th Meeting Registration Board
Form 5A
COPP
valid
upto 105-2017.
GMP
valid
upto 1709-2017.
from India
as
per
Import
Policy
Order,
2016.
COPP
valid
upto1005-2017.
Approved
as
per
Import
Policy for
Finished
Drugs
GMP
complian
t as per
COPP.
Free
sales
certificat
e issued
dated 2602-2016.
GMP
valid
upto 1709-2017.
COPP
valid
upto 1005-2017.
GMP
complian
t as per
COPP.
Free
sales
issued
dated 2671
Approved
as
per
Import
Policy for
Finished
Drugs
Road, District- Specifications
Solan
(H.P)
174101, India.
24 months
16.
M/s.
Revive
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
M/s.
United
Biotech (P) Ltd.,
Village
Bagbania,
Baddi-Nalagarh
Road, DistrictSolan
(H.P)
174101, India.
17.
M/s.
Revive
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Manufactured
by
M/s.
United
Biotech (P) Ltd.,
Village
Bagbania,
Baddi-Nalagarh
Road, DistrictSolan
(H.P)
174101, India.
12-2015.
GMP
valid
upto 1709-2017.
Ambilip 50mg Injection
Defered as
the
Each vial contains:product
Liposomal
does not
Amphotericin
fall in the
USP………50mg
GMP
priority
complian list.
Antifungal
t as per Moreover
COPP.
AntiManufacturer’s
fungal
Specifications
Free
drugs are
sales
not
24 months
issued
importable
dated 26- from India
02-2016. as
per
Import
GMP
Policy
valid
Order,
upto 17- 2016
09-2017.
Oncotar
100mg Form 5A
MHRA.
COPP
Approved
Injection
Cytarabine
valid
as
per
Dy. No 30 100mg/ml by upto 10- Import
Each ml contains:dated 04- M/s Pfizer.
05-2017. Policy for
Cytarabine
injection 07-2014
Finished
BP………100mg
Rs.100,000 Local.
GMP
Drugs
Water for injection s /Cytarine
complian
IP………….q.s.
100mg, 500mg t as per
As per PRC & 1gm by M/s COPP.
Atco.
Acute
myeloid
FSC
leukaemia and for
issued
other acute leukaemias
dated 26for children and adults
02-2016.
USP Specifications
GMP
24 months
valid
upto 1709-2017.
Minutes for 260th Meeting Registration Board
Form 5A
MHRA.
Ambisome
Dy No.29 50mg Powder
dated 04- for Infusion by
B 07-2014
M/s Gilead.
Rs.100,000
/Local.
Anfogen
As
per 50mg,
SRO.
Ferozsons
COPP
valid
upto 1005-2017.
72
18.
19.
20.
M/s.
Revive
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Unicristin 1mg injection Form 5A
Each ml contains:Vincristine
Sulphate
USP…..1mg
Indicated
for
Manufactured
leukemias, malignant
by
lymphomas, multiple
M/s.
United myeloma, solid tumors
Biotech (P) Ltd.,
Village
USP Specifications
Bagbania,
Baddi-Nalagarh 24 months
Road, DistrictSolan
(H.P)
174101, India.
M/s.
Novartis Afinitor
2mg
Pharma
Dispersible Tablets
(Pakistan)
Limited,
15 Each dispersible tablet
West
Wharf, contains:Karachi.
Everolimus……………
…2mg
Manufactured
(for harmone receptor
by.
M/s.
Novartis positive advaced breast
Pharma
Stein cancer, neuro-endocrine
AG,
Stein, tumors of pancreatic
Switzerland.
origion, gastro-intestinal
or lung origin renal cell
carcinoma)
30 months
M/s.
Novartis Afinitor
3mg
Pharma
Dispersible Tablets
(Pakistan)
Each dispersible tablet
Limited,
15 contains:West
Wharf, Everolimus……………
Karachi.
…3mg
MHRA.
Vincristine
Dy. No 25 Sulphate
dated 04- 1mg/ml
by
07-2014
M/s Hospira.
Rs.100,000
/Local. Vinfate
by M/s Aster.
As
per
SRO
COPP
valid
upto 1005-2017.
GMP
complian
t as per
COPP.
FSC
issued
dated 2602-2016.
GMP
valid
upto 1709-2017
Approved
as
per
Import
Policy for
Finished
Drugs
Form 5A
Dossier
is
photocop
y fee Rs.
50,000 is
photocop
y.
Photocop
y
of
COPP
provided.
GMP
attached.
Deferred
for
the
verificatio
n of fee
and
submissio
n of valid
legalized
CoPP.
FDA. Afinitor
2mg, 3mg &
Dy No. Nil 5mg Disperz
dated 16- Tablets by M/s
07-2014
Novartis.
Rs.50,000/Rs.
126,000/30
’s.
Form 5A
FDA. Afinitor
2mg, 3mg &
Dy No. 88 5mg Disperz
dated 16- Tablets by M/s
07-2014
Novartis.
Rs.50,000/-
(for harmone receptor Rs.189000/
Manufactured
positive advaced breast 30’s
by.
M/s.
Novartis cancer, neuro-endocrine
Minutes for 260th Meeting Registration Board
Dossier
is
photocop
y fee Rs.
50,000 is
photocop
y.
Photocop
y
of
73
Deferred
for
the
verificatio
n of fee
and
submissio
n of valid
legalized
CoPP.
Pharma
Stein tumors of pancreatic
AG,
Stein, origion, gastro-intestinal
Switzerland.
or lung origin renal cell
carcinoma)
COPP
provided.
GMP
attached.
Manufacturer’s
Specifications
21.
30 months
Afinitor
5mg Form 5A
Dispersible Tablets
Dy No. 87
Each dispersible tablet dated 16contains:07-2014
Everolimus…………… Rs.50,000/…5mg
Rs.315000/
Manufactured
(for harmone receptor 30’s
by.
M/s.
Novartis positive advaced breast
Pharma
Stein cancer, neuro-endocrine
AG,
Stein, tumors of pancreatic
Switzerland.
origion, gastro-intestinal
or lung origin renal cell
carcinoma)
M/s.
Novartis
Pharma
(Pakistan)
Limited,
15
West
Wharf,
Karachi.
FDA. Afinitor
2mg, 3mg &
5mg Disperz
Tablets by M/s
Novartis.
Dossier
is
photocop
y fee Rs.
50,000 is
photocop
y.
Photocop
y
of
COPP
provided.
GMP
attached.
Deferred
for
the
verificatio
n of fee
and
submissio
n of valid
legalized
CoPP.
MHRA. Iressa COPP
250mg
f/c not
tablet by M/s provided
AstraZeneca.
GMP not
attached.
per
Stability
data as
per
condition
s of Zone
IV-A not
attached.
Finished
product
specifica
tions are
Deferred
for
the
submissio
n
of
following:
a.
valid
legalized
COPP
b. Stability
data as per
conditions
of
Zone
IV-A.
c. Finished
product
specificati
ons.
Manufacturer’s
Specifications
22.
30 months
M/s.
Macter Gefwin 250mg Tablets
International
Limited, F-216, Each
Film Coated
SITE, Karachi.
Tablets contains:Gefitinib………..250m
Manufactured
g
by
M/s.
Atlanta Excipients………qs
Biological (Pvt)
Ltd.,Village(Advanced or metaKotla,
static non small cell
Barotiwala,
lung cancer)
Baddi,
Distt.
Solan,
(H.P)
India.
Minutes for 260th Meeting Registration Board
Form 5A
Dy.
No
3121 Dated
07-08-2014
Rs.50,000/Rs.As
PRC
74
23.
24.
M/s.
Macter
International
Limited,F-216,
SITE,
Karachi. /
Marketing
Authorization:
M/s.
Atlanta
Biological (Pvt)
Ltd.,Poddar
Court 9th Floor,
Gate No.1, 18
Rabindra Sarani,
Kolkata-700001,
India.
Manufacturing
facility:
M/s.
Ladley
Formulations
Village Kotla,
Barotiwala,
Distt.
Solan
(H.P), India.
Cytonib Tablet 100mg
M/s.
Macter
International
Limited,F-216,
SITE,
Karachi. /
Marketing
Authorization:
M/s.
Atlanta
Biological (Pvt)
Ltd.,
Poddar
th
Court 9 Floor,
Gate No.1, 18
Rabindra Sarani,
Bortemore
Injection
Each tablets contains:Imatinib
Mesylate………100mg
Form 5A
Dy. No 872
Dated
29-08-2014
Rs.50,000/-
(Philadelphia
chromosome positive
chronic
myeloid
leukemia)
MHRA.
Glivec 100mg
& 400mg f/c
by
M/s
Novartis.
Local. Glivec
100mg
&
400mg by M/s
Novartis
Pharma.
Manufacturer’s
Specifications
02 years
not
provided.
Sole
Agency
agreeme
nt is not
attached
COPP
valid
upto 2208-2014
but the
addresse
s
of
Market
authoriza
tion
holder
and
manufact
urer are
not
as
per
COPP.
d.
Sole
Agency
agreement.
Deferred
for
the
clarificatio
n
of
following:
a. COPP
as
the
addresses
of Market
authorizati
on holder
and
manufactu
rer are not
as
per
COPP.
b. Stability
GMP not data as per
provided. Zone IVStability A.
data as
per Zone
IV-A not
provided.
3.5mg Form 5A
Dy. No 873
dated 29Each vial contains:08-2014
Bortezomib…………3. Rs.50,000/5mg
As
per
(Lumphocutic
PRC.
leukemia,
indolent
non-Hodgkin’s
lymphoma, multiple
myeloma).
Minutes for 260th Meeting Registration Board
MHRA.
Velcade 3.5mg
(as mannitol
boronic ester)
Powder
for
solution
for
injection.
COPP
valid up
to 22-082014 but
the
addresse
s
of
Market
authoriza
tion
holder
and
manufact
75
Deferred
for
the
submissio
n
/
clarificatio
n of the
following
a.
addresses
of market
authorizati
on holder
and
Kolkata-700001, 02 years
India.
Manufacturing
facility:
M/s.
Ladley
Formulations
Village Kotla,
Barotiwala,
Distt.
Solan
(H.P), India.
25.
M/s.
GlaxoSmithKlin
e
Pakistan
Limited,
35Dockyard Road,
West
Wharf,
Karachi-74000.
Market
Authorization
Holder
M/s.
Requip
Tablets
PD
2mg Form 5A
MHRA..
Aimpart Excel
Dy
No. 2mg, 4mg and
Each prolonged release 6581 R&I 8mg
tablets contains:dated
8- prolonged
Ropinirole
09-2014
release tablets
hydrochloride
Rs.50,000/- by
M/s
equivalent
to
2mg
Zantiva
ropinirole free base
Will
be
submitted
(Non-ergoline D2/D3 later
dopamine agonist)
Minutes for 260th Meeting Registration Board
urer are
not
as
per
COPP.
Stability
data not
attached.
Finished
product
specifica
tions are
not
provided.
Internati
onaly the
product
is present
as
mannitol
boronic
ester.
Clarificat
ion
whether
the
product
is
in
liquid
form or
powder
form.
manufactu
rer are not
as
per
COPP.
b.Stability
data as per
conditions
of
Zone
IV A.
c.Finished
product
specificati
ons.
d.
Internation
aly
the
product is
present as
mannitol
boronic
ester.
e.whether
the
product is
in liquid
form
or
powder
form.
COPP
issued
dated1007-2014
vide No.
014/1680
by Spain.
GMP
complian
t as per
COPP.
Approved
as
per
Import
Policy for
Finished
Drugs
76
Glaxosmithkline New formuation
, S.A. Severo
Ochoa, 2 28760- 18 months
Tres
Cantos
(Madrid) Spain.
Manufactured
by
M/s
Glaxo
Wellcome, S.A.
Avda.
De
Extremadura, n
3 09400-Aranda
De
Duero
(Burgos) Spain.
26.
M/s.
GlaxoSmithKlin
e
Pakistan
Limited,
35Dockyard Road,
West
Wharf,
Karachi-74000.
Requip
Tablets
PD
4mg Form 5A
MHRA..
Aimpart Excel
Dy No.656 2mg, 4mg and
Each prolonged release R&I dated 8mg
tablets contains:08-09-2014 prolonged
Ropinirole
Rs.50,000/- release tablets
hydrochloride
by
M/s
equivalent
to
4mg Will
be Zantiva
Market
ropinirole free base
submitted
Authorization
later
Holder
(Non-ergoline D2/D3
M/s.
dopamine agonist)
Glaxosmithkline New formuation
, S.A. Severo
Ochoa, 2 28760- (24 months)
Tres
Cantos
(Madrid) Spain.
Manufactured
by
M/s
Glaxo
Wellcome, S.A.
Avda.
De
Extremadura, n
3 09400-Aranda
De
Duero
(Burgos) Spain.
COPP
issued
dated1007-2014
vide No.
014/1678
by Spain.
GMP
complian
t as per
COPP.
Approved
as
per
Import
Policy for
Finished
Drugs
27.
M/s.
Requip PD
8mg 08-09-2014
GlaxoSmithKlin Tablets
Rs.50,000/e
Pakistan
Limited,
35- Each prolonged release
COPP
issued
dated1007-2014
Approved
as
per
Import
Policy for
Minutes for 260th Meeting Registration Board
MHRA
Aimpart Excel
2mg, 4mg and
8mg
77
28.
Dockyard Road, tablets contains:West
Wharf, Ropinirole
Karachi-74000. hydrochloride
equivalent
to
8mg
Market
ropinirole free base
Authorization
Holder
(Non-ergoline D2/D3
M/s.
dopamine agonist)
Glaxosmithkline New formulation
, S.A. Severo
Ochoa, 2 28760Tres
Cantos (24 months)
(Madrid) Spain.
Manufactured
by
M/s
Glaxo
Wellcome, S.A.
Avda.
De
Extremadura, n
3 09400-Aranda
De
Duero
(Burgos) Spain.
prolonged
release tablets
by
M/s
Zantiva
vide No. Finished
014/1679 Drugs
by Spain.
GMP
complian
t as per
COPP.
M/s.
Bayer
Pakistan
(Private)
Limited, C-21,
S.I.T.E., Karachi
Germany.
Visanne
(Dienogest)
2mg Tablets
COPP
issued
dated 1106-2014.
GMP
issued
dated 2604-2013.
Approval
status
require
to
be
provided.
Now the
firm has
requeste
d for the
finished
import
from
Germany
.
Visanne
(Dienogest) Form 5A
2mg Tablets
Dated 10Each tablet contains:09-2014
Dienogest………….2m vide diary
g
No. 667
Rs.50,000/(Steroid Hormones)
Not
New Molecule
mentioned
Manufacturer’s
Specifications
Product license
holder:
M/s. Jenapharm
GmbH & Co.
KG,
OttoSchott-Strasse
15
D-07745
Jena Germany
36 months
Bulk
Manufacturer,
Packaging and
final release:
M/s.
Bayer
Weimar GmbH
&
Co.
KG
DÖbereinerstras
se 20 99427
Minutes for 260th Meeting Registration Board
78
Approved
as
per
Import
Policy for
Finished
Drugs
29.
Weimar,
Germany.
M/s. PharmEvo
(Pvt) Ltd.,
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi
Bicatero 50mg Tablets
Each film coated tablets
contains:Bicalutamide
USP……….50mg
(Adjuant
to
radial
prostectomy or radioManufactured
therapy in patients with
By.
M/s.
Hetero locally
advanced
Labs
Limited prostate cancer)
Unit – VI Sy
No. 410 & 411, USP Specifications
APIIC
Formulation
02 years
SEZ, Polepally
Village,
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
30.
M/s. PharmEvo
(Pvt) Ltd.,
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi
Manufactured
By.
M/s.
Hetero
Labs
Limited
Unit – VI Sy
No. 410 & 411,
APIIC
Formulation
SEZ, Polepally
Village,
Bentero
Injection
Form 5A
MHRA.
Bicalutamide
Dy. No 673 50mg f/c by
Dated 11- M/s
Sun
09-2014
pharma.
Rs.100,000
/Local.
Calutide 50mg
As per PRC by M/s AJ.
Mirza.
100mg Form 5 A
FDA.
Bendamustine
Dy. No 676 powder
for
Each vial contains:dated 11- infusion
by
Bendamustin
09-2014
M/s Hospira.
Hydrochloride………… Rs.100,000
100mg
/Water
for
injections……….Ph.Eu As
per
r….q.s.
SRO
(Lumphocutic
leukemia,
indolent
non-Hodgkin’s
lymphoma, multiple
myeloma)
COPP
valid
upto 1909-2014.
GMP
complian
t as per
COPP.
Deferred
for
the
submissio
n
of
Stability
data as per
conditions
of
Zone
IV-A
&
Photocop valid
y
of legalized
GMP
COPP.
valid
upto 1909-2014.
Stability
data is
not
as
per
condition
s of Zone
IV-A.
COPP
valid
upto 3012-2015.
Photocop
y
of
GMP 1909-2014.
Stability
data is
not
as
per
condition
s of Zone
IV-A.
Manufacturer’s
Minutes for 260th Meeting Registration Board
79
Deferred
for
the
submissio
n
of
a.Stability
data as per
conditions
of
Zone
IV-A.
b.valid
legalized
COPP.
c.Separate
applicatio
n for the
registratio
n
applicatio
Jadcherla
Specifications
Mandal,
Mahaboob
02 years
Nagar
(Dist)
509301, Andhra
Pradesh, India.
31.
32.
M/s. PharmEvo
(Pvt) Ltd.,
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi
Bortero 3.5mg Injection
Firm has n for WFI.
not
applied
for
separate
registrati
on
of
water for
injection.
MHRA.
Velcade 3.5mg
Each vial contains:Dy. No 673 (as mannitol
Bortezomib…….3.5mg dated 11- boronic ester)
Water for Injection 09-2014
Powder
for
Ph.Eur….q.s
Rs.100,000 solution
for
/
injection.
(Lumphocutic
per
Manufactured
leukemia,
indolent As
SRO.
By.
non-Hodgkin’s
M/s.
Hetero lymphoma, multiple
Labs
Limited myeloma)
Unit – VI Sy
No. 410 & 411, Manufacturer’s
APIIC
Specifications
Formulation
SEZ, Polepally 02 years
Village,
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
COPP
valid
upto 3012-2015
M/s. PharmEvo Capetero 500mg Tablets Form 5A
(Pvt) Ltd.,
COPP
valid
Minutes for 260th Meeting Registration Board
Form 5A
MHRA.
Capecitabine
Photocop
y
of
GMP
valid
upto 1909-2014.
Stability
data not
provided.
Internati
onaly the
product
is present
as
mannitol
boronic
ester.
Firm has
not
applied
for
separate
registrati
on
of
water for
injection.
Deferred
for
the
submissio
n
of
a.Stability
data as per
conditions
of
Zone
IV-A.
b.valid
legalized
COPP.
c.Separate
applicatio
n for the
registratio
n
applicatio
n for WFI.
Deferred
for
the
80
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi.
Each film coated tablets
contains:Capecitabine
USP………500mg
(adjuant treatment of
patients
following
Manufactured
surgery of stage III
By.
colon cancer, metaM/s.
Hetero static
colo-rectal
Labs
Limited cancer)
Unit – VI Sy
No. 410 & 411, USP Specifications
APIIC
Formulation
02 years
SEZ, Polepally
Village,
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
33.
M/s. PharmEvo
(Pvt) Ltd.,
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi
Dy. No 678
dated 1109-2014
Rs.100,000
/As
SRO.
500mg f/c by upto 19- submissio
M/s Accord.
09-2014. n
of
a.Stability
Local. Xeloda Photocop data as per
500mg by M/s y GMP conditions
Roche.
valid
of
Zone
per
upto 19- IV-A.
09-2014. b.valid
legalized
Stability COPP.
is not as c.Separate
per
applicatio
condition n for the
s of Zone registratio
IV A.
n
applicatio
n for WFI.
Capetero 150mg Tablets Form 5A
MHRA.
Capecitabine
Each film coated tablets dy. NO 675 Accord 150mg
contains:dated 11- f/c by M/s
Capecitabine
09-2014
Accord.
USP………150mg
Rs.100,000
/(adjuant treatment of
per
Manufactured
patients
following As
By.
surgery of stage III SRO
M/s.
Hetero colon cancer, metaLabs
Limited static
colo-rectal
Unit – VI Sy cancer)
No. 410 & 411,
APIIC
USP Specifications
Formulation
SEZ, Polepally 02 years
Village,
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
Minutes for 260th Meeting Registration Board
COPP
valid
upto 1909-2014.
Deferred
for
the
submissio
n
of
Stability
Photocop data as per
y GMP conditions
valid
of
Zone
upto 19- IV-A
&
09-2014. valid
legalized
Stability COPP.
is not as
per
condition
s of Zone
IV A.
81
34.
35.
36.
509301, Andhra
Pradesh, India.
M/s
GlaxoSmithKlin
e
Pakistan
Limited
35Dockyard Road,
West
Wharf,
Karachi.
Anoro Ellipta
Dry Powder Inhaler
Each
pre-dispensed
dose contains.
Umeclidinium…….62.5
mcg
Vilanterol
(as
trifenatate)…25mcg
(Long acting muscarinic
M/s
Glaxo antagonist
(LAMA),
Operations UK and a long-acting beta-2
Limited, Ware agonist (LABA)
UK
New Molecule
MHRA. Ano Already
Ellipta by M/s approved
Dy.
No: GSK
in 254th
693 dated
meeting
18-09-2014
but later
50,000/on
dated 18deleted
09-2014
in 256th
meeting
MRP will
as
the
be
decision
submitted
on new
later
molecule
s was not
clear.
COPP
issued on
06-082014.
M/s.
Novartis Sandostatin 0.2mg/ml Form 5A
MHRA.
COPP
Pharma
Multi-dose Vial
Dy. No 701 Sandostatin
issued by
(Pakistan)
dated 22- 1000mcg/5ml Swiss
Limited,
15 Each 5ml vial contains:- 09-2014
by
M/s medica
West
Wharf, Octreotide……………. Rs.50,000/- Novartis.
Switzerla
Karachi.
1mg
nd
on
Rs.9400/5
21-032014.
Product
Acromegaly/Carcinoid ml vial
GMP 07License Holder. Tumors / Vasoactive
M/s.
Novartis Intestinal tumors
04-2014.
Pharma Schweiz
AG,
6343,
Risch,
Switzerland.
Manufacturer’s
Specifications
Manufactured
By
M/s
Novartis 48 months
Pharma Stein
AG
Schaffhauserstr
asse 4332 Stein,
Switzerland
M/s.
Novartis Sandostatin 0.5mg/ml Form 5A
MHRA.
COPP
Pharma
Ampoule
Dy.
NO Sandostatin
issued on
(Pakistan)
700 Dated 500mcg/1ml
21-03Minutes for 260th Meeting Registration Board
Form-5A
82
Approved
as
per
Import
Policy for
Finished
Drugs
Approved
as
per
Import
Policy for
Finished
Drugs
Approved
as
per
Import
37.
Limited,
15 Each 1ml ampoule
West
Wharf, contains:Karachi.
Octreotide…………….
0.5mg
Product
License Holder. Acromegaly/Carcinoid
M/s.
Novartis Tumors / Vasoactive
Pharma Schweiz Intestinal tumors
AG, 6343, Risch
, Switzerland.
Manufacturer’s
Specifications
Manufactured
36 months
By
M/s
Novartis
Pharma Stein
AG
Schaffhauserstr
asse 4332 Stein,
Switzerland
M/s.
Kivexa Tablets
GlaxoSmithKlin Each film coated tablets
e
Pakistan contains:Limited,
35- Abacavir 600mg (as
Dockyard Road, abacavir sulfate) and
West
Wharf, Lamivudine………..300
Karachi.
mg
22-09-2014
Rs.50,000/Rs.23,000/
5
ampoules.
by
M/s 2014 by Policy for
Novartis.
Switzerla Finished
nd.
Drugs
GMP 0704-2014
Form 5A
MHRA.
COPP
Kivexa by M/s issued
Dy No. 729 ViiV
dated 16R&I dated
05-2014
30-09-2014
vide no.
Rs.50,000/10/14/76
509 by
Will
be
EMA.
Market
(HIV Indicated for the submitted
GMP
Authorization
management of HIV later.
complian
Holder
infection)
t as per
M/s
ViiV New formulation &
COPP.
Healthcare UK Anti HIV
Limited,
980
Great
West 36 months
Road, Brentford,
Middlesex, TW8
9GS,
United
Kingdom
Manufactured
by M/s. M/s
GlaxoSmithKlin
e
Pharmaceuticals
SA,
ul.
Grunwaldzka
189,
60-322
Minutes for 260th Meeting Registration Board
83
Approved
as
per
Import
Policy for
Finished
Drugs
38.
Poznan, Poland.
Site Responsible
for Primary &
Secondary
Packaging
M/s
Glaxo
Wellcome S.A.,
Avenida
Extremadura 3,
Aranda
de
Duero, Burgos,
09400, Spain.
M/s.
GlaxoSmithKlin
e
Pakistan
Limited,
35Dockyard Road,
West
Wharf,
Karachi.
Tivicay Tablets
Form 5-A
MHRA.
Dy.No.45
Tivicay
Each film coated tablet R&I Dated M/s ViiV
contains:16-10-2014
Dolutegravir
(as Rs.50,000/Dolutegravir
Sodium)……50mg
Price will
be provided
Market
(HIV. Indicated for the later
Authorization
management of HIV
Holder
infection)
M/s
ViiV New Molecule
Healthcare UK
Limited,
980 24 months
Great
West
Road, Brentford,
Middlesex, TW8
9GS,
United
Kingdom
Legalize
by d COPP
was
issued by
EMA
dated.
19.082014
Manufactured
by M/s. Glaxo
Operations UK
Ltd,
Priory
Street,
Ware,
Hertfordshire
SG12
ODJ,
United
Kingdom.
Site Responsible
for Primary &
Secondary
Packaging
M/s
Glaxo
Minutes for 260th Meeting Registration Board
84
Approved
as
per
Import
Policy for
Finished
Drugs
39.
40.
Wellcome S.A.,
Avenida
Extremadura 3,
Aranda
de
Duero, Burgos,
09400, Spain.
M/s.
RG
Pharmaceutica
(Pvt)
Ltd.,
Progressive
Square, Block 6,
Shahra-e-Faisal,
Karachi-75400./
M/s. Shin Poong
Pharmaceutical
Co. Ltd., 70,
Sandan-ro
19beon-gil,
Danwon-gu
Ansan-si
Gyeonggido,
Korea.
M/s.
Premier
Agencies,
60-Muslimabad,
Jamshed
Quarters M.A.
Jinnah
Road
Extension,
Karachi.-74800
Pyramax 180mg/60mg
Each film coated tablets
contains:Artesunate…………60
mg
Pyronaridine
tetraphosphate………18
0mg
(Pyronaridine
in
combination
with
artesunate,
an
artemisinin derivative).
New
Molecule
/
formualtion
02 years
Form 5A
WHO
approved
Dy No. 84 formulation
dated 10- for treatment
11-2014
of malaria
Rs.50,000/-
Free
sales
certificat
e issued
dated 1708-2011
vide No.
Rs.
2014142/tablet
A1-0403.
GMP
certificat
e issued
dated 1707-2013
vide No.
2013D1-2253.
Gemtero 1.0g Injection Form 5A
MHRA.
COPP/Fr
Gemcitabine
ee sales
Each vial contains:DY. No 71 1g Powder for certificat
Gemcitabine
dated 13- injection
by e
not
Hydrochloride
11-2014
M/s Ranbaxy
attached.
equivalent
to Rs.100,000
GMP
Gemcitabine 1.0g for /
certificat
injection
e is not
As
per
attached.
Stability
(Advanced or met- SRO
data is
static bladder cancer
not
as
in combination with
per
cisplatin, locally or
condition
meta-static
s of Zone
adenocarcinoma
of
IV-A.
pancreas)
Manufactured
by
M/s.
Hetero
Labs Limited ,
Unit-VI,
Sy.
No.410 & 411,
APIIC
Formulation
SEZ, Polepally USP Specifications
Village,
Jadcherla
02 years
Mandal,
Mahaboob
Nagar
(Dist)
Minutes for 260th Meeting Registration Board
85
Approved
as
per
Import
Policy for
Finished
Drugs
Deferred
for
the
submissio
n of valid
legalized
COPP and
Stability
data as per
conditions
of
Zone
IV-A.
41.
42.
509301, Andhra
Pradesh, India.
M/s.
Premier
Agencies,
60-Muslimabad,
Jamshed
Quarters M.A.
Jinnah
Road
Extension,
Karachi
Gemtero
Injection
200mg Form 5A
MHRA.
Gemcitabine
Dated 13- 200mg
Each vial contains:11-2014
Powder
for
Gemcitabine
vide diary injection
by
Hydrochloride
No. 73
M/s Hospira
equivalent
to Rs.100,000
Gemcitabine 200mg for /injection
As
per
Manufactured
by
(Advanced or met- SRO.
M/s.
Hetero static bladder cancer
Labs Limited ,
in combination with
Unit-VI,
Sy. cisplatin, locally or
No.410 & 411, meta-static
APIIC
adenocarcinoma
of
Formulation
pancreas)
SEZ, Polepally
Village,
USP Specifications
Jadcherla
Mandal,
02 years
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
M/s.
Premier Paclitero
30mg/5ml Form 5A
MHRA.
Agencies,
Injection
Paclitaxel
60-Muslimabad,
Dy. No 74 6mg/ml Conc.
Jamshed
Each vial contains:Dated 13- for solution for
Quarters M.A. Paclitaxel
11-2014
infusion
by
Jinnah
Road USP………..30mg/5ml Rs.100,000 M/s
Medac
Extension,
/
(5ml, 16.7ml,
Karachi.-74800 (Monotherapy
50ml
&
for
per 100ml).
meta-static
breast As
Manufactured
cancer.
In SRO
Local.
by
combination
with
M/s.
Hetero Gemcitabin for metaPanataxel
Labs Limited ,
100mg,
static adenocarcinoma
Unit-VI,
Sy. of pancreas)
150mg, 300mg
No.410 & 411,
& 30mg by
APIIC
USP Specifications
M/s
Formulation
Ferozsons.
SEZ, Polepally 02 years
Village,
Minutes for 260th Meeting Registration Board
COPP/Fr
ee sales
certificat
e
not
attached.
GMP
certificat
e is not
attached.
Stability
data is
not
as
per
condition
s of Zone
IV-A.
COPP
valid
upto 3012-2015.
Deferred
for
the
submissio
n of valid
legalized
COPP and
Stability
data as per
conditions
of
Zone
IV-A.
Deferred
for
the
submissio
n of valid
legalized
Photocop COPP and
y
of Stability
GMP
data as per
upto 19- conditions
09-2014. of
Zone
IV-A.
Stability
data not
as
per
condition
s of Zone
IV A.
86
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
43.
M/s.
Premier
Agencies,
60-Muslimabad,
Jamshed
Quarters
M.A.
Jinnah
Road Extension,
Karachi.-74800
Paclitero 100mg/16.7ml Form 5A
Injection
Dy. No 72
Each vial contains:dated 13Paclitaxel
11-2014
USP………..100mg/16. Rs.100,000
7ml
/
(Monotherapy
for As
M/s.
Hetero meta-static
breast SRO
Labs Limited ,
cancer.
In
Unit-VI,
Sy. combination
with
No.410 & 411, Gemcitabin for metaAPIIC
static adenocarcinoma
Formulation
of pancreas)
SEZ, Polepally
Village,
USP Specifications
Jadcherla
Mandal,
02 years
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
44.
M/s.
Premier
Agencies,
60-Muslimabad,
Jamshed
Quarters
M.A.
Jinnah
Road Extension,
Karachi
Paclitero
Injection
MHRA.
Paclitaxel
6mg/ml Conc.
for solution for
infusion
by
M/s
Medac
(5ml, 16.7ml,
50ml
&
per 100ml).
300mg Form 5A
Local.
Panataxel
100mg,
150mg, 300mg
& 30mg by
M/s
Ferozsons.
MHRA.
Paclitaxel
Dy. No 75 6mg/ml Conc.
Each vial contains:dated 13- for solution for
Paclitaxel
11-2014
infusion
by
USP………..300mg/50 Rs.100,000 M/s
Medac
ml
/(5ml, 16.7ml,
50ml
&
per 100ml).
(Monotherapy
for As
M/s.
Hetero meta-static
breast SRO
Labs Limited ,
Local.
cancer.
In
Unit-VI,
Sy. combination
Panataxel
with
No.410 & 411, Gemcitabin for meta100mg,
APIIC
150mg, 300mg
static adenocarcinoma
Formulation
& 30mg by
of pancreas)
Minutes for 260th Meeting Registration Board
COPP
valid
upto 3012-2015.
Deferred
for
the
submissio
n of valid
legalized
Photocop COPP and
y
of Stability
GMP
data as per
valid
conditions
upto 19- of
Zone
09-2014. IV-A.
Stability
data not
as
per
condition
s of Zone
IV A.
COPP
valid
upto 3012-2015.
Deferred
for
the
submissio
n of valid
legalized
Photocop COPP and
y
of Stability
GMP
data as per
valid
conditions
upto 19- of
Zone
09-2014. IV-A.
Stability
data is
not
as
per
87
45.
SEZ, Polepally
Village,
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
M/s.
GlaxoSmithKlin
e
Pakistan
Limited,
35Dockyard Road,
West
Wharf,
Karachi.
USP Specifications
M/s
Ferozsons.
condition
s of Zone
IV A.
02 years
Mekinist 0.5mg Tablets Form 5A
MHRA.
Mekinist f/c
Each film coated tablets 03-12-2014 tablet 0.5mg &
contains:vide diary 2mg by M/s
Trametinib
dimethyl/ No.188
Novartis.
sulfoxide equivalent to Rs.50,000/0.5mg trametinib
As per PRC
Manufactured
Mono therapy or in
by :combination
with
M/s.
Debrafenib
for
GlaxoSmithKlin patients
with
une Manufacturing resectable or metS.p.A., Strada static melanoma
Provinciale
Asolana,
90, New molecule.
43056 San Polo
di
Torrile, Manufacturer’s
Parma, Italy.
Specifications
Primary
&
02 years
Secondary
Packaging
Site:M/s.
Glaxo
Wellcome S.A.
Avenida
Extremadura, 3,
09400 Aranda
de
Duero,
Burgos, Spain.
Market
Authorization
Holder
Glaxo
Group
Ltd, 980 Great
West
Road,
Brentford,
Middlesex TW8
Minutes for 260th Meeting Registration Board
The firm
has
provided
2
COPPs.
The first
COPP
issued
dated 1909-2014
by EMA
says that
“The
product
is
not
actualy
in
the
market
of
exportin
g
country
”
GMP
complian
t as per
COPP.
The 2nd
COPP
issued
dated 2109-2015
says that
the
product
is on free
sale in
the
88
Approved
as
per
Import
Policy for
Finished
Drugs
9GS,
United
Kingdom.
46.
M/s.
GlaxoSmithKlin
e
Pakistan
Limited,
35Dockyard Road,
West
Wharf,
Karachi.
exportin
g
country.
Mekinist 2mg Tablets
MHRA.
Mekinist f/c
Each film coated tablets Dy. No 187 tablet 0.5mg &
contains:Dated 02- 2mg by M/s
Trametinib
dimethyl/ 12-2014
Novartis.
sulfoxide equivalent to Rs.50,000/2mg trametinib
As per PRC
Manufactured
Mono therapy or in
by :combination
with
M/s.
Debrafenib
for
GlaxoSmithKlin patients
with
une Manufacturing resectable or metS.p.A., Strada static melanoma
Provinciale
Asolana,
90, New molecule.
43056 San Polo
di
Torrile, Manufacturer’s
Parma, Italy.
Specifications
Primary
&
02 years
Secondary
Packaging
Site:M/s.
Glaxo
Wellcome S.A.
Avenida
Extremadura, 3,
09400 Aranda
de
Duero,
Burgos, Spain.
Market
Authorization
Holder
Glaxo
Group
Ltd, 980 Great
West
Road,
Brentford,
Middlesex TW8
9GS,
United
Kingdom.
Minutes for 260th Meeting Registration Board
Form 5A
The firm
has
provided
2
COPPs.
The first
COPP
issued
dated 1909-2014
by EMA
says that
“The
product
is
not
actualy
in
the
market
of
exportin
g
country
”
GMP
complian
t as per
COPP.
The 2nd
COPP
issued
dated 2109-2015
says that
the
product
is on free
sale in
the
exportin
g
country.
89
Approved
as
per
Import
Policy for
Finished
Drugs
47.
M/s.
Care
Takers
the
Healthcare
Company,
131-B,
M.A.
Johar
Town,
Lahore.
Microbar HD Powder
for Suspension
Each 100gm contains:Barium
Sulpahte
B.P…………..95gm
Palatable
Base
q.s……………..100gm
(X-Ray Contrast Media)
Eskay 03 years
Form 5A
Dy No. 233
dated 1512-2014
Rs.50,000/-
COPP
valid up
to 2-52015.
GMP
vslif upto
2-52015.
Deferred
for
the
confirmati
on as XRay
Contrast
Media is
not
included
for priority
considerati
on
Already
approved
in 254th
meeting
but later
on
deleted
by
the
Board in
256th
meeting
as
the
decision
on new
molecule
s is not
clear.
COPP
Issued on
28-102014
Approved
as
per
Import
Policy for
Finished
Drugs
M/s.
Speciality
Chemicals,
Plot No. 207-B
& 208 Surat
Special
Economic Zone,
Road
No.-4,
G.I.D.C., At &
Post
Sachin,
Surat, India.
48.
M/s.
GlaxoSmithKlin
e
Pakistan
Limited,
35Dockyard Road,
West
Wharf,
Karachi-74000.
Incruse Ellipta
Form-5A
Dry Powder Inhaler
Each
pre-dispensed
dose contains.
Umeclidinium
(equivalent to 74.2 mcg
of
umecidinium
bromide)…….62.5mcg
Dy.
No:
234 dated
15-12-2014
50,000/dated 1512-2014
Manufactured
by
Will
be
M/s.
Glaxo (Long acting muscarinic submitted
Operations UK antagonist (LAMA)
later
Limited, Priory
Street,
Ware New molecule.
Hertfordshire
SG12
ODG,
United
Kingdom.
Market
Authorization
Holder
M/s
Glaxo
Minutes for 260th Meeting Registration Board
90
49.
Group Ltd, 980
Great
West
Road, Brentford,
Middlesex TW8
9GS,
United
Kingdom.
M/s.
Novartis
Pharma
(Pakistan)
Limited,
15
West
Wharf,
Karachi.
Manufactured
By
M/s.
Novartis
Pharma
Stein
AG,
Stein,
Switzerland.
50.
M/s.
Novartis
Pharma
(Pakistan)
Limited,
15
West
Wharf,
Karachi.
Zykadia 150mg Hard Form 5A
Gelatin Capsules
Dy. No 243
Each capsule contains:- dated 17Ceritinib…………..150 12-2014
mg
Rs.50,000/-
MHRA.
Zykadia
150mg capsule
by
M/s
Novartis.
COPP
valid
upto 0707-2016
issued by
US FDA.
Deferred
for
the
clarificatio
n
regarding
approval
status of
product by
regulataor
y authority
of
Switzerlan
d.
MHRA. Jakavi
5, 10, 15 &
Dy No. Nil 20mg by M/s
dated 24- Novartis.
12-2014
Rs.50,000/-
Dossier
is
photocop
y
fee
Rs.50,00
0
is
photocop
y.
Photoco
py COPP
issued
dated0711-2014.
GMP
complian
t as per
COPP.
Stability
data as
per
condition
s of Zone
IV-B
attached.
Deferred
for
the
verificatio
n of fee,
submissio
n
valid
legalized
COPP
(Anaplastic lymphoma Rs.450,000
kinase
positive /50’s
advanced non small capsules.
cell lung cancer)
Manufacturer’s
Specifications
24 months
Jakavi 10mg Tablet
Each tablet contains:Ruxolitinib………..10
mg
Form 5A
(Myelo
fibrosis,
M/s.
Novartis polycythemia vera)
Rs.418520/
Pharma
Stein
56’s tablets
AG,
Stein, Manufacturer’s
Switzerland.
Specifications
24 months
Minutes for 260th Meeting Registration Board
91
51.
52.
M/s. PharmEvo
(Pvt) Ltd.,
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi
M/s.
Hetero
Labs
Limited
Unit – VI Sy
No. 410 & 411,
APIIC
Formulation
SEZ, Polepally
Village,
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
M/s. PharmEvo
(Pvt) Ltd.,
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi
Temotero
Capsule
250mg Form 5A
MHRA.
Temodal 5mg,
DY.
272 20mg, 100mg,
Each
hard gelatin dated 24- 140mg, 180mg
capsule contains:12-2014
& 250mg by
Temozolomide………
Rs.100,000 M/s Merck
…..250mg
/
Local.
(For newly diagnosed As
per Temoside
SRO
20mg, 100mg
Glioblastoma
& 250mg by
multiforme
M/s AJ. Mirza.
concomitantly
with
radiotherapy)
Manufacturer’s
Specifications
02 years
Temotero 5mg Capsule
MHRA.
Temodal 5mg,
Each
hard gelatin Dy. No 273 20mg, 100mg,
capsule contains:dated 24- 140mg, 180mg
Temozolomide………
12-2014
& 250mg by
…..5mg
Rs.100,000 M/s Merck
/(For newly diagnosed
As
per
Manufactured
Glioblastoma
SRO
By.
multiforme
M/s.
Hetero concomitantly
with
Labs
Limited radiotherapy)
Unit – VI Sy
No. 410 & 411, Manufacturer’s
APIIC
Specifications
Formulation
SEZ, Polepally 02 years
Village,
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
Minutes for 260th Meeting Registration Board
Form 5A
COPP
valid
upto 3012-2015.
Deferred
for
the
submissio
n
of
stability
Photocop data as per
y
of conditions
GMP
of
Zone
valid
IV A and
upto 19- valid
09-2014. legalized
COPP
Stability
is not as
per
condition
s of Zone
IV A.
COPP
valid
upto 3012-2015.
Deferred
for
the
submissio
n
of
stability
Photocop data as per
y
of conditions
GMP
of
Zone
valid
IV A and
upto 19- valid
09-2014. legalized
COPP
Stability
is not as
per
condition
s of Zone
IV A.
92
53.
54.
509301, Andhra
Pradesh, India.
M/s. PharmEvo
(Pvt) Ltd.,
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi
Temotero
Capsule
20mg Form 5A
MHRA.
Temodal 5mg,
Dy.
NO 20mg, 100mg,
Each
hard gelatin 270 Dated 140mg, 180mg
capsule contains:24-12-2014 & 250mg by
Temozolomide………
Rs.100,000 M/s Merck
…..20mg
/Local.
(For newly diagnosed As
per Temoside
Manufactured
SRO
20mg, 100mg
By.
Glioblastoma
M/s.
Hetero multiforme
& 250mg by
Labs
Limited concomitantly
M/s AJ. Mirza.
with
Unit – VI Sy radiotherapy)
No. 410 & 411,
APIIC
Manufacturer’s
Formulation
Specifications
SEZ, Polepally 02 years
Village,
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
COPP
valid
upto 3012-2015.
M/s. PharmEvo
(Pvt) Ltd.,
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi
Temotero
Capsule
100mg Form 5A
Original
not
provided.
Photocy
COPP
valid
upto 3012-2015.
Photocop
y
of
GMP
valid
upto 1909-2014.
MHRA.
Temodal 5mg,
Dy. No 271 20mg, 100mg,
Each
hard gelatin dated 24- 140mg, 180mg
capsule contains:12-2014
& 250mg by
Temozolomide………
Rs.100,000 M/s Merck
…..100mg
/Local.
(For newly diagnosed As
per Temoside
Manufactured
SRO
20mg, 100mg
By.
Glioblastoma
M/s.
Hetero multiforme
& 250mg by
Labs
Limited concomitantly
M/s AJ. Mirza.
with
Unit – VI Sy radiotherapy)
No. 410 & 411,
APIIC
Manufacturer’s
Formulation
Specifications
SEZ, Polepally
Village,
02 years
Jadcherla
Minutes for 260th Meeting Registration Board
Deferred
for
the
submissio
n
of
stability
Photocop data as per
y
of conditions
GMP
of
Zone
valid
IV A and
upto 19- valid
09-2014. legalized
COPP
Stability
is not as
per
condition
s of Zone
IV A.
Stability
is not as
per
condition
93
Deferred
for
the
submissio
n
of
stability
data as per
conditions
of
Zone
IV A and
valid
legalized
COPP
Mandal,
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
s of Zone
IV A.
55.
M/s. Gene-Tech
Laboratories,
Head
Office.
246/B, PECHS,
Block-6,
Karachi.
ADPEM 500 Injection
Form 5A
MHRA.
Alimta 100mg
Each vial contains:Dy No.255 &
500mg
Pemetrexed Disodium
R&I dated powder
for
eq.
to 24-12-2014 conc.
For
Pemetrexed……..……
Rs.100,000 infusion
by
……500mg
/M/s Eli Lilly.
Manufactured
Mannitol
by
USP…………..500mg
Rs.70,000/ Local. Alimta
M/s.
Adley
vial
100mg
&
Formulations,
500mg by M/s
(Malignant
pleural
Vill. Kotla, PO. mesothelioma
Eli Lilly.
nonBorotiwala,
small cell lung cancer)
Tehsil: Baddi,
Distt.
Solan, 24 months
Himachal (H.P)
Pradesh, India.
COPP
valid
upto 0802-2015.
No.
HFW-H
(DRUG)
22/05
(Vol.VI)
56.
M/s. Gene-Tech
Laboratories,
Head
Office.
246/B, PECHS,
Block-6,
Karachi.
CAPAD 500mg Tablets
Form 5A
Manufactured
by
M/s.
Adley
Formulations,
Vill. Kotla, PO.
Borotiwala,
Tehsil: Baddi,
Distt.
Solan,
Himachal (H.P)
Pradesh, India.
(adjuant treatment of
patients
following
surgery of stage III
colon cancer, metastatic
colo-rectal
cancer)
COPP
valid
upto 0802-2015.
No.
HFW-H
(DRUG)
22/05
(Vol.VI)
Each film coated tablet
contains:Capecitabine
USP…………..500mg
24 months
Minutes for 260th Meeting Registration Board
MHRA.
Capecitabine
Dy No.256 500mg f/c by
R&I dated M/s Accord.
24-12-2014
Rs.100,000 Local. Xeloda
/500mg by M/s
Roche.
Rs.2083/10
’s
Deferred
for
the
submissio
n
of
following
a. Stability
data as per
conditions
of
Zone
IV A
GMP
b.Sole
certificat agency
e valid agreement
upto 08- c.
Drug
02-2015 Sales
No.
License.
HFW-H
(DRUG)
22/05
(Vol.VI)
Deferred
for
the
submissio
n
of
following
a. Stability
data as per
conditions
of
Zone
IV A
GMP
b.Sole
certificat agency
e valid agreement
upto 08- c.
Drug
02-2015 Sales
No.
License.
HFW-H
(DRUG)
22/05
94
(Vol.VI)
57.
M/s. Gene-Tech
Laboratories,
Head
Office.
246/B, PECHS,
Block-6,
Karachi.
BORTIAD
Injection
2.0mg Form 5-A
Manufactured
by
M/s.
Adley
Formulations,
Vill. Kotla, PO.
Borotiwala,
Tehsil: Baddi,
Distt.
Solan,
Himachal (H.P)
Pradesh, India.
(Lymphocytic
leukemia,
indolent Not
mentioned
non-Hodgkin’s
lymphoma, multiple
myeloma)
Each vial contains:Bortezomib……………
…..2.0mg
24 months
Minutes for 260th Meeting Registration Board
Dy No.257
R&I dated
24-12-2014
Rs.100,000
/-
COPP
valid
upto 0802-2015.
No.
HFW-H
(DRUG)
22/05
(Vol.VI)
GMP
certificat
e valid
upto 0802-2015
No.
HFW-H
(DRUG)
22/05
(Vol.VI)
Approval
status in
reference
countries
is
not
provided.
Internati
onaly the
product
is present
as
mannitol
boronic
ester.
Clarificat
ion
whether
the
product
is
in
liquid
form or
powder
form.
95
Deferred
for
the
submissio
n
of
following
a.
Approval
status by
reference
regulatory
authorities
b.Stability
data as per
conditions
of
Zone
IV A.
c.Sole
agency
agreemend
d.Drug
Sales
License.
58.
M/s. Gene-Tech
Laboratories,
Head
Office.
246/B, PECHS,
Block-6,
Karachi.
ADGEF 250mg Tablet
Form 5-A
MHRA. Iressa
250mg
f/c
Each film coated tablet Dy No.261 tablet by M/s
contains:R&I dated AstraZeneca.
Gefitinib……………25 24-12-2014
0mg
Rs.100,000 Local.
/Manufactured
(Advanced or metaby
static non small cell Rs.140,000
M/s.
Adley lung cancer)
/15’s pack
Formulations,
Vill. Kotla, PO. 24 months
Borotiwala,
Tehsil: Baddi,
Distt.
Solan,
Himachal (H.P)
Pradesh, India.
COPP
valid
upto 0802-2015.
No.
HFW-H
(DRUG)
22/05
(Vol.VI)
59.
M/s. Gene-Tech
Laboratories,
Head
Office.
246/B, PECHS,
Block-6,
Karachi.
ADMINE 100mg Tablet Form 5-A
COPP
valid
upto 0802-2015.
No.
HFW-H
(DRUG)
22/05
(Vol.VI)
MHRA.
Glivec 100mg
Each film coated tablet Dy No.259 & 400mg f/c
contains:R&I dated by
M/s
Imatinib Mesylate
24-12-2014 Novartis.
Eq.
to Rs.100,000
Imatinib…………100m /Local. Glivec
M/s.
Adley g
100mg
&
Formulations,
Rs.11083/1 400mg by M/s
Vill. Kotla, PO. (Philadelphia
0’s pack
Novartis
Minutes for 260th Meeting Registration Board
Deferred
for
the
submissio
n
of
following
a. Stability
data as per
conditions
of
Zone
IV A
GMP
b.Sole
certificat agency
e valid agreement
upto 08- c.
Drug
02-2015 Sales
No.
License.
HFW-H
(DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
96
Deferred
for
the
submissio
n
of
following
a. Stability
data as per
conditions
of
Zone
IV A
Borotiwala,
Tehsil: Baddi,
Distt.
Solan,
Himachal (H.P)
Pradesh, India.
chromosome
chronic
leukemia)
positive
myeloid
Pharma.
Manufacturer’s
Specifications
24 months
60.
M/s. Gene-Tech
Laboratories,
Head
Office.
246/B, PECHS,
Block-6,
Karachi.
ADMINE 400mg Tablet Form 5-A
MHRA.
Glivec 100mg
Each film coated tablet Dy No.260 & 400mg f/c
contains:R&I dated by
M/s
Imatinib Mesylate
24-12-2014 Novartis.
Eq.
to Rs.100,000
Imatinib…………400m /Local. Glivec
g
100mg
&
Rs.46667/1 400mg by M/s
(Philadelphia
0’s pack
Novartis
Pharma.
chromosome positive
chronic
myeloid
leukemia)
M/s.
Adley
Formulations,
Vill. Kotla, PO.
Borotiwala,
Tehsil: Baddi,
Distt.
Solan,
Himachal (H.P)
Pradesh, India.
Manufacturer’s
Specifications
24 months
Minutes for 260th Meeting Registration Board
GMP
certificat
e valid
upto 0802-2015
No.
HFW-H
(DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
COPP
valid
upto 0802-2015.
No.
HFW-H
(DRUG)
22/05
(Vol.VI)
b.Sole
agency
agreement
c.
Drug
Sales
License.
Deferred
for
the
submissio
n
of
following
a. Stability
data as per
conditions
of
Zone
IV A
GMP
b.Sole
certificat agency
e valid agreement
upto 08- c.
Drug
02-2015 Sales
No.
License.
HFW-H
(DRUG)
22/05
(Vol.VI)
Stability
97
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
61.
M/s. Gene-Tech
Laboratories,
Head
Office.
246/B, PECHS,
Block-6,
Karachi.
ERLOTAD
Tablet
100mg Form 5A
Each film coated tablet
contains:Erlotinib Hydochloride
Eq.
to
M/s.
Adley Erlotinib…………….10
Formulations,
0mg
Vill. Kotla, PO.
Borotiwala,
(Non small cell lung
Tehsil: Baddi, cancer or pancreatic
Distt.
Solan, cancer)
Himachal (H.P)
Pradesh, India.
Manufacturer’s
Specifications
24 months
Minutes for 260th Meeting Registration Board
MHRA.
Tarceva 25mg,
Dy No. 258 100mg
&
R&I dated 150mg
f/c
24-12-2014 tablets by M/s
Rs.100,000 Roche.
/Local. Tarceva
As
per 25mg, 100mg
SRO
& 150mg f/c
tablets by M/s
Roche.
COPP
valid
upto 0802-2015.
No.
HFW-H
(DRUG)
22/05
(Vol.VI)
Deferred
for
the
submissio
n
of
following
a. Stability
data as per
conditions
of
Zone
IV A
GMP
b.Sole
certificat agency
e valid agreement
upto 08- c.
Drug
02-2015 Sales
No.
License.
HFW-H
(DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
98
62.
M/s. Gene-Tech
Laboratories,
Head
Office.
246/B, PECHS,
Block-6,
Karachi.
Manufactured
by
M/s.
Adley
Formulations,
Vill. Kotla, PO.
Borotiwala,
Tehsil: Baddi,
Distt.
Solan,
Himachal (H.P)
Pradesh, India..
ERLOTAD
Tablet
150mg Form 5A
Each film coated tablet
contains:Erlotinib Hydochloride
Eq.
to
Erlotinib…………….15
0mg
(Non small cell lung
cancer or pancreatic
cancer)
MHRA.
Tarceva 25mg,
Dy No. 254 100mg
&
R&I dated 150mg
f/c
24-12-2014 tablets by M/s
Rs.100,000 Roche.
/Local. Tarceva
As
per 25mg, 100mg
SRO
& 150mg f/c
tablets by M/s
Roche.
Manufacturer’s
Specifications
24 months
COPP
valid
upto 0802-2015.
No.
HFW-H
(DRUG)
22/05
(Vol.VI)
Deferred
for
the
submissio
n
of
following
a. Stability
data as per
conditions
of
Zone
IV A
GMP
b.Sole
certificat agency
e valid agreement
upto 08- c.
Drug
02-2015 Sales
No.
License.
HFW-H
(DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
63.
Sport Vis TM pre-filled
syringe for peri-articular
injection
Each pre-filled syringe
contains:1.2ml
1%
low
molecular
weight
sodium hyaluronatein
MDT phosphate
buffered
M/s. Group 9
Pakistan,
MI, 19-C Rahat
Commercial
Lane 2, DHA
Phase-6,
Karachi.
M/s.
Minutes for 260th Meeting Registration Board
Form 5A
Dy
284
dated 2912-2014
Rs.50,000/-
Free
sales
certificat
e valid
upto
dated 0110-2016
by swiss
medic
99
Deferred
for
the
clarificatio
n as the
complete
descriptio
n
as
applied on
Form 5A
64.
Int,SA,
Rue
du
31
Decembre, 36
1207 Geneva,
Switzerland.
Manufacturing
site address:
Hyaltech Ltd.,
Starlaw
Business Park
EH54
8SF
Livingston,
United
Kingdom.
M/s.
Langene
Biotech,
Head
Office.
246/B, PECHS,
Block-6,
Karach-75400.
M/s. Aburaihan
Pharmaceutical
Company,
No.1, Hojr ebne
Oday
Ave,
Tehranpars
Tehran-I.R. Iran.
saline
(Peri-articular injection)
but
complete
descripti
on
as
applied
on Form
5A is not
mentione
d on free
sales.
Medical
Device
is
not
same
as
mentioned
on
free
sales
certificate.
Firm will
provide
either
CoPP or
FSC and
GMP
Form 5A
Non
legalized
copy of
COPP
dated 1709-2014
attached.
DSL is
not
attached.
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
Deferred
for
the
submissio
n
of
following
a. Valid
legalized
COPP.
b. Drugs
Sales
License.
c. Stability
data as per
conditions
of
Zone
IV-A
d.
Sole
agency
agreement.
Form 5A
COPP
valid
upto 2-52015.
GMP
valid
upto 2-52015.
Deferred
for
the
confirmati
on as XRay
Contrast
Media is
not
36 months
New molecule
Letrax 2.5mg Tablet
MHRA. Femra
2.5mg
f/c
Each film coated tablet Dy No. 01 tablet by M/s
contains:dated 01- Novartis.
Letrozole
01-2015
(micronized)…….……. Rs.100,000 Local. Femra
.2.5mg
/2.5mg by M/s
Novartis.
(Adjuant treatment of Rs.6000/30
’s Pack.
post-menopausal
women with harmone
recpotor
positive
invasive early breast
cancer)
Manufacturer’s
Specifications
03 years
65.
M/s.
Care
Takers
the
Healthcare
Company, 131B, M.A. Johar
Town, Lahore.
M/s.
Microbar CAT 2 Liquid
Suspension
Each 100ml contains:Barium
Sulpahte
B.P…………..7gm
Palatable
Base
q.s……………..100ml
Eskay (X-Ray Contrast Media)
Minutes for 260th Meeting Registration Board
Dy No. 12
dated 0801-2015
Rs.50,000/-
100
66.
67.
Speciality
Chemicals,
Plot No. 207-B
& 208 Surat
Special
Economic Zone,
Road
No.-4,
G.I.D.C., At &
Post
Sachin,
Surat, India.
M/s.
Care
Takers
the
Healthcare
Company, 131B, M.A. Johar
Town, Lahore.
03 years
included
for priority
considerati
on
Microbar for Enema
(Disposable
Kit)
Powder
for
Rectal
Suspension
Each 100gm contains:Barium
Sulpahte
B.P…………..92gm
M/s.
Eskay Base
Speciality
q.s……………………
Chemicals,
….100gm
Plot No. 207-B (X-Ray Contrast Media)
& 208 Surat 03 years
Special
Economic Zone,
Road
No.-4,
G.I.D.C., At &
Post
Sachin,
Surat, India.
Form 5A
M/s. PharmEvo
(Pvt) Ltd.,
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi
Iritero
40mg/2ml
MHRA.
Campto
Dy. No 14 20mg/ml,
dated 08- conc.
For
01-2015
solution 40mg,
Rs.100,000 100mg,
&
/300mg.
Manufactured
By.
M/s.
Hetero
Labs
Limited
Unit – VI Sy
No. 410 & 411,
APIIC
Formulation
SEZ, Polepally
(Advanced Colorectal As
cancer)
SRO
Dy No. 11
dated 0801-2015
Rs.50,000/-
Injection Form 5A
Each vial contains:Irinotecan
Hydrochloride
…….40mg
Manufacturer’s
Specifications
03 years
Minutes for 260th Meeting Registration Board
per
COPP
valid
upto 2-52015.
GMP
valid
upto 2-52015.
Deferred
for
the
confirmati
on as XRay
Contrast
Media is
not
included
for priority
considerati
on
COPP/Fr
ee sales
certificat
e is not
attached.
GMP
certificat
e is not
attached.
Stability
data is
not
as
per
condition
s of Zone
IV-A.
Deferred
for
the
submissio
n
of
following
a. Stability
data as per
conditions
of
Zone
IV-A.
b. Valid
Legalized
CoPP.
101
Village,
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
68.
69.
M/s. PharmEvo
(Pvt) Ltd.,
Plot No. A-29,
North
West
Industrial Zone,
Port
Qasim,
Karachi
Iritero
100mg/5ml
Injection Form 5 A
Manufactured
By.
M/s.
Hetero
Labs
Limited
Unit – VI Sy
No. 410 & 411,
APIIC
Formulation
SEZ, Polepally
Village,
Jadcherla
Mandal,
Mahaboob
Nagar
(Dist)
509301, Andhra
Pradesh, India.
(Advanced Colorectal As
cancer)
SRO
M/s. Biomedics
Medical System,
F-597, F-Block,
Satellite Town,
Rawalpindi.
Ipraneb 500 mcg /2ml
Nebuliser Solution
Each vial contains:Irinotecan
Hydrochloride
…….100mg
MHRA.
Campto
Dy. No 13 20mg/ml,
dated 08- conc.
For
01-2015
solution 40mg,
Rs.100,000 100mg,
&
/300mg.
per
Manufacturer’s
Specifications
03 years
MHRA.
Atrovent 2ml
Dy No.20 250mcg/ml by
Each 2ml vial contains:- dated 14- M/s
Ipratropium
01-2015
Boehringer.
Bromide……………… Rs.50,000/Manufactured
…….500mcg/2ml
by
Rs.450/Via
M/s.
Ain (Anticholinergics)
l 2ml
Medicare
New Formulation
SDN.BHD,
Jalan
6/44, Manufacturer’s
Kawasan
Specifications
Minutes for 260th Meeting Registration Board
Form 5A
COPP/Fr
ee sales
certificat
e is not
attached.
GMP
certificat
e is not
attached.
Stability
data is
not
as
per
condition
s of Zone
IV-A.
Deferred
for
the
submissio
n
of
following
a. Stability
data as per
conditions
of
Zone
IV-A.
b. Valid
Legalized
CoPP.
COPP
issued by
Malaysia
Drug
Control
Authorit
y
on
dated 3110-2014
vide
Number
1879/201
4.
Approved
as
per
Import
Policy for
Finished
Drugs
102
Perindustrian
Pengkalan
02 years
Chepa 2, 16100
Kota
Bharu
Kelantan Darul
Naim, Malaysia.
70.
M/s. Ali Gohar
&
Company
(Pvt) Limited,
State
Life
Building 1B, I.I
Chundrigar
Road, Karachi.
Manufacture by.
M/s.
AlconCouveur N.V.
Rijksweg 14, B2870,
Puurs,
Belgium.
Site for Quality
Control, Primary
&
Secondary
Packaging.
M/s
Alcon
Research
Ltd
(Subsidiary of
Alcon
Laboratories,
Simbrinza Eye Drops,
Suspension
Contains:Brinzolamide………….
10mg/ml
Brimonidine
Tartrate
2mg
eq.to
Brimonidine…….1.3mg
/ ml
24 months
(Ophthalmic)
New Formulation
Minutes for 260th Meeting Registration Board
Form 5-A
Dy No.33
23-02-2015
Rs.50,000/-
GMP
certificat
e issued
dated 2910-2014
vide No.
413/14
valid
upto 0401-2017
Stability
data on
the
condition
s
of
water
loss
is
attached
being
semi
permeabl
e
container
s.
EMA.
Original
Simbrinza by legalized
M/s Alcon
COPP
was
issued by
EMA on
dated
01-092014.
GMP
issued by
balgium
on dated
17-052013
Stability
data not
as
per
Zone IV
A.
Deferred
for
the
submissio
n
of
stability
data as per
conditions
of zone IV
A.
103
71.
Inc),
ASPEX
manufacturing
Facility, 6201
South Freeway,
Fort Worth, TX
76134-2099,
USA
Market
Authorization:
Alcon
Laboratories
(UK)
Ltd,
Frimley
Business Park,
Frimley,
Camberley
GU16
7SR,
United
Kingdom.
M/s.
Novartis
Pharma
(Pakistan)
Limited,
15
West
Wharf,
Karachi.
Signifor LAR Powder Form 5-A
for Suspension for
Injection
Dy No.314
R&I dated
Each vial contains:29-05-2015
Pasireotide……………. Rs.50,000/20mg
(as pasireotide pamoate) Rs.450,000
Manufactured
/ 1’s
By
M/s.
Novartis (Treatment
of
Pharma
AG, Acromegaly)
Lichtstrasse 35, New Molecule
4056
Basel,
Switzerland.
Manufacturer’s
Specifications
Market
Authorization:
Novartis
36 months
Europharm
Limited,
Wimblehurst
Road, Horsham,
West
Sussex
RH12
5AB,
United Kingdom
Minutes for 260th Meeting Registration Board
MHRA.
Signifor
Powder
for
injection
20mg, 40mg
& 60mg by
M/s Novartis
Orignal
legalized
COPP
was
issued by
Europea
n
Medicine
Agency
on
19-022015.
The
GMP
certificat
e
says
that the
site
is
licensed
to
manufact
ure
medicina
l
products
excluded
sterile
Deferred
for
the
clarificatio
n/submissi
on
of
following
a. Status
of
manufactu
ring site
for
the
manufactu
ring
of
sterile
products
as GMP
states that
site
is
licensed to
manufactu
re
medicinal
products
excluded
sterile
products.
b.
104
products.
72.
M/s.
Novartis
Pharma
(Pakistan)
Limited,
15
West
Wharf,
Karachi.
Signifor LAR Powder Form 5-A
for Suspension for
Injection
Dy No.315
dated 29Each vial contains:05-2015
Pasireotide……………. Rs.50,000/40mg
(as pasireotide pamoate) Rs.750,000
/1’s
(Treatment
of
Acromegaly)
(36
months)
New Molecule
MHRA.
Signifor
Powder
for
injection
20mg, 40mg
& 60mg by
M/s Novartis
Manufactured
By
M/s.
Novartis
Pharma
AG,
Lichtstrasse 35,
4056
Basel,
Switzerland.
Manufacturer’s
Market
Authorization: Specifications
Novartis
Europharm
36 months
Limited,
Wimblehurst
Road, Horsham,
West
Sussex
RH12
5AB,
United Kingdom
73.
M/s.
Novartis Signifor LAR Powder Form 5-A
MHRA.
Pharma
for Suspension for
Signifor
(Pakistan)
Injection
Dy No.313 Powder
Minutes for 260th Meeting Registration Board
Orignal
legalized
COPP
was
issued by
Europea
n
Medicine
Agency
on
19-022015.
The
GMP
certificat
e
says
that the
site
is
licensed
to
manufact
ure
medicina
l
products
excluded
sterile
products.
Orignal
legalized
for COPP
Registratio
n
applicatio
n
of
Solvent on
separate
applicatio
n.
Deferred
for
the
clarificatio
n/submissi
on
of
following
a. Status
of
manufactu
ring site
for
the
manufactu
ring
of
sterile
products
as GMP
states that
site
is
licensed to
manufactu
re
medicinal
products
excluded
sterile
products
b.
Registratio
n
applicatio
n
of
Solvent on
separate
applicatio
n.
Deferred
for
the
clarificatio
105
Limited,
15
West
Wharf, Each vial contains:Karachi.
Pasireotide…………….
60mg
(as pasireotide pamoate)
Manufactured
(Treatment
of
By
M/s.
Novartis Acromegaly)
Pharma
AG, New Molecule
Lichtstrasse 35,
4056
Basel, Manufacturer’s
Switzerland.
Specifications
Market
Authorization: 36 months
Novartis
Europharm
Limited,
Wimblehurst
Road, Horsham,
West
Sussex
RH12
5AB,
United Kingdom
74.
M/s.
ICI
Pakistan
Limited,
Life
Sciences
Business,
ICI
House, 5 West
Wharf, Karachi
R&I dated injection
was
29-05-2015 20mg, 40mg issued by
Rs.50,000/- & 60mg by Europea
M/s Novartis
n
Rs.1250,00
Medicine
0/1’s
Agency
on
19-022015.
The
GMP
certificat
e
says
that the
site
is
licensed
to
manufact
ure
medicina
l
products
excluded
sterile
products.
Martxel
500mg Form 5A
Lyophilized Powder for
injection solution for Dy.
No
intravenous infusion
330 dated
01-06-2015
Each vial contains:Rs.100,000
Pemetrexed
as /disodium………….500
Manufactured
mg
As
per
by
SRO
M/s. Eriochem (Malignant
pleural
S.A.
mesothelioma
nonRuta 12, Km small cell lung cancer)
452
(3107),
Minutes for 260th Meeting Registration Board
MHRA.
Alimta 100mg
&
500mg
powder
for
conc.
For
infusion
by
M/s Eli Lilly.
COPP
issued on
29-122014 by
Argentin
a is valid
for
12
month.
Local. Alimta
100mg
& GMP
500mg by M/s complian
Eli Lilly.
t as per
COPP.
n/submissi
on
of
following
a. Status
of
manufactu
ring site
for
the
manufactu
ring
of
sterile
products
as GMP
states that
site
is
licensed to
manufactu
re
medicinal
products
excluded
sterile
products
b.
Registratio
n
applicatio
n
of
Solvent on
separate
applicatio
n.
Approved
as
per
Import
Policy for
Finished
Drugs.
Firm will
provide
valid
legalized
CoPP and
chairman
will permit
further
106
75.
76.
77.
Colonia
Manufacturer’s
Avellaneda,
Specifications
Departamento
Parana,
Entre 24 months
Rios, Argentina.
processing
of case
M/s. Pharmatec
Pakistan (Pvt)
Ltd.,
D-86/A
Mangopir Road,
S.I.T.E, Karachi.
Manufactured
By
M/s.
L.MOLTENI &
C, DEI F.LLI
ALITTI
SOCIETA’DI
ESERCIZIO
S.P.A.
S.S.67
(TOSCO
ROMAGNOLA
) LOCALITA
GRANATIERI50018, ITALY.
M/s. Pharmatec
Pakistan (Pvt)
Ltd.,
D-86/A
Mangopir Road,
S.I.T.E, Karachi.
/
Manufactured
By
M/s.
L.MOLTENI &
C, DEI F.LLI
ALITTI
SOCIETA’DI
ESERCIZIO
S.P.A.
S.S.67
(TOSCO
ROMAGNOLA
) LOCALITA
GRANATIERI50018, ITALY.
M/s.
Merixil
Approved
as
per
Import
Policy for
Finished
Drugs
Stability
data as
per
condition
s of Zone
IV-B.
Oramorph
2mg/ml Form 5A
MHRA.
Certificat
Syrup
Dy. No 320 Oramorph
e
of
dated 01- 10mg/5ml by Medicina
Each ml contains:06-2015
M/s
l product
Morphine
Rs.100,000 Boehringer.
03-03Sulphate………..2mg
/2015.
GMP
(Natural
Opium Rs.648/100
issued
Alkaloids)
ml
dated 0722-2014.
New formulation
Manufacturer’s
Specifications
36 months
Oramorph
20mg/ml Form 5A
Oral Solution
Dy. No 319
dated 01Each ml contains:06-2015
Morphine
Rs.100,000
Sulphate………..20mg /(Natural
Alkaloids)
Opium Rs.829/20
ml
MHRA.
Certificat
Oramorph
e
of
20mg/ml by Medicina
M/s
l product
Boehringer
03-032015.
GMP
issued
dated 0722-2014.
Approved
as
per
Import
Policy for
Finished
Drugs
MHRA.
Approved
New formulation
Manufacturer’s
Specifications
36 months
Biopac
30mg/5ml Form 5A
Minutes for 260th Meeting Registration Board
COPP
107
Pharma,
Office # 28,
Second Floor,
Rose Plaza, I-8
Markaz,
Islamabad.
Manufactyured
By
M/s.
Biolyse
Pharma
Corporation, 59
Welland Vale
Road,
ST
Catharines
Ontario
L2S
3Y2, Canada.
78.
M/s.
Genome
Pharmaceuticals
(Pvt) Ltd., Plot #
16/1, Phase IV,
Industrial Estate,
Hattar,
Distt,
Haripur./
Injection
Each ml contains:Paclitaxel………….…6
mg
Dy No. 349
dated 1506-2015
Rs.100,000
.
(Monotherapy
for As
meta-static
breast SRO.
cancer.
In
combination
with
Gemcitabin for metastatic adenocarcinoma
of pancreas)
Paclitaxel
6mg/ml Conc.
for solution for
infusion
by
M/s
Medac
(5ml, 16.7ml,
per 50ml
&
100ml).
USP Specifications
M/s.
Genome
Pharmaceuticals
(Pvt) Ltd., Plot #
16/1, Phase IV,
as
per
Import
Policy for
Finished
Drugs
GMP
Complia
nt as per
COPP.
30 months
Wego
Single 09-07-2015
Disposable Blood Bag
Rs.50,000/Each 100ml of CPDA
contains:Citric
acid
monohydrate……..…0.
327g
Sodium
citrate
dihydrate…………2.63
g
Sodium
biphosphate
monohydrate…0.222g
Dextrose
monohydrate….3.19g
Adenine………0.0275g
Water
for
injection…………q.s
(Medical consumables)
(Photoco
py)
of
Certificat
e
for
Exportati
on
of
Medical
Products
issued by
Governm
ent
of
China on
dated.2005-2014
Original
GMP
is
not
attached
Deferred
for
the
submissio
n
of
following
a. Valid
legalized
COPP
b. Stability
data as per
water loss
conditions
as per ICH
Guidelines
.
Wego
Double 09-07-2015
Disposable Blood Bag
Rs.50,000/Each 100ml of CPDA
contains:-
(Photoco
py)
of
Certificat
e
for
Deferred
for
the
submissio
n
of
M/s. Shandong
Weigao Group
Medical
Polymer
Co.,
Ltd. 10 Mashan
Road High-Tech
Industrial
Development
Zone, Weihai,
Shandong
Province,
People’s
Blood Bag
Republic
of
China.
02 years
79.
Local.
Panataxel
100mg,
150mg, 300mg
& 30mg by
M/s
Ferozsons.
issued on
11-082014 by
Health
Canada.
Minutes for 260th Meeting Registration Board
108
80.
81.
Industrial Estate,
Hattar,
Distt,
Haripur./
M/s. Shandong
Weigao Group
Medical
Polymer
Co.,
Ltd. 10 Mashan
Road High-Tech
Industrial
Development
Zone, Weihai,
Shandong
Province,
People’s
Republic
of
China.
Citric
acid
monohydrate.…0.327g
Sodium
citrate
dihydrate………2.63g
Sodium
biphosphate
monohydrate…..0.222g
Dextrose
monohydrate….3.19g
Adenine………0.0275g
Water
for
injection……………q.s
(Medical consumables)
M/s.
Genome
Pharmaceuticals
(Pvt) Ltd., Plot #
16/1, Phase IV,
Industrial Estate,
Hattar,
Distt,
Haripur./
M/s. Shandong
Weigao Group
Medical
Polymer
Co.,
Ltd. 10 Mashan
Road High-Tech
Industrial
Development
Zone, Weihai,
Shandong
Province,
People’s
Republic
of
China.
Wego Triple Disposable 09-07-2015
Blood Bag
Rs.50,000/Each 100ml of CPDA
contains:Citric
acid
monohydrate…0.327g
Sodium
citrate
dihydrate………2.63g
Sodium
biphosphate
monohydrate…0.222g
Dextrose
monohydrate…..3.19g
Adenine……0.0275g
Water
for
injection…………q.s
(Medical consumables)
M/s.
Genome
Pharmaceuticals
(Pvt) Ltd., Plot #
16/1, Phase IV,
Industrial Estate,
Hattar,
Distt,
Wego
Quadruple 09-07-2015
Disposable Blood Bag
Rs.50,000/Each 100ml of CPDA
contains:Citric
acid
monohydrate…0.327g
Blood Bag
Exportati
on
of
Medical
Products
issued by
Governm
ent
of
China on
dated.2005-2014
Original
GMP
is
not
attached
following
a. Valid
legalized
COPP
b. Stability
data as per
water loss
conditions
as per ICH
Guidelines
.
(Photoco
py)
of
Certificat
e
for
Exportati
on
of
Medical
Products
issued by
Governm
ent
of
China on
dated.2005-2014
Original
GMP
is
not
attached
Deferred
for
the
submissio
n
of
following
a. Valid
legalized
COPP
b. Stability
data as per
water loss
conditions
as per ICH
Guidelines
.
(Photoco
py)
of
Certificat
e
for
Exportati
on
of
Deferred
for
the
submissio
n
of
following
a. Valid
02 years
Blood Bag
02 years
Minutes for 260th Meeting Registration Board
109
Haripur./
M/s. Shandong
Weigao Group
Medical
Polymer
Co.,
Ltd. 10 Mashan
Road High-Tech
Industrial
Development
Zone, Weihai,
Shandong
Province,
People’s
Republic
of
China.
82.
Sodium
citrate
dihydrate………2.63g
Sodium
biphosphate
monohydrate…0.222g
Dextrose
monohydrate…3.19g
Adenine…0.0275g
Water
for
injection…………q.s
(Medical consumables)
Medical
Products
issued by
Governm
ent
of
China on
dated.2005-2014
Original
GMP
is
not
attached
Blood Bag
legalized
COPP
b. Stability
data as per
water loss
conditions
as per ICH
Guidelines
.
02 years
M/s.
Bayer Sivextro 200mg Film
Pakistan (Pvt) Coated Tablets
Limited, C-21,
S.I.T.E, Karachi. Each film coated tablet
contains:Manufacturing Tedizolid
&
Primary, Phosphate……….200m
g
Secondary
Packaging and
(Oxazolidinone/antibioti
Quality
c)
Control by:
M/s.
Patheon New Molecule
Inc.
Whitby
Regional
Manufacturer’s
Operations
Specifications
(WRO)
111
Consumers
03 years
Drive Whitby,
Ontario
LIN
5Z5, Canada.
Market
Authorization.
Cubist
(UK)
Ltd, Unit 1
Horizon
Business
Village,
1
Brooklands
Road,
Weybridge,
Minutes for 260th Meeting Registration Board
Form 5-A
Dy No.98
30-07-2015
Rs.50,000/Not
mentioned
Original
legalized
COPP
was
issued by
EMA on
dated 2205-2015.
Deferred
for
the
submissio
n
of
following
a.
clarificatio
n
of
complete
The
details of
GMP is release site
issued by as release
Health
site is not
Canda
mentioned
dated 21- on COPP.
04-2015
valid
upto
1
year.
Release
is
not
mentione
d
in
COPP
however
the firm
has
submitte
d
the
110
Surrey
KT13
ORU,
United
Kingdom
83.
declarati
on
for
the same.
Released
by:
M/s.
Bayer
Pharma
AG
Mullerstr
asse 178
13353
Berlin,
Germany
M/s.
Bayer
Pakistan (Pvt)
Limited, C-21,
S.I.T.E, Karachi.
Sivextro Powder for Form 5-A
MHRA.
Original Deferred
Concentrate
for
Sivextro
by legalized for
the
Solution for infusion Dy No.42 M/s Merck
COPP
submissio
200mg
dated 30was
n
of
07-2015
issued by following
Rs.50,000/EMA on a.
Manufactured, Each vial contains:Tedizolid
dated 22- clarificatio
Quality
05-2015. n
of
Control
& Phosphate……….200m Not
g
mentioned
complete
Primary
(Oxazolidinone/antibioti
The
details of
Packaging by:
M/s.
Patheon c)
GMP is release site
Italia S.p.A. 2 New Molecule
issued by as release
Trav. SX Via
itlay 21- site is not
Morolense,
5 Manufacturer’s
08-2014. mentioned
03013
Specifications
on COPP.
Ferentino, FR,
Final
Italy.
Site 03 years
Release
&
Responsible for
secondar
quality
y
Control.
package
Redox s.n.c di
site
is
Arosio Antonia
not
e. C., Viale
mentione
Stucchi, 62/26,
d
in
20900 Monza
COPP
(MB), Italy.
however
Market
Authorization.
the firm
Cubist
(UK)
has
Ltd, Unit 1
submitte
Horizon
d
the
Minutes for 260th Meeting Registration Board
111
Business
Village,
1
Brooklands
Road,
Weybridge,
Surrey
KT13
ORU,
United
Kingdom
84.
85.
M/s. AJ Mirza
Pharma
(Pvt)
Ltd., 7-Ground
Floor,
Shafi
Court,
Merewether
Road,
Civil
Lines, Karachi.
Cytomid 250mg Tablet
Form 5A
Each uncoated tablet
contains:Flutamide
USP………….250mg
Excipients……………
….q.s.
Diary No.
179 R&I
dated 2008-2015
Rs.100,000
/-
Manufactured
by
M/s. Cipla Ltd.,
Verna Industrial
Estate, Verna,
India.
(Treatment
Advanced
cancer)
M/s.
Novartis
Pharma
(Pakistan)
Limited,
15
West
Wharf,
Karachi./
Product
Licence
Holder:
Caflam Capsule
Each capsule contains:Diclofenac
potassium……….50mg
(Anti-inflammatory and
analgesic)
of RS. 4200/prostate 100’s
Manufacturer’s
Specifications
New Molecule
Minutes for 260th Meeting Registration Board
Form 5-A
Dy No.106
03-08-2015
Rs.50,000/20’s
/Rs.560
MHRA
Approved
declarati
on
for
the same.
Seconda
ry
Packagi
ng
&Releas
ed by:
M/s.
Bayer
Pharma
AG
Mullerstr
asse 178
13353
Berlin,
Germany
.
COPP
valid
upto 1610-2016.
GMP
complian
t as per
COPP.
Approved
as
per
Import
Policy for
Finished
Drugs
GMP
valid
upto 1610-2016.
COPP
was
issued by
Swiss
Medic
Switzerla
nd
on
26-012015
Deferred
for
the
submissio
n
of
following
a.
confirmati
on
of
approval
112
M/s.
Novartis 30 months
Pharma Schweiz
AG, 6343 Risch,
Switzerland.
Address
of
Manufacturing
Site:
M/s.
Catalent
Germany
Eberbach GmbH
Gammelsbacher
Strasse 2 69412
Eberbach/Baden
, Germany.
86.
M/s.
Novartis
Pharma
(Pakistan)
Limited,
15
West
Wharf,
Karachi.
Farydak 10mg Capsule
Each capsule contains:Panobinostat………..10
mg
Minutes for 260th Meeting Registration Board
Product
is on the
market
of
exportin
g
country.
The
certifyin
g
authority
arragge
for
periodic
inspectio
n
not
applicabl
e.
GMP
certificat
e issued
by
German
authoriti
es on 0711-2013
The
COPP
issued by
Germany
says that
product
is not on
the
market
for use in
the
exportin
g
countries
Form 5A
MHRA.
COPP
Farydak 10mg, issued by
Dy. No 304 15mg & 20mg US FDA
Dated 08- by
M/s for three
09-2015
Novartis.
strengths
Rs.50,000/and valid
status in
reference
countries
as COPP
issued by
Germany
says that
product is
not on the
market for
use in the
exporting
countries
b.
clarificatio
n
of
regulatory
free sales
status in
exporting
country.
Deferred
for
the
clarificatio
n of free
sales
status in
113
87.
(Multiple Myeloma in
Manufactured
combination
with Rs.950,000
by
Bortezomib
& /6’s
M/s.
Novartis Dexamethasone).
Capsules
Farmaceutica
New Molecule
SA, Barbera del
Valles, Spain.
Manufacturer’s
Specifications
the
exporting
country.
M/s.
Novartis
Pharma
(Pakistan)
Limited,
15
West
Wharf,
Karachi.
upto 3107-2017.
The
product
is
not
available
for free
sale in
the
36 months
country
of origin.
GMP
issued
dated 1203-2013
Farydak 15mg Capsule Form 5A
MHRA.
COPP
Farydak 10mg, issued by
Each capsule contains:- Dy. No 302 15mg & 20mg US FDA
Panobinostat………..15 dated 08- by
M/s and valid
mg
09-2015
Novartis.
upto 31Rs.50,000/07-2017.
The
(Multiple Myeloma in
product
combination
with Rs.125500
is
not
Bortezomib
& 0/6’s
capsules
available
Dexamethasone).
for free
New Molecule
sale in
Manufacturer’s
the
Specifications
country
of origin.
36 months
GMP
issued
dated 1203-2013
Deferred
for
the
clarificatio
n of free
sales
status in
the
exporting
country.
Farydak 20mg Capsule
Deferred
for
the
clarificatio
n of free
sales
status in
the
exporting
country.
M/s.
Novartis
Farmaceutica
SA, Barbera del
Valles, Spain.
88.
M/s.
Novartis
Pharma
(Pakistan)
Limited,
15
West
Wharf,
Karachi.
M/s.
Novartis
Farmaceutica
SA, Barbera del
Valles, Spain.
Each capsule contains:Panobinostat………..20
mg
Form 5A
MHRA.
Farydak 10mg,
Dy.
No. 15mg & 20mg
301 Dated by
M/s
08-09-2015 Novartis.
Rs.50,000/-
(Multiple Myeloma in
combination
with Rs.
Bortezomib
& 1560,000/6
’s capsule
Dexamethasone).
New Molecule
Minutes for 260th Meeting Registration Board
COPP
issued by
US FDA
and valid
upto 3107-2017.
The
product
is
not
available
for free
114
sale in
the
country
of origin.
GMP
issued
dated 1203-2013
Manufacturer’s
Specifications
36 months
89.
M/s.
Pharmawell
(Pvt) Ltd. 244-Y
Block,
Commercial
Area Phase III,
DHA, Lahore.
Lenara 2.5mg Tablets
90.
M/s.
Novartis
Pharma
(Pakistan)
Limited,
15
West
Wharf,
Karachi.
Entresto
200mg
MHRA. Femra
2.5mg
f/c
Each film coated tablet Dated 15- tablet by M/s
contains:09-2015
Novartis.
Letrozole…….2.5mg
vide diary
No.
399 Local. Femra
(Adjuant treatment of Rs.100,000 2.5mg by M/s
/Novartis.
post-menopausal
M/s.
women with harmone
Kwangdong
recpotor
positive Rs.6,0000/
Pharmaceutical
invasive early breast 30’s
Co. Ltd., 114, cancer).
Sandan-ro,
Pyeongtack-Si,
(USP Specs)
Gyeonggi-do,
Republic
of 36 months
Kora.
Product
License
Holder:M/s.
Novartis
Pharma
Stein
AG,
Stein,
Switzerland.
Manufacturer:
M/s.
Novartis
to
Form 5A
Uperio Form 5A
Each film coated tablet
contains:Sacubitril/Valsartan
226.206mg
(Corresponds
to
Sacubtril/Valsartan free
anhydrous acid) 200mg
Sacubitril/Valsartan
Sodium salt Hydrate,
Crystal modification A
Scubitril/
Valsartan
200mg
Corrosponds
to
Minutes for 260th Meeting Registration Board
Dy No. 329
dated 30092015Rs.50,
000/Rs.27240/2
8tablets
COPP
issued
dated 3006-2015
vide no.
2015D1-1817.
GMP
issued
dated 2707-2015
vide no.
2015D1-2068.
Stability
data as
per
condition
s of Zone
IV
B
attached.
COPP
was
issued by
Swiss
Medic
Switzerla
nd
on
17-092015
GMP
complian
t as per
COPP.
COPP
mentioni
ng two
Approved
as
per
Import
Policy for
Finished
Drugs.
Panel shall
confirm
the
anticancer
facility for
the
manufactu
ring of the
drug at the
time
of
foreign
inspection
Approved
as
per
Import
Policy for
Finished
Drugs
115
91.
92.
93.
Pharma
Stein Sacubitril 97.2mg and
AG,
Stein, Valsartan 102.8mg
Switzerland.
(Treatment of Heart
M/s.
Novartis Failure)
Singapore
New Molecule
Pharmaceutical
24 months
Manaufacturing
Ptc. Ltd., 10
Tuas Bay Lane
637461
Singapore,
Singapore.
M/s. Highnoon Pirfenex 200mg Tablet
Laboratories
Each film coated tablet
Limited,
17.5 contains:KM,
Multan Pirfenidone………200
Road, Lahore. / mg
M/s. Cipla Ltd.,
Village Malpur, (Idiopathic Pulmonary
Baddi District Fibrosis)
Solan, Himachal New Molecule
Pradesh, India.
24 months
M/s.
Merixil
Pharma,
Office # 28,
Second Floor,
Rose Plaza, I-8
Markaz,
Islamabad.
Manufactured
by
M/s.
Eirgen
Pharma
Ltd.
64/65 Westside
Business Park
Old Kilmeaden
Road,
Waterford,
Ireland.
manufact
urers
without
detaisl of
manufact
uring
processe
s.
Form 5-A
Dy No.287
30-09-2015
Rs.100,000
/-
Temoeirgen
Capsules
20mg Form 5A
dy. No. 381
dated 09Each capsule contains:- 10-2015
Temozolamide……….2 Rs.100,000
0mg
/-
MHRA.
Temodal 5mg,
20mg, 100mg,
140mg, 180mg
& 250mg by
M/s Merck
(For newly diagnosed
As
per
Glioblastoma
SRO /5’s
multiforme
concomitantly
with
radiotherapy)
Local.
Temoside
20mg, 100mg
& 250mg by
M/s AJ. Mirza.
COPP
and
GMP
was
issued by
India on
dated 2104-2015
valid up
to 29-082017
Deferred
for
the
confirmati
on
of
approval
status in
reference
countries.
COPP
issued on
04-022015.
GMP
complian
t as per
COPP.
Approved
as
per
Import
Policy for
Finished
Drugs
Manufacturer’s
Specifications
24 months
M/s. Gene-Tech Osateofil Solution for Form 5A
MHRA.
COPP
Laboratories,
Injection
Bondronat
No.
Head
Office.
Dy No. 397 2mg/2ml by 2014Minutes for 260th Meeting Registration Board
Deferred
for
the
submissio
116
246/B, PECHS, Each vial contains:Block-6,
Ibandronate
Karachi.
Sodium………2mg/2ml
94.
95.
Manufactured
by
M/s.
Nanjing
Hencer
Pharmaceutical
Co. Ltd., No. 18
Jichang Road,
Lishui
Economic
&
Technological
Development
Zone, Nanjing
City,
Jiangsu
Province, China.
M/s.
Merixil
Pharma,
Office # 28,
Second Floor,
Rose Plaza, I-8
Markaz,
Islamabad. /
M/s.
Laboratorios
Normon, S.A.
Ronda
De
Valdecarrizo, 6,
Tres
Cantos,
28760, Madrid,
Spain.
R&I dated M/s Roche
15-10-2015
Rs.100,000
/-
(Nitrogen –containing
group
of Rs.8650/vi
Bisphosphonates)
al
Prevention of skeletal
muscle
events
in
patients with Breast
Cancer and Bone
Metastasis
3 years
Exemestane
25mg Tablet
Normon Form 5A
Dy. No 547
dated 22Each coated tablets 12-2015
contains:Rs.100,000
Exemestane…………… /25mg
As
per
(Treatment
of SRO/3x10’
s tablets
postmanupausal
woman with oestrogen
positive
invasive
breast cancer)
146-1
issued
dated 2909-2014
valid
upto
2
years.
n
of
following
a. Stability
data as per
conditions
of
Zone
IV A.
b. Drugs
GMP
sales
certificat license
e valid c.
Sole
upto 08- agency
04-2018 Agreemen
No.
t
CN2013
0099.
COPP
Deferred
not
for
the
provided. submissio
n
of
following
a. Stability
data as per
ICH
guidelines
b. Valid
legalized
COPP.
Manufacturer’s
Specifications
24 months
M/s.
Merixil Zoledronic
Acid
Pharma,
Normon
4mg/5ml
Office # 28, Injectable
Second Floor,
Rose Plaza, I-8 Each 5ml concentrate
Markaz,
vial contains:Islamabad.
Zoledronic
acid
Monohydrate 4.264mg
Manufactured
eq
to
zoledronic
By
M/s.
acid……….4mg
Minutes for 260th Meeting Registration Board
Form 5A
MHRA.
Zoledronic
Dy.
No. Acid 4mg/5ml
546 R&I by
M/s
dated 22- Intrapharm.
12-2015
Rs.100,000
/As
COPP
issued on
24-022016.
GMP
complian
t as per
COPP.
Approved
as
per
Import
Policy for
Finished
Drugs
per
117
Laboratorios
Normon, S.A.
Ronda
De
Valdecarrizo, 6,
Tres
Cantos,
28760, Madrid,
Spain.
SRO
GMP
issued
13-062014.
(Prevention of skeletal
related events (e.g
tumor
induced
hypercalcemia)
in
adult patients with
advanced
malignancies involving
bone).
Manufacturer’s
Specifications
96.
97.
24 months
M/s.
Merixil Ondansetron Normon Form 5A
Pharma,
8mg Injection
Dy. No 548
Office # 28,
Dated 22Second Floor, Each 4ml vial contains:- 12-2015
Rose Plaza, I-8 Ondansetron…………. Rs.100,000
Markaz,
8mg
/Islamabad.
(as
hydrochloride
dihydrate)
As
per
Manufactured
SRO/ 1x5
by
M/s.
Anti
emetic
for ampoules
Laboratorios
chemotherapy induced
Normon, S.A. emesis.
Ronda
De
Valdecarrizo, 6,
Tres
Cantos, Manufacturer’s
28760, Madrid, Specifications
Spain.
36 months
M/s. Medi Mark Xmeron 50mg Injection Form 5-A
Pharmaceuticals Each ml contains:Dy No.
,
Rocuronium
23-12-2015
Liaqut Chowk, Bromide……..10mg
Rs.100,000
Sahiwal./
(Muscle
relaxants, /M/s. Zhejiang peripherally
acting
Xianju
agents)
Pharmaceuticals 24 months
Co. Ltd., No.6,
Xingye Road,
Modern Block,
Ecnomic Zone,
Xianju,
Zhejiang, China.
Minutes for 260th Meeting Registration Board
MHRA.Ondan
setron 2mg/ml
by
M/s
Hameln
COPP
issued on
25-022016.
GMP
Complia
nt as per
COPP.
Approved
as
per
Import
Policy for
Finished
Drugs
GMP
issued
dated 1306-2014.
China
Council
for the
Promotio
n
of
Internati
onal
Trade
china
chamber
of
internati
onal
commerc
e issued
Deferred
for
confirmati
on
whether
formulatio
n
is
already
registered
or
otherwise
118
98.
M/s.
Revive
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Oncotar-500 Injection
M/s.
Revive
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Egymelan
Injection
Form 5A
Dy.
NO
616 dated
31-12-2015
Rs.50,000/(Acute
myeloid & 50,000
Manufactured
leukaemia and for dated 24by
other acute leukaemias 06-2016.
M/s.
United for children and adults
Biotech
(P) )
Limited,
As per PRC
Bagbania,
USP Specifications
Baddi-Nalagarh 2 years
Road, DistrictSolan (Himachal
Pradesh)
174101, India.
99.
Each ml contains:Cytarabine
BP…………….100mg
50mg Form 5A
Each vial contains:Melphalan
Hydrochloride
Minutes for 260th Meeting Registration Board
Original
legalized
COPP
25-092015
valid
upto 2409-2016.
FSC
issued by
Xianju
Food and
Drug
Administ
ration of
China
25-092015
valid
upto 2409-2016
MHRA.
Free sale
Cytarabine
issued
500mg/5ml by dated 26M/s Hospira.
02-2016.
COPP
Local.
valid up
Cytarine
to 10-05500mg by M/s 2017
Atco
Photocop
y
of
GMP is
legalized
valid
upto 1709-2017.
MHRA.
Melphalan
Dy. No 617 50mg powder
dated 31- for injection
12-2015
by M/s Aspen.
Rs.50,000/-
Approved
as
per
Import
Policy for
Finished
Drugs
COPP
valid
upto 1005-2017.
Approved
as
per
Import
Policy for
Finished
Photocop Drugs
119
eq.
to
Melphalan
(Anhydrous)…….50mg As
Manufactured
SRO.
By
M/s.
United (Multiple
Myeloma
Biotech
(P) and Ovarian Cancer)
Limited,
New Molecule
Bagbania,
Baddi-Nalagarh Manufacturer’s
Road, District- Specifications
Solan (Himachal 2 years
Pradesh)
174101, India.
Revive
100. M/s.
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
K-Styrn 15gm Sachet
y
of
GMP
valid
upto 1709-2017.
per
Form-5A
Each sachet contains:Dy No.613
Calcium
Polystyrene 31-12-2015
Sulfonate………15gm
Rs.50,000/-
Japan.
Polystryene
Sulphonate
Sachet 15gm.
(Potassium Binder)
Manufactured
Manufacturer’s
by
M/s.
United Specifications
Biotech (P) Ltd., 02 years
Village
Bagbania,
Baddi-Nalagarh
Road, DistrictSolan
(H.P)
174101, India.
Revive
101. M/s.
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Amphotin
Injection
Free sale
issued
dated 2602-2016.
COPP
valid up
to 10-052017.
Leglalize
d
photocop
y
of
GMP
valid
upto 1709-2017
Lip-50 Form 5A
MHRA.
Abelcet
Dy No. 614 5mg/ml
Each vial contains:31-12-2015 Amphotericin
Amphotericin B Lipid Rs.50,000/- B
lipid
Complex…50mg
complex(10ml
As per PRC ,
20ml)
M/s.
United (Antifungal)
Concen. For
Biotech (P) Ltd.,
infusion
by
Village
Manufacturer’s
M/s Teva.
Bagbania,
Specifications
Baddi-Nalagarh 2 years
Road, DistrictSolan (Himachal
Pradesh)
Minutes for 260th Meeting Registration Board
Deferred
for
confirmati
on
whether
formulatio
n
is
already
registered
or
otherwise
Free sale
issued
dated 2602-2016.
COPP
valid
upto 105-2017
Deferred
as
the
product
does not
fall in the
priority
list.
Moreover
AntiLegalize fungal
d
drugs are
photocop not
y
of importable
GMP
from India
valid
as
per
120
174101, India.
Revive
102. M/s.
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Vonaz 200 Injection
M/s.
United
Biotech (P) Ltd.,
Village
Bagbania,
Baddi-Nalagarh
Road, DistrictSolan (Himachal
Pradesh)
174101, India.
Revive
103. M/s.
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Manufacturer’s
Specifications
2 years
Manufactured
by
M/s.
GENFARMA
LABORATORI
O, S.L. Site
address Avda.
De
la
Constitucion,
198-199
Poligono
Industrial Monte
Boyal,
Casarrubios del
Monte
45950
(Toledo)
Espana, Spain.
Market
Authorization
Each ml contains:Voriconazole….200mg
(Antifungal)
upto 17- Import
09-2017. Policy
Order,
2016
Form 5A
MHRA. Vfend Free sale Deferred
200mg powder issued
as AntiDy No. 615 for infusion by dated 26- fungal
dated 31- Pfizer.
02-2016. drugs are
12-2015
COPP
not
Rs.50,000/valid
importable
upto 10- from India
As per PRC
5-2017.
as
per
GMP
Import
valid
Policy
upto 17- Order,
09-2017. 2016.
Colicraft 1,000,000 IU Form 5A
powder for solution for
Injection
Dy No. 619
31-12-2015
Each vial contains:Rs.50,000/Colistimethate Sodium
…1,000,000 I.U
As per PRC
(Antibiotic)/Polymyxin
)
MHRA.
Colomycin
1MIU by M/s
Forest.
COPP
issued
dated 0405-2016.
Deferred
for
confirmati
on
whether
Firm is formulatio
GMP
n
is
complian already
t as per registered
COPP.
or
otherwise
USP Specifications
03 years
Minutes for 260th Meeting Registration Board
121
Holder.
M/s
G.E.S
Genericos
Espanoles
Laboratorio, S.A
Colquide,6Portal, Spain
Servier
104. M/s.
Research
and
Pharmaceuticals
Pakaistan
Private Limited,
65
Main
Boulevard
Gulberg,
Lahore.
Implicor Film Coated
Tablets
Each film coated tablet
contains:Metoprolol
Tartrate………….50mg
Ivabradine……………
……….5mg
(Antianginal)
18 months
Form 5A
Dy no. 172
dated 1002-2016
Rs.100,000
/-
M/s.
Les
Laboratoirie
Industrie, 905,
route de Saran
45520
Gidy,
France.
105. M/s. AJ Mirza
Pharma
(Pvt)
Ltd., 7-Ground
Floor,
Shafi
Court,
Merewether
Road,
Civil
Lines, Karachi.
M/s. Cipla Ltd,
S-103 to S-105,
S-107 to S-112,
L-138, L-147,
L-147/1 to L147/3, L-147/A,
Verna Industrial
Finpecia Film Coated Form 5A
Tablets
Dy No.174
Each film coated tablets dated 12contains:02-2016
Finasteride
Rs.100,000
USP…………1mg
/(Anti Androgenic)
36 months
Minutes for 260th Meeting Registration Board
As
SRO
COPP
(Photoco
py) was
issued by
France
on dated
18-092015.
GMP
photocop
y
attached
Stability
data is
not
as
per
condition
s of Zone
IV
A
however
stress
stability
data
attached.
COPP
valid
upto 1610-2016.
GMP
complian
t as per
COPP.
Deferred
for
the
submissio
n
of
following
a. Valid
legalized
COPP
b.Stability
data as per
conditions
of zone IV
A.
c.
Approval
status in
reference
countries.
Defered as
the
product
does not
fall in the
priority
list.
per
122
Estate, Verna,
Goa.
Genix
106. M/s.
Pharma
(Private)
Limited, 44-45B,
Korangi
Creek
Road,
Karachi-75190. /
Manufactured
by :M/s. NOBILUS
ENT
Swarszewska
45,
01-821
Warsaw,
Poland.
Supplying
Agent:
M/s. Labosuan
S.L.
calle
Einsten 8-28108
Alcobendas,
Madrid, Spain.
Genix
107. M/s.
Pharma
(Private)
Limited, 44-45B,
Korangi
Creek
Road,
Karachi-75190. /
Manufactured
by :M/s. NOBILUS
ENT
Swarszewska
45,
01-821
Warsaw,
Poland.
Supplying
Agent:
M/s. Labosuan
S.L.
calle
Einsten 8-28108
Genitinib 100mg Hard Form 5A
Gelatin Capsule
Dy. No 206
Each capsule contains:- dated 04Imatinib Mesilate
03-2016
eq.
Rs.100,000
Imatinib………………. /.100mg
MHRA.
Glivec 100mg
& 400mf f/c
tablet by M/s
Novartis.
COPP,
GMP &
stability
data not
attached.
Form 5A
is
incomple
te.
Finish
product
specifica
tions are
not
attached.
Deferred
for
the
submissio
n
of
following
a.Valid
Legalized
COPP
b. Stability
data as per
conditions
of
Zone
IV A.
c.
Completio
n of Form
5A.
d. Finish
product
specificati
ons.
COPP,
GMP &
stability
data not
attached.
Form 5A
Local. Glivec is
100mg
& incomple
400mg by M/s te.
Novartis
Finish
Pharma.
product
specifica
tions are
not
attached.
Deferred
for
the
submissio
n
of
following
a.Valid
Legalized
COPP
b. Stability
data as per
conditions
of
Zone
IV A.
c.
Completio
n of Form
5A.
d. Finish
product
specificati
(Philadelphia
chromosome positive
chronic
myeloid
leukemia)
Shelf Life 2 years
(Vol. 1 of 3 )
Genitinib 400mg Hard Form 5A
Gelatin Capsule
Dy. No 313
Each capsule contains:- dated 04Imatinib Mesilate
03-2016
eq.
Rs.100,000
Imatinib………………. /.400mg
(Philadelphia
chromosome positive
chronic
myeloid
leukemia)
Shelf Life 2 years
Minutes for 260th Meeting Registration Board
MHRA.
Glivec 100mg
& 400mg f/c
by
M/s
Novartis.
123
Alcobendas,
Madrid, Spain.
Genix
108. M/s.
Pharma
(Private)
Limited, 44-45B,
Korangi
Creek
Road,
Karachi-75190. /
Manufactured
by:
M/s. Samyang
Genex
Corporation,
1688-3, Sinildong Daedeokgu Daejeon 306220, Korea.
Analytical
Testing
&
Batch Release
by:
M/s. Aq Vida
GmbH KaiserWilhelm-Str.89
20355 Hamburg,
Germany.
Marketing
Authorization
Holder:
M/s. Labosuan
S.L.
calle
Einsten 8-28208
Alcobendas,
Madrid, Spain.
Genix
109. M/s.
Pharma
(Private)
Limited, 44-45B,
Korangi
Creek
Road,
Karachi-75190. /
Manufactured
by:
M/s. Samyang
ons.
Genoxaltin
50mg Form 5A
Powder for Infusion
Dy.
208
Each vial contains:dated
Oxaliplatin………..50m 02-03-2016
g
Rs.100,000
/Treatment
of
metastatic colorectal Not
cancer)
provided.
MHRA.
Oxaliplatin
50mg
&
100mg powder
for solution for
infusion
by
M/s Actavis.
COPP
issued
dated 1903-2016
COPP
strength
is
mentione
d
as
5mg/ml
Pack
sizes are
not
mentione
d
on
COPP.
GMP
complian
t as per
COPP.
Single
COPP
for
2
products.
Deferred
for
the
clarificatio
n
of
strength
5mg/ml on
COPP
whereas
the firm
has
applied in
powder
form
in
Form 5A.
MHRA.
Oxaliplatin
50mg
&
100mg powder
for solution for
infusion
by
M/s Actavis.
COPP
issued
dated 1903-2016
COPP
strength
is
mentione
d
as
5mg/ml
Deferred
for
the
clarificatio
n
of
strength
5mg/ml on
COPP
whereas
the firm
has
Shelf Life 3 years
Genoxaltin
100mg Form 5A
Powder for Infusion
Dy. No 209
Each vial contains:dated 02Oxaliplatin………..100 03-2016
mg
Rs.100,000
/Treatment
of
metastatic colorectal
cancer)
Minutes for 260th Meeting Registration Board
124
Genex
Corporation,
1688-3, Sinildong Daedeokgu Daejeon 306220, Korea.
Analytical
Testing
&
Batch Release
by:
M/s. Aq Vida
GmbH KaiserWilhelm-Str.89
20355 Hamburg,
Germany.
Marketing
Authorization
Holder:
M/s. Labosuan
S.L.
calle
Einsten 8-28208
Alcobendas,
Madrid, Spain.
Genome
110. M/s.
Pharma,
House # 593-B,
Street # 10,
Chaklala
Scheme
III,
Rawalpindi.
Manufactcured
by
M/s.
"Belmedprepara
ty" RUE, 30
Fabritsius Str.
220007 Minsk,
Republic
of
Belarus.
Shelf Life 3 years
Zoledron Lyophilized Form 5A
Powder for Solution for
Infusion
Dy. No 246
dated 14Each vial contains:03-2016
Zoledronic Acid (as Rs.100,000
Zoledronic
acid /monohydrate)………… As
per
…………4mg
SRO
(Prevention of skeletal
related
events(e.g
tumor
induced
hypercalcemia)
in
adult patients with
advanced
malignancies involving
bone).
Manufacturer’s
Specifications
MHRA.
Zoledronic
Acid 4mg/5ml
by
M/s
Intrapharm.
GMP
complian
t as per
COPP.
applied in
powder
form
in
Form 5A.
Docume
nts are
not
legalized
.
COPP
issued on
31-072015 by
Republic
of
Belarus.
GMP
complian
t as per
COPP.
GMP
valid
upto 1010-2017.
Approved
as
per
Import
Policy for
Finished
Drugs
02 years
Minutes for 260th Meeting Registration Board
125
Genome
111. M/s.
Pharma,
House # 593-B,
Street # 10,
Chaklala
Scheme
III,
Rawalpindi./
Manufactcured
by
M/s.
"Belmedprepara
ty" RUE, 30
Fabritsius Str.
220007 Minsk,
Republic
of
Belarus.
Gemcitabel Lyophilized Form 5A
Powder for Solution for
Infusion
Dy. No 237
R&I 14-03Each vial contains:2016
Gemcitabine
Rs.100,000
Hydrochloride
/…1000mg
(Advanced or met- AS
static bladder cancer SRO
in combination with
cisplatin, locally or
meta-static
adenocarcinoma
of
pancreas)
per
USP Specifications
02 years
M/s.
Genome
Gemcitabel Lyophilized Form 5A
112.
Pharma,
Powder for Solution for
House # 593-B, Infusion
Dy.
No.
Street # 10,
236 dated
Chaklala
Each vial contains:14-03-2016
Scheme
III, Gemcitabine
Rs.100,000
Rawalpindi.
Hydrochloride ..200mg /
Manufactcured
by
M/s.
"Belmedprepara
ty" RUE, 30
Fabritsius Str.
220007 Minsk,
Republic
of
Belarus.
(Advanced or metstatic bladder cancer As
in combination with SRO
cisplatin, locally or
meta-static
adenocarcinoma
of
pancreas)
per
USP Specifications
02 years
Genome Methobel Lyophilized Form 5A
113. M/s.
Pharma,
Powder for Solution for
House # 593-B, Injection
Dy.
238
Street # 10,
R&I dated
Minutes for 260th Meeting Registration Board
Docume
nts are
not
legalized
.
COPP
issued on
31-072015 by
Republic
of
Belarus.
GMP
complian
t as per
COPP.
GMP
valid
upto 1010-2017.
Docume
nts are
not
legalized
.
COPP
issued on
31-072015 by
Republic
of
Belarus.
GMP
complian
t as per
COPP.
GMP
valid
upto 1010-2017.
Docume
nts are
not
legalized
Approved
as
per
Import
Policy for
Finished
Drugs.
Firm has
provided
valid
legalized
CoPP
Approved
as
per
Import
Policy for
Finished
Drugs.
Firm has
provided
valid
legalized
CoPP
Approved
as
per
Import
Policy for
126
Chaklala
Scheme
III,
Rawalpindi./
Manufactcured
by
M/s.
"Belmedprepara
ty" RUE, 30
Fabritsius Str.
220007 Minsk,
Republic
of
Belarus.
Genome
114. M/s.
Pharma,
House # 593-B,
Street # 10,
Chaklala
Scheme
III,
Rawalpindi.
Manufactcured
by
M/s.
"Belmedprepara
ty" RUE, 30
Fabritsius Str.
220007 Minsk,
Republic
of
Belarus.
Each vial contains:Methotrexate
sodium……..50mg
14-03-2016
as Rs.100,000
/
(Antineoplastic drug)
USP Specifications
02 years
Anastrozole-Belmed
Film Coated Tablets
Each film coated tablets
contains:Anastrozole………….1
mg
(Treatment
of
harmone
recpotor
positive
advanced
breast cancer in post
menopausal women
)
Manufacturer’s
Specifications
02 years
115. M/s. LDS (Pvt)
Ltd.,
57/1 A Satellite
Town,
RawalpindiPakistan.
Temozol 20 Capsules
Each
hard
gelatin
capsule contains:Temozolomide………
……20mg
Minutes for 260th Meeting Registration Board
.
COPP
issued on
31-07As per PRC
2015 by
Republic
of
Belarus.
GMP
complian
t as per
COPP.
GMP
valid
upto 1010-2017.
Form 5A
MHRA.
Docume
Anastrozole
nts are
Dy. No 239 1mg f/c by not
dated 14- M/s consilent. legalized
03-2016
.
Rs.100,000 Local.
COPP
/
Anastrozole
issued on
1mg by M/s 09-02As per PRC Pfizer
2015 by
Republic
of
Belarus.
GMP
complian
t as per
COPP.
GMP
valid
upto 1010-2017.
Finished
Drugs.
Firm has
provided
valid
legalized
CoPP
Approved
as
per
import
Policy for
Finished
Drugs, as
firm has
provided
valid
legalized
CoPPprovi
ded.
Panel shall
confirm
the
anticancer
facility for
the
manufactu
ring of the
drug at the
time
of
foreign
inspection
Form 5A
MHRA.
COPP
Approved
Dy.No. 314 Temodal 5mg, valid up as
per
R&Idated
20mg, 100mg, to 2-8- import
22-04-2016 140mg, 180mg 2016.
Policy for
Rs.50,
& 250mg by
Finished
000/& M/s Merck
GMP
Drugs
127
Manufactured
by:M/s.
Khandelwal
Laboratories
Pvt. Ltd., Plot
B-1,
Wagle
Industrial Estate,
Thane-400 604,
Maharashtra,
India.
116. M/s. LDS (Pvt)
Ltd.,
57/1 A Satellite
Town,
RawalpindiPakistan.
50,000 18valid
(For newly diagnosed 03-2016.
Local.
upto 02Temoside
08-2016.
Glioblastoma
20mg, 100mg
multiforme
& 250mg by
concomitantly
with
radiotherapy)
M/s AJ. Mirza.
Manufacture’s
Specifications
24 months
Temozol 100 Capsules
Form 5A
Dy No.315
Each
hard
gelatin R&I
capsule contains:22-04-2016
Temozolomide………
Rs.50,000/……100mg
&
Rs.50,000
(For newly diagnosed dated 1803-2016.
Glioblastoma
multiforme
concomitantly
with
radiotherapy)
MHRA.
Temodal 5mg,
20mg, 100mg,
140mg, 180mg
& 250mg by
M/s Merck
Doxorubin
Hydrochloride
injection
MHRA.
Doxorubicin
50mg by M/s
Teva
Manufactured
by:M/s.
Khandelwal
Laboratories
Pvt. Ltd., Plot
B-1,
Wagle Manufacturer’s
Industrial Estate, specifications.
Thane-400 604,
Maharashtra,
24 months
India.
117. M/s. LDS (Pvt)
Ltd.,
57/1 A Satellite
Town,
RawalpindiPakistan. /
Manufactured
by:M/s.
Khandelwal
Laboratories
Pvt. Ltd., Plot
B-1,
Wagle
Industrial Estate,
Thane-400 604,
50 Form 5A
for Dy.
311
Dated 2204-2016
Each vial contains:Rs.50,000/Doxorubicin
&Rs.50,00
Hydrochloride
0 dated 18USP……………….50
03-2016.
mg
Lactose USP………q.s. Rs.1625/Vi
al
(Small
cell
lung
cancer, Breast cancer,
bladder
carcinoma,
Hodgkin’s disease)
Minutes for 260th Meeting Registration Board
Local.
Temoside
20mg, 100mg
& 250mg by
M/s AJ. Mirza.
COPP
valid
upto 0208-2016.
GMP
valid
upto 0208-2016.
Approved
as
per
import
Policy for
Finished
Drugs
COPP
valid
upto 0208-2016
.
Deferred
for
the
clarificatio
n of the
following
Local. Adrim
a.Fresh
by M/s Atco
GMP
Sole
valid
agency
upto 02- agreement
08-2016 as
.
clarificatio
n of the
status of
registratio
n letter as
128
India.
the
products
are already
approved
in
227th
meeting
with M/s
Scarlet.
USP Specifications
30 months
118. M/s. LDS (Pvt)
Ltd.,
57/1 A Satellite
Town,
RawalpindiPakistan. /
Manufactured
by:M/s.
Khandelwal
Laboratories
Pvt. Ltd., Plot
B-1,
Wagle
Industrial Estate,
Thane-400 604,
India.
Epichlor 10 Powder for
injection (Lyophilized)
Each vial contains:Epirubicin
Hydrochloride
BP…………10mg
119. M/s. LDS (Pvt)
Ltd.,
57/1 A Satellite
Town,
RawalpindiPakistan. /
Manufactured
by:M/s.
Khandelwal
Laboratories
Pvt. Ltd., Plot
B-1,
Wagle
Industrial Estate,
Thane-400 604,
India.
Epichlor 50 Powder for Form 5A
injection (Lyophilized)
Dy. No 313
Each vial contains:R&I dated
Epirubicin
22-04-2016
Hydrochloride
Rs.50,000/BP…………50mg
&
Rs.50,000
(Used in Neoplastic dated 18conditions
breast, 03-2016.
ovarian, Gastric, lung
and
Colorectal Rs. 2540/carcinomas, Malignant per vial
lymphomas)
(Used in Neoplastic
conditions
breast,
ovarian, Gastric, lung
and
Colorectal
carcinomas, Malignant
lymphomas)
Form-5A
MHRA.
Epirubicine
Dy No. 404 10mg & 50mg
R&I-dated powder
for
18.03.2016 solution
for
injection
by
Rs50000/M/s Actavis
dated 1803-2016
Local.
Balance
Anthracin
Rs50000/50mg & 10mg
dated 22- by M/s Atco
04-2016
COPP
valid up
to 2-82016
GMP
valid
upto 0208-2016.
.
Approved
as
per
import
Policy for
Finished
Drugs
COPP
valid
upto 0208-2016.
GMP
valid
upto 0208-2016.
Approved
as
per
import
Policy for
Finished
Drugs
36 months
MHRA.
Epirubicine
10mg & 50mg
powder
for
solution
for
injection
by
M/s Actavis
Local.
Anthracin
50mg & 10mg
by M/s Atco
Manufacture’s
Specifications
36 months
120. M/s. LDS (Pvt) Doxorubin
Minutes for 260th Meeting Registration Board
10 Form 5A
MHRA.
Photocop Deferred
129
Ltd.,
57/1 A Satellite
Town,
RawalpindiPakistan.
Manufactured
by:M/s.
Khandelwal
Laboratories
Pvt. Ltd., Plot
B-1,
Wagle
Industrial Estate,
Thane-400 604,
India.
Hydrochloride
injection
for Dy.
312
Dated 2204-2016
Each vial contains:Rs.50,000/Doxorubicin
&Rs.50,00
Hydrochloride
0 dated 18USP………….10mg
03-2016.
Lactose USP…q.s.
Rs.490/Via
(Small
cell
lung l
cancer, Breast cancer,
bladder
carcinoma,
Hodgkin’s disease)
Doxorubicin
y
of
10mg by M/s COPP
Teva
valid
upto 02Local. Adrim 08-2016.
by M/s Atco
Photocop
y
of
GMP
valid
upto 0208-2016.
for
the
clarificatio
n of the
following
a.Fresh
Sole
agency
agreement
as
clarificatio
n of the
status of
registratio
n letter as
the
products
are already
approved
in
227th
meeting
with M/s
Scarlet.
MHRA.
Cyclophospha
mide 1000mg
by M/s Baxter
Deferred
for
the
clarificatio
n of the
following
a.Fresh
Sole
agency
agreement
as
clarificatio
n of the
status of
registratio
n letter as
the
products
are already
approved
in
227th
meeting
with M/s
Scarlet.
USP Specifications
30 months
121. M/s. LDS (Pvt)
Ltd.,
57/1 A Satellite
Town,
RawalpindiPakistan. /
Manufactured
by:M/s.
Khandelwal
Laboratories
Pvt. Ltd., Plot
B-1,
Wagle
Industrial Estate,
Thane-400 604,
India.
Oncomide 1000 Powder Form 5A
for injection
Dy. No 316
dated 22Each vial contains:04-2016
Cyclophosphamide
Rs.50,000/anhydrous 1.07gm
& 18-03Equivalent
to 2016
Cyclophosphamide…..1 Rs.50,000.
.00gm
Rs.230/vial
(Chronic Lymphocytic
Leukaemis
&Acute
Lymphocytic
Leukaemis)
USP Specifications
36 months
Minutes for 260th Meeting Registration Board
Photocop
y
of
COPP
valid
upto 02Local. Zyman 08-2016
by M/s Al- Photocop
Habib
y
of
GMP
valid
upto 0208-2016.
130
122. M/s. LDS (Pvt)
Ltd.,
57/1 A Satellite
Town,
RawalpindiPakistan.
Manufactured
by:M/s.
Khandelwal
Laboratories
Pvt. Ltd., Plot
B-1,
Wagle
Industrial Estate,
Thane-400 604,
India.
Bortemib 3.5 Powder Form 5A
for
Injection Dy.
NO
(Lyophilized)
407 dated
18-03-2016
Each vial contains:Rs.50,000/Bortezomib…………3.
5mg
Rs.27500/v
ial
(Lumphocutic
leukemia,
indolent
non-Hodgkin’s
lymphoma, multiple
myeloma)
Manufacturer’s
Specifications
24 months
123. M/s. LDS (Pvt)
Ltd.,
57/1 A Satellite
Town,
RawalpindiPakistan./
Manufactured
by:M/s.
United
Biotech (P) Ltd.,
Bagbania,
Baddi-Nalagarh
Road, District
Solan, Himachal
Pradash-174
101, India.
Unilistin Colistimethate
Sodium for Injection
BP 1 Million IU
Each vial contains:Colistimethate Sodium
BP……1,000,000 IU
Minutes for 260th Meeting Registration Board
Form 5-A
Dy.No.318
25-04-2016
Rs.50,000/-
MHRA.
Velcade 3.5gm
powder
for
solution
for
injection.
COPP
valid
upto 0208-2016
.
GMP
valid
upto 0208-2016
.
Internati
onaly the
product
is present
as
mannitol
boronic
ester.
Deferred
for
the
clarificatio
n
as
product is
approved
by
reference
regulatory
authorities
as
mannitol
boronic
ester form.
Antibioti
cs
are
not
importab
le from
India.
Sole
agency
agreeme
nt is not
provided.
FSC
issued
dated 261-2016.
Stability
data as
per zoneIV is not
provided
Finish
product
specifica
tions are
not
Deferred
as
the
product is
a me too
not a new
drug.
131
provided.
Genix
124. M/s.
Pharma
(Private)
Limited, 44-45B,
Korangi
Creek
Road,
Karachi-75190. /
Manufactured
by :M/s.
Jiangsu
Hengrui
Medicine
Co.
Ltd.,
UNo.38
Huanghe Road,
Lianyungang
Economic and
Technological
Development
Zone, Jiangsu,
China.
Leeza 2.5mg Tablets
Form 5A
MHRA. Femra
2.5mg
f/c
Each film coated tablets Dy
No. tablet by M/s
contains:R&I Dated Novartis.
Letrozole………….2.5 19-09-2016
mg
Rs.100,000 Local. Femra
/2.5mg by M/s
(Adjuant treatment of
Novartis.
post-menopausal
women with harmone
recpotor
positive
invasive early breast
cancer)
Fee Rs
100,000
is
a
photocop
y.
Dossier
is
a
duplicate
.
COPP
valid
upto 1802-2018.
GMP
complian
t as per
COPP.
GMP
valid
upto 1802-2018.
Approved
as
per
Import
Policy for
Finished
Drugs.
Panel shall
confirm
the
anticancer
facility for
the
manufactu
ring of the
drug at the
time
of
foreign
inspection.
Chairman
Registrati
Board is
authorized
for
the
issuance
of
Registratio
n
letter
after
verificatio
n of fee
from
Budget &
Accounts.
Graton
125. M/s.
Pharma,
Suit No. 102,
The
Plaza,
Clifton
2
Talwar, Karachi.
Manufactured
by
M/s.
Yangtze
River
Zoltran
4mg/5ml
Injection Form 5A
Free
sales
certificat
e issued
on 2701-2016.
GMP
valid
upto 1303-2018
Approved
as
per
import
Policy for
Finished
Drugs
USP Specifications.
02 years
Each vial contains:Zoledronic
acid……..4mg
MHRA.
Zoledronic
Dy. No 348 Acid 4mg/5ml
Dated 20- by
M/s
04-2016
Intrapharm.
Rs.100,000
/
(Prevention of skeletal
related
events(e.g As
tumor
induced SRO
Minutes for 260th Meeting Registration Board
per
132
Pharmaceutical
Group Sichuan
Hairong
Pharmaceutical
Co.
LTd.,
Dujiangyan
High
Tech
Development
Zone, Sichuan,
China.
Graton
126. M/s.
Pharma,
Suit No. 102,
The
Plaza,
Clifton
2
Talwar, Karachi.
Manufactured
by
M/s.
Yangtze
River
Pharmaceutical
Group Co. Ltd
1
South
,
Yangtze River
Road, Taizhou,
Jiangsu, 225321
China.
hypercalcemia)
in
adult patients with
advanced
malignancies involving
bone).
Manufacturer’s
Specifications
2 years
Grataxel 100mg/16.7ml Form 5A
injection
Dy.
No.
Each vial contains:1026 Dated
Paclitaxel………….100 18-04-2016
mg
Rs.100,000
/
(Monotherapy
for
meta-static
breast
per
cancer.
In As
combination
with SRO
Gemcitabin for metastatic adenocarcinoma
of pancreas)
USP Specifications
03 years
Roche Esbriet Hard Capsules
127. M/s.
Pakistan
Each hard capsules
Limited,
contains:37-C, Bock-6, Pirfenidone…..267mg
P.E.C.H.S.
Karachi./
(Anti-fibrotic agent)
M/s. Made for
Roche
New Molecule
Registration
Limited,
4 years
Welwyn Garden
City, UK by F.
Hoffmann-La
Roche
Ltd.,
Basel,
Switzerland
manufacturing
Minutes for 260th Meeting Registration Board
Form 5-A
Dy No.350
29-04-2016
Rs.50,000/-
MHRA.
COPP
Paclitaxel
18-046mg/ml Conc. 2016.
for solution for
infusion
by
M/s
Medac
(5ml, 16.7ml,
50ml
&
100ml).
Approved
Local.
Panataxel
100mg,
150mg, 300mg
& 30mg by
M/s
Ferozsons.
FDA. Esbriet Orignal
by
M/s legalized
Genetech.
COPP is
not
provided.
Deferred
for
the
submissio
n
of
following
a.valid
legalized
COPP
b.Stability
data as per
conditions
of
Zone
IV A.
133
Site
Catalent
Pharma
Solutions LLC,
Winchester
(KY), USA.
Revive
128. M/s.
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Manufactured
by
M/s.
United
Biotech
(P)
Limited,
Bagbani, Baddi,
Nalagarh Road,
District, Solan,
India.
Revive
129. M/s.
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
Octreotide
Injection
50mcg Form 5A
Each vial of ampoule
contains:Octreotide
acetate
equivalent to 0.05mg
milligrams of octreotide
……50mcg
(Acromegaly/Carcinoi
d Tumors/Vasoactive
Intestinal tumors)
FDA.
Sandostatin
Dy No. 357 50mcg/ml by
dated
M/s Novartis.
29-04-2016
Rs.50,000/- Local.
& 50,000 Sandostatin
dated 24- 0.05mg/ml &
06-2016.
0.1mg/ml by
M/s Novartis.
As
per
SRO
Free sale
issued
dated 2602-2016.
COPP
valid
upto 105-2017.
GMP
valid
upto 1709-2017.
Approved
as
per
import
Policy for
Finished
Drugs
Free sale
issued
dated 2602-2016.
COPP
valid
upto 105-2017.
GMP
valid
upto 1709-2017
Approved
as
per
import
Policy for
Finished
Drugs
Manufacturer’s
Specifications
03 years
Octreotide
Injection
100mcg Form 5A
FDA.
Sandostatin
Dy.
356 100mcg/ml by
Each vial of ampoule Dated 29- M/s Novartis.
contains:04-2016
Octreotide
acetate Rs.50,000/- Local.
equivalent to octreotide & 50,000 Sandostatin
…100mcg
dated 24- 0.05mg/ml &
Manufactured
06-2016.
0.1mg/ml by
by
M/s.
United (Acromegaly/Carcinoi
M/s Novartis.
Biotech
(P) d Tumors/Vasoactive
Limited,
As
per
Intestinal tumors)
Bagbani, Baddi,
SRO.
Nalagarh Road, Manufacturer’s
District, Solan, Specifications
India.
03 years
Revive Vasmed Injection
Form-5 A
130. M/s.
Health Care,
Office 503, 5th Each
ampoule Dy No 354.
Minutes for 260th Meeting Registration Board
MHRA.
Free sale Approved
Vasopressin
certificat as
per
20IU/ml
by e issued import
134
Floor, 6 Main contains:Gulberg,
Jail Synthetic
Road, Lahore.
Vasopressin….20 IU
29-04-2016
Rs.50,000/As per PRC
Manufactured
by
M/s.
United
Biotech (P) Ltd.,
Village
Bagbania,
Baddi-Nalagarh
Road, DistrictSolan
(H.P)
174101, India.
Revive
131. M/s.
Health Care,
Office 503, 5th
Floor, 6 Main
Gulberg,
Jail
Road, Lahore.
(Synthetic
Hormone)
New Molecule
USP specifications
03 yearts
Vinotec 50mg Injection
par on 26- Policy for
02-2016. Finished
COPP
Drugs
valid
upto105-2017.
GMP
valid
upto 1709-2017.
MHRA.
Free sale
Navelbine
issued
Each vial of 5ml Dy. No 359 10mg/ml
dated 26contains:Dated 29- (5ml) by M/s 11-2015.
Vinorelbine as Tartrate 04-2016
Pierre.
COPP
eq.
to Rs.50,000/valid
Vinorelbine…….50mg & 50,000 Local. Vilne upto 10dated 24- by M/s Ghani 5-2017.
Manufactured
(Stage III & IV small 06-2016.
Brothers
GMP
by
M/s.
United cell
valid
lung
cancer,
Biotech (P) Ltd., Advance Breast cancer As
per
upto 17Village
for stage III & IV)
PRC.
09-2017.
Bagbania,
Baddi-Nalagarh USP Specifications
Road, DistrictSolan
(H.P) 03 years
174101, India.
Revive Colicraft 2,000,000 IU Form 5A
MHRA.
COPP
132. M/s.
Health
Care, Lypholized powder for
Colomycin
was
Office No.503, solution for Injection
Dy No.358 1MIU & 2 issued by
5th Floor, 6
R&I dated MIU by M/s Spain on
Main Gulberg, Each vial contains:29-04-2016 Forest.
dated 04Jail
Road, Colistimethate Sodium Rs.50,000/05-2016.
Lahore.
…2,000,000 I.U
GMP
As
per
complian
M/s.
(Antibiotic)/Polymyxin PRC.
t as per
GENFARMA
)
COPP
LABORATORI
dated 04O, S.L. Site USP Specifications
05-2016.
address Avda.
De
la 03 years
Constitucion,
Minutes for 260th Meeting Registration Board
Form 5A
M/s
Sterile.
Approved
as
per
import
Policy for
Finished
Drugs
Deferred
for
confirmati
on
whether
formulatio
n is me too
or
otherwise
135
198-199,
Poligono
Industrial Monte
Boyal,
Casarrubios del
Monte
45950
(Toledo)
Espana, Spain.
133. M/s. Amgomed,
Office # 5, 1st
Floor Rose 1,
Plaza
I-8
Markaz,
Islamabad.
Irinotecan
medac Form 5A
100mg/5ml Injection
Dy. No 362
Each vial contains:Dated 29Irinotecan……..100mg 04-2016
Rs.100,000
(Advanced Colorectal /cancer)
Market
As
per
authorization
SRO/5ml
holder
M/s. MEDAC,
Manufacturer’s
Gesellschaft fur Specifications
klinische
Spezialpraparate 03 years
mbH,
Fehlandtstrasse
3
20354
Hamburg,
Germany.
Labelling,
Secondary
Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr,
6,
22880 Wedel,
Germany.
Manufactured
by
M/s
Oncotec
Minutes for 260th Meeting Registration Board
MHRA.
Campto
20mg/ml
(100mg/5ml)
Conc.
For
solution
for
infusion
by
M/s Pfizer.
COPP
issued
dated 1804-2016.
GMP
complian
t as per
COPP.
Approved
as
per
import
Policy for
Finished
Drugs
Local. CPT-11
injection
by
M/s Medinet.
136
pharma
produktin
GmbH,
Am
Pharmapark,
06861 DessauRosslau,
Germany.
134. M/s. Amgomed,
Office # 5, 1st
Floor Rose 1,
Plaza
I-8
Markaz,
Islamabad.
Manufactured
by
M/s.
CSPC
Ouyi
Pharmaceutical
Co. Ltd., No.88,
Yangzi
Road,
Shijiazhuang
City of China.
LipAd Injection
Each vial contains:20mg
Doxorubicin
Hydrochloride in 10ml
pegylated liposomal
(Alone for meta-static
breast
cancer,
advanced
ovarian
cancer.
In
combination
with
Bortezomide
for
treatment
of
progressive multiple
myeloma.)
Form 5A
MHRA.
Caelyx
Dy. No 362 2mg/ml conc.
dated 29- For solution
04-2016
for infusion.
Rs.100,000
/Local.
Doxopeg by
As
per M/s
SRO.
Ferozsons.
Free sale
issued
dated 1204-2016.
Approved
as
per
import
Policy for
Finished
GMP of Drugs
the
manufact
uring
place not
provided.
Form 5A
COPP
issued
dated 1804-2016.
GMP
complian
t as per
COPP.
Manufacturer’s
Specifications
24 months
Temomedac
Capsule
100mg
135. M/s. Amgomed,
Office # 5, 1st
Floor Rose 1,
Plaza
I-8 Each capsule contains:Markaz,
Temozolomide………1
Islamabad.
00mg
MHRA.
Temodal 5mg,
Dy. No 363 20mg, 100mg,
Dated 29- 140mg, 180mg
04-2016
& 250mg by
Rs.100,000 M/s Merck
/(For newly diagnosed
Local.
Market
As
per Temoside
authorization
Glioblastoma
SRO.
20mg, 100mg
holder
multiforme
M/s. MEDAC,
& 250mg by
concomitantly
with
Gesellschaft fur radiotherapy)
M/s AJ. Mirza.
klinische
Spezialpraparate Manufacturer’s
mbH,
Specifications
Fehlandtstrasse
03 years
3
20354
Minutes for 260th Meeting Registration Board
Approved
as
per
import
Policy for
Finished
Drugs
137
Hamburg,
Germany.
Labelling,
Secondary
Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr,
6,
22880 Wedel,
Germany.
Manufactured
by
M/s
Oncotec
pharma
produktin
GmbH,
Am
Pharmapark,
06861 DessauRosslau,
Germany.
136. M/s. Amgomed,
Office # 5, 1st
Floor Rose 1,
Plaza
I-8
Markaz,
Islamabad.
Market
authorization
holder
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Fehlandtstrasse
3
20354
Hamburg,
Germany.
Paclitaxel
medac Form 5 A
100mg/16.7ml Injection
Dy.
NO
Each vial contains:364 dated
Paclitaxel…………100 29-04-2016
mg
Rs.100,000
/(Monotherapy
for
per
meta-static
breast As
cancer.
In SRO/16.7m
combination
with l.
Gemcitabin for metastatic adenocarcinoma
of pancreas)
)
USP Specifications
Minutes for 260th Meeting Registration Board
MHRA.
Paclitaxel
6mg/ml Conc.
for solution for
infusion
by
M/s
Medac
(5ml, 16.7ml,
50ml
&
100ml).
Local.
Panataxel
100mg,
150mg, 300mg
& 30mg by
M/s
Ferozsons.
COPP
issued
dated 1804-2016.
GMP
complian
t as per
COPP.
Single
COPP
for two
products
.
Approved
as
per
import
Policy for
Finished
Drugs
138
03 years
Labelling,
Secondary
Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr,
6,
22880 Wedel,
Germany.
Manufactured
by
M/s
Oncotec
pharma
produktin
GmbH,
Am
Pharmapark,
06861 DessauRosslau,
Germany.
137. M/s. Amgomed,
Office # 5, 1st
Floor Rose 1,
Plaza
I-8
Markaz,
Islamabad.
Market
authorization
holder
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Fehlandtstrasse
3
20354
Hamburg,
Germany.
Labelling,
Secondary
Paclitaxel
medac Form 5A
300mg/50ml Injection
Dy.363
Each vial contains:dated 29Paclitaxel…………300 04-2016
mg
Rs.100,000
/(Monotherapy
for
per
meta-static
breast As
cancer.
In SRO/50ml.
combination
with
Gemcitabin for metastatic adenocarcinoma
of pancreas)
USP Specifications
MHRA.
Paclitaxel
6mg/ml Conc.
for solution for
infusion
by
M/s
Medac
(5ml, 16.7ml,
50ml
&
100ml).
COPP
issued
dated 1804-2016.
GMP
complian
t as per
COPP.
.
Approved
as
per
import
Policy for
Finished
Drugs
Local.
Panataxel
100mg,
150mg, 300mg
& 30mg by
M/s
Ferozsons.
03 years
Minutes for 260th Meeting Registration Board
139
Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr,
6,
22880 Wedel,
Germany.
Manufactured
by
M/s
Oncotec
pharma
produktin
GmbH,
Am
Pharmapark,
06861 DessauRosslau,
Germany.
138. M/s. Amgomed,
Office # 5, 1st
Floor Rose 1,
Plaza
I-8
Markaz,
Islamabad.
Market
authorization
holder
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Fehlandtstrasse
3
20354
Hamburg,
Germany.
Labelling,
Secondary
Packaging,
Topotecan medac 4mg Form 5A
Injection
Dy. No 360
Each vial contains:Dated 29Topotecan
as 04-2016
Hydrochloride……..4m Rs.100,000
g
/(Small
cell
Lung As
SRO.
Cancer treatment)
FDA.
Topotecan 1, 3
&
4mg
solution
for
injection
by
M/s Sandoz.
Local.
per Hycamtin
M/s GSK
COPP
issued
dated 1804-2016.
GMP
complian
t as per
COPP.
Approved
as
per
import
Policy for
Finished
Drugs
by
Manufacturer’s
Specifications
03 years
Minutes for 260th Meeting Registration Board
140
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr,
6,
22880 Wedel,
Germany.
Manufactured
by
M/s
Oncotec
pharma
produktin
GmbH,
Am
Pharmapark,
06861 DessauRosslau,
Germany.
139. M/s. Amgomed,
Office # 5, 1st
Floor Rose 1,
Plaza
I-8
Markaz,
Islamabad.
Ocladra
2mg/ml Form 5A
injection (5ml vial)
Dy. No 361
Each vial contains:Dated 29Cladribine
04-2016
Hydrochloride……..10 Rs.50,000/mg
As
per
Manufactured
(Treatment of Hairy PRC.
by
M/s.
Mustafa cell Leukaemia)
Nevzat (MN),
Ilac San. Ve Tic. Manufacturer’s
A.S.
Specifications
Cobancesme
03 years
Mah. Sanyi Cad.
No.13
Yenibosna/Istan
bul, Turkey.
Servier
140. M/s.
Research
and
Pharmaceuticals
Pakaistan
VIACORAM
3.5/2.5
Tablet
Each tablet contains:Perindopril
Minutes for 260th Meeting Registration Board
Form 5-A
Dy No. 371
05-05-2016
Rs.50,000/-
MHRA. Litak
2mg/ml
Solution
for
injection
5ml/10mg by
M/s Lipomed.
COPP
issued on
22-012016
.
GMP
complian
t as per
COPP.
Approved
as
per
import
Policy for
Finished
Drugs
Original
legalized
COPP is
not
Deferred
for
the
submissio
n
of
141
Private Limited,
65
Main
Boulevard
Gulberg,
Lahore. /
M/s.
Servier
Deutschland
GmbH
Elsenheimerster
80687 Munich,
Germany.
Merixil
141. M/s.
Pharma,
Office # 28,
Second Floor,
Rose Plaza, I-8
Markaz,
Islamabad.
Manufactured
by
M/s.
GP
Pharma,
Polígono
Industrial
Els
Vinyets
-Els
Fogars, Sector 2.
Carretera
Comarcal C244,
Km, 22 08777
Sant Quintí De
Mediona
Barcelona,
Spain.
Arginine………..3.5mg
Amlodipine……………
……2.5mg
(ACE inhibitors and
calcium
channel
blockers)
provided
following
Valid
legalized
COPP/
GMP
certificate
& stability
data as per
conditions
of
Zone
IV A.
COPP
issued on
12-042016.
Approved
as
per
import
Policy for
Finished
Drugs
New formulation
02 years
Lutrate 3month Depot Form 5A
(22.5mg) Injection
Dy.
No.
Each vial contains:
387 Dated
Leuprorelin
acetate 04-05-2016
powder for prolonged Rs.100,000
release suspension for /injection….…22.5 mg
(Palliative treatmentof
locally advanced &
metastatic
prostate
cancer)
Manufacturer’s
Specifications.
Shelf life : 36months
Merixil Sterile Solvent For
142. M/s.
Pharma,
Lutrate Depot 3 month
Minutes for 260th Meeting Registration Board
MHRA.
Lutrate
22.5mg
&
3.75mg
powder
and
solvent
for
prolonged
release
suspension for
As
Per injection.
SRO/Kit
(New
The
molecule)
commercial
kit includes
i.Glass Vial
of
Leuprorelin
ii.Prefilled
glass
syringe 2ml
containing
solvent.
iii.Polycarb
onate
HDPE
Adaptor
system
with
syringe
with
needle.
Form 5A
MHRA.
Dy. No 385 Lutrate
GMP
complian
t as per
COPP.
GMP
issued
dated 2910-2014
COPP
Approved
issued on as
per
142
Office # 28,
Second Floor,
Rose Plaza, I-8
Markaz,
Islamabad.
Manufactured
by
M/s.
GP
Pharma,
Polígon
Industrial
Els
Vinyets
-Els
Fogars, Sector 2.
Carretera
Comarcal C244,
Km, 22 08777
Sant Quintí De
Mediona
Barcelona,
Spain.
Merixil
143. M/s.
Pharma,
Office # 28,
Second Floor,
Rose Plaza, I-8
Markaz,
Islamabad.
Manufactured
by
M/s.
GP
Pharma,
Polígon
Industrial
Els
Vinyets
-Els
Fogars, Sector 2.
Carretera
Comarcal C244,
Km, 22 08777
Sant Quintí De
Mediona
Barcelona,
Spain.
Depot (22.5mg)
Dated 0405-2016
Each pre filled syringe Rs.100,000
2ml contains:/-
22.5mg
&
3.75mg
powder
and
solvent
for
prolonged
0.8% mannitol solution
release
in water for injection.
Free
of suspension for
Cost along injection.
For
reconstitution with
For
purpose
Lutrate
Manufacturer’s
Depot
3
Specifications
month
Depot
Shelf life: 36 months
(22.5mg)
12-042016.
(Same
COPP
for
powder
and
solvent)
Lutrate 1month Depot Form 5A
(3.75mg) Injection
Dy. No 139
Each vial contains:
Datedm 04Leuprorelin
acetate 05-2016
powder for prolonged Rs.100,000
release suspension for /injection….…3.75 mg
As
per
(Palliative treatmentof SRO/Kit
locally advanced &
metastatic
prostate The
commercial
cancer)
kit includes
i.Glass Vial
Manufacturer’s
of
Specifications
Leuprorelin
ii.Prefilled
Shelf life : 36months
glass
syringe 2ml
containing
solvent.
iii.Polycarb
onate
COPP
issued
dated 1204-2016.
(Original
Embassy
attested)
Minutes for 260th Meeting Registration Board
MHRA.
Lutrate
22.5mg
&
3.75mg
powder
and
solvent
for
prolonged
release
suspension for
injection.
import
Policy for
Finished
Drugs
GMP
issued
dated 2910-2014
Approved
as
per
import
Policy for
Finished
Drugs
GMP
complian
t as per
COPP.
Local.
Lectrum
3.75mg
by Embassy
M/s
Sandoz attested
with solvent
GMP
issued
dated 2910-2014
143
Merixil
144. M/s.
Pharma,
Office # 28,
Second Floor,
Rose Plaza, I-8
Markaz,
Islamabad. /
Manufactured
by
M/s.
GP
Pharma,
Polígon
Industrial
Els
Vinyets
-Els
Fogars, Sector 2.
Carretera
Comarcal C244,
Km, 22 08777
Sant Quintí De
Mediona
Barcelona,
Spain.
Revive
145. M/s.
Health
Care,
Office No.503,
5th Floor, 6
Main Gulberg,
Jail
Road,
Lahore.
M/s.
Biotech
Limited,
Bagbani,
Nalagarh
District,
India.
United
(P)
Baddi,
Road,
Solan,
HDPE
Adaptor
system
with
syringe
with
needle..
Sterile Solvent For Form 5 A
Lutrate Depot 1 month
Depot (3.75mg)
Dy. No 386
dated 04Each pre filled syringe 05-2016
2ml contains:
Rs.100,000
0.8% mannitol solution /in water for injection.
For
purpose
reconstitution Free
Cost
Manufacturer’s
Specifications
Shelf life: 36 months
MHRA.
Lutrate
22.5mg
&
3.75mg
powder
and
solvent
for
prolonged
release
suspension for
of injection.
Same
applicati
on
applied
for
Lutrate
Depot 3
month
Depot
(22.5mg)
COPP
Local.
issued
Lectrum
dated 123.75mg
by 04-2016.
M/s
Sandoz
with solvent
GMP
complian
t as per
COPP.
GMP
issued
dated 2910-2014.
Amphotin
50mg Form-5-A
MHRA.
Free sale
Injection (Lyophilized)
Fungizone
issued
Dy No.374 50mg powder dated 26Each vial contains:dated 04- for solution by 02-2016.
Amphotericin
B 05-2016
M/s
E.R COPP
(Lyophilized)……….50 Rs.50,000/- Squibb.
valid
mg
&
upto
Rs.50,000
Local.
GMP
dated 24- Medinet
valid
(Anti-fungal)
06-2016.
upto 17Manufacturer’s
09-2017.
Specifications
As
per
SRO
02 years
Minutes for 260th Meeting Registration Board
Rejected
as already
approved
at
S.No.142
Defered as
the
product
does not
fall in the
priority
list.
Moreover
Antifungal
drugs are
not
importable
from India
as
per
144
Revive
146. M/s.
Health
Care,
Office No.503,
5th Floor, 6
Main Gulberg,
Jail
Road,
Lahore.
Import
Policy
Order,
2016
MHRA.
COPP
Approved
Zoledronic
issued
as
per
Acid 4mg/5ml dated 04- import
Conc.
for 05-2016. Policy for
solution
for GMP
Finished
Injection
by complian Drugs
M/s
t as per
Intrapharm.
COPP.
Zimta 4mg/5ml Conc. Form 5A
for
solution
for
Injection
Dy. No 376
Dated 04Each vial contains:05-2016
Zoledronic
Rs.50,000/Acid………….4mg
& 50,000
dated 24(Prevention of skeletal 06-2016.
Local. Zometa
related events (e.g
by
M/s
tumor
induced
Novartis
hypercalcemia)
in
adult patients with
advanced
malignancies involving
bone).
Manufactured
By
M/s.
Alfa
Wassermann
S.p.A
VIA
Enrico Fermi, 165020 Alanno
(PE), Italy
Final Product
Manufacturer’s
release by
M/s Biomendi, Specifications
S.A. Poligono
Industrial
de 02 years
Bernedo,
s/n,
Bernedo, 01118
Alava, Spain.
Servier
147. M/s.
Research
and
Pharmaceuticals
Pakaistan
Private Limited,
65
Main
Boulevard
Gulberg,
Lahore.
M/s.
Les
Laboratoirie
Industrie, 905,
route de Saran
45520
Gidy,
France.
Triveram 20/5/5 Tablets
Each film coated tablets
contains:Atorvastatin…………
……20mg
Perindopril
Arginine………5mg
Amlodipine……………
…..5mg
(Statin/ACE
Inhibitors/Calcium
Antagonist)
New formulation
02 years
Minutes for 260th Meeting Registration Board
Form 5-A
Dy. No.382
05-05-2016
Rs.50,000/-
Original
legalized
COPP /
GMP is
not
provided.
Deferred
for
the
submissio
n
of
following
a.Approva
l status by
reference
regulatory
authorities
b.valid
legalized
COPP
c.Stability
data as per
conditions
of
Zone
145
IV A.
Servier
148. M/s.
Research
and
Pharmaceuticals
Pakaistan
Private Limited,
65
Main
Boulevard
Gulberg,
Lahore./
M/s.
Les
Laboratoirie
Industrie, 905,
route de Saran
45520
Gidy,
France.
Triveram
20/10/5
Tablets
Each film coated tablets
contains:Atorvastatin…………
……20mg
Perindopril
Arginine………10mg
Amlodipine……………
…..5mg
Form 5-A
Dy. No.385
05-05-2016
Rs.50,000/-
Original
legalized
COPP is
not
provided.
(Statin/ACE
Inhibitors/Calcium
Antagonist)
New formulation
Servier
149. M/s.
Research
and
Pharmaceuticals
Pakaistan
Private Limited,
65
Main
Boulevard
Gulberg,
Lahore./
M/s.
Les
Laboratoirie
Industrie, 905,
route de Saran
45520
Gidy,
France.
02 years
Triveram 10/5/5 Tablets
Each film coated tablets
contains:Atorvastatin…………
……10mg
Perindopril
Arginine………5mg
Amlodipine……………
…..5mg
Form 5-A
Dy No.384
05-05-2016
Rs.50,000/-
Original
legalized
COPP is
not
provided.
(Statin/ACE
Inhibitors/Calcium
Antagonist)
New formulation
02 years
Servier
150. M/s.
Research
and
Pharmaceuticals
Pakaistan
Private Limited,
65
Main
Boulevard
Gulberg,
Triveram
20/10/10
tablets
Each film coated tablets
contains:Atorvastatin…………
……20mg
Perindopril
Arginine………10mg
Minutes for 260th Meeting Registration Board
Form 5-A
Dy No.386
05-05-2016
Rs.50,000/-
Original
legalized
COPP is
not
provided.
Deferred
for
the
submissio
n
of
following
a.Approva
l status by
reference
regulatory
authorities
b.valid
legalized
COPP
c.Stability
data as per
conditions
of
Zone
IV A.
Deferred
for
the
submissio
n
of
following
a.Approva
l status by
reference
regulatory
authorities
b.valid
legalized
COPP
c.Stability
data as per
conditions
of
Zone
IV A.
Deferred
for
the
submissio
n
of
following
a.Approva
l status by
reference
146
Lahore./
M/s.
Les
Laboratoirie
Industrie, 905,
route de Saran
45520
Gidy,
France.
Amlodipine……………
…..10mg
(Statin/ACE
Inhibitors/Calcium
Antagonist)
New formulation
02 years
Triveram
40/10/10
tablets
Each film coated tablets
contains:Atorvastatin…………
……40mg
Perindopril
Arginine………10mg
Amlodipine……………
…..10mg
Servier
151. M/s.
Research
and
Pharmaceuticals
Pakaistan
Private Limited,
65
Main
Boulevard
Gulberg,
Lahore./
M/s.
Les
Laboratoirie
Industrie, 905, (Statin/ACE
route de Saran Inhibitors/Calcium
45520
Gidy, Antagonist)
France.
New formulation
Servier
152. M/s.
Research
and
Pharmaceuticals
Pakaistan
Private Limited,
65
Main
Boulevard
Gulberg,
Lahore./
M/s.
Servier
Deutschland
GmbH
Elsenheimerster
80687 Munich,
Germany.
02 years
Viacoram 7/5 Tablets
Each tablets contains:Perindopril
Arginine………7mg
Amlodipine……………
…..5mg
(ACE
Inhibitors/Calcium
channel blockers, ATC)
New formulation
02 years
Minutes for 260th Meeting Registration Board
Form 5-A
Dy No.383
05-05-2016
Rs.50,000/-
Form 5A
Dy No.381
05-05-2016
Rs.50,000/-
Original
legalized
COPP is
not
provided.
Original
Legalize
d COPP
is
not
provided
regulatory
authorities
b.valid
legalized
COPP
c.Stability
data as per
conditions
of
Zone
IV A.
Deferred
for
the
submissio
n
of
following
a.Approva
l status by
reference
regulatory
authorities
b.valid
legalized
COPP
c.Stability
data as per
conditions
of
Zone
IV A.
Deferred
for
the
submissio
n
of
following
a.Approva
l status by
reference
regulatory
authorities
b.valid
legalized
COPP
c.Stability
data as per
conditions
of
Zone
IV A.
147
Atco Bendamustine
Form 5A
153. M/s.
Laboratories
Hydochloride Injection
Limited, B-18, 100mg
Dy. No 308
S.I.T.E. Karachi.
Dated 06Each vial contains:05-2016
Bendamustine
Rs.50,000/Manufactured
Hydochloride………..1
by
M/s. Fresenius 00mg
Rs.25000/v
Kabi Oncolony Mannitol
Ph. ial
Limited, Village Eur……120mg
KIshanpura,
P.O.
Guru (Lumphocutic
Majra,
Tehsil leukemia,
indolent
Nalagarh, Distt. non-Hodgkin’s
Solan (H.P) 174 lymphoma, multiple
101, India.
myeloma)
FDA.
Bendamustine
powder
for
infusion
by
M/s Hospira.
COPP
valid
upto 0301-2015.
GMP
certificat
e
not
provided.
Stability
data as
per
condition
s of Zone
IV-B
attached.
MHRA.Ondan
setron 2mg/ml
by
M/s
Hameln
COPP
issued on
01-042014 by
Portagal.
Deferred
for
the
submissio
n of GMP
status of
the firm as
CoPP does
not reflect
GMP
status.
Manufacturer’s
Specifications
24 months
154. M/s. Amgomed, Amtron 8 mg (2mg/ml) Form 5A
Office # 5, 1st solution for injection
Floor Rose 1,
Dy.
No
Plaza
I-8 Each 8mg/4ml ampoule 1039 dated
Markaz
contains:
26.09.2016
Islamabad.
Ondansetron
Rs.100000/
………..8mg/4ml
Product
License Holder
M/s
Farmoz- (Antimetics used in As
per
Sociedade
cancer
induced SRO/ pack
Tecnico
of 5
vomiting)
Medicinal’ S.A.
Rua da Tapada Manufacturer’s
Grande,
2, Specifications
Abrunheira
03years
2710-089 Sintra,
Portugal.
Manufactured
by.
M/s
Laboratorios
Vitoria,
S.A.
(Fab) Rua Elias
Minutes for 260th Meeting Registration Board
Deferred
for
clarificatio
n of date
of
Local. Zofran
submissio
by M/s GSK
GMP
n
of
complian applicatio
t as per n
COPP.
148
Garcia,
28Venda
Nova
2700-327
Amadora,
Portugal & M/s.
Atlantic Pharma,
Producoes
Farmacueticals,
SA Rua da
Tapand, n 2
Abruheeira
Sintra,
2710089, Portugal
155. M/s.
Pharmawell
(Pvt) Ltd. 244-Y
Block,
Commercial
Area Phase III,
DHA, Lahore.
Cyclocure
Capsule
25mg Form 5A
MHRA.
COPP
Deferred
Neoral
Soft issued
as firm has
Dated 11- Gelatin
dated 03- not
Each soft gel capsule 09-2015
Capsule 25mg 08-2015 submitted
contains:vide diary by
M/s vide no. real time
Cyclosporin………….2 No.
309 Novartis
2015052 stability
5mg
Rs.100,000
9 valid data upto
/upto
2 assigned
M/s.
North (Immunosuprent)
years.
shelf life,
China Co. Ltd,
Rs.1940
GMP
of
Zone
No. 115 Hainan (Manufacturer’s Specs) /50’s
valid
IV A.
Road,
upto 26Economic
& 24 months
06-2017
Techonological
vide no.
Development
HF20120
Zone,
014.
Shijiazhuang,
Stability
China
data as
per
condition
s of Zone
IVA
attached.
Cyclocure
50mg Form 5A
COPP
Deferred
156. M/s.
Pharmawell
Capsule
issued
as firm has
(Pvt) Ltd. 244-Y
Dated 11dated 03- not
Block,
Each soft gel capsule 09-2015
08-2015 submitted
Commercial
contains:vide diary
vide no. real time
Area Phase III, Cyclosporin………….5 No.
310
2015052 stability
DHA, Lahore.
0mg
Rs.100,000
7 valid data upto
/upto
2 assigned
M/s.
North (Immunosuprent)
years.
shelf life,
China Co. Ltd,
Rs.3881
GMP
of
Zone
Minutes for 260th Meeting Registration Board
149
No. 115 Hainan (Manufacturer’s Specs)
Road,
Economic
& 24 months
Techonological
Development
Zone,
Shijiazhuang,
China
157. M/s.
GlaxoSmithKlin
e
Pakistan
Limited,
35Dockyard Road,
West
Wharf,
Karachi-74000.
/50’s
Triumeq Tablet
Form 5A
Each film coated tablets
contains:Dolutegravir
as
sodium……50mg
Abacavir
as
sulfate…….600mg
Lamivudine…….300m
g
Dy No. 404
R&I dated
24-05-2016
Rs.50,000/-
Market
Authorization
Holder
M/s
ViiV Anti-HIV,
Healthcare UK new molecule
Limited,
980
Great
West 36 months
Road, Brentford,
Middlesex, TW8
9GS,
United
Kingdom
Will
be
submitted
later
valid
IV A.
upto 2606-2017
vide no.
HF20120
014.
Stability
data as
per
condition
s of Zone
IVA
attached
COPP
Approved
issued
dated1002-2016
vide No.
01/16/95
860 by
EMA.
GMP
complian
t as per
COPP.
Manufactured
by M/s. Glaxo
Operations UK
Ltd,
Priory
Street,
Ware,
Hertfordshire
SG12
ODJ,
United
Kingdom.
Site Responsible
for Primary &
Secondary
Packaging
Minutes for 260th Meeting Registration Board
150
M/s
Glaxo
Wellcome S.A.,
Avenida
Extremadura 3,
Aranda
de
Duero, Burgos,
09400, Spain.
158. M/s Johnson &
Johnson
Pakistan
Pvt
Ltd, Karachi
Name
of
Distributor
M/s
Ethicon,
LLC 475 C
Street
Los
Frailes
Industrial Park
Guaynabo, PR,
USA 00969
Name
of
Manufacturer:M/s
Surgical
Specialities
Puerto
Rico,
Inc; Angiotech
PR Inc. Doing
business
as
Angiotech
Puerto
Rico,
Inc; Road 459
KM
0.6
Montana
Industrial Park
Aguadilla, PR,
USA 00603.
Product Code
SXMD1B100
SXMD1B101
SXMD1B102
SXMD1B103
SXMD1B104
SXMD1B105
SXMD1B106
SXMD1B402
Stratafix Knotless tissue Form 5A
control device
Dy No. 679
Each unit of device dated 11contains:04-2014
Polydioxanone/PGARs.50,000.
PCL/Polypropylene
Not
(Class
III
Medical mentioned
device)
New Molecule
Certificat
e
to
foreign
Governm
ent No.
1171-62013
issued
dated 1406-2013
valid
upto
2
years.
Medical
Device
Deferred
for
the
expert
opinion
from
Expert
Committe
e
for
Medical
Devices
(ECMD).
Product Description
PS-1 2-0 PGA-PCL 30CM
PS-2 3-0 PDO 45CM
PSL 0 PGA-PCL 60CM
PS-2 2-0 PGA-PCL 30CM
PS-2 2-0 PGA-PCL 60CM
PS-2 3-0 PGA-PCL 30CM
PS-2 3-0 PGA-PCL 60CM
RB-1 3-0 PGA-PCL 20CM
Minutes for 260th Meeting Registration Board
151
SXMD1B403
SXMD1B404
SXMD1B405
SXMD1B406
SXMD1B407
SXMD1B408
SXMD1B409
SXMD2B150
SXMD2B400
SXMD2B401
SXMD2B402
SXMD2B403
SXMD2B404
SXMD2B405
SXMD2B406
SXMD2B407
SXMD2B408
SXMD2B409
SXMD2B410
SXMD2B411
SXMD2B412
SXMD2B413
SXMD2B413
SXMD2B414
SXPD1B100
SXPD1B101
SXPD1B400
SXPD1B401
SXPD2B200
SXPD2B201
SXPD2B202
SXPD2B400
SXPD2B401
SXPD2B402
SXPD2B403
SXPD2B404
SXPD2B405
SXPD2B406
SXPD2B407
SXPD2B409
SXPD2B408
RB-1 2-0 PGA-PCL 20CM
RB-1 0 PGA-PCL 20CM
SH 2-0 PGA-PCL 20CM
SH 0 PGA-PCL 20CM
CT-1 2-0 PGA-PCL 45CM
CT-1 0 PGA-PCL 45CM
CT-1 1 PGA-PCL 45CM
2PS-l 3-0 UNO MONODERM 30X30
2MH -0- UNDYED MONODERM 14X14
2MH -0- UNDYED MONODERM 36X36
2R8-1 2-0 U MND 16X1613MM LOR
2RB-l 3-0 U MND 16X1613MM LOR
2FS-2 2-0 UNDYED MONODERM 7X7
2FS-2 3-0 UNDYED MONODERM 7X7
2FS-2 2-0 UNDYD MONODERM 14X14
2FS-2 3-0 UNDYD MONODERM 14X14
2FS-2 2-0 UNDYD MONODERM 30X30
2FS-2 3-0 UNDYD MONODERM 30X30
2FS-l 2-0 UND MONODERM 30X30
2FS 2-0 UNDYD MONODERM 14X14
2FS 2-0 UNDYD MONODERM 30X30
2FS 3-0 UNDYD MONODERM 30X30
2FS 3-0 UNDYD MONODERM 30X30
2CP-2 -0- UNDYD MONODERM 14X14
PS-2 2-0 PDO 45CM
PS-2 3-0 PDO 45CM
CT-1 0 PDO 20CM
CT-1 0 PDO 30CM
20S-6 #2 PDO 24X24
20S-6 #2 POD 30 X 30
20S-8 #2 PDO 36 X 36
2MO-4 #2 PDO 36 X 36
2CT-1 -2- PDO 14X 14
2CT-1 #2 PD024X24
2CT -1 #2 PDO 30 X 30
2CT-3-1- PDO 14X14 13MM LDR
2CTX #2 PDO 36 X 36
2MH -0- PDO 7X7 13MM LEADER
2MH -0- PDO 14X1413MMLEADER
2MH-1-PDO 14X14
2MH -0- PDO 24 X 24
Minutes for 260th Meeting Registration Board
152
SXPD2B410
SXPD2B411
SXPD2B412
SXPD2B413
SXPD2B414
SXPD2B415
SXPD2B416
SXPD2B417
SXPD2B418
SXPD2B419
SXPD2B420
SXPD2B421
SXPD2B422
SXPD2B423
SXPD2B424
SXPD2B425
SXPD2B426
SXPL1B400
SXPL2B400
SXPL2B401
SXPP1A100
SXPP1A101
SXPP1A200
SXPP1A201
SXPP1A300
SXPP1A301
SXPP1A302
SXPP1A400
SXPP1A401
SXPP1A402
SXPP1A403
SXPP1A404
SXPP1A405
SXPP1A406
SXPP1A407
SXPP1A408
SXPP1A409
SXPP1A410
SXMP1B101
SXMP1B102
SXMP1B103
2MH #1 PDO 24 X 24
2MH #1 PDO 30 X 30
2MH -0- PDO 36 X 36
2SH-0- PDO 10 X 10 13MM LEADER
2SH -0- PDO 14 X 14 13MMLEADER
2CP-2 #I PDO 24X24
2CP-2 #2 PDO 24 X 24
2FS 2-0 PDO 14X14
2FS -0- PDO 14 X 14
2FS 2-0 PDO 24 X 24
2FS -0- PDO 24 X 24
2FS-2 4-0 PDO 7 X 7
2FS-2 3-0 PDO 7X7
2FS-2 3-0 PDO 14 X 14
2V-26 3-0 PDO 24 X 24
2V-26 3-0 PDO 14X14
2V-4 3-0 PDO 24X24
DE12 0 PPN 30CM
2CT-1 -2- CL PPN 24X24
2CT-3 -1- CL PPN 14X1413MM LDR
STRATAFIX SYMM PDS PLUS 45cm; PS-1; 3-0; Plastics
STRATAFIX SYMM PDS PLUS 45cm; PS-2; 3-0; Plastics
STRATAFIX SYMM PDS PLUS 45cm; OS-6; 0; Ortho
STRATAFIX SYMM PDS PLUS 45cm; OS-6; 1; Ortho
STRATAFIX SYMM PDS PLUS 45cm; CTXB; 1; Ethiguard
STRATAFIX SYMM PDS PLUS 45cm; CTB-1; 1; Ethiguard
STRATAFIX SYMM PDS PLUS 45cm; CTXB; 0; Ethiguard
STRATAFIX SYMM PDS PLUS 45cm; CTX; 1
STRATAFIX SYMM PDS PLUS 45cm; CT-1; 0
STRATAFIX SYMM PDS PLUS 45cm; CTX; 0
STRATAFIX SYMM PDS PLUS 45cm; CT-1; 2-0
STRATAFIX SYMM PDS PLUS 45cm; CT-1; 1
STRATAFIX SYMM PDS PLUS 45cm; CT; 1
STRATAFIX SYMM PDS PLUS 45cm; CT; 0
STRATAFIX SYMM PDS PLUS 45cm; CT-2; 0
STRATAFIX SYMM PDS PLUS 45cm; CT-2; 2-0
STRATAFIX SYMM PDS PLUS 45cm; SH; 2-0
STRATAFIX SYMM PDS PLUS 45cm; SH; 3-0
MONOCRYL PLUS 30CM M -2 USP 3/0 SGLE ARMED PS-1
MONOCRYL PLUS 45CM M -2 USP 3/0 SGLE ARMED PS-1
MONOCRYL PLUS 60CM M -2 USP 3/0 SGLE ARMED PS-1
Minutes for 260th Meeting Registration Board
153
SXMP1B104
SXMP1B105
SXMP1B106
SXMP1B107
SXMP1B108
SXMP1B109
SXMP1B110
SXMP1B111
SXMP1B113
SXMP1B114
SXMP1B115
SXMP1B116
SXMP1B117
SXMP1B118
SXMP1B119
SXMP1B120
SXMP1B408
SXMP1B409
SXMP1B410
SXMP1B411
SXMP1B412
SXMP1B413
SXMP1B414
SXMP1B415
SXMP1B416
SXMP1B417
SXMP1B419
SXMP1B420
SXMP1B421
SXMP1B424
SXMP1B425
SXMP1B426
SXMP1B427
SXMP1B428
SXMP1B429
SXMP1B430
SXMP1B431
SXMP1B432
SXMP1B433
SXMP1B434
SXMP1B435
MONOCRYL PLUS70CM M -2 USP 3/0 SGLE ARMED PS-1
MONOCRYL PLUS15 CM M -2 USP 3/0 SGLE ARMED PS-2
MONOCRYL PLUS 30CM M -2 USP 3/0 SGLE ARMED PS-2
MONOCRYL PLUS 45CM M -2 USP 3/0 SGLE ARMED PS-2
MONOCRYL PLUS 60CM M -2 USP 3/0 SGLE ARMED PS-2
MONOCRYL PLUS 70CM M -2 USP 3/0 SGLE ARMED PS-2
MONOCRYL PLUS 30CM M -2 USP 3/0 SGLE ARMED PS
MONOCRYL PLUS 45CM M -2 USP 3/0 SGLE ARMED PS
MONOCRYL PLUS 70CM M -2 USP 3/0 SGLE ARMED PS
MONOCRYL PLUS 30CM M -1.5 USP 4/0 SGLE ARMED PS-1
MONOCRYL PLUS 45CM M -1.5USP 4/0 SGLE ARMED PS- 1
MONOCRYL PLUS 70CM M -1.5 USP 4/0 SGLE ARMED PS- 1
MONOCRYL PLUS 30CM M -1.5 USP 4/0 SGLE ARMED PS-2
MONOCRYL PLUS 45CM M -1.5USP 4/0 SGLE ARMED PS- 2
MONOCRYL PLUS 70CM M -1.5 USP 4/0 SGLE ARMED PS- 2
MONOCRYL PLUS 45CM M1.5 USP 4/0 SGLE ARMED PS-4
MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED SH
MONOCRYL PLUS 20CM M3 USP 2/0 SGLE ARMED SH
MONOCRYL PLUS 30CM M3 USP 2/0 SGLE ARMED SH
MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED CT-1
MONOCRYL PLUS 30 CM M3 USP 2/0 SGLE ARMED CT-1
MONOCRYL PLUS 45 CM M3 USP 2/0 SGLE ARMED CT-1
MONOCRYL PLUS 70 CM M3 USP 2/0 SGLE ARMED CT-1
MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED CT-2
MONOCRYL PLUS 30 CM M3 USP 2/0 SGLE ARMED CT-2
MONOCRYL PLUS 45 CM M3 USP 2/0 SGLE ARMED CT-2
MONOCRYL PLUS 70 CM M3 USP 2/0 SGLE ARMED CT-2
MONOCRYL PLUS 30 CM M3 USP 2/0 SGLE ARMED PSL
MONOCRYL PLUS 70 CM M3 USP 2/0 SGLE ARMED PSL
MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED RB-1
MONOCRYL PLUS 30CM M2 USP3/0 SGLE ARMED RB-1
MONOCRYL PLUS 70CM M2 USP3/0 SGLE ARMED RB-1
MONOCRYL PLUS 20CM M2 USP3/0 SGLE ARMED SH
MONOCRYL PLUS 70CM M2 USP3/0 SGLE ARMED SH
MONOCRYL PLUS 45CM M2 USP3/0 SGLE ARMED CT-1
MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED BB
MONOCRYL PLUS 30CM M2 USP3/0 SGLE ARMED BB
MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED ST-4
MONOCRYL PLUS 30CM M2 USP3/0 SGLE ARMED ST-4
MONOCRYL PLUS 15CM M1.5 USP4/0 SGLE ARMED RB-1
MONOCRYL PLUS 30CM M1.5 USP4/0 SGLE ARMED RB-1
Minutes for 260th Meeting Registration Board
154
SXMP1B436
SXMP1B437
SXPP1B101
SXPP1B102
SXPP1B103
SXPP1B104
SXPP1B105
SXPP1B106
SXPP1B107
SXPP1B108
SXPP1B109
SXPP1B110
SXPP1B111
SXPP1B112
SXPP1B113
SXPP1B114
SXPP1B115
SXPP1B116
SXPP1B117
SXPP1B118
SXPP1B201
SXPP1B202
SXPP1B203
SXPP1B204
SXPP1B205
SXPP1B401
SXPP1B402
SXPP1B403
SXPP1B404
SXPP1B405
SXPP1B406
SXPP1B407
SXPP1B408
SXPP1B409
SXPP1B410
SXPP1B411
SXPP1B412
SXPP1B413
SXPP1B414
SXPP1B415
SXPP1B416
MONOCRYL PLUS 70CM M1.5 USP4/0 SGLE ARMED RB-1
MONOCRYL PLUS 70CM M1.5 USP4/0 SGLE ARMED SH
PDS PLUS VIO 45CM M3 UPS/2-0 SGLE ARMED FS
PDS PLUS VIO 70CM M3UPS/2-0 SGLE ARMED FS
PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED PS-2
PDS PLUS VIO 30CM M2 UPS/3-0 SGL ARMED PS-2
PDS PLUS VIO 45CM M2 UPS/3-0 SGLE ARMED PS-2
PDS PLUS VIO 70CM M2 UPS/3-0 SGLE ARMED PS-2
PDS PLUS VIO 30CM M2 UPS/3-0 SGLE ARMED PS-2
PDS PLUS VIO 45CM M2 UPS/3-0 SGLE ARMED PS-2
PDS PLUS VIO 70 CM M2 UPS/3-0 SGLE ARMED PS
PDS PLUS VIO 70 CM M2 UPS/3-0 SGLE ARMED PS-1
PDS PLUS VIO 15 CM M2 UPS/4-0 SGLE ARMED PS-2
PDS PLUS VIO 30CM M2 UPS/4-0 SGLE ARMED PS-2
PDS PLUS VIO 45CM M2 UPS/4-0 SGLE ARMED PS-2
PDS PLUS VIO 70CM M1.5 UPS/4-0 SGLE ARMED PS-2
PDS PLUS VIO 30CM M2 UPS/4-0 SGLE ARMED PS-1
PDS PLUS VIO 45CM M2 UPS/4-0 SGLE ARMED PS-1
PDS PLUS VIO60CM M2 UPS/4-0 SGLE ARMED PS-1
PDS PLUS VIO 45CM M2 UPS/4-0 SGLE ARMED PS
PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED OS-6
PDS PLUS VIO 45CM M3.5 UPS/0 SGLE ARMED CP-2
PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED OS-6
PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED OS-8
PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED MO-4
PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED CT X
PDS PLUS VIO 90CM M4 UPS/1 SGLE ARMED CTX
PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED CP-2
PDS PLUS VIO 20CM M3.5 UPS/0 SGLE ARMED V-34
PDS PLUS VIO 30CM M3.5 UPS/0 SGLE ARMED CT-2
PDS PLUS VIO 15CM M3.5 UPS/0 SGLE ARMED CT-1
PDS PLUS VIO 45CM M3.5 UPS/0 SGLE ARMEDCT-1
PDS PLUS VIO 70CM M3.5 UPS/0 SGLE ARMED CT-1
PDS PLUS VIO 15CM M3 UPS/2-0 SGLE ARMED CT-1
PDS PLUS VIO 30CM M3 UPS/2-0 SGLE ARMED CT-1
PDS PLUS VIO 45CM M3 UPS/2-0 SGLE ARMED CT-1
PDS PLUS VIO 70CM M3 UPS/2-0 SGLE ARMED CT-1
PDS PLUS VIO 15CM M3UPS/2-0 SGLE ARMED CT-2
PDS PLUS VIO 70CM M3 UPS/2-0 SGLE ARMED CT-2
PDS PLUS VIO 15CM M3 UPS/2-0 SGLE ARMED SH
PDS PLUS VIO 30CM M3 UPS/2-0 SGLE ARMED SH
Minutes for 260th Meeting Registration Board
155
SXPP1B417
SXPP1B418
SXPP1B419
SXPP1B420
SXPP1B421
SXPP1B422
SXPP1B423
SXPP1B424
SXPP1B425
SXPP1B426
SXPP1B427
SXPP1B428
SXPP1B429
SXPP1B430
SXPP1B431
SXPP1B450
SXPP1B451
SXPP1B452
PDS PLUS VIO 70CM M3 UPS/2-0 SGLE ARMED SH
PDS PLUS VIO 20CM M3 UPS/2-0 SGLE ARMED V-7
PDS PLUS VIO 30CM M3 UPS/2-0 SGLE ARMED UR-6
PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED SH
PDS PLUS VIO 70CM M2 UPS/3-0 SGLE ARMED SH
PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED RB-1
PDS PLUS VIO 70CM M2 UPS/3-0 SGLE ARMED RB-1
PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED ST-4
PDS PLUS VIO 70CM M2 UPS/3-0 SGLE ARMED CT-2
PDS PLUS VIO 70CM M1.5UPS/4-0 SGLE ARMED SH
PDS PLUS VIO 15CM M1.5UPS/4-0 SGLE ARMED RB-1
PDS PLUS VIO 30CM M1.5 UPS/4-0 SGLE ARMED RB-1
PDS PLUS VIO 30CM M4UPS/1 SGLE ARMED CT-1
PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED CT-1
PDS PLUS VIO 70CM M4UPS/1 SGLE ARMED CT-1
PDS PLUS VIO 30CM M3.5 UPS/0 SGLE ARMED CT-1
PDS PLUS VIO 70 CM M3.5UPS/0 SGLE ARMED M05
PDS PLUS VIO 30CM M3.5 UPS/0 SGLE ARMED EN-S
Muhammad Ansar Evaluator-I
Replies of the import cases deferred in 259th meeting of the Registration Board.
159.
M/s
Merixil
Pharma,
Office
#28, 2nd
floor Rose
Plaza, I-8,
Markaz,
Islamabad.
Tablet
Azastrole 1mg
Form 5A
TGA.
Azastrole
1mg
The firm
has
submitted
18-042014 vide
diary No. Arimedex Legalized
314 R&I 1mg by
Free sale
Rs.100,0 M/s ICI
issued dated
00.
30-12-2013.
Stability
(Treatment of As per
data as per
SRO/3x1
conditions
Manufact harmone
0’s
of Zone IVured by
recpotor
M/s Eris
A
positive
Pharmace advanced
Legalized
utical
GMP
breast cancer
(Australia) in
certificate
post
Pty Ltd, 6 menopausal
issued dated
Eastren
women)
25-02-2013.
Road
South
Manufacturer’s
Each film
coated tablet
contains:Anastrozole…
….1mg
Minutes for 260th Meeting Registration Board
Now the
firm has
submitted
that in
registration
dossier
license to
manufactur
e
therapeutic
goods
(Legalized)
, the antineoplastic
agents
tablet
section is
mentioned
in its
attachments
Approved
as
per
import
Policy for
Finished
Drugs.
Product is
approved
by
TGA
which is a
reference
regulatory
authority.
156
160.
161.
Melbourn
e VIC
3205,
Australia.
(230)
Specifications
M/s
Merixil
Pharma,
Office
#28, 2nd
floor Rose
Plaza, I-8,
Markaz,
Islamabad.
(231)
Manufact
ured by
M/s Eris
Pharmace
utical
(Australia)
Pty Ltd, 6
Eastren
Road
South
Melbourn
e VIC
3205,
Australia.
(231)
Tablet Gynotril
2.5mg
M/s
Merixil
Pharma,
Office
Tablet Bicalox
50mg
Form 5A
18-04Each film
2014 vide
coated tablet
diary No.
contains:313 R&I
Letrozole…….2 Rs.100,0
.5mg
00.
TGA.
Gynotril
2.5mg
The firm
has
submitted
Femara
2.5mg by
M/s
Novartis
Legalized
Free sale
issued dated
30-12-2013.
Stability
data as per
conditions
of Zone IVA
Legalized
GMP
certificate
issued dated
25-02-2013.
TGA.
Bicalox
50mg
The firm
has
submitted:-
As per
(Adjuant
treatment
of SRO/3x1
0’s
postmenopausal
women
with
harmone
recpotor
positive
invasive early
breast cancer)
USP
Specifications
Each film
Form 5A
18-042014 vide
Minutes for 260th Meeting Registration Board
furthermore
the firm has
replied that
the product
is TGA
approved
brand and
also same
is available
on the site
of TGA.
Now the
firm has
submitted
that in
registration
dossier
license to
manufactur
e
therapeutic
goods
(Legalized)
, the antineoplastic
agents
tablet
section is
mentioned
in its
attachments
furthermore
the firm has
replied that
the product
is TGA
approved
brand and
also same
is available
on the site
of TGA.
Now the
firm has
submitted
that in
Approved
as
per
import
Policy for
Finished
Drugs.
Product is
approved
by
TGA
which is a
reference
regulatory
authority.
Approved
as
per
import
Policy for
157
#28, 2nd
floor Rose
Plaza, I-8,
Markaz,
Islamabad.
Manufact
ured by
M/s Eris
Pharmace
utical
(Australia)
Pty Ltd, 6
Eastren
Road
South
Melbourn
e VIC
3205,
Australia.
(232)
162.
M/s Zam
Zam
Corporatio
n, Suit No.
205-206,
Beaumont
Plaza,
Beaumont
Road,
Karachi
Manufact
ured by
M/s LEO
Pharma
A/S
Industripa
rken 55
DK-2750
Ballerup,
coated tablet
contains:Bicalutamide…
….50mg
diary No.
315 R&I
Rs.100,0
00.
Adjuant to
radial
prostectomy or
radio-therapy in
patients with
locally
advanced
prostate cancer
As per
SRO/
Casodex
50mg by
M/s ICI
Legalized
Free sale
issued dated
30-12-2013.
Stability
data as per
conditions
of Zone IVA
Legalized
GMP
certificate
issued dated
25-02-2013.
USP
Specifications
Daivobet Gel.
Form 5A
Denmark The firm
Daivobet has
Each gm
26-12Gel by
submitted:contains:2013 vide M/s LEO.
Calcipotriol…
diary No.
Free sales
…..…50mcg
469 R&I
certificate
Betamethasone Rs.50,00
10-12Dipropionate… 0
2012(legali
…....0.5mg
zed
photocopy).
Rs.1600/
GMP issued
Topical Vitamin 15gm
dated 01D analogue &
tube
06-2010.
Steroid.
registration
dossier
license to
manufactur
e
therapeutic
goods
(Legalized)
, the antineoplastic
agents
tablet
section is
mentioned
in its
attachments
furthermore
the firm has
replied that
the product
is TGA
approved
brand and
also same
is available
on the site
of TGA.
Now the
firm has
replied the
product is
Denmark
approved
which is
reference
country.
Finished
Drugs.
Product is
approved
by
TGA
which is a
reference
regulatory
authority.
Approved
as
per
import
Policy for
Finished
Drugs.
Manufacturer’s
Specifications
Minutes for 260th Meeting Registration Board
158
Denmark.
(189)
163.
164.
M/s
Amgomed
, office
No. 05, 1st
floor,
Rose 1
Plaza, I-8,
Markaz,
Islamabad.
From
Manufactu
red By
M/s West
Pharma,
Producoes
de
Especialia
es
Farmaceut
icas, SA
Rua Joao
De Deus,
n. 11,
Amadora,
2700-486,
Portugal.
(227)
M/s
Revive
Healthcare
, Office
503, 5th
Floor, 6
Main
Gulberg,
Jail Road,
Lahore,
Pakistan.
Letroze 2.5mg
tablet
Each film
coated tablet
contains:Letrozole…….2
.5mg
Form 5A
11-042014 vide
diary No.
297 R&I
Rs.100,0
00
TGA.
Gynotril
2.5mg
Femara
2.5mg by
M/s
Novartis
(Adjuant
treatment
of As per
SRO/30
posttablets
menopausal
women
with
harmone
recpotor
positive
invasive early
breast cancer)
USP
Specifications
Vesna Injection
200mg
Each 1ml
contains:Sodium-2Sulphanylethan
esulphonate
BP……100mg
Antineoplastic
Agent
Manufactu
red by
USP
M/s
Specifications
Form 5A
MHRA.
Mesna
02-08200mg/2
2013 vide ml by
diary No. M/s
1001 R&I Claris
Rs.100,0 Lifescien
00
ces UK.
As per
SRO/2ml
ampoule
Minutes for 260th Meeting Registration Board
The firm
has
submitted
Now the
firm has
submitted
the GMP
COPP
legalized
Legalized
which
issued dated shows the
19-11-2013. details of
Firm is
sections i.e
GMP
firm has
compliant
non sterile
as per
antineoplas
COPP
tic tablet
Legalized
section.
issued dated
19-11-2013.
Stability
data as per
conditions
of Zone IVA.
Approved
as
per
import
Policy for
Finished
Drugs.
The firm
has
submitted
Legalized
COPP valid
upto 10-092013.
Stability
data as per
conditions
of Zone IVA.
Legalized
GMP dated
13.09.2010.
Approved
as
per
import
Policy for
Finished
Drugs.
Now the
firm has
submitted
the COPP
for the
Vesna valid
upto 10-052017 which
shows that
the product
is available
in alone.
159
United
Biotech
(P) Ltd.
FC/B-1
(Extn.)
Mohan
Cooperati
ve
Industrial
Estate,
Mathura
Road,
New
Delhi110044,
India.
(129)
The following product of M/s. Revive Health Care, Lahore was discussed in the 243rd meeting of
the board and was approved.
It is submitted that there is a typographical mistake in the formulation the Sodium 2Sulphanylethansulphonate 100mg were written inadvertently.
M/s. Revive Health Care,
Lahore. /
M/s. United Biotech (P)
Limited, Bagbani, Baddi,
Nalagarh Road, District,
Solan, India.
Ifomid-M 1gm Injection
As per
02 years Approved as
Each vial contains:SRO/PRC
per import
Ifosfamide…………….1gm
Policy
for
Sodium 2Finished
Sulphanylethansulphonate
Drugs.
BP……………..……100mg
(ATC Class: L01AA06).
The correct formulation is as under
165.
M/s. Revive Health Care,
Lahore. /
M/s. United Biotech (P)
Limited, Bagbani, Baddi,
Nalagarh Road, District,
Solan, India.
Ifomid-M 1gm Injection
As per 02 years valid COPP Approved as
Each vial contains:SRO/PRC
valid upto per import
Ifosfamide…………….1gm
10-05-2017 Policy for
Finished
(ATC Class: L01AA06).
Drugs.
Minutes for 260th Meeting Registration Board
160
Muhammad Ansar Evaluator-I
Replies of product deferred in 254th meeting of the Board.
166. Importer
M/s Efroz
Chemical
Industries (Pvt)
Limited, 12-C
Block 6,
P.E.C.H.S. off
Shahrah-eFaisal, Karachi
Manufacturer
M/s Dae Hwa
Pharmaceuticals
Co., Ltd
495- Hanu-ro-,
Hoenseong-eup,
Hoenseong,
Gangwon-do,
Republic of
Korea.
KETOFAST
Cataplasma
Form5A
Each sheet (9x13cm2,
Dy No
11.7gm) contains:
: 468
Ketoprofen…..25.07mg dated
26-01NSAID
11
15000/Manufacturer
dated
26-0111
85000/dated
19-0214
Rs.
500/Per 6’s
Sheets
Minutes for 260th Meeting Registration Board
International
availibility
not
confirmed.
Kefentech
Plaster by
M/s Matrix
Reg
#047624.
Deferred for:
Evidence of
approval of
same dosage
form, generic
and strength
in reference
drug agency.
Confirmation
of address of
the
manufacturer
of the
applied
product as
the address
mentioned
on Form-5A
& GMP is
different
from the
address
mentioned in
the COPP.
Moreover,
address of
manufacturer
on sole
agency
agreement is
different
from address
of above
mentioned
documents.
Clarfication
that applied
drug is
generic
Legalized
GMP
issued
dated 2801-2016
by Korea.
Legalized
COPP
issued
dated 2605-2016
by Korea.
Product is
in free
sale in
Korea.
Local
Kefentech
by M/s
Matrix.
161
Deferred for
the
confirmation
of approval
status
by
reference
regulatory
authorities
product
hence
clinical data
and clinical
justification
is not
required.
Stability data
as per
WHO/ICH
Zone-IV A.
Muhammad Ansar Evaluator-I
Routine Import Applications
Veterinary Import applications Routine
Decision
167.
168.
M/s. Ghazi
Brothers,
Karachi-75350.
/
M/s. Pharmacia
& Upjohn
Company A
Division of
Pfizer Inc.
Kalamazoo,
Michigan,
U.S.A.
362
M/s. Ghazai
Brothers,
Karachi-75350.
/
M/s. Pharmacia
& Upjohn
Company A
Division of
Pfizer Inc.
Kalamazoo,
Michigan,
U.S.A.
Spectramast DC
Suspension
Each 10ml Plastet
Disposable Syringe
contains:Ceftiofur
Equivalents (as the
hydrochloride
sale)…500mg
Form 5-A
Rs. 50,000/vide Dy. No.
628 dated 2905-2013
FDA.
Ceftifur
500mg by
M/s M/s.
Pharmacia
& Upjohn
COPP
issued by
US FDA
dated 2003-2013.
GMP
compliant
as per
COPP.
Approved
as
per
import
Policy for
Finished
Drugs.
FDA.
Ceftifur
250mg by
M/s M/s.
Pharmacia
& Upjohn
COPP
issued by
US FDA
dated 0910-2015.
GMP
compliant
as per
COPP.
Approved
as
per
import
Policy for
Finished
Drugs.
Decontrolled/1
0ml
(Antibiotic).
Manufacturer’s
specifications
Spectramast LC
Suspension
Each 10ml Plastet
Disposable Syringe
contains:Ceftiofur
Equivalents to
Ceftiofur …125mg
Form 5-A
Rs. 50,000/vide Dy. No.
627 dated 2905-2013
Decontrolled/1
0ml
(Antibiotic).
Minutes for 260th Meeting Registration Board
162
363
169.
M/s. Ghazi
Brothers,
Ghazi House,
D-35. K.D.A.
Scheme No.1,
Miran
Muhammad
Shah Road,
Karachi-75350
Product
License
Holder:M/s. Agrovet
Market S.A.,
Av. Canada
3792 San Luis,
Lima, Peru.
Manufacturer
Under Product
License
Holder:M/s. Pharmadix
Corp. S.A.C.
Urbanizacion La
Aurora-Ate
Lima 3-Peru.
170.
426
M/s. Ghazi
Brothers,
Karachi.
M/s. Bayer New
Zealand
Limited,
Hillcrest,
Auckland, New
Zealand.
Manufacturer’s
specifications
24 Months
ADEFORTEX
Injectable Solution
Each mL contains:Vitamin A (Palmitic
ester of Vitamin
A)……………500,0
00 I.U
Vitamin D3 (Pure
Cholecalciferol)…..
75,000 I.U
Vitamin E (AlphaTocopherol
Acetate)……………
..50mg
Form 5-A
Dy. No. 211
R&I Rs.
50,000/- dated
19-03-2014 &
Rs. 50,000
dated 30-072016 dy No.
822.
Local.
Duravit
AD3E
Injection by
M/s Mylab.
Free sale
issued
dated 1912-2012.
GMP
issued
dated 0602-2013.
Approved
as
per
import
Policy for
Finished
Drugs.
Free sales
certificate
issued
dated 1110-2012.
GMP
issued
dated 1505-2013.
Approved
as
per
import
Policy for
Finished
Drugs.
Decontrolled/1
00ml
Vitamin
Supplement.
Manufacturer’s
Specifications
03 years
Ovuprost Aqueous
Injectable Solution
Each mL contains:Cloprostenol (as
Sodium)…..250ug
GynaecologicalsOxytocics.
Form 5-A
Rs. 50,000/vide Dy. No.
53 dated 6-012014 &
Rs.50,000
dated 30-072016 dy
No.820.
Delzamazin
by M/s Prix
B.P Specifications
410
Minutes for 260th Meeting Registration Board
Decontrolled/
163
171.
M/s. Ghazi
Brothers,
Ghazi House,
D-35. K.D.A.
Scheme No.1,
Miran
Muhammad
Shah Road,
Karachi-75350
Ectomethrn 200
Emulsion liquid.
Product License
Holder:M/s. Agrovet
Market S.A.,
San Luis, Lima,
Peru.
Ectoparasiticide.
Each mL
emulsifiable
concentrate
contains:Cypermethrin…...20
0mg
Manufacturer’s
Specifications
Form 5-A
Rs. 50,000/vide Dy. No.
212 dated 1903-2014 & Rs
50,000 dated
30-07-2016
Dy No.821.
Free sales
certificate
Local.
issued
Cypothern
dated 29200
10-2013.
Solution by GMP
star
compliant
issued
dated2910-2013.
Approved
as
per
import
Policy for
Finished
Drugs.
Free sales
certificate
issued
dated 2609-2012.
GMP
compliant
as per
FSC dated
26-092012.
Approved
as
per
import
Policy for
Finished
Drugs.
Decontrolled/
10ml, 20ml,
50ml, 100ml,
250ml, 500ml
& 1 litre.
Manufacturer
Under Product
License
Holder:M/s. Pharmadix
Corp. S.A.C.
Urbanizacion La
Aurora-Ate
Lima 3-Peru.
172.
429
M/s. Ghazi
Brothers,
Ghazi House,
D-35. K.D.A.
Scheme No.1,
Miran
Muhammad
Shah Road,
Karachi
Product License
Holder.
M/s Cevasa S.A
23rd Street N
293 Pilar
Industrial Park,
Pilar State of
Buenos Aires,
Cevasametrina 20
Emulsion solution.
Each 100mL
emulsifiable
concentrate
contains:Cypermethrin…...20
g
Form 5-A
Rs. 50,000/vide Dy. No.
209 dated 1903-2014 &
Rs.50,000
dated 30-072016 dy No.
823.
Ectoparasiticide.
Manufacturer’s
Specifications
Minutes for 260th Meeting Registration Board
Local.
Cypothrin
20 by Star
labs
Decontrolled/
20ml, 50ml,
100ml, 500ml
& 1 litre.
164
Argentina.
Manufactured
by.
Midori S.R.L,
Stephenson
3294,
Tortuguitas,
Buenos Aires,
Argentina
425
Human Import Applications Routine
173.
174.
M/s Novartis
Pharma
(Pakistan),
Limited 15 West
Wharf, Karachi
Manufactured
by
M/s Sandoz
Private Ltd.
MIDC Plot No.
8-A/2 & 8-B
TTC Industrial
area Kalwe
Block Village
Dighe Navi ,
Mumbai, India.
195
M/s Novartis
Pharma
(Pakistan),
Limited 15 West
Wharf, Karachi
M/s Sandoz
Private Ltd.
MIDC Plot No.
8-A/2 & 8-B
TTC Industrial
area Kalwe
Block Village
Micocept
Capsule
Each Capsule
Contains:
Mycophenolate
Mofetil………...250
mg
(Immunosuppressant
)
Form 5-A
Dairy No.
1263
dated 21-122012
Rs.100000/Rs.2925//50tabs
Rs.58.50/Tab
Manufacturer’s
Specifications
Micocept
Film coated tablets
Each film coated
tablet Contains:
Mycophenolate
Mofetil……..500mg
(Immunosuppressant
)
Manufacturer’s
Specifications
Minutes for 260th Meeting Registration Board
Form 5-A
Dairy No.
1264
dated 21-122012
Rs.100000/Rs.6000//50tabs
Rs.120/Tab
COPP
issued
dated 1712-2014
by TGA.
GMP
compliant
as per
CoPP.
CoPP
valid upto
20-032015 by
India.
GMP
valid upto
20-032015.
COPP
issued
dated 1712-2014
by TGA.
GMP
compliant
as per
CoPP.
CoPP
valid upto
20-032015 by
Approved
as
per
Import
policy for
Finished
Drugs and
complianc
e of Import
Policy
Order,
2016
165
Dighe Navi ,
Mumbai, India.
94
175.
M/s Umar
Pharma Pvt Ltd,
C 5/6, Auqaf
Plaza Dabgari
Garden,
Peshwar.
Manufactured
by
M/s
Genepharma
S.A, 18th Km,
Marathonosaven
ue-15351,
Pallini-Greece.
Femaplex 2.5mg
tablet
Each film coated
tablet contains:Letrozole….2.5mg
(Adjuant treatment
of post-menopausal
women with
harmone recpotor
positive invasive
early breast
cancer).
USP Specifications
Form 5A
Dy No. 1071
dated 20-082013
Rs.100,000/
MHRA.
Femra
2.5mg f/c
tablet by
M/s
Novartis.
As per SRO
Local.
Femra
2.5mg by
M/s
Novartis.
Form 5A
MHRA.
Soltamox
20mg tablet
by M/s
Aurobindo.
India.
GMP
valid upto
20-032015.
COPP
issued
dated 2506-2013.
GMP
compliant
as per
COPP.
131
176.
M/s Umar
Pharma Pvt Ltd,
C 5/6, Auqaf
Plaza Dabgari
Garden,
Peshwar.
Manufactured
by
M/s
Genepharma
S.A, 18th Km,
Marathonosaven
ue-15351,
Pallini-Greece.
Zymoplex 20mg
tablet
Each tablet
contains:Tamoxifen Citrate
eq to
Tamoxifen…….20m
g
Dy No. 1070
dated 20-082013
Rs.100,000/
As per SRO
Local.
Cytotam by
M/s AJ
Mirza.
COPP
issued
dated 2506-2013.
GMP
compliant
as per
COPP.
Oestrogen Receptor
Positive Early Breast
Cancer
133
177.
M/s Umar
Pharma Pvt Ltd,
C 5/6, Auqaf
Plaza Dabgari
Garden,
Zymoplex 10mg
tablet
Each tablet
contains:-
Minutes for 260th Meeting Registration Board
Form 5A
Dy No. 1068
dated 20-082013
TGA.
Cosudex
50mg by
M/s
Astrazeneca
COPP
issued
dated 2506-2013.
GMP
Approved
as per
Import
Policy for
Finished
Drugs.
Panel shall
confirm
the
anticancer
facility for
the
manufactu
ring of the
drug at the
time of
foreign
inspection.
Approved
as per
Import
Policy for
Finished
Drugs.
Panel shall
confirm
the
anticancer
facility for
the
manufactu
ring of the
drug at the
time of
foreign
inspection.
Approved
as per
Import
Policy for
Finished
166
178.
179.
Peshwar.
Manufactured
by
M/s
Genepharma
S.A, 18th Km,
Marathonosaven
ue-15351,
Pallini-Greece.
132
Tamoxifen Citrate
Rs.100,000/
eq to
Tamoxifen…….10m As per SRO
g
M/s Umar
Pharma Pvt Ltd,
C 5/6, Auqaf
Plaza Dabgari
Garden,
Peshwar.
Manufactured
by
M/s
Genepharma
S.A, 18th Km,
Marathonosaven
ue-15351,
Pallini-Greece.
130
Bicamide 50mg
tablet
M/s A. Feroz &
Co, Medicine
Street No. 01,
Marriot Road,
Karachi.
Manufactured
by
M/s HLL
Lifecare
Limited
Akkulam,
Thiruvananthap
uran Kerala,
India.
102
Star Haemopack
Single Blood Bag
Oestrogen Receptor
Positive Early Breast
Cancer
Each film coated
tablet contains:Bicalutamide…….5
0mg
Form 5A
Dy No. 1069
dated 20-082013
Rs.100,000/
As per SRO
Adjuant to radial
prostectomy
or
radio-therapy
in
patients with locally
advanced
prostate
cancer
Form 5A
Dy No.1495
R&I dated 1203-2013 Rs.
50,000 & Rs.
50,000 dated
05-11-2013 dy
No.303.
Each 100ml of
anticoagulant
solution CPDA-1
contains:Citric acid
(Anhydrous)……….
.…..0.299gm
Sodium Citrate
As per Brand
(Dihydrate)…..2.63g leader/500ml
m
Monobasic Sodium
Phosphate
Minutes for 260th Meeting Registration Board
.
Local.
Calutide by
M/s AJ
Mirza.
MHRA.
Soltamox
20mg tablet
by M/s
Aurobindo.
Local.
Arimidex
by M/s ICI.
compliant
as per
COPP.
COPP
issued
dated 2506-2013.
GMP
compliant
as per
COPP.
COPP
issued
dated 0302-2014
valid upto
2 years.
GMP
compliant
as per
COPP.
Drugs.
Panel shall
confirm
the
anticancer
facility for
the
manufactu
ring of the
drug at the
time of
foreign
inspection.
Approved
as per
Import
Policy for
Finished
Drugs.
Panel shall
confirm
the
anticancer
facility for
the
manufactu
ring of the
drug at the
time of
foreign
inspection.
Approved
as per
Import
Policy For
Finished
Drugs
167
(Monohydrate)……
…….0.222gm
Dextrose
(Anhydrous)………
……..2.90gm
Adenine
(Anhydrous)…..0.02
75gm
WFI…….QS to
100ml
Anticoagulant
Solution
180.
M/s A. Feroz &
Co, Medicine
Street No. 01,
Marriot Road,
Karachi.
Manufactured
by
M/s HLL
Lifecare
Limited
Akkulam,
Thiruvananthap
uran Kerala,
India.
103
Manufacturer’s
Specifications
Star Haemopack
Double Blood Bag
Each 100ml of
anticoagulant
solution CPDA-1
contains:Citric acid
(Anhydrous)……….
.…..0.299gm
Sodium Citrate
(Dihydrate)…..2.63g
m
Monobasic Sodium
Phosphate
(Monohydrate)……
…….0.222gm
Dextrose
(Anhydrous)………
……..2.90gm
Adenine
(Anhydrous)…..0.02
75gm
WFI…….QS to
100ml
Form 5A
Dy No.1496
R&I dated 1203-2013 Rs.
50,000& Rs.
50,000 dated
05-11-2013 dy
No.303.
COPP
issued
dated 0302-2014
valid upto
2 years.
GMP
compliant
as per
COPP.
Approved
as per
Import
Policy For
Finished
Drugs
As per Brand
leader/500ml
Anticoagulant
Solution
Manufacturer’s
Minutes for 260th Meeting Registration Board
168
Specifications
181.
182.
M/s A.Feroz
&
Co Medicine
Street
no.1,Marriot
road, Karachi,
Pakistan.
Star PGA Suture
with needle
Manufactured
by
Shanghai
Pudong
Jinhuan Medical
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
PGA
(Polyglycolicacid)
Suture
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
M/s A.Feroz
&
Co Medicine
Street
no.1,Marriot
road, Karachi,
Pakistan.
Manufactured
by
Shanghai
Pudong
Jinhuan Medical
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
PGA is a synthetic
absorbable surgical
suture with needle.
Form 5A
Diary No.
174 R&I
dated 22-062011
Rs.15000&
Rs.85,000
dated 04-112013 dy No.
208 R&I
.
Sizes. USP
5-0~USP 3
With round
& reverse
cutting
Free sale
certificate
is valid
upto 2102-2013.
Deferred
for
submission
of complete
details
regarding
sizes
and
shapes of
sutures
Sizes. USP
6-0~USP 1
With round
cutting,
normal
cutting &
reverse
cutting
Free sale
certificate
is valid
upto 2102-2013.
Deferred
for
submission
of complete
details
regarding
sizes
and
shapes of
sutures
Sutures
As per SRO
Star Nylon Suture
with Needle
Nylon Suture is a
monofilament of
Polyamide Nylon &
the material is nonabsorable.
Suture
Minutes for 260th Meeting Registration Board
Form 5A
Diary No.
181 R&I
dated 22-062011
Rs.15000 &
Rs.85,000
dated 04-112013 dy No.
208 R&I
.
As per SRO
169
Area,Shanghai,
China 201204.
183.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
M/s A.Feroz
&
Co Medicine
Street
no.1,Marriot
road, Karachi,
Pakistan.
Manufactured
by
Shanghai
Pudong
Jinhuan Medical
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
184.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
M/s A.Feroz
&
Co Medicine
Street
no.1,Marriot
road, Karachi,
Pakistan.
Star Chromic Catgut
Suture with needle.
Chromic catgut is
BSE Free &
produced from
intestinal serosa.
Suture.
Form 5A
Diary No.
178 R&I
dated 22-062011
Rs.15000 &
Rs.85,000
dated 04-112013 dy No.
208 R&I
.
Sizes. USP
4-0~USP 2
With round
& reverse
cutting
Free sale
certificate
is valid
upto 2102-2013.
Deferred
for
submission
of complete
details
regarding
sizes
and
shapes of
sutures
Sizes. USP
5-0~USP 2
With round,
round
double,
straight
cutting &
reverse
cutting
Free sale
certificate
is valid
upto 2102-2013.
Deferred
for
submission
of complete
details
regarding
sizes
and
shapes of
sutures
As per SRO
Star Polypropylene
Suture with needle.
Polypropylene
Suture is a
monofilament.
Suture.
Manufactured
by
Shanghai
Pudong
Jinhuan Medical
Products
Minutes for 260th Meeting Registration Board
Form 5A
Diary No.
180 R&I
dated 22-062011
Rs.15000 &
Rs.85,000
dated 04-112013 dy No.
208 R&I
.
As per SRO
170
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
185.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
M/s A.Feroz
&
Co Medicine
Street
no.1,Marriot
road, Karachi,
Pakistan.
Manufactured
by
Shanghai
Pudong
Jinhuan Medical
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
186.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
M/s A.Feroz
&
Co Medicine
Street
no.1,Marriot
road, Karachi,
Pakistan.
Manufactured
by
Star Polyester Suture Form 5A
with needle
Diary No.
176 R&I
Braided polyester
dated 22-06suture.
2011
Rs.15000 &
Suture
Rs.85,000
dated 04-112013 dy No.
208 R&I
.
Sizes. USP
6-0~USP 2
With round
& reverse
cutting
Free sale
certificate
is valid
upto 2102-2013.
Deferred
for
submission
of complete
details
regarding
sizes
and
shapes of
sutures
Sizes. USP
5-0~USP 3
With round
& reverse
cutting
Free sale
certificate
is valid
upto 2102-2013.
Deferred
for
submission
of complete
details
regarding
sizes
and
shapes of
sutures
As per SRO
Star PGA Suture
with needle
PGLA-Poly
(glycolide-co
lactide) (90/10)
braided, coated
synthetic absorbable
surgical suture.
Minutes for 260th Meeting Registration Board
Form 5A
Diary No.
177 R&I
dated 22-062011
Rs.15000 &
Rs.85,000
dated 04-112013 dy No.
171
Shanghai
Pudong
Jinhuan Medical
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
187.
188.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
M/s Samerians
Enterprise, 4First Floor, H.J.
centre Kuchi
Gali No.2,
Marriot Road,
Karachi.
Manufacture
by
M/s Medico
(Huaian) Co.
Ltd, No.09
South
Guangzhou
Road 223005,
Huaian,
Jiangsu, China
164
M/s Samerians
Enterprise, 4First Floor, H.J.
centre Kuchi
Gali No.2,
Marriot Road,
Karachi.
Manufacture
by
M/s Medico
(Huaian) Co.
Ltd, No.09
Suture
208 R&I
As per SRO
MASTER Suture
Polyglycolic with
Needles
Suture
Form 5A
Diary No.
233 R&I
dated 10-102013
Rs.100000
As per SRO
MASTER Suture
Form 5A
Chromic Catgut with
Needles
Diary No. 90
R&I dated 241-2014
Suture
Rs.100000
Minutes for 260th Meeting Registration Board
As per SRO
Shape
Normal
cutting
with sizes
3/8, 1/2,,
Reverse
Cutting
with
sizes3/8,
1/2, and
round
with sizes
Free sales
certificate
issued
dated2705-2013
Deferred
for
submission
of complete
details
regarding
sizes
and
shapes of
sutures
Shape
Normal
cutting
with sizes
3/8, 1/2,,
Reverse
Cutting
with
sizes3/8,
1/2, and
round
with sizes
Deferred
for
submission
of complete
details
regarding
sizes
and
shapes of
sutures
172
Free sales
certificate
issued
dated2705-2013
South
Guangzhou
Road 223005,
Huaian,
Jiangsu, China
189.
190.
197
M/s Samerians
Enterprise, 4First Floor, H.J.
centre Kuchi
Gali No.2,
Marriot Road,
Karachi.
Manufacture
by
M/s Medico
(Huaian) Co.
Ltd, No.09
South
Guangzhou
Road 223005,
Huaian,
Jiangsu, China
165
M/s Samerians
Enterprise, 4First Floor, H.J.
centre Kuchi
Gali No.2,
Marriot Road,
Karachi.
Manufacture
by
M/s Medico
(Huaian) Co.
Ltd, No.09
South
Guangzhou
Road 223005,
Huaian,
Jiangsu, China
MASTER Suture
Polypropylene with
Needles
Suture
Form 5A
Diary No.
232 R&I
dated 10-102013
Rs.100000
As per SRO
MASTER Suture
Silk Braided with
Needles
Suture
Form 5A
Diary No. 91
R&I dated 241-2014
Rs.100000
As per SRO
Shape
Normal
cutting
with sizes
3/8, 1/2,,
Reverse
Cutting
with
sizes3/8,
1/2, and
round
with sizes
Free sales
certificate
issued
dated2705-2013
Deferred
for
submission
of complete
details
regarding
sizes
and
shapes of
sutures
Shape
Normal
cutting
with sizes
3/8, 1/2,,
Reverse
Cutting
with
sizes3/8,
1/2, and
round
with sizes
Free sales
certificate
issued
dated2705-2013
Deferred
for
submission
of complete
details
regarding
sizes
and
shapes of
sutures
196
Minutes for 260th Meeting Registration Board
173
191.
M/s Novartis
Pharma Pakistan
Ltd, Karachi
Manufactured
By
M/s Catalent
Germany
Eberbach
GmbH,
Gammelsbacher
Strasse 2
Eberbach D69412 Germany
Name and
address of
Applicant
M/s Novartis
Pharmaceuticals
Australia Pty
Ltd, 54
Waterloo Road,
North Ryde
NSW 2113,
Australia
221
Sandimmun Neural
50mg
Each capsule
contains:Cyclosporin……50
mg
Form 5A
Dy No. 235
dated 21-032014
Rs.10,000.
As per SRO
Immunosuprassant
Minutes for 260th Meeting Registration Board
COPP
issued by
TGA
dated 1311-2013.
GMP
compliant
as per
COPP.
Deferred
for
submission
of CoPP to
confirm
free sale
174
Muhammad Ansar Evaluator-I
Routine applications for local manufacturer.
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name + Dosage
Form + Strength)
Composition
Pharmacological Group
Finished product Specification
Type of
Form
Initial date,
diary
Fee
including
differential
fee
Demanded
Price / Pack
size
192. M/s Medicraft
Pharmaceuticals
Pvt Ltd,
Industrial Estate,
Hayatabad,
Peshawar
2201
193. M/s Safe
Pharmaceuticals
Pvt Ltd, Karachi
Source of
Pellets
M/s Vision
Pharmaceuticals
Kahuta road,
Islamabad
Irose Injection 5ml
Form 5
Each ml contains:Iron sucrose complex eq to
elemental
iron………..………20mg
Haematinic
USP Specifications
25-03-2013
vide diary
182 (R&I)
Rs.20,000.
Fayneec Capsule 50mg
Form 5
Each capsule contains:Diclofenac Sodium as SR
pellets………..………50mg
Dy No. Nil
dated 17-022010
Rs.8000
(Photocopy)
& 22-052013
Rs.12000
(Photocopy)
Anti-Rheumatics
USP Specifications
As per SRO
15
As per SRO
Minutes for 260th Meeting Registration Board
Remarks on the
formulation (if
any) including
International
status in stringent
drug regulatory
agencies /
authorities
Remarks
by
Evaluator/
Decision
Decision
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
MHRA. Venofer
by M/s Vifor
Approved
Local. Venofer
by M/s RG
GMP compliant
as per inspection
report dated 2705-2016.
Deflamat 50mgKapseln by M/s
Astellas Pharma
GmbH Austria.
Fee
Rs.8000 &
Rs.12,000/are
photocopy.
Local. Mobikare
50mg by M/s
Barrett Hodgson
GMP compliant
as per inspection
report dated 0906-2015.
175
Approved.
Photocopy
fee
challanswill
be verified
by Budget &
Accounts
Division and
Chairman
Registration
Board will
permit
issuance of
registration
letter.
194. M/s Rasco
Pharma, 5.5 Km
Raiwind road,
Lahore.
(1784)
Pioglimp-DS tablet
Form 5
Each tablet contains:Pioglitazone as
HCl………..………30mg
Glimepiride………..4mg
Dy No. nil
dated 29-062012
Rs.8000
(Photocopy)
& Rs.12,000
dated 30-072013 dy no.
9349 R&I.
Anti diabetic
Manufacturer’s Specifications
FDA. Duetact
4mg/30mg by
M/s Takeda
Local. Piotone
4/30 by M/s
Atco.
GMP compliant
as per inspection
date 09-09-2015.
As per SRO
195. M/s Care
Carnyl Syrup
Pharmaceuticals,
8-Km Raiwind
Each ml contains:road, Lahore.
Terbutaline
Sulphate………..………0.3mg
(1004)
Bronchodialator
Manufacturer’s Specifications
Form 5
Dy No. nil
dated 24-052011
Rs.8000
(Photocopy)
& Rs.12,000
dated 30-072013
(Photocopy).
MHRA. Bricanyl
0.3mg/ml Syrup
by M/s
AstraZeneca.
Local. Britanyl
by M/s Barrett
Hodgson
GMP compliant
as per inspection
date 19-12-2014.
As per SRO
196. -do(1069)
Hepacare Syrup
Form 5
Each 5ml contains:L-Ornithine LAspartate…………300mg
Nicotinamide………..…24mg
Riboflavin sodium
phosphate….……….0.76mg
Dy No. nil
dated 24-052011
Rs.8000
(Photocopy)
& Rs.12,000
dated 30-072013
(Photocopy).
Liver Supplement
Local Hepa-Merz
by M/s Brookes
GMP compliant
as per inspection
date 19-12-2014.
Fee
Rs.8000 is
a
photocopy.
Approved.
Photocopy
fee
challanswill
be verified
by Budget &
Accounts
Division and
Chairman
Registration
Board will
permit
issuance of
registration
letter.
Fee
Approved.
Rs.8000 & Photocopy
12000 are
fee
photocopy. challanswill
be verified
by Budget &
Accounts
Division and
Chairman
Registration
Board will
permit
issuance of
registration
letter.
Fee
Deferred for
Rs.8000 & the
12000 are
confirmation
photocopy. of approval
Approval
status by
status in
regulatory
reference
authorities
countries is of reference
not
countries
provided.
Manufacturer’s Specifications
197. M/s Amarant
Pharmaceuticals
Tica 90mg tablet
Each tablet contains:-
Minutes for 260th Meeting Registration Board
As per SRO
Form-5
21-08-2013
FDA. Brilinta
90mg & 60mg by
Approval
status in
176
Deferred for
the
Ticagrelor………90mg
Anti-coagulant
Manufacturer’s Specifications
vide diary
No. 1560
R&I
Rs.20,000.
As per
SRO/30’s.
M/s Astrazeneca
GMP compliant
as per inspection
dated 04-112015.
Pakistan is
not
provided.
confirmation
of approval
status in
Pakistan
198. -do(2514)
Esonap Tablet 375/20mg
Each tablet contains:Naproxen………….375mg
Esomeprazole
Magnesium….……..20mg
Analgesic/PPI
Manufacturer’s Specifications
Form-5
21-08-2013
vide diary
No. 1559
R&I
Rs.20,000.
As per
SRO/30’s.
FDA. Vimovo
delay release
tablet 20/375mg
by M/s Horizon
GMP compliant
as per inspection
dated 04-112015.
Approval
status in
Pakistan is
not
provided.
Deferred for
confirmation
of approval
status in
Pakistan
199. -do(2515)
Mafinil 100mg tablets
Each tablet contains:Modafinil……100mg
Psychotic drug
USP Specifications
Form-5
21-08-2013
vide diary
No. 1561
R&I
Rs.20,000.
As per
SRO/20’s.
MHRA.Modafinil
100mg by M/s
Teva
Local. V-Zac
100mg tablet by
M/s Wilshire
GMP compliant
as per inspection
dated 04-112015.
(Pvt) Ltd, 158,
D. Tore, Gadap
Road, Super
Highway,
Karachi.
(2513)
Minutes for 260th Meeting Registration Board
Approved
177
Replies of Products deferred in 258th meeting of the Board.
200.M/s Sami
Pharmaceuticals
Pvt Ltd,
Karachi.
1892
201.-do1891
202.M/s Barett
Hodgson
Karachi.
94
Stein 175mg/5ml
Suspension
Each 5ml of
reconstituted
suspension contains:Erdosteine
MS……..175mg
(Mucolytic)
Manufacturer’s
Specifications
Form-5
4-08-2012
vide
diary No.
Nil
Rs.8,000
(Photocopy)
&
12,000
dated 2907-2013.
Rs.
178/100ml
Denmark.
Erodin
175mg/5ml by
M/s Orion
Stein 150mg Capsule
Each Capsule
contains:Erdosteine
MS………..150mg
(Mucolytic)
Manufacturer’s
Specifications
Form-5
4-08-2012
vide
diary No.
Nil
Rs.8,000
(Photocopy)
&
12,000
dated 2907-2013.
Rs. 178/ 20
Capsules
Denmark.
Erdotin 150mg
capsule by M/s
Orion pharma.
Local. Erdos
capsule 150mg
by M/s
Genome
Deferred for
the
Following
verification
of Fee.
Rs.8000.
Approval
status
inreference
Regulatory
authorities.
Mobikare Plus
Tablet
Each tablet contains:
Misoprostol……..200mcg
Diclofenac Sodium ….
75mg
(Non-Steroidal
Antiinfammatory
with Synthetic
Prostaglandin E1 analog)
Form-5
Dy. No: 159
dated.
15-07-2010
Rs.8000/Rs.12,000/2x10’s /
Rs.450/-
Arthrotec
MHRA, FDA
Deferred in
255th meeting
for:
Original fee
Challan of Rs:
12000/-.
Commitment as
per 251st
meeting.
Last inspection
report.
Reply of letter
no.
Minutes for 260th Meeting Registration Board
Local. Erdos
suspension
175mg/5ml by
M/s Genome.
Cytopan (Getz)
Deferred for
the Following
verification
of Fee.
Rs.8000.
Approval
status
inreference
Regulatory
authorities.
It has been
verified
that the
product is
in free sale
in
Denmark
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
It has been Approved.
verified
Photocopy
that the
fee
product is challanswill
in free sale be verified
in
by Budget
Denmark
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Copy of Fee
Challan
provided.
Commitment
provided
Me
too
product, so
stability not
required.
Inspection
report dated
03.02.16
provided.
178
Deferred for
confirmation
of
double
punch/layer
machine from
area FID.
203.-do95
204.M/s
Sami
Pharma,
Karachi.
Deferred
in
250th meeting
Mobikare Plus Tablet
Each tablet contains:Diclofenac
Sodium……...….50mg
Misoprostol………200mcg
NSAID+Prostaglandin
analogue
Manufacturer’s
Specifications
Form-5
15-06-2010
vide diary #
160 Rs.8000
R&I & 21-052013 diary #
___ Rs.12000
Photocopy
attached
As per SRO
FDA
Arthrotec
Tablet by M/s
Searle.
NovoTeph DR Sachet
20mg
Each sachet contains:
Enteric coated
granules (22.5%) of
Form-5
Dy. No:
8000/- dated
31-12-10
12000/-
Nexium Sachet
of AstraZeneca
USA
Nexum
delayed relaese
Minutes for 260th Meeting Registration Board
Arthrotec Tablet
by M/s Pfizer.
F.612/2013Reg-II
dated 01
October
2013 not
satisfactory but
board decided to
submit stability
studies in
previous
meeting.
Proof of double
core
compression
machine
required. for
stability studies
was dispensing
10-09- 2010 and
Manufacturing
date 27-08-09.
Supportive data
Stability studies
as
per
RB
decision in 251st
meeting.
Deferred for in
254th meeting of
RB
Double
compression
machine require
to be verified.
Commitment as
per the decision
of RB is not
attached.
Fresh inspection
report conducted
within
the
period of 1 year
is not attached.
Outline method
of manufacture
is not provided.
Photocopy
of
fee
Rs.12000
attached original
is required.
Picture
of
machine
along with
invoice
provided.
Picture
of
machine
along with
invoice
provided.
Commitment
provided.
Inspection
report dated
03.02.16.
Copy of fee
Challan
provided.
Deferred for
rectification
of following:
Source of
Esomeprazole
Deferred for
confirmation
of
double
punch/layer
machine from
area FID and
fee challan.
Approved
179
744
Esomeprazole
magnesium Trihydrate
eq to
Esomeprazole…20mg
PPI
Manufacturer
dated 29-0713
& Rs.80,000
vide dy No.
2791 R&I
dated 17-062016
Sachet of
Getz(Approved
in 227th
meeting of
RB)
granules,
their
composition,
certificate of
analysis,
stability
studies as per
zone IV and
in case of
import of
pellets,
legalized
GMP
certificate of
the source
along with
the requisite
fee prescribed
under the
rules is not
submitted.
Nexium Sachet
of AstraZeneca
USA
Nexum
delayed relaese
Sachet of
Getz(Approved
in 227th
meeting of
RB)
Deferred for
rectification
of following:
Source of
Esomeprazole
granules,
their
composition,
certificate of
analysis,
stability
studies as per
zone IV and
in case of
import of
pellets,
legalized
GMP
certificate of
the source
along with
the requisite
fee prescribed
under the
Source Of Pellets.
M/s RA Chem Pharma Rs. 450/Ltd, Plot #A-19/C
Pack of 14’s
Road No.18 IDA,
Nacharam Hydrabad,
Andhrapradesh, India
205.-doDeferred in
250th meeting
746
NovoTeph DR Sachet
40mg
Each sachet contains:
Enteric coated
granules (22.5%) of
Esomeprazole
magnesium Trihydrate
eq. to
Esomeprazole…40mg
PPI
Manufacturer
Form-5
Dy. No:
8000/- dated
31-12-10
12000/dated 29-0713
Rs. 1800/-&
Rs.80,000
vide dy No.
2792 R&I
dated 17-06Source Of Pellets.
2016
M/s RA Chem Pharma Pack of
Ltd, Plot #A-19/C
14’s
Road No.18 IDA,
Nacharam Hydrabad,
Andhrapradesh, India
Minutes for 260th Meeting Registration Board
Approved
180
rules is not
submitted.
Minutes for 260th Meeting Registration Board
181
Evaluator-IV Mr. Salateen Wasim Philip
Routine cases:S/N
Name
and Brand Name
address
of
manufacturer / (Proprietary name
Dosage
Form
Applicant
Strength)
206.
M/s CCL
Pharmaceuticals
(Pvt.) Ltd, 62Industrial
Estate, Kot
Lakhpat,
Lahore
Priority # 2263
International
Remarks /
status
in Observation
+ Initial date, diary
stringent
s
regulatory
+
Fee
including agencies
differential fee
Me-too status
Composition
Demanded Price /
GMP status as
Pharmacological Group Pack size
depicted
in
inspection
Finished
product
report (dated)
Specification
Decision
Tablet Nitox 500mg
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter.
Approved
Each film coated tablet
contains:Nitazoxanide 500mg
Antidiarreal /
antiprotozoal
Specifications:-
Type of Form
Form 5 with fee Rs
20,000/- vide Dy. #
nil dated 19-042013
(Photocopy)
Pack size of SRO
FDA approved
Alinia- Romark
Nitazide-Helix
Inspection
report dated
11-03-2015
Manufacture
207.
M/s CCL
Pharmaceuticals
(Pvt.) Ltd, 62Industrial
Estate, Kot
Lakhpat,
Lahore
Priority # 2261
Tablet velamer 800mg
Each film coated tablet
contains:Sevelamer HCl 800mg
Non absorbed phosphate
binder
Specifications:-
Form 5 with fee Rs
20,000/- vide Dy. #
nil dated 19-042013
FDA approved
RenagelGenzyme
Sevela-Hilton
Pack size of 30’s
Manufacture
Minutes for 260th Meeting Registration Board
182
208.
M/s CCL
Pharmaceuticals
(Pvt.) Ltd, 62Industrial
Estate, Kot
Lakhpat,
Lahore
Priority # 2264
Nitox powder for
Suspension
Each 5ml of reconstituted
suspension contains:Nitazoxanide 100mg
Form 5 with fee Rs
20,000/- vide Dy. #
nil dated 19-042013
FDA approved
Alinia- Romark
Approved
Nitazide-Helix
Pack size of 30ml
Antidiarrheal /
antiprotozoal
Specifications:Manufacture
209.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1467
Swapped
Cynfo 1g IV Injection
Each combination pack
contains:
Sterile powder of
fosfomycin sodium eq. to
Fosfomycin..1g
Water for injection …10
ml
31-10-2011
Dy.No.283
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Firm is GMP
compliant as
per inspection
dated 03-112015
Rs. 110/- per vial
(Anti biotic)
210.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1486
Swapped
211.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1487
Swapped
Capsule Colcin 8mg
Each capsule contains
Thiocolchicoside IP 8mg
Muscle relaxant
Manufacture
Specification
Capsule Colcin 4mg
Each capsule contains
Thiocolchicoside IP 4mg
Muscle relaxant
Manufacture
Specification
Minutes for 260th Meeting Registration Board
21-03-2012
Dy.No.644
Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size of
10’s  Rs. 300/20s  Rs. 600/-
21-03-2012
Dy.No.647
Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size & priec
as per SRO
Firm is GMP
compliant as
per inspection
dated 03-112015
Muscoril –
Sanofi, France
Muscoril Searle
Firm is GMP
compliant as
per inspection
dated 03-112015
Proof
of
approval
status
of
same
dosage form
in reference
countries
and
Pakistan not
provided.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan
and
fee
challan
The
Deferred for
proposed
confirmatio
dosage form n
of
doesn’t
approval
exist
in status
by
Pakistan
reference
and
regulatory
reference
authorities
countries.
and
Pakistan
and
fee
challan
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
183
212.
213.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Injection Colcin 4mg/2ml
Priority # 1489
Swapped
Muscle relaxant
Manufacture
Specification
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Colcin 0.25% Ointment
Priority # 1488
Swapped
214.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1806
swapped
Each 2ml ampoule
contains
Thiocolchicoside IP 4mg
Sodium chloride 16.8mg
Each gram contains
Thiocolchicoside IP
2.5mg
Muscle relaxant
Manufacture
Specification
Tablet Esylate 500mg
Each tablet contains
Etamsylate BP 500mg
Hemostatic agent
Manufacture
Specification
21-03-2012
Dy.No.654
Form 5
Rs.8000/Rs.l2,000/31-07-2013
Board will
permit
issuance of
registration
letter
Deferred for
clarification
of
master
formulation
and role of
sodium
chloride
either active
or inactive
ingredient
and
fee
challan
Muscoril –
Sanofi, France
Muscoril Searle
(Photocopy)
Pack size of
ampoule & price as
per SRO
06-04-2012
Dy.No.676
Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Firm is GMP
compliant as
per inspection
dated 03-112015
Firm is GMP
compliant as
per inspection
dated 03-112015
Pack size of 30gm
tube  Rs. 280/-
29-08-2011
Dy # 1127 Form 5
Rs. 8000/Rs.12,000/- 31-072013 (Photocopy)
Pack size & price
as per PRC
The
proposed
dosage form
doesn’t
exist
in
Pakistan
and
reference
countries.
Dicynene
500mg –
Sanofi France
Cytoplex –
AGP Reg#
061420
Firm is GMP
compliant as
per inspection
dated 03-112015
Minutes for 260th Meeting Registration Board
184
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan
and
fee
challen.
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
215.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1524
swapped
216.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1521
swapped
217.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 836
swapped
Injection Esylate
125mg/ml
13-06-2012
Dy # 1671, Form 5
Rs.20,000/-
Each ml contains
Etamsylate BP 125mg
(Photocopy)
Hemostatic agent
Manufacture
Specification
Pack size of
6s  Rs. 120/-
Injection Esylate
250mg/2ml
13-06-2012
Dy # 1126, Form 5
Rs.8,000/Rs. 12000/31-07-2013
Each 2ml contains
Etamsylate BP 250mg
Hemostatic agent
Manufacture
Specification
Tablet Viptin-Met 50/500
Each film coated tablet
contains
Vildagliptin MS 50mg
Metformin HCl BP
500mg
Anti-diabetic
Manufacture
Specification
Minutes for 260th Meeting Registration Board
(Photocopy)
Pack size & price
as per SRO
18-071-2012
Dy.No.1329 Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size & price
as per SRO
Firm is GMP
compliant as
per inspection
dated 03-112015
Proof
of
approval
status
of
same
dosage form
in reference
countries
not
provided.
A product of
OM Pharma Switzerland
Cytoplex –
AGP Reg #
061419
Firm is GMP
compliant as
per inspection
dated 03-112015
TGA approved
Galvumet –
Novartis
Galvusmet Novartis
Firm is GMP
compliant as
per inspection
dated 03-112015
185
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan
and
fee
challan.
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
218.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1421
swapped
Tablet Neo-Moor 50mg
Each extended release
film coated tablet
contains
Desvenlafaxine (as
succinate monohydrate)
50mg
03-10-2011
Dy.No.235 Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size & price
as per SRO
Anti-depressant
Manufacture
Specification
219.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1469
swapped
Tablet Neo-Moor 100mg
Each extended release
film coated tablet
contains
Desvenlafaxine (as
succinate monohydrate)
100mg
03-10-2011
Dy.No.234 Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size & price
as per SRO
Anti-depressant
Manufacture
Specification
220.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1422
swapped
Tablet ULIP 30mg
Each tablet contains
Ulipristal Acetate 30mg
Synthetic Progesterone –
Contraceptive
Manufacture
Specification
Minutes for 260th Meeting Registration Board
23-09-2011
Dy.No.196 Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size
5s  Rs. 500/-
TGA approved
Pristiq – Pfizer.
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
Lafaxine Genix
Firm is GMP
compliant as
per inspection
dated 03-112015
FDA approved
Pristiq – Wyeth
Lafaxine Genix
Firm is GMP
compliant as
per inspection
dated 03-112015
MHRA
approved
ellaOne-HRA
Elcat – Genix
Hormonal
section of the
firm is GMP
compliant as
per inspection
dated 03-112015
186
registration
letter
221.
222.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Tablet Eriva 0.5 mg
Priority # 1595
swapped
Anti-viral
Manufacture
Specification
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Tablet Viptin 50mg
Priority # 802
swapped
223.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1805
Each film coated tablet
contains
Entecavir monohydrate
eq to entecavir 0.5 mg
Each film coated tablet
contains
Vildagliptin MS 50mg
Anti-Diabetic
Manufacture
Specification
Mofest infusion 400mg
/100ml
Each 100ml contains
Moxifloxacin 400mg
Antibiotics
Manufacture
Specification
Minutes for 260th Meeting Registration Board
23-09-2011
Dy.No.196 Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size
5s  Rs. 500/-
MHRA
approved
Baraclude –
Bristol
BVIR-Bosch
Firm is GMP
compliant as
per inspection
dated 03-112015
18-07-2012
Dy # 1331 Form 5
Rs.8000/Rs.12,000/31-07-2013
(Photocopy)
MHRA
approved
Galvus –
Novartis
Pack size  as per
SRO
Firm is GMP
compliant as
per inspection
dated 03-112015
25-01-2011
Dy.No.380 Form 5
Rs.8000/Rs.l2,000/31-07-2013
Moxibar –
B&H
(Photocopy)
Pack size 100ml as
per SRO
Galvus
Firm is GMP
compliant as
per inspection
dated 03-112015
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Proof
of In proposed
approval of strength of
same
moxifloxaci
strength in n
reference
400mg/100
countries.
ml, it has
been
observed
that
crystallizati
on occurs
187
224.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 746
225.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Novoteph Insta Sachet
40/1680
Each sachet contains
Esomeprazole
Magnesium Trihydrate
USP eq to Esomeprazole
40mg
Sodium carbonate BP
1680mg
PPI-anti ulcer
Manufacture
Specification
Tablet Mefloq-plus
220/100
Each tablet contains
Mefloquine HCl eq to
Mefloquine BP 220mg
Artesunate MS 100mg
Priority # 1791
Anti malarial
Manufacture
Specification
Minutes for 260th Meeting Registration Board
31-12-2010
Dy.No.2275
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size 14s 
Rs. 1825/-
25-03-2013
Dy.No.181
Rs.20,000/-
Pack size
3s  Rs. 360/6s  Rs. 720/-
Firm is GMP
compliant as
per inspection
dated 03-112015
Proof
of
approval
status
of
same
dosage form
in reference
countries
not
provided.
Firm is GMP
compliant as
per inspection
dated 03-112015
The
proposed
formulation
doesn’t
exist
in
reference
countries
and
Pakistan.
188
and product
is
not
stable.
The Board
directed
firm
to
follow
innovator
brand’s
formulation
i.e.
Moxifloxaci
n
400mg/250
ml
and
submit
revised
Form 5.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan
and
fee
challan.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities /
WHO and
Pakistan.
226.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1040
swapped
227.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1041
swapped
228.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1084
swapped
229.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1793
swapped
Tablet GPRIDE-M 1/500
Each film coated tablet
contains
Glimepiride USP 1mg
Metformin HCl BP
500mg
20-01-2012
Dy.No.474 Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size & price
as per SRO
Anti-diabetic
Manufacture
Specification
Tablet GPRIDE-M 2/500
Each film coated tablet
contains
Glimepiride USP 2mg
Metformin HCl BP
500mg
20-01-2012
Dy.No.475 Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size & price
as per SRO
Anti-diabetic
Manufacture
Specification
Tablet GPRIDE-M
2/1000
Each film coated tablet
contains
Glimepiride USP 2mg
Metformin HCl BP
1000mg
Anti-diabetic
Manufacture
Specification
Atpro Pedriatric
Suspension
Each 5ml of reconstituted
suspension contains
Atovaquone USP 125mg
Proguanil HCl BP 50mg
Anti-Malarial
Manufacture
Specification
Minutes for 260th Meeting Registration Board
20-01-2012
Dy.No.475 Form 5
Rs.8000/Rs.l2,000/31-07-2013
(Photocopy)
Pack size of
10’s  Rs. 300/20s  Rs. 600/-
Firm is GMP
compliant as
per inspection
dated 03-112015
Hipride –
Hilton
Firm is GMP
compliant as
per inspection
dated 03-112015
Hipride –
Hilton
Firm is GMP
compliant as
per inspection
dated 03-112015
22-10-2012
Dy # 1669 Form 5
Rs.20,000/-
(Photocopy)
Pack size of
30ml  Rs. 1200/-
Firm is GMP
compliant as
per inspection
dated 03-112015
Proof
of
approval
status
of
same
dosage form
in reference
countries
not
provided.
Proof
of
approval
status
of
same
dosage form
in reference
countries
not
provided.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan
and
fee
challan.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
fee
challan
Proof
of
approval
status
of
same
dosage form
in reference
countries
not
provided.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
fee
challan.
Proof
of
approval
status
of
same
dosage form
in reference
countries &
Pakistan not
provided.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities /
WHO and
Pakistan
and
fee
challan.
189
230.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1793
swapped
231.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1806
swapped
232.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1792
swapped
233.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1727
swapped
Atpro Pedriatric tablet
Each tablet contains
Atovaquone USP 125mg
Proguanil HCl BP 50mg
Anti-Malarial
Manufacture
Specification
Atpro Pedriatric Tablet
Each tablet contains
Atovaquone USP 187mg
Proguanil HCl BP 75mg
Anti-Malarial
Manufacture
Specification
29-08-2011
Dy # 95 Form 5
Rs.8,000/Rs. 12000/31-07-2013
(Photocopy)
Pack size of
6s, 12s & 30s as
per SRO
29-08-2011
Dy # 96 Form 5
Rs. 8000/Rs.12,000/- 31-072013 (Photocopy)
Pack size of
6s, 12s & 30s
Per tablet  Rs.
522.50/-
Atpro DS Pedriatric
Suspension
22-10-2012
Dy # 1671, Form 5
Rs.20,000/-
Each 5ml of reconstituted
suspension contains
Atovaquone USP 250mg
Proguanil HCl BP 100mg
(Photocopy)
Pack size of
30ml  Rs. 2000/-
Anti-Malarial
Manufacture
Specification
Tablet Dofyl 400 mg
Each tablet contains
Doxofylline MS 400 mg
Bronchodilator
Manufacture
Specification
Minutes for 260th Meeting Registration Board
26-12-2012
Dy # 1813 Form 5
Rs. 20000
(Photocopy)
Pack size & price
as per PRC
Firm is GMP
compliant as
per inspection
dated 03-112015
Firm is GMP
compliant as
per inspection
dated 03-112015
Firm is GMP
compliant as
per inspection
dated 03-112015
Firm is GMP
compliant as
per inspection
dated 03-112015
Proof
of
approval
status
of
same
dosage form
in reference
countries &
Pakistan not
provided.
Proof
of
approval
status
of
same
dosage form
in reference
countries &
Pakistan not
provided.
Proof
of
approval
status
of
same
dosage form
in reference
countries &
Pakistan not
provided.
Proof
of
approval
status
of
same
formulation
in proposed
strength in
reference
regulatory
authorities
190
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities /
WHO and
Pakistan
and
fee
challan.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities /
WHO and
Pakistan
and
fee
challan.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities /
WHO and
Pakistan
and
fee
challan.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities /
WHO and
Pakistan
234.
M/s Sami
Pharmaceuticals
(Pvt.) Ltd, F-95,
Off. Hub River
Road, S.I.T.E,
Karachi
Priority # 1728
swapped
235.
M/s PharmEvo
(Private)
Limited, A-29,
North Western
Industrial Zone,
Port Qasim,
Karachi
Dofyl 100mg/5ml Syrup
Each 5ml contains
Doxofylline MS 100mg
Bronchodilator
Manufacture
Specification
Tablet IRMAX 100/10
Each film coated tablet
contains
Ibresartan 100mg
Amlodipine Besylate
13.87mg eq to
Amlodipine 10mg
Priority # 2539
26-12-2012
Dy # 1812, Form 5
Rs.20,000/-
Broxane - Opal
(Photocopy)
Firm is GMP
compliant as
per inspection
dated 03-112015
Pack size & price
as per SRO
25-04-2013
Dy.No.1656 Form 5D
Rs.50,000/-
Aimix –
Dainnpon
Sumitomo
Pharma, Japan
Pack size
10s  Rs. 445/14s  Rs. 623/28S  Rs. 1246/-
Firm is GMP
compliant as
per inspection
dated 03-112015
Anti-hypertensive
Manufacture
Specification
236.
M/s PharmEvo
(Private)
Limited, A-29,
North Western
Industrial Zone,
Port Qasim,
Karachi
Priority # 2535
Tablet IRMAX 150/5
25-04-2013
Dy.No.1656 Form 5D
Rs.50,000/-
Each film coated tablet
contains
Ibresartan 100mg
Amlodipine Besylate 6.93 Pack size
10s  Rs. 490/mg eq to Amlodipine
14s  Rs. 686/5mg
28S  Rs. 1372/Anti-hypertensive
Manufacture
Specification
Minutes for 260th Meeting Registration Board
Firm is GMP
compliant as
per inspection
dated 03-112015
not
provided.
and
fee
challan.
Proof
of
approval
status
of
same
formulation
in proposed
strength in
reference
regulatory
authorities
not
provided.
Stability
data
required as
per
guidelines
provided in
251st
RB
meeting.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
fee
challan
Proof
of
approval
status
of
same
formulation
in proposed
strength in
reference
regulatory
authorities
not
provided.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan.
191
Deferred for
proof
of
approval
status
of
same
formulation
in reference
countries
and
Pakistan.
237.
M/s PharmEvo
(Private)
Limited, A-29,
North Western
Industrial Zone,
Port Qasim,
Karachi
Tablet IRMAX 150/10
Each film coated tablet
contains
Ibresartan 150mg
Amlodipine Besylate
13.87 mg eq to
Amlodipine 10mg
Priority # 2533
25-04-2013
Dy.No.1658 Form 5D
Rs.50,000/-
Pack size
10s  Rs. 510/14s  Rs. 714/28S  Rs. 1428/-
Firm is GMP
compliant as
per inspection
dated 03-112015
Anti-hypertensive
Manufacture
Specification
238.
M/s PharmEvo
(Private)
Limited, A-29,
North Western
Industrial Zone,
Port Qasim,
Karachi
Priority # 2538
Tablet IRMAX 300/5
25-04-2013
Dy.No.1658 Form 5D
Rs.50,000/-
Each film coated tablet
contains
Ibresartan 300mg
Amlodipine Besylate 6.93 Pack size
10s  Rs. 800/mg eq to Amlodipine
14s  Rs. 1120/5mg
28S  Rs. 2240/-
Firm is GMP
compliant as
per inspection
dated 03-112015
Anti-hypertensive
Manufacture
Specification
239.
M/s PharmEvo
(Private)
Limited, A-29,
North Western
Industrial Zone,
Port Qasim,
Karachi
Tablet IRMAX 300/10
Each film coated tablet
contains
Ibresartan 300mg
Amlodipine Besylate
13.87 mg eq to
Amlodipine 10mg
Priority # 2539
25-04-2013
Dy.No.1657 Form 5D
Rs.50,000/-
Pack size
10s  Rs. 820/14s  Rs. 1148/28S  Rs. 2296/-
Firm is GMP
compliant as
per inspection
dated 03-112015
Anti-hypertensive
Manufacture
Specification
240.
M/s PharmEvo
(Private)
Limited, A-29,
North Western
Industrial Zone,
Port Qasim,
Karachi
Tablet Inosita plus 50/850 25-04-2013
Priority # 2266
PPI-anti ulcer
Manufacture
Specification
Each film coated tablet
contains
Sitagliptin (as phosphate
monohydrate)50mg
Metformin HCl 850mg
Minutes for 260th Meeting Registration Board
Dy.No.266 Form 5
Rs.20,000/-
Pack size 10s 
Rs. 1100/-
Proof
of
approval
status
of
same
formulation
in proposed
strength in
reference
regulatory
authorities
not
provided.
Proof
of
approval
status
of
same
formulation
in proposed
strength in
reference
regulatory
authorities
not
provided.
Proof
of
approval
status
of
same
formulation
in proposed
strength in
reference
regulatory
authorities
not
provided.
TGA approved
Janumet –
Merck
Australia
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan.
Approved
Janumet -MSD
Firm is GMP
compliant as
per inspection
dated 03-11192
2015
241.
M/s PharmEvo
(Private)
Limited, A-29,
North Western
Industrial Zone,
Port Qasim,
Karachi
Priority # 2536
242.
M/s PharmEvo
(Private)
Limited, A-29,
North Western
Industrial Zone,
Port Qasim,
Karachi
Priority # 2536
243.
M/s PharmEvo
(Private)
Limited, A-29,
North Western
Industrial Zone,
Port Qasim,
Karachi
Tablet Infixa 2.5mg
Each film coated tablet
contains
Rivaroxiban 2.5mg
Factor Xa Inhibitor
Manufacture
Specification
Tablet Infixa 5mg
Each film coated tablet
contains
Rivaroxiban 5mg
Factor Xa Inhibitor
Manufacture
Specification
Tablet IRMAX 100/5
Each film coated tablet
contains
Ibresartan 100mg
Amlodipine Besylate
6.93mg eq to Amlodipine
5mg
Priority # 2535
Anti-hypertensive
Manufacture
Specification
Minutes for 260th Meeting Registration Board
29-08-2013
Dy.No.1659 Form 5D
Rs.50,000/-
(Photocopy)
Pack size
7s  Rs. 1050/10s  Rs. 1550/14s  Rs. 2100/29-08-2013
Dy.No.832 Form 5-D
Rs.50,000/-
(Photocopy)
Pack size
7s  Rs. 2100/10s  Rs. 3000/14s  Rs. 4200/-
MHRA
approved
Xarelto –
Bayer
Firm is GMP
compliant as
per inspection
dated 03-112015
Firm is GMP
compliant as
per inspection
dated 03-112015
25-04-2013
Dy.No.1660 Form 5D
Rs.50,000/-
Aimix –
Dainnpon
Sumitomo
Pharma, Japan
Pack size
10s  Rs. 425/14s  Rs. 595/28S  Rs. 1190/-
Firm is GMP
compliant as
per inspection
dated 03-112015
Proof
of
approval
status
of
same
dosage form
in Pakistan
not
provided.
Proof
of
approval
status
of
same
dosage form
in reference
countries
and
Pakistan.
Deferred for
provision of
stability
data as per
guidelines
provided by
the Board
IN
251st
meeting and
fee challan.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan
and
fee
challan.
Stability
Deferred for
data
submission
required as of stability
per
data
guidelines
required as
provided in per
251st
RB guidelines
meeting.
provided in
251st
RB
meeting.
193
244.
M/s Unison
Chemical worls,
15KM Raiwind
Road, Lahore
Priority # 403
Tablet Cyclocam 20mg
Each tablet contains
Piroxicam beta dextrin
191.2mg eq to Piroxicam
20mg
NSAID
USP Specification
04-10-2010
Dy.No.266 Form 5
Rs.8,000/02-12-2013
Rs. 12000/-
(Photocopy)
Pack size 2 x 10 
as per SRO
Marketing
authorization to
Chiesi –UK
and
manufactured
by Chiesi Italy.
Brexin – Chiesi
Firm is GMP
compliant as
per inspection
report.
245.
M/s Highnoon
Laboratories
Limited, 17.5
km, Multan
Road, Lahore
Priority # 2299
swapped
246.
Tablet Niacol XR
1000mg
Each extended released
tablet contains
Niacin 1000mg
Anti-hyperlipidemia
USP Specification
M/s Highnoon
Laboratories
Limited, 17.5
km, Multan
Road, Lahore
Tablet Niacol XR 500mg
Priority # 2300
swapped
Anti-hyperlipidemia
USP Specification
Each extended released
tablet contains
Niacin 500mg
Minutes for 260th Meeting Registration Board
04-03-2011
Dy.No.3189 Form 5D
Rs.15,000/Rs. 35000/30-07-2013
Dy # nil dated 30-072013
FDA approved
Niaspan – Kos
Pharmaceutical
s
Pack size
7s  Rs. 560/10s  Rs. 800/-
Firm is GMP
compliant as
per inspection
dated 09-032015
01-03-2011
Dy.No.3189 Form 5D
Rs.15,000/Rs.35000/30-07-2013
Dy # nil dated 30-072013
FDA approved
Niaspan – Kos
Pharmaceutical
s
Pack size
7s  PRC
10s  PRC
Firm is GMP
compliant as
per inspection
dated 09-032015
Niaspan Merck
Niaspan Merck
Firm
previously
applied on
Form 5-D
but
now
product is
being
registered in
Pakistan.
Firm
previously
applied on
Form 5-D
but
now
product is
being
registered in
Pakistan.
194
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved
Approved
247.
248.
M/s Highnoon
Laboratories
Limited, 17.5
km, Multan
Road, Lahore
Tablet Niacol XR 750mg
Priority # 2300
swapped
Anti-hyperlipidemia
USP Specification
M/s MBL
Pharma, Plot #
B-77/A, Hub
Industrial
Trading Estate
Balauchistan.
Priority # 1533
249.
M/s MBL
Pharma, Plot #
B-77/A, Hub
Industrial
Trading Estate
Balauchistan.
Priority # 871
Each extended released
tablet contains
Niacin 750mg
Tablet Melidone 10mg
Each film coated tablet
contains
Domperidone 10mg
Dopamine blocking agent
/ antiemetic
BP Specification
Tablet Astin 40/240
Each tablet contains
Artemether 40mg
Lumefantrine 240mg
Antimalarial
Manufacture
Specification
Minutes for 260th Meeting Registration Board
01-03-2011
Dy.No.3189 Form 5D
Rs.15,000/Rs.35000/30-07-2013
Dy # nil dated 30-072013
FDA approved
Niaspan – Kos
Pharmaceutical
s
Pack size
7s  PRC
10s  PRC
Firm is GMP
compliant as
per inspection
dated 09-032015
16-04-2012
Dy.No.722 Form 5
Rs.8000/-
MHRA
approved
Motillium Zentiva
(Photocopy)
Rs.12,000/05-08-2013
Pack size 5 x 10 
as per SRO
17-02-2011
Dy.No.492 Form 5
Rs.8000/-
(Photocopy)
Rs.12,000/05-08-2013
Pack size 8s & 16s
 as per SRO
Niaspan Merck
Firm
previously
applied on
Form 5-D
but
now
product is
being
registered in
Pakistan.
Approved
Approved
with black
box
warning.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
Domotin Benson
Firm is GMP
compliant as
per inspection
report dated
02-05-2016
WHO
recommended
formulation
Amalar Bloom
Firm is GMP
compliant as
per inspection
report dated
02-05-2016
195
registration
letter
250.
M/s MBL
Pharma, Plot #
B-77/A, Hub
Industrial
Trading Estate
Balauchistan.
Fasid Cream 15gm
Each gram contains
Fusidic Acid 20mg
Antibiotics
BP Specification
Priority # 1569
251.
M/s MBL
Pharma, Plot #
B-77/A, Hub
Industrial
Trading Estate
Balauchistan.
Priority # 875
252.
M/s MBL
Pharma, Plot #
B-77/A, Hub
Industrial
Trading Estate
Balauchistan.
27-04-2012
Dy.No.753
Rs.8000/Photocopy
Rs.12,000/05-08-2013
Pack size of 15gm
as per SRO
Mb Din suspension 60ml
Each 5ml of reconstituted
suspension contains
Cephradine USP 250mg
Antibiotics
USP Specification
Viospan DS suspension
30ml
Each 5ml of reconstituted
suspension contains
Cefixime (as trihydrate)
200mg
Priority # 1549
Antibiotics
USP Specification
Minutes for 260th Meeting Registration Board
19-02-2011
Dy.No.505-A
Rs.8000/Photocopy
Rs.12,000/05-08-2013
Pack size of 60ml
as per SRO
27-04-2012
Dy.No.750
Rs.8000/Photocopy
Rs.12,000/05-08-2013
Pack size of 30ml
as per SRO
MHRA
approved
Fusidin - Leo
Approved
with change
of brand
name.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Sidic - Epoch
Firm is GMP
compliant as
per inspection
report dated
02-05-2016
FDA approved
brand
Velosef
Firm is GMP
compliant as
per inspection
report dated
02-05-2016
FDA approved
brand Suprax Lupin
Caricef - Sami
Firm is GMP
compliant as
per inspection
196
report dated
02-05-2016
253.
M/s Pliva
Pakistan (Pvt.)
Ltd, Plot # B-77,
Hub Industrial
Trading Estate,
Balauchistan.
Tablet Diamet
Each tablet contains
Glucosamine Sulphate
USP 500mg
Chondroitin Sulphate
USP 400mg
Priority # 862
Dietary supplement
USP Specification
254.
M/s Pliva
Pakistan (Pvt.)
Ltd, Plot # B-77,
Hub Industrial
Trading Estate,
Balauchistan.
Tablet Meelas 5mg
Each chewable tablet
contains
Montelukast Sodium USP
equivalent to Montelukast
5mg
Priority # 864
Bronchodilators
USP Specification
255.
M/s Pliva
Pakistan (Pvt.)
Ltd, Plot # B-77,
Hub Industrial
Trading Estate,
Balauchistan.
Tablet Meelas 10mg
Each film coated tablet
contains
Montelukast Sodium USP
equivalent to Montelukast
10mg
Priority # 863
Bronchodilators
USP Specification
Minutes for 260th Meeting Registration Board
17-02-2011
Dy.No.487
Rs.8000/Photocopy
Rs.12,000/19-9-2013
Pack size
2 x 10s  Rs.
320/-
17-02-2011
Dy.No.486 Form 5
Rs.8000/(Photocopy)
Rs.12,000/19-9-2013
Pack size
10s  Rs. 170/14s  Rs. 240/-
17-02-2011
Dy.No.485
Rs.8000/(Photocopy)
Rs.12,000/19-9-2013
Pack size
10s  Rs. 190/14s  Rs. 310/-
Firm is GMP
compliant as
per inspection
report dated
02-05-2016
MHRA
approved
Singlulair –
Merck,UK
Amisped Sanofi
Firm is GMP
compliant as
per inspection
report dated
02-05-2016
MHRA
approved branf
of Accord
AsfreeMedisure
Firm is GMP
compliant as
per inspection
Chairman
Registration
Board will
permit
issuance of
registration
letter
Proof
of
approval
status
of
same
dosage form
in reference
countries.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
Pack
of and
locally
Pakistan
registered
and
fee
brand.
challan.
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
197
report dated
02-05-2016
256.
M/s MBL
Pharma, Plot #
B-77/A, Hub
Industrial
Trading Estate
Balauchistan.
Fomatin Suspension 60ml
Each 5ml contains
Famotidine 10mg
Anti ulcer
USP Specification
Priority # 1570
Minutes for 260th Meeting Registration Board
10-05-2012
Dy.No.859
Rs.8000/Photocopy
Rs.12,000/05-08-2013
Pack size as per
SRO
Firm is GMP
compliant as
per inspection
report dated
02-05-2016
Chairman
Registration
Board will
permit
issuance of
registration
letter
i. Applicant
s shall
revise
their
formulati
on as per
innovator
(new
registrati
on
applicatio
n with
complete
fee)
within six
months if
manufact
uring
facility is
approved
by CLB.
ii. For
already
registered
drugs,
same
procedur
e as
mentione
d above
(at Sr.
No. i)
shall be
adopted.
Otherwis
e show
cause
notice
shall be
issued for
de198
Deferred as
per decision
of 250th RB
meeting as
under:i.
Applica
nts shall
revise
their
formula
tion as
per
innovat
or (new
registrat
ion
applicat
ion with
complet
e fee)
within
six
months
if
manufa
cturing
facility
is
approve
d by
CLB.
ii. For
already
registered
drugs,
same
procedur
e as
mentione
d above
(at Sr.
257.
M/s MBL
Pharma, Plot #
B-77/A, Hub
Industrial
Trading Estate
Balauchistan.
Priority # 1571
258.
M/s MBL
Pharma, Plot #
B-77/A, Hub
Industrial
Trading Estate
Balauchistan.
Priority # 1547
Vanax Suspension 60ml
Each 5ml contains
Dexibuprofen 100mg
NSAID
Manufacture
Specification
Kanz Dry Powder
Suspension
Each 5ml of reconstituted
suspension contains
Ciprofloxacin HCl.2H2O
eq to Ciprofloxacin
250mg
Antibiotics
Manufacture
Specification
Minutes for 260th Meeting Registration Board
10-05-2012
Dy.No.857
Rs.8000/Photocopy
Rs.12,000/05-08-2013
Pack size as per
SRO
27-04-2012
Dy.No.753
Rs.8000/Photocopy
Rs.12,000/05-08-2013
Pack size of 60ml
as per SRO
Dexib –Tabros
Firm is GMP
compliant as
per inspection
report dated
02-05-2016
Novidat - Sami
Firm is GMP
compliant as
per inspection
report dated
02-05-2016
registrati
on of
registered
drugs in
this
formulati
on.
iii. All such
applicatio
n shall be
processed
on
priority
basis.
No. i)
shall be
adopted.
Otherwis
e show
cause
notice
shall be
issued for
deregistrati
on of
registered
drugs in
this
formulati
on.
iii. All such
applicatio
n shall be
processed
on
priority
basis.
Proof
of
approval
status
of
same
dosage form
in reference
countries.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
fee
challan.
Deferred for
 Proof of
approval
status of
same
dosage
form in
referenc
e
countrie
s.
 Product
is under
Proof
of
approval
status
of
same
dosage form
in reference
countries.
Product is
under
review as
innovator
brand is in
199
base form
of
active
ingredient
while firm
has applied
as salt form.
259.
260.
M/s Asian
Continental
(Pvt.) Ltd, D-32,
S.I.T.E, Super
Highway,
Karachi.
Artim Plus Suspension
Priority # 1630
Antimalarial
Manufacture
Specification
M/s Asian
Continental
(Pvt.) Ltd, D-32,
S.I.T.E, Super
Highway,
Karachi.
Injection Vitadol 5mg
Priority # 1593
Vitamin
USP Specification
Each 5ml of reconstituted
suspension contains
Artemether 15mg
Lumefantrine 90mg
Each 1ml ampoule
contains
Cholecalciferol (Vit. D3)
5mg
Minutes for 260th Meeting Registration Board
21-05-2012
Dy.No.955
Rs.8000/Rs.12,000/05-09-2013
(Photocopy)
Pack size 30ml x
60ml  as per
SRO
17-05-2012
Dy.No.884
Rs.8000/Rs.12,000/05-09-2013
(Photocopy)
Pack size 30ml x
60ml  as per
SRO
WHO
recommended
formulation
review
as
innovato
r brand
is
in
base
form of
active
ingredie
nt while
firm has
applied
as salt
form.
 Fee
challan
Approved
with change
of brand
name.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Artem -Hilton
Firm is GMP
compliant as
per inspection
report dated
11-11-2015
Vit D3 B.O.N,
France
Indrop-D ,
Neutro
Firm is GMP
compliant as
per inspection
report dated
200
261.
M/s Atco
Laboratories
Limited, B-18,
S.I.T.E, Karachi
Priority # 1502
Afantrine DS Dry
Suspension
Each 5ml of reconstituted
suspension contains
Artemether MS 30mg
Lumefantrine MS 180mg
Antimalarial
Manufacture
Specification
262.
M/s Atco
Laboratories
Limited, B-18,
S.I.T.E, Karachi
Priority # 1990
16-02-2012
Dy.No.581
Rs.8000/Photocopy
Rs.12,000/05-08-2013
Pack size of 30ml
& 60ml as per SRO
11-11-2015
Chairman
Registration
Board will
permit
issuance of
registration
letter
WHO
recommended
formulation
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Artem plus Hilton
Firm is GMP
compliant
Vorinaz Powder for Oral
suspension
19-11-2012
1774 Form 5-D
Rs.50,000/-
Vfend-MHRA
approved
Each 5ml of reconstituted
suspension contains
Voriconazole 200mg
(Photocopy)
Hongos-CCL
Reg#077021
Pack size of 30ml
& 60ml as per SRO
GMP
compliant
section
(Triazole Anti-fungal
agent)
Manufacture
Specification
Minutes for 260th Meeting Registration Board
Firm
previously
applied on
Form 5-D
but
now
product is
locally
registered
and firm has
submitted
application
of
prescribed
Form 5.
201
263.
M/s Atco
Laboratories
Limited, B-18,
S.I.T.E, Karachi
Priority # 1500
Tablet Xecam-P 4/500
Each film coated tablet
contains
Lornoxicam MS 4mg
Paracetamol BP 500mg
(Muscle relaxant )
Manufacture
Specification
264.
M/s Atco
Laboratories
Limited, B-18,
S.I.T.E, Karachi
Priority # 1501
Tablet Xecam-P 8/500
Each film coated tablet
contains
Lornoxicam MS 8mg
Paracetamol BP 500mg
(Muscle relaxant )
Manufacture
Specification
265.
M/s Atco
Laboratories
Limited, B-18,
S.I.T.E, Karachi
Tablet Panel 10mg
Each film coated tablet
contains
Perampanel 10mg
16-02-2012
Dy.No.584 Form 5-D
Rs.15000/Rs.35,000/05-08-2013
GMP
compliant
section
(Photocopy)
Pack size of 14s &
28s as per SRO
16-02-2012
Dy.No.584 Form 5-D
Rs.15000/Rs.35,000/05-08-2013
GMP
compliant
section
(Photocopy)
Pack size of 14s &
28s as per SRO
29-03-2011
Dy.No.490 Form 5-D
Rs.15000/Rs.35,000/05-08-2013
MHRA
approved
Fycompa Eisai
Priority # 2164
(Antiepileptic)
Manufacture
Specification
266.
M/s Atco
Laboratories
Limited, B-18,
S.I.T.E, Karachi
Priority # 2375
Tablet Alodip-H
Each film coated tablet
contains
Aliskiren (as
hemifumarate) MS 300
mg
Amlodipine (as besylate)
BP 5mg
Hydrochlorthiazide BP
12.5mg
Pack size of 7s, 14s
& 28s
Per tablet  Rs.
375/-
GMP
compliant
section
29-03-2011
Dy.No.490 Form 5-D
Rs.15000/Rs.35,000/05-08-2013
USFDA
approved
AmturnideNovartis
Pack size of 14s &
28s as per SRO
GMP
compliant
section
The
proposed
formulation
doesn’t
exist
in
reference
countries
and
Pakistan.
The
proposed
formulation
doesn’t
exist
in
reference
countries
and
Pakistan.
Stability
data
required as
per
guidelines
provided in
251st
RB
meeting.
Stability
data
required as
per
guidelines
provided in
251st
RB
meeting.
(Cardiovascular drug )
Manufacture
Specification
Minutes for 260th Meeting Registration Board
202
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
fee
challan.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
fee
challan
Deferred for
provision of
stability
data
required as
per
guidelines
provided in
251st
RB
meeting.
Deferred for
provision of
stability
data
required as
per
guidelines
provided in
251st
RB
meeting.
267.
M/s Atco
Laboratories
Limited, B-18,
S.I.T.E, Karachi
Priority # 2656
268.
M/s Pacific
Pharmaceuticals
Limited, 30th
km, Multan
Road, Lahore
Tablet Aloglip-M
12.5/1000
Each film coated tablet
contains
Alogliptin Benzoate MS
eq to Alogliptin 12.5mg
Metformin HCl BP
1000mg
(Cardiovascular drug )
Manufacture
Specification
Rifin Dispersible tablet
Each dispersible tablet
contains
Rifampicin 60mg
Isoniazid 30mg
Priority # 1981
(Antimycobacterial)
Manufacture
Specification
269.
M/s Pacific
Pharmaceuticals
Limited, 30th
km, Multan
Road, Lahore
Rifin Dispersible tablet
Each dispersible tablet
contains
Rifampicin 60mg
Isoniazid 60mg
Priority # 1982
(Antimycobacterial)
Manufacture
Specification
Minutes for 260th Meeting Registration Board
24-10-2013
Dy.No.273 Form 5-D
Rs.15000/Rs.35,000/05-08-2013
Pack size of 10s,
14s 20s & 30s as
per SRO
USFDA
approved
Kazano Takeda
GMP
compliant
section
16-11-2012
Form 5
20,000
(Photocopy)
WHO -UN
prequalified
formulation
Pack size of
28s  Rs. 335.40/56s  Rs. 670.79/-
GMP
compliant
section
16-11-2012
Form 5
20,000
(Photocopy)
WHO -UN
prequalified
formulation
Pack size of
28s  Rs. 337.93/56s  Rs. 675.86/-
GMP
compliant
section
Stability
data
required as
per
guidelines
provided in
251st
RB
meeting.
 To
deposit
remainin
g fee for
prescrib
ed Form
5-D.
 Stability
studies
as
per
guidelin
es
provided
in 251st
RB
meeting.
Deferred for
provision of
stability
data
required as
per
guidelines
provided in
251st
RB
meeting.
Deferred for
following
shortcoming
s
 To
deposit
remainin
g fee for
prescrib
ed Form
5-D.
 Stability
studies
as
per
guidelin
es
provided
in 251st
RB
meeting.
Deferred for
 To
following
deposit
remainin shortcoming
g fee for s
prescrib
 To
ed Form
deposit
5-D.
remainin
g fee for
 Stability
prescrib
studies
ed Form
as
per
5-D.
guidelin
es
 Stability
provided
studies
in 251st
as
per
203
270.
M/s NabiQasim
Industries
(Private)
Limited, 17/24,
Korangi
Industrial Area,
Korangi,
Karachi
Kenazol 2% Lotion
Each ml contains:
Ketoconazole… 20 mg
08-05-2013
Dy.No.304 Form 5
Rs.20,000/(Photocopy)
(Antifungal agent)
Manufacture
Specification
Pack size of 30ml
& 60ml as per SRO
Conaz - Atco
Firm is GMP
compliant
RB
meeting.
guidelin
es
provided
in 251st
RB
meeting.
To provide
proof
of
approval of
same
dosage form
in reference
countries.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
fee
challan.
 To
provide
primary
packagin
g details.
Deferred for
 Primary
packagin
g details.
 Proof of
approval
status of
same
dosage
form in
same
primary
packing
by
reference
regulator
authoritie
s
and
Pakistan.
Priority # 2294
271.
M/s Surge
Laboratories
(Private)
Limited, 10th,
KM Faisalabad
Road, Bikhi
District,
Sheikhupura.
Dexol 5% infusion
Each 100 ml contains:
Dextrose Anhydrous USP
5gm (5% w/v)
(Carbohydrate)
USP Specification
27-6-2011
Dy # 1487
8000/- Form 5
12000/16-01-2014
Pack size
100ml, 500 ml,
1000ml as per SRO
Priority # 1545
swapped
Minutes for 260th Meeting Registration Board
204
272.
M/s Surge
Laboratories
(Private)
Limited, 10th,
KM Faisalabad
Road, Bikhi
District,
Sheikhupura.
Priority # 1351
swapped
273.
M/s Surge
Laboratories
(Private)
Limited, 10th,
KM Faisalabad
Road, Bikhi
District,
Sheikhupura.
Injection Alset
Each 5ml vial contains:
Palonosetron (as HCl)
0.25mg
(5HT3 receptor
antagonist)
Manufacture
Specification
Preslin Injection 20mg
Each ml contains:
Hydralazine HCl USP
20mg
(Antihypertensive)
USP Specification
Priority # 1202
swapped
Minutes for 260th Meeting Registration Board
27-6-2011
Dy # 1487
8000/- Form 5
12000/16-01-2014
MHRA
approved
Aloxi –
Chughai
Pack size
100ml, 500 ml,
1000ml as per SRO
Aloxetron –
Atco
approved in
228th meeting
for improt
26-4-2012
8000/- Form 5
12000/16-01-2014
(Photocopy)
Pack size of 30ml
& 60ml as per SRO
 Me too Deferred for
status
 Confirm
needs
ation of
confirmat
pack
ion
size.
 Provision of
approval
status
of
same
dosage
form
in
Pakistan, as
reference
mentioned
in Form 5
is
not
correct.
 Complete Deferred for
form
5 provision of
required.
 Complete
form 5.
 Original
challan
 Original
receipt
challan
required.
receipt.
 Complete  Complete
descriptio
descriptio
n
of
n
of
dosage
dosage
form
form.
required.
 Proof of
approval
 Commit
ment
status of
required
same
as
per
dosage
decision
form in
st
of 251
reference
RB
countires
meeting.
and
Pakistan
 Latest
inspectio
 Commit
n report
ment as
required.
per
decision
of 251st
RB
205
meeting.
 Latest
inspection
report.
 Fee challan
274.
M/s Surge
Laboratories
(Private)
Limited, 10th,
KM Faisalabad
Road, Bikhi
District,
Sheikhupura.
Water for injection
Water for injection 50ml
(Diluent)
USP Specification
Priority # 1853
Minutes for 260th Meeting Registration Board
29-8-2012
8000/- Form 5
12000/16-01-2014
(Photocopy)
Pack size of 30ml
& 60ml as per SRO
 Complete Deferred for
form
5 provision of
required.
 Complete
form 5.
 Original
challan
 Original
receipt
challan
required.
receipt.
 Complete  Clinical
descriptio
Indicatio
n
of
n
dosage
 Proof of
form
availabilit
required.
y of same
pack size
 Commit
ment
in
required
reference
as
per
countires
decision
and
st
of 251
Pakistan.
RB
 Proof of
meeting.
approval
status of
 Latest
inspectio
same
n report
dosage
required.
form in
reference
 Indicatio
countires
n
of
and
dosage
Pakistan
form.
 Commit
ment as
per
decision
of 251st
RB
meeting.
 Latest
inspectio
n report.
 Intended
206
use.
 Fee
challan
275.
M/s Surge
Laboratories
(Private)
Limited, 10th,
KM Faisalabad
Road, Bikhi
District,
Sheikhupura.
Priority # 1204
276.
M/s Surge
Laboratories
(Private)
Limited, 10th,
KM Faisalabad
Road, Bikhi
District,
Sheikhupura.
Priority # 1545
Sunvega 39 mg injection
Each 0.25ml pre filled
syringe contains
Paliperidone palmitate
39mg
(Prolonged released)
29-8-2012
8000/- Form 5
12000/16-01-2014
(Photocopy)
USFDA
approved
Invega
sustenna –
Janssen
 Complete Deferred for
form 5-D  Complete
required.
form 5-D.
 Original
 Original
challan
challan
receipt
receipt.
required.
 Complete
descriptio
 Complete
descriptio
n
of
n
of
dosage
dosage
form.
form
 Commit
required.
ment as
per
 Commit
ment
decision
required
of 251st
as
per
RB
decision
meeting.
of 251st  Latest
RB
inspectio
meeting.
n report
required.
 Latest
inspectio
 manufact
n report
uring
required.
facility of
pre-filled
 Proof of
manufact
syringes.
uring
 Fee
facility of
challan
pre-filled
syringes.
USFDA
approved
Invega
sustenna –
Janssen
 Complete Deferred for
form 5-D  Complete
required.
form 5-D.
 Original
 Original
challan
challan
receipt
receipt.
required.
 Complete
descriptio
 Complete
descriptio
n
of
n
of
dosage
Pack size of 30ml
& 60ml as per SRO
(Dopamine antagonist)
USP Specification
Sunvega 39 mg injection
Each 0.25ml pre filled
syringe contains
Paliperidone palmitate
39mg
(Prolonged released)
(Dopamine antagonist)
USP Specification
Minutes for 260th Meeting Registration Board
29-8-2012
8000/- Form 5
12000/16-01-2014
(Photocopy)
Pack size of 30ml
& 60ml as per SRO
207
dosage
form
required.
 Commit
ment
required
as
per
decision
of 251st
RB
meeting.
 Latest
inspectio
n report
required.
 Proof of
manufact
uring
facility of
pre-filled
syringes.
277.
M/s Venus
Pharma, 23km,
Multan Road,
Lahore
Priority # 498
Viofer Injection
Each 5ml ampoule
contains
Iron sucrose eq to
elemental iron 100mg (20
mg / ml)
(Hematinic)
USP Specification
Minutes for 260th Meeting Registration Board
02-12-2010 Dy #
4534
8000/- Form 5
12000/05 -11-2013
FDA approved
Venofer –
Lutipold
(Photocopy)
Venofer – RG
Pack size of 30ml
& 60ml as per SRO
form.
 Commit
ment as
per
decision
of 251st
RB
meeting.
 Latest
inspectio
n report.
 manufact
uring
facility of
pre-filled
syringes.
 Fee
challan
Approved
with change
of brand
name.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
GMP
compliant
section vide
inspection
report dated
208
278.
M/s Venus
Pharma, 23km,
Multan Road,
Lahore
Priority # 668
Viofer Infusion 100 ml
Part I
Each 5ml ampoule
contains
Iron sucrose eq to
elemental iron 100mg (20
mg / ml)
Part II
Sodium Chloride 0.9%
02-12-2010 Dy #
4534
8000/- Form 5
12000/05 -11-2013
FDA approved
Venofer –
Lutipold
(Photocopy)
Venofer – RG
Pack size
100ml  Rs. Rs.
1000/-
GMP
compliant
section vide
inspection
report dated
(Hematinic)
USP Specification
279.
280.
M/s Venus
Pharma, 23km,
Multan Road,
Lahore
Normal Saline 0.9%
Priority # 669
(Electrolyte)
USP Specification
M/s Venus
Pharma, 23km,
Multan Road,
Lahore
Priority # 499
Each ml contains
Sodium Chloride 9 mg
Tablet Apresolin - 10
Each tablet contains
Hydralazine HCl 10mg
(Antihypertensive)
USP Specification
Minutes for 260th Meeting Registration Board
02-12-2010 Dy #
4534
8000/- Form 5
12000/05 -11-2013
(Photocopy)
GMP
compliant
section vide
inspection
report dated
Pack size
100ml  Rs. 45/-
02-11-2010
Dy # 4207
8000/- Form 5
12000/05 -11-2013
FDA approved
Aspresolin –
Novartis
(Photocopy)
GMP
compliant
section vide
inspection
report dated
Pack size
1 x 50  Rs. 103/-
Proof
of
approval
status
of
same
dosage form
in
glass
bottle
as
primary
container
The product
is not yet
registered in
Pakistan in
proposed
strength
209
Deferred for
confirmatio
n
of
approval
status
of
same
formulation
by refrence
regulatory
authorities
and
Pakistan
and
fee
challan.
Deferred for
confirmatio
n
of
approval
status
of
same
formulation
in
glass
bottle
as
primary
container by
refrence
regulatory
authorities
and
Pakistan
and
fee
challan
Deferred for
 Applicati
on
on
prescribe
d Form 5D along
with
other
legal and
codal
formalitie
s because
the
proposed
281.
M/s Hilton
Pharma (Pvt.)
Ltd, 13, Sector
15, Korangi
Industrial Area,
Karachi
Priority # 2122
swapped
282.
M/s Hilton
Pharma (Pvt.)
Ltd, 13, Sector
15, Korangi
Industrial Area,
Karachi
Priority # 2120
swapped
Colt Drops 125mg / 5ml
Each 5ml after
reconstitution contains
Clarithromycin 125mg
(granules for oral
suspension)
(Antibiotics)
USP Specification
Tablet Maxit-Neuro
Each film coated tablet
contains
Diclofenac Sodium 50mg
Thiamine(Vitamin B1)
50mg
Pyridoxine HCl (Vit B6)
50mg
Cyanocobalamin
(Vitamin B12) 250 mcg
Form 5 with
prescribed fee of Rs
20,000 vide Dy #
1168 dated 03-072013
Pack size as per
PRC
Form 5 with
prescribed fee of Rs
20,000 vide Dy #
1297 dated 11-072013
Pack size as per
PRC
formulati
on is not
yet
registered
in
Pakistan.
 Fee
challan
Approved
with change
of
brand
name
because
proposed
brand name
resembles
with already
registered
brand name.
MHRA
approved brand
of Sandoz
Klaricid –
Abbott
GMP
compliant
section vide
inspection
report dated
GMP
compliant
section vide
inspection
report dated
Proof
of
approval
status
of
same
dosage form
in reference
countries
and
Pakistan.
Rejected as
formulation
is
not
approved by
reference
regulatory
authorities
and
Pakistan.
Firm needs
to provide
following
documents /
information
for
completion
of
application.
 Proof of
approval
status of
Deferred for
confirmatio
n
of
approval
status
of
same
formulation
/
dosage
form
by
reference
regulatory
authorities.
(pain reliever)
Manufacture
Specification
283.
M/s Hilton
Pharma (Pvt.)
Ltd, 13, Sector
15, Korangi
Industrial Area,
Karachi
Hilto-D Sachet
Priority # 2117
swapped
(Vitamin)
Manufacture
Specification
Each Sachet contains
Vitamin D3
(Cholecalciferol) 600,000
IU
Minutes for 260th Meeting Registration Board
Form 5-D with
prescribed fee of Rs
50,000 vide Dy #
1408 dated 19-072013
Pack size
30s  Rs. 900/-
GMP
compliant
section vide
inspection
report dated
210
284.
M/s Hilton
Pharma (Pvt.)
Ltd, 13, Sector
15, Korangi
Industrial Area,
Karachi
Priority # 2143
swapped
285.
M/s Hilton
Pharma (Pvt.)
Ltd, 13, Sector
15, Korangi
Industrial Area,
Karachi
Priority # 2142
swapped
Capsule toploss 7.5/46
Each capsule contains
Phentermine 7.5 mg
Topiramate 46 mg
(anti-epileptic)
Manufacture
Specification
Capsule toploss 11.25/69
Each capsule contains
Phentermine 11.25 mg
Topiramate 69 mg
(anti-epileptic)
Manufacture
Specification
Minutes for 260th Meeting Registration Board
Form 5-D with
prescribed fee of Rs
50,000 vide Dy # 699
dated 31-01-2013
Pack size
10s  Rs. 4300/20s  Rs. 8600/30s  Rs. 12,900/-
Form 5-D with
prescribed fee of Rs
50,000 vide Dy # 697
dated 31-01-2013
Pack size
10s  Rs. 5150/20s  Rs. 10300/30s  Rs. 15,450/-
same
dosage
form in
referenc
e
countrie
s.
FDA approved Firm needs Deferred of
Qsymia , Vivus to provide  Complet
following
e
documents /
descripti
information
on
of
GMP
for
dosage
compliant
completion
form.
section vide
of

Formula
inspection
application.
tion
report dated
 Complet
details
e
as
per
descripti
innovato
on
of
r brand.
dosage
 Stability
form.
data as
 Formula
per
tion
guidelin
details
es
of
as
per
251st RB
innovato
meeting.
r brand.
 Stability
data as
per
guidelin
es
of
251st RB
meeting.
FDA approved Firm needs Deferred for
Qsymia , Vivus to provide  Complet
following
e
documents /
descripti
information
on
of
GMP
for
dosage
compliant
completion
form.
section vide
of
 Formula
inspection
application.
tion
report dated
 Complet
details
e
as
per
211
286.
M/s Hilton
Pharma (Pvt.)
Ltd, 13, Sector
15, Korangi
Industrial Area,
Karachi
Priority # 2142
swapped
Capsule toploss 15/92
Each capsule contains
Phentermine 15 mg
Topiramate 92 mg
(anti-epileptic)
Manufacture
Specification
Minutes for 260th Meeting Registration Board
Form 5-D with
prescribed fee of Rs
50,000 vide Dy # 694
dated 31-01-2013
Pack size
10s  Rs. 5800/20s  Rs. 11600/30s  Rs. 17,400/-
descripti
innovato
on
of
r brand.
dosage
 Stability
form.
data as
per
 Formula
tion
guidelin
details
es
of
st
as
per
251 RB
innovato
meeting.
r brand.
 Stability
data as
per
guidelin
es
of
st
251 RB
meeting.
FDA approved Firm needs Deferred for
Qsymia , Vivus to provide  Complet
following
e
documents /
descripti
information
on
of
GMP
for
dosage
compliant
completion
form.
section vide
of
 Formula
inspection
application.
tion
report dated
 Complet
details
e
as
per
descripti
innovato
on
of
r brand.
dosage
 Stability
form.
data as
 Formula
per
tion
guidelin
details
es
of
as
per
251st RB
innovato
meeting.
r brand.
 Stability
data as
per
guidelin
es
of
st
251 RB
meeting.
212
287.
M/s Hilton
Pharma (Pvt.)
Ltd, 13, Sector
15, Korangi
Industrial Area,
Karachi
Priority # 2387
288.
M/s Hilton
Pharma (Pvt.)
Ltd, 13, Sector
15, Korangi
Industrial Area,
Karachi
Priority # 2391
Ariza Injection IM
Each 1.3ml vial contains
Aripiprazole 9.75mg
(psychotropic drug)
Manufacture
Specification
Ariza oral solution
Each ml contains
Aripiprazole 1mg
(anti-psychotic)
Manufacture
Specification
Form 5-D with
prescribed fee of Rs
50,000 vide Dy #
1302 dated 01-072013
Pack size
5s  Rs. 2254/10s  Rs. 4508/30s  Rs. 13,524/Form 5-D with
prescribed fee of Rs
50,000 vide Dy #
1299 dated 01-072013
Pack size
60ml  Rs. 5880/120ml  Rs.
11170/-
240ml  Rs.
FDA approved
Abilify –
Otsuka
GMP
compliant
section vide
inspection
report dated
FDA approved
Abilify –
Otsuka
GMP
compliant
section vide
inspection
report dated
Proof
of
segregated
manufacturi
ng facility
for
psychotropi
c injection
not
provided.
Deferred for
provision of
stability
data as per
guidelines
provided in
251st
RB
meeting.
Proof
of
segregated
manufacturi
ng facility
for
psychotropi
c
oral
solution not
provided.
Deferred for
provision of
stability
data as per
guidelines
provided in
251st
RB
meeting.
Me
too
status needs
confirmatio
n.
Deferred for
confirmatio
n
of
approval
status
in
Pakistan.
20000/-
289.
M/s Hilton
Pharma (Pvt.)
Ltd, 13, Sector
15, Korangi
Industrial Area,
Karachi
Priority # 2346
Tablet Hilpru 600 mg
Each film coated tablet
contains
Prulifloxacin 600mg
(Antibiotics)
Manufacture
Specification
Form 5 with
prescribed fee of Rs
50,000 vide Dy # 104
dated 23-01-2013
Pack size & price
as per PRC
Tablet Unidrox
- Aziende
Chimiche
Riunite
Angelini
Francesco A.C.R.A.F.
S.p.A. Viale
Amelia 70 00181 Rome,
Italy
Pruking
600mg,
Wilshire
GMP
compliant
section vide
inspection
report dated
Minutes for 260th Meeting Registration Board
213
290.
M/s Medisearch
Pharmacal
(Pvt.) Ltd, 5km,
Raiwind Manga
Road, Lahore
Priority # 669
291.
Gerd Cure Tablet
Each tablet contains
Itopride HCl 50mg
(prokinetic / antiemetic)
Manufacture
Specification
M/s Medisearch
Pharmacal
(Pvt.) Ltd, 5km,
Raiwind Manga
Road, Lahore
Capsule Diclofast 50mg
Priority # 988
(NSAID)
Manufacture
Specification
Each capsule contains
Diclofenac Sodium 50
mg
Minutes for 260th Meeting Registration Board
31-08-2012 Dy #
8556
8000/- Form 5
12000/05 -11-2013
Pack size
3 x 10  Rs. 425/-
31-08-2012 Dy #
8554
8000/- Form 5
12000/31 -07-2013
Pack size
2 x 10  Rs. 180/-
Ganaton –
Abbott
GMP
compliant
section vide
inspection
report dated
Phlogin brookes
GMP
compliant
section vide
inspection
report dated
Product
under
review.
Deferred as
product is
under
review and
latest
inspection
report of the
firm
conducted
within one
year
and
decision of
CLB
on
recommend
ation
of
PQCB,
Punjab
Complete
Deferred for
description
 Complet
of dosage
e
form
not
descripti
provided.
on
of
dosage
form.
 Proof of
approval
status of
dosage
form in
referenc
e
countire
s.
 Latest
inspectio
n report
of
the
firm
conducte
d within
one year
and
decision
of CLB
on
recomm
214
endation
of
PQCB,
Punjab
292.
M/s Medisearch
Pharmacal
(Pvt.) Ltd, 5km,
Raiwind Manga
Road, Lahore
Tablet Nexpro 550mg
Priority # 1078
(NSAID)
USP Specification
Each tablet contains
Naproxen sodium 550mg
eq to Naproxen 500mg
Minutes for 260th Meeting Registration Board
31-08-2012 Dy #
8554
8000/- Form 5
12000/31 -07-2013
Pack size
3 x 10  Rs. 240/-
Anex –
Pharmevo
GMP
compliant
section vide
inspection
report dated
Complete
Deferred for
description
 Complet
of dosage
e
form
not
descripti
provided.
on
of
dosage
form.
 Proof of
approval
status of
dosage
form in
referenc
e
countire
s.
 Latest
inspectio
n report
of
the
firm
conducte
d within
one year
and
decision
of CLB
on
recomm
endation
of
PQCB,
Punjab
215
293.
M/s Pharmatec
Pakistan (Pvt.)
Ltd, D-86/A,
S.I.T.E,
Karachi.
Priority # 1204
Tablet Morease SR
Each film coated delayed
released tablet contains
Doxylamine Succinate
10mg
Vitamin B6 10mg
Folic Acid 2.5mg
(Antihistamine / ant
allergy / anti nauseant )
Manufacture
Specification
Minutes for 260th Meeting Registration Board
29-8-2012
8000/- Form 5
12000/16-01-2014
Diclectin –
Canada
(Photocopy)
Envepe- RG
Pharmaceutica
Pack size of 30’s as
per SRO
Defererd for
 The
proposed
 The
formulati
proposed
on is not
formulati
as
per
on
innovator
doesn’t
brand and
match
me too in
with the
Pakistan.
already
registered
 Original
brands
challan
because
receipt
proposed
required.
formulati
on
contains
folic acid
which is
not
in
formulati
on
of
already
registered
brands.
 Original
challan
receipt
required.
 Approval
status by
reference
regulator
authoritie
s.
 Fee
challan
216
294.
M/s Pharmatec
Pakistan (Pvt.)
Ltd, D-86/A,
S.I.T.E,
Karachi.
Tablet Lanthanate 500mg
Each chewable tablet
contains
Lanthanum (as carbonate
hydrate) 500mg
Priority # 1956
(Phosphate Binder )
Manufacture
Specification
295.
M/s Genix
Pharma (Pvt.)
Ltd, 44,45-B,
Korangi Creek
Road, Karachi.
Tablet Metvil
Each film coated tablet
contains
Metformin HCl 1000mg
Vildagliptin 50mg
29-8-2012
8000/- Form 5
12000/16-01-2014
(Photocopy)
Pack size of 30’s as
per SRO
30-11-2010
Dy No.2076 Form 5
Rs.8000/Rs.12,000/25-9-2013
(Photocopy)
Priority # 643
(Anti-diabetic)
Manufacture
Specification
Minutes for 260th Meeting Registration Board
Pack size of 10’s &
30’s as per SRO
USFDA
approved
Fosrenol –
DSM
Pharmaceutical
s –Greenville
Blvd
US Patent
5,968,976
MHRA
approved
Eucreas –
Novartis
GalvusmetNovartis
GMP
compliant
section
Deferred for
 Original
challan
 Original
receipt
challan
required.
receipt.
 Complete  Complete
descriptio
descriptio
n
of
n
of
dosage
dosage
form
form.
required.
 Commit
 Commit
ment as
ment
per
required
decision
as
per
of 251st
decision
RB
st
of 251
meeting.
RB
 Latest
meeting.
inspectio
n report.
 Latest
inspectio
 Proof of
n report
approval
required.
status of
same
 Proof of
approval
formulati
status of
on
/
same
dosage
dosage
form in
form in
Pakistan.
Pakistan.
 Fee
challan
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
217
296.
M/s Obsons
Pharmaceuticals
, 209-S,
Industrial
Estate.
Kotlakhpat,
Lahore
Capsule Flucob 150mg
Each capsule contains
Fluconazole 150mg
(Anti-diabetic)
Manufacture
Specification
22-6-2011
8000/- Form 5
12000/19-12-2013
(Photocopy)
Pack size & price
as per SRO
M/s Obsons
Pharmaceuticals
, 209-S,
Industrial
Estate.
Kotlakhpat,
Lahore
Priority # 1171
Tablet OBMOX 400 mg
Each film coated tablet
contains
Moxifloxacin (as HCl)
400mg
(Antibiotics)
Manufacture
Specification
Dy # 2705
22-6-2011
Rs. 8000/Form 5
Dy # 1281
19-12-2013
Rs. 12000/(Photocopy)
Pack size
1 x 5s  Rs.
692.95/-
298.
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
FludermNabiQasim
GMP
compliant
section vide
inspection
report dated
07-07-2015.
Priority # 1170
297.
MHRA
approved
Azocan-P ,
FDC
M/s Obsons
Pharmaceuticals
, 209-S,
Industrial
Estate.
Kotlakhpat,
Lahore
Tablet AZICOB 250mg
Priority # 1181
(Antibiotics)
Manufacture
Specification
Each film coated tablet
contains
Azithromycin (as
dihydrate)
250mg
Minutes for 260th Meeting Registration Board
Dy # 2705
22-6-2011
Rs. 8000/Form 5
Dy # 1281
19-12-2013
Rs. 12000/(Photocopy)
Pack size
6s  as per SRO
MHRA
approved
Avelox
Moxiget - Getz
GMP
compliant
section vide
inspection
report dated
07-07-2015.
MHRA
approved brand
of actavis, UK
Azopik – Wise
GMP
compliant
section vide
inspection
report dated
07-07-2015.
218
registration
letter
299.
M/s Irza
Pharma (Pvt.)
Ltd, 10.2km,
Lahore
Sheikhupura
Road, Lahore
Priority # 1917
300.
M/s Irza
Pharma (Pvt.)
Ltd, 10.2km,
Lahore
Sheikhupura
Road, Lahore
Priority # 1914
301.
M/s Irza
Pharma (Pvt.)
Ltd, 10.2km,
Lahore
Sheikhupura
Road, Lahore
Priority # 1014
Zeesulf Suspension
Each 5ml of suspension
contains
Zinc Sulphate USP 20mg
18/10/2012
Fee Rs. 20,000/Form 5
(Photocopy)
WHO
recommended
formulation
(Antidiarrheal )
USP Specification
Pack size & price
as per SRO
GMP
compliant
section vide
inspection
report dated
21-03-2016
Tablet Vilvus 50mg
18/10/2012
Dy # 211 dated 1710-2012
Fee Rs. 20,000/Form 5
MHRA
approved
GalvusNovartis
(Photocopy)
Galvus –
Novartis
Each tablet contains
Vildagliptin 50mg
(Anti-diabetic)
Manufacture
Specification
Injection I-Mide
Each 2ml contains
Metoclopramide HCl
10mg (5mg/ml)
(Anti-dopaminergic)
Manufacture
Specification
Minutes for 260th Meeting Registration Board
Pack size & price
as per SRO
18/10/2012
Dy # 211 dated 1710-2012
Fee Rs. 20,000/Form 5
(Photocopy)
Pack size & price
as per SRO
 Product
is under
review
and
waiting
for
commen
ts
of
WHO.
Deferred as
product is
under
review and
sent
for
comments
of WHO.
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
GMP
compliant
section vide
inspection
report dated
21-03-2016
Metoclopramid
e Injection –
Sandoz Canada
Maxolon-GSK
GMP
compliant
section vide
inspection
report dated
21-03-2016
219
302.
M/s Irza
Pharma (Pvt.)
Ltd, 10.2km,
Lahore
Sheikhupura
Road, Lahore
Priority # 1916
303.
M/s Irza
Pharma (Pvt.)
Ltd, 10.2km,
Lahore
Sheikhupura
Road, Lahore
Priority # 1915
304.
M/s Irza
Pharma (Pvt.)
Ltd, 10.2km,
Lahore
Sheikhupura
Road, Lahore
Priority # 1785
Tablet Gabatin 100mg
Each tablet contains
Gabapentin USP 100mg
(Anti-epileptic)
Manufacture
Specification
Tablet Gabatin 300mg
Each tablet contains
Gabapentin USP 300mg
(Anti-epileptic)
Manufacture
Specification
Neotral Sachet
Each sachet contains
Sodium Chloride 3.5gm
Potassium Chloride
1.5gm
Sodium Citrate 2.9gm
Dextrose Anhydrous
20gm
(Electrolyte)
Manufacture
Specification
Minutes for 260th Meeting Registration Board
18/10/2012
Fee Rs. 20,000/Form 5
Gabapen –
Batala
(Photocopy)
GMP
compliant
section vide
inspection
report dated
21-03-2016
Pack size & price
as per SRO
18/10/2012
Fee Rs. 20,000/Form 5
Gabapen –
Batala
(Photocopy)
GMP
compliant
section vide
inspection
report dated
21-03-2016
Pack size & price
as per SRO
02-07-2012
Rs. 8,000/Form 5
17-05-2013
Rs. 12000/-
(Photocopy)
Pack size & price
as per SRO
Approved
in
th
247
RB
meeting being
high osmolar
formulation
Proof
of
approval
status
of
same
dosage form
in reference
countries
not
provided.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
fee
challan
Proof
of
approval
status
of
same
dosage form
in reference
countries
not
provided.
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
fee
challan
Firm
doesn’t
possess
Sachet
(General)
Section
Rejected as
firm doesn’t
possess
Sachet
(General)
Section
Peditral -Searle
GMP
compliant
section vide
inspection
report dated
21-03-2016
220
305.
M/s Lahore
Chemical &
Pharmaceutical
Works (Pvt.)
Ltd, 137Ferozpur Road,
Lahore
Priority # 1867
306.
M/s Lahore
Chemical &
Pharmaceutical
Works (Pvt.)
Ltd, 137Ferozpur Road,
Lahore
Priority # 1868
Tablet ARTEMEF DS
Each tablet contains
Artemether 40mg
Lumefantrine 240mg
(Antimalarial)
Manufacture
Specification
Tablet ARTEMEF DS
Each tablet contains
Artemether 80mg
Lumefantrine 480mg
(Antimalarial)
Manufacture
Specification
Minutes for 260th Meeting Registration Board
05-09-2012
Rs. 8,000/Form 5
(Photocopy)
Dy#1134
16-12-2013
Rs. 12000/-
WHO
recommended
formulation
Artem - Hilton
Commitmen
t required as
per decision
of 251st RB
meeting.
Pack size
8s  Rs. 280/-
05-09-2012
Rs. 8,000/Form 5
(Photocopy)
Dy#1131
16-12-2013
Rs. 12000/-
Pack size
6s  Rs. 312/-
Latest
inspection
report
conducted
within one
year.
WHO
recommended
formulation
Artem - Hilton
Latest
inspection
report
conducted
within one
year.
Commitmen
t required as
per decision
of 251st RB
meeting.
221
Approved
with change
of
brand
name. firm
has
provided
requisite
documents.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved
with change
of
brand
name. firm
has
provided
requisite
documents.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
307.
M/s Mass
Pharma (Pvt)
Ltd, 17-km,
Ferozepur
Road, Lahore
Priority # 2038
308.
309.
Tablet VIMC-D
Each film coated tablet
contains:Ossein Mineral complex
83mg eq. to residual
mineral salts 24.8mg,
collagen 224mg, other
protenins 88.4mg, trace
elements fl,mg, Zn, Fe,
Ni, Cu) corresponding to
approx 440mg
hydroxyapatite.
M/s Sharex
Laboratories
(Pvt.) Ltd, KLP,
Road,
Sadiqabad
Pyodex Solution 10%
Priority # 285
Antiseptic
USP specification
M/s Sharex
Laboratories
(Pvt.) Ltd, KLP,
Road,
Sadiqabad
Priority # 285
Each 100ml contains:Iodinated povidone 10gm
eq to iodine 1gm
Cynoplex Injection
Each 2ml ampoule
contains:Vitamin B1 BP 10mg
Vitamin B2 BP 2mg
Vitamin B6 BP 5mg
Nicotinamide BP 75mg
Dexpanthanol BP 5mg
Dy# 10276
10-12-2012
Rs. 20,000/Form 5
Onsate – AGP
(Photocopy)
Pack size
Per tablet  Rs.
10/-
Dy# 3539
16-03-2011
Rs. 8,000/Form 5
Dy #1084
29-05-2014
MHRA
approved
Betadine
Poviderm Bexter
Latest
inspection
report
required
Pack size
Per tablet  Rs.
10/Dy# 3271
08-03-2011
Rs. 8,000/Form 5
Dy #1087
29-05-2014
Murfy plex –
Murfy
Latest
inspection
report
required
Pack size
25s  Rs. 90/-
Vitamin
Manufacture specification
Minutes for 260th Meeting Registration Board
222
Deferred for
verification
of atomic
absorption
spectrophot
ometer by
area
FID
required for
analytical
testing of
the product
and
fee
challan
Deferred for
Latest
inspection
report
conducted
within one
year
and
section
Deferred for
 Latest
inspectio
n report
conducte
d within
one
year.
 Confirm
ation of
approval
status by
referenc
e
regulator
authoriti
es and
Pakistan
310.
M/s Basel
Pharmaceuticals
, 227-Phase II,
Multan
Industrial
Estate, Multan
Priority # 285
Capsule Befol Vit
Each capsule contains:Dried ferrous Sulphate
150mg
Folic acid 0.5mg
Thiamine mononitrate
2mg
Riboflavin 2mg
Pyridoxine HCl 1mg
Nicotinamide 10mg
Ascorbic acid 50mg
Dy# 843
21-11-2013
Rs. 20,000/Form 5
Fefol-vit, GSK
Pack size
10s  Rs. 141/-
Vitamins
Manufacture specification
311.
M/s Zafa
Pharmaceutical
Laboratories
(Pvt.) Ltd, L1/B, Block 22,
Federal “B”
Industrial Area,
Karachi
Priority # 2742
312.
M/s Zafa
Pharmaceutical
Laboratories
(Pvt.) Ltd, L1/B, Block 22,
Federal “B”
Industrial Area,
Karachi
Priority # 1989
ZipPain 25mg Capsule
Each softgel capsule
contains
Diclofenac Potassium
25mg
(NSAID)
Manufacture
Specification
Tablet Durata 30 mg
Each film coated tablet
contains
Dapoxetine HCl eq to
Dapoxetine 30mg
(SSRIs)
Manufacture
Specification
Minutes for 260th Meeting Registration Board
28-11-2013
Dy.No.2039
Form 5-D
Rs.50,000/-
Pack size & price
as per SRO
FDA approved
Zipsor - US
Patents:
6,365,180;
7,662,858;
7,884,095;
7,939,518;
8,110,606;
6,287,594;
8,623,920
Distributed by:
Depomed, Inc.
Newark, CA
94560, USA
Issued: 5/2016
28-11-2013
Form 5
Rs.20,000/-
MHRA
approved
Priligy
(Photocopy)
(Photocopy)
Pack size & price
as per SRO
Latest
Deferred for
inspection
 Latest
report
inspectio
required
n report
Commitmen
required
t required
 Commit
Complete
ment as
manufacturi
per
ng method
decision
required
of 251st
RB
meeting.
 Complet
e
manufac
turing
method.
 Vitamin
policy
Stability
Deferred for
data as per provision of
guidelines
Stability
provided in data as per
251st
RB guidelines
meeting.
provided in
251st
RB
meeting and
fee challan
The product
in proposed
strength is
not
yet
registered in
Pakistan.
223
Deferred for
provision of
application
on
prescribed
Form 5-D
because
product in
proposed
strength is
not
yet
registered in
Pakistan
and
fee
challan
313.
M/s Highnoon
Laboratories
Ltd, 17.5km,
Multan Road,
Lahore
Tablet Cidine XR
Each extended released
tablet contains
Cinitapride as acid
tartrate 3mg
Priority # 2381
(Prokinetic drugs)
Manufcature
Specification
314.
315.
M/s Highnoon
Laboratories
Ltd, 17.5km,
Multan Road,
Lahore
Tablet Cidine XR
Priority # 2747
(Proton Pump Inhibitor)
Manufcature
Specification
M/s Highnoon
Laboratories
Ltd, 17.5km,
Multan Road,
Lahore
Capsule Tres-Orix forte
Priority # 2380
swapped
Each tablet contains
Dexrabeprazole sodium
5mg
Each capsule contains
Carnitine Hydrochloride
150mg Lysine
Hydrochloride 150mg
Coenzyme B12 1mg
Cyproheptadine orotate
1.5mg
(Nutritional Supplement)
Minutes for 260th Meeting Registration Board
22-11-2012
Fee Rs. 20,000/Form 5
(Photocopy)
Pack size & price
as per SRO
3-10-2011
Form 5-D
15000/35000/30-07-2013
(Photocopy)
Pack size
10s  Rs. 150/14s  Rs. 210/28s  Rs. 420/-
18-10-2012
Form 5
20000/-
(Photocopy)
Pack size
10s  Rs. 100/14s  Rs. 200/28s  Rs. 300/-
Proof
of
approval
status
of
same
formulation
in
same
strength in
reference
countries &
Pakistan.
Proof
of
approval
status
of
same
formulation
in
same
strength in
reference
countries &
Pakistan.
Proof
of
approval
status
of
same
formulation
in
same
strength in
reference
countries &
Pakistan.
224
Deferred for
confirmatio
n
of
approval
status
of
same
formulation
by reference
regulatory
authorities
and
Pakistan
and
fee
challan
Deferred for
confirmatio
n
of
approval
status
of
same
formulation
by reference
regulatory
authorities
and
Pakistan
and
fee
challan
Deferred for
confirmatio
n
of
approval
status
of
same
formulation
by reference
regulatory
authorities
and
Pakistan nd
fee challan.
316.
M/s Highnoon
Laboratories
Ltd, 17.5km,
Multan Road,
Lahore
Priority # 2748
swapped
317.
M/s Seatle
(Private)
Limited, 45-km,
Multan Road,
Lahore
Priority # 2414
318.
M/s Merck
(Private)
Limited, 7, Jail
Road, Quetta
Priority # 1969
Tablet Spasnol 80/80
Each tablet contains
Phlorglucinol 80mg
Trimethylphlorglucinol
80mg
(Antispasmodic)
Manufacture specification
Tablet Exlem 3mg
Each tablet contains
Bromazepam 3mg
18-10-2013
Form 5
20000/-
Spasfon –
France
(Photocopy)
Spasfon Himont
Pack size as per
SRO
18-10-2013
Form 5
20000/-
(Photocopy)
(Benzodiazepines)
Manufacture specification Pack size as per
SRO
Tablet Osteolock
Each film coated tablet
contains
Glucosamine Sulphate
2KCl USP eq. to
Glucosamine Sulphate
500mg
Chondroitin Sulphate
USP 400mg
Deferred as
product
/
formulation
is
under
review.
The Board
advised to
issue
reminder
for
to
experts for
their
opinion
TGA approved
LexotanRoche
Lexotanil
Roche
05-11-2012
Dy # 1728 Form 5
Rs.20,000/-
Gevolox –
Hilton
(Photocopy)
GMP
compliant
section vide
inspection
report dated
13-14 May
2016
Pack size
20s  Rs. 320/-
Proof
of
manufacturi
ng facility
of
tablet
psychotropi
c
(Osteoarthritis)
Manufacture
specification
Minutes for 260th Meeting Registration Board
225
Rejected as
firm doesn’t
possess
segregated
manufacturi
ng facility
of
tablet
psychotropi
c as per
requirement
of Central
Licensing
Board.
Deferred for
confirmatio
n
of
approval
status
of
same
formulation
by reference
regulatory
authorities
and
fee
challan.
319.
M/s Merck
(Private)
Limited, 7, Jail
Road, Quetta
Priority # 1429
Lumairia Dry Suspension
Each 5ml of reconstituted
suspension contains
Artemether 15mg
Lumefantrine 90mg
(Antimalarial)
Manufacture
specification
320.
M/s Merck
(Private)
Limited, 7, Jail
Road, Quetta
Lumairia Tablet 80/480
Each Tablet contains
Artemether 80mg
Lumefantrine 480mg
Priority # 1424
(Antimalarial)
Manufacture
specification
321.
M/s Merck
(Private)
Limited, 7, Jail
Road, Quetta
Lumairia Tablet 40/240
Each Tablet contains
Artemether 40mg
Lumefantrine 240mg
Priority # 1431
(Antimalarial)
Manufacture
specification
Minutes for 260th Meeting Registration Board
16-11-2011
Dy.No.361 Form 5
Rs.8000/Rs.12,000/05-09-2013
(Photocopy)
Pack size
30ml  Rs. 90/-
16-11-2011
Dy.No.361 Form 5
Rs.8000/Rs.12,000/05-09-2013
(Photocopy)
Pack size
30ml  Rs. 90/-
16-11-2011
Dy.No.361 Form 5
Rs.8000/Rs.12,000/05-09-2013
(Photocopy)
Pack size
10s  Rs. 264/-
WHO
recommended
formulation
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
Artem – Hilton
GMP
compliant
section
WHO
recommended
formulation
Artem – Hilton
GMP
compliant
section
WHO
recommended
formulation
Artem – Hilton
GMP
compliant
section
226
registration
letter
322.
M/s Merck
(Private)
Limited, 7, Jail
Road, Quetta
Lumairia Tablet 20/120
Each Tablet contains
Artemether 20mg
Lumefantrine 120mg
Priority # 1428
(Antimalarial)
Manufacture
specification
323.
M/s Merck
(Private)
Limited, 7, Jail
Road, Quetta
Priority # 2049
Mercip Powder for
suspension 250mg/5ml
Each 5ml of reconstituted
suspension contains
Ciprofloxacin HCl.2H2O
USP eq to Ciprofloxacin
250mg
(Antibiotics)
USP specification
324.
M/s Merck
(Private)
Limited, 7, Jail
Road, Quetta
Priority # 2048
16-11-2011
Dy.No.361 Form 5
Rs.8000/Rs.12,000/05-09-2013
(Photocopy)
Pack size
16s  Rs. 320/-
16-11-2011
Dy.No.361 Form 5
Rs.8000/Rs.12,000/05-09-2013
(Photocopy)
13-12-2012
Dy.No.361 Form 5
Rs. 20,000/-
Each 5ml of reconstituted
suspension contains
Ciprofloxacin HCl.2H2O
USP eq to Ciprofloxacin
250mg
(Photocopy)
Minutes for 260th Meeting Registration Board
Artem – Hilton
GMP
compliant
section
GMP
compliant
section
Pack size
60ml  Rs. 160/-
Mercip Powder for
suspension 125mg/5ml
(Antibiotics)
USP specification
WHO
recommended
formulation
Pack size
60ml  Rs. 90/-
GMP
compliant
section
Product
under
review.
The
innovator
brand is in
base form
while it is in
salt form.
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Deferred as
product is
under
review.
The
innovator
brand is in
base form
while it is in
salt form.
The
Rejected as
proposed
the
dosage form proposed
doesn’t
dosage form
exist in this doesn’t
strength in exist
in
reference
proposed
countries.
strength in
reference
countries.
227
325.
M/s Star
Laboratories
(Pvt.) Ltd, 23km, Multan
Road, Lahore
Priority # 2400
swapped
326.
M/s Star
Laboratories
(Pvt.) Ltd, 23km, Multan
Road, Lahore
Priority # 2636
swapped
Irosoft Injection
Each 5ml contains
Ferric sucrose complex
eq to elemental iron
100mg
(Iron preparation)
USP specification
Irosoft Syrup
Each 5ml contains
Iron (III) hydroxide
polymaltose complex eq.
to elemental iron 50mg
(Iron preparation)
USP specification
Minutes for 260th Meeting Registration Board
17-07-2013
Form 5
Rs. 20,000/-
(Photocopy)
Pack size of
ampoule
5ml x 5  Rs.
1250/-
17-07-2013
Form 5
Rs. 20,000/-
(Photocopy)
Pack size of
ampoule
5ml x 5  Rs.
1250/-
TGA approved
Venofer –
Aspen Pharma
Australia
Approved
with change
of brand
name.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved
with change
of brand
name.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Venofer-RG
GMP
compliant
section
TGA approved
Maltofer –
Aspen Pharma
Australia
Ferosoft-Hilton
GMP
compliant
section
228
327.
M/s Pharmix
Laboratories
(Private)
Limited, 21-km,
Ferozepur
Road, Lahore
Priority # 402
Tablet Pepzym
Each coated tablet
contains
Pancreatin USP 210 FIP
P.U
Metoclopramide
(HCL.2H2O) 6mg
Bromelain 35000 P.U.
Polysiloxane 50mg
Sodium Dehydrocholate
20mg
30-09-10
Rs.8000/- Form 5
30-7-2013
Rs. 12000/-
Plasil with
enzyme –
Pacific
(Photocopy)
GMP
compliant
section
Pack size of
30s  Rs. 300/-
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
fee
challan
(Digestive Enzyme)
Manufacture specification
328.
M/s Pharmix
Laboratories
(Private)
Limited, 21-km,
Ferozepur
Road, Lahore
Priority # 400
Tablet Vital
Each film coated tablet
contains
Vitamin A (Acetate) USP
5000 I.U
Vitamin C (Ascorbic
Acid) BP 500mg
Vitamin E USP 200 I.U
Vitamin D
(Cholecalciferol D3) USP
100 I.U
Folic Acid BP 200 mcg
Vitamin B1 (Thiamine
mononitrate) USP 15mg
Vitamin B2 (Riboflavin)
USP 15mg
Zinc BP 40mg
Copper BP 2mg
Manganses BP 1.5mg
Selenium BP 40.5mcg
08-09-2010
Rs.8000/- Form 5
30-7-2013
Rs. 12000/-
Occulovit –
Ethical
Laboratories
(Photocopy)
GMP
compliant
section
Pack size of
30s  Rs. 510/-
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities,
vitamin
policy and
fee challan
(Vitamins/ minerals)
Manufacture specification
329.
M/s Pharmix
Laboratories
(Private)
Limited, 21-km,
Ferozepur
Road, Lahore
Polyrol Syrup
Each 5ml contains:
Iron (III) Hydroxide
Polymaltose Complex
Eq. to elemental Iron
………50mg
Priority # 688
Iron preparation
Manufacture
Minutes for 260th Meeting Registration Board
21-12-2010
Rs.8000/- Form 5
30-7-2013
Rs. 12000/-
(Photocopy)
Pack size of
30ml & 60ml as per
SRO
TGA approved
MaltoferAspen Pharma,
Australia
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Ferosoft Hilton
GMP
229
specification
330.
M/s Pharmix
Laboratories
(Private)
Limited, 21-km,
Ferozepur
Road, Lahore
Priority # 401
Tablet Vitamax
Each tablet contains
Vitamin A (Acetate) USP
10mg
Vitamin C (Ascorbic
acid) USP 60mg
Vitamin E USP 30mg
Vitamin D
(Cholecalciferol D3) USP
10 mcg
Folic Acid USP 0.400mg
Vitamin B1 (Thiamine
mononitrate) USP
1.50mg
Vitamin B2 (Riboflavin)
USP 1.70mg
Vitamin B6 (Pyridoxine)
USP 2 mg
Vitamin B12
(Cyanocobalamin) USP 6
mcg
Niacin USP 20mg
Pantothenic acid USP
10mg
D-Biotin USP 30 mcg
Calcium USP 130mg
Phosphorus USP 100mg
Iodine USP 150 mcg
Iron USP 18 mg
Magnesium USP 100mg
Copper USP 2mg
Zinc USP 15mg
Potassium USP 37.50mg
Maganese USP 2.50mg
Chromium USP 10 mcg
Molybdenum USP 10
mcg
Selenium USP 10 mcg
Chloride USP 34 mg
Minutes for 260th Meeting Registration Board
compliant
section
30-9-2010
Rs.8000/- Form 5
30-7-2013
Rs. 12000/(Photocopy)
Chairman
Registration
Board will
permit
issuance of
registration
letter
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities,
vitamin
policy and
fee challan
Once a Day –
CCL
GMP
compliant
section
Pack size of
30s  Rs. 390/-
230
(Digestive Enzyme)
Manufacture specification
331.
M/s Renacon
Pharma (Pvt.)
Ltd, 18-km,
Ferozpur Road,
Opp Nishtar
Colony, Lahore
Priority # 1991
Renacit Hemodialysis
Concentrate Dry (RCTD)
19-11-2012
Rs.20000/- Form 5
Renasol –
Minntech
(Photocopy)
After mixing and dilution
of Part A & Part B by the
Haemodialysis machine,
the resultant concentrate:Sodium 140 mmol/L
Potassium 2.0 mmol/L
Calcium 1.5 mmol/L
Magnesium 0.75 mmol/L
Chloride 109.25 mmol/L
Citrate 0.8 mmol/L
Bicarbonate 35.0 mmol/L
Glucose 5.5 mmol/L
Pack size of
30s  Rs. 300/-
License
renewed on 2109-2015.
GMP
compliant
section
 The
internatio
nal
availabilit
y
provided
is
different
in
compositi
on from
proposed
formulati
on.
Deferred for
reevaluation
and
comparison
of
formulation
approved by
regulatory
authorities
of reference
countires
and
fee
challan.
Part A:Sodium 105.0 mmol/L
Potassium 2.0 mmol/L
Calcium 1.5 mmol/L
Magnesium 0.75 mmol/L
Chloride 109.25 mmol/L
Citrate 0.8 mmol/L
Glucose 5.5 mmol/L
Part B:Sodium 35 mmol/L
Bicarbonate 35 mmol/L
(Concentrate for
Bicarbonate
Hemodialysis)
Manufacture
specification
332.
M/s Pharmacare
Labs (Pvt.) Ltd,
129/1 Industrial
Estate, Kot
Lakhpat,
Lahore
Pharxime DS Suspension
Priority # 1463
(Cephalosporin)
USP specification
Each 5ml of reconstituted
suspension contains:Cefixime trihydrate eq to
cefixime 200mg
Minutes for 260th Meeting Registration Board
27-12-2011
Rs.8000/- Form 5
30-7-2013
Rs. 12000/-
(Photocopy)
Pack size & price
as per leader brand
FDA Approved
brand suprax
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
Caricef-sami
GMP
compliant
section vide
inspection
report dated
29-07-2015
231
permit
issuance of
registration
letter
333.
M/s Pharmacare
Labs (Pvt.) Ltd,
129/1 Industrial
Estate, Kot
Lakhpat,
Lahore
Priority # 1461
334.
335.
Tablet Malout
Each tablet contains:Artemether 80mg
Lumefantrine 480mg
(Antimalarial)
Manufacture
specification
27-12-2011
Rs.8000/- Form 5
30-7-2013
Rs. 12000/-
WHO
recommended
formulation
(Photocopy)
Artem - Hilton
Pack size & price
as per leader brand
FDA approved
Dycloject –
Javelin pharms
(Photocopy)
Deborn-L
(Wellborne)
Injection Frendic 75mg
Priority # 1093
(NSAID)
Pack size & price
Manufacture specification
as per leader brand
Each 3ml ampoule
contains:Diclofenac sodium 75mg
FDA approved
Cyclokapron –
Pfizer
(Photocopy)
Brino -Sami
Fledonil Injection
Priority # 1093
Anti fibrinolytic
Pack size & price
Manufacture specification
as per leader brand
Minutes for 260th Meeting Registration Board
GMP
compliant
section 16-022016
28-5-2011
Rs.8000/14-5-2013
Rs.12000/-
M/s Friends
Pharma (Pvt.)
Ltd, 31-km,
Ferozpur Road,
Lahore
Each ampoule of 5ml
contains:Tranexamic acid 500mg
GMP
compliant
section vide
inspection
report dated
29-07-2015
28-5-2011
Rs.8000/- Form 5
14-5-2013
Rs.12000/-
M/s Friends
Pharma (Pvt.)
Ltd, 31-km,
Ferozpur Road,
Lahore
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
GMP
compliant
section
232
Chairman
Registration
Board will
permit
issuance of
registration
letter
336.
M/s Friends
Pharma (Pvt.)
Ltd, 31-km,
Ferozpur Road,
Lahore
Xylodent Injection
31-12-2012
Form 5 - Rs. 20000/-
Each ml contains:Lidocaine HCl 20mg
Epinephrine (as tartrate)
10 ug
Dy # 10383 dated
31-12-2012
Priority # 2091
(Anesthetic agent)
USP specification
337.
338.
Pack size
2ml ampoule as per
leader brand
28-5-2011
Rs.8000/- Form 5
14-5-2013
Rs.12000/-
FDA approved
product
A product of
Harmaann,
lahore
GMP
compliant
section
M/s Friends
Pharma (Pvt.)
Ltd, 31-km,
Ferozpur Road,
Lahore
Phenate Injection
Priority # 1096
(Antihistamine)
JP specification
Pack size
2ml ampoule as per
leader brand
GMP
compliant
section
M/s Friends
Pharma (Pvt.)
Ltd, 31-km,
Ferozpur Road,
Lahore
Norobion Injection
28-5-2011
Rs.8000/- Form 5
14-5-2013
Rs.12000/-
Neurobion France
Priority # 1088
Each 2ml contains:Phenireamine maleate
45.5mg
Each 3 ml ampoule
contains:Vitamin B1 100mg
Vitamin B6 100mg
Vitamin B12 1000mcg
(Vitamin)
Manufacture specification
Minutes for 260th Meeting Registration Board
(Photocopy)
Pack size & price
as per leader brand
Approved
Avil-Sanofi,
Germany
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved
with change
of brand
name.
AVil-sanofi
Neurobion Merck
GMP
compliant
section
233
339.
M/s Pakistan
Pharmaceutical
Products (Pvt.)
Ltd, D-122,
S.I.T.E, Karachi
Tablet Vastec 20mg
Each film coated tablet
contains:Rosuvastatin (As
calcium) 20mg
23-04-2011
Dy.No.986 Form 5
Rs.8000/(Photocopy)
Rs.12,000/31-07-2013
Priority # 1002
(Lipid regulating drug)
Pack size & price
Manufacture specification as per leader brand
340.
341.
23-04-2011
Dy.No.986 Form 5
Rs.8000/(Photocopy)
Rs.12,000/31-07-2013
M/s Pakistan
Pharmaceutical
Products (Pvt.)
Ltd, D-122,
S.I.T.E, Karachi
Tablet Candia 32mg
Priority # 1021
(Anti hypertensive )
Manufacture specification Pack size & price
as per leader brand
Each tablet contains:Candesartan Cilexetil
32mg
30-04-2011
Dy.No.1057 Form 5
Rs.8000/(Photocopy)
Rs.12,000/31-07-2013
M/s Pakistan
Pharmaceutical
Products (Pvt.)
Ltd, D-122,
S.I.T.E, Karachi
Tablet Candia 4mg
Priority # 1018
(Anti hypertensive )
Manufacture specification Pack size & price
as per leader brand
Each tablet contains:Candesartan Cilexetil
4mg
Minutes for 260th Meeting Registration Board
MHRA
approved
crestor Astrazeneca
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
AmroAmarant
GMP
compliant
section vide
inspection
report dated
31-12-2015
MHRA
approved
Amias –
Takeda
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Carac Wilshire
GMP
compliant
section vide
inspection
report dated
31-12-2015
MHRA
approved
Amias –
Takeda
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
Carac Wilshire
GMP
compliant
section vide
inspection
report dated
31-12-2015
234
issuance of
registration
letter
342.
M/s Pakistan
Pharmaceutical
Products (Pvt.)
Ltd, D-122,
S.I.T.E, Karachi
Tablet Zolot 75 mg
Each film coated tablet
contains:Clopidogrel (as Hydrogen
Sulphate) 75mg
30-04-2011
Dy.No.1061 Form 5
Rs.8000/(Photocopy)
Rs.12,000/31-07-2013
MHRA
approved brand
of Accord
Lowplat Pharmevo
Priority # 1020
343.
M/s Pakistan
Pharmaceutical
Products (Pvt.)
Ltd, D-122,
S.I.T.E, Karachi
Priority # 1019
(Antiplatelet)
USP specification
Pack size & price
as per leader brand
Tablet Alfa-one
30-04-2011
Dy.No.1056 form 5
Rs.8000/(Photocopy)
Rs.12,000/31-07-2013
Each tablet contains:Alfacalcidol 0.5 ug
(Vitamin D analogue)
USP specification
Pack size & price
as per leader brand
344.
M/s Pakistan
Pharmaceutical
Products (Pvt.)
Ltd, D-122,
S.I.T.E, Karachi
Priority # 1530
Zinkid 20mg / 5ml Syrup
Each 5ml contains:
Elemental Zinc as zinc
sulphate
monohydratre..……20
mg
(Mineral Supplement)
USP specification
Minutes for 260th Meeting Registration Board
30-04-2011
Dy.No.1056 form 5
Rs.8000/(Photocopy)
Rs.12,000/31-07-2013
Pack size & price
as per leader brand
GMP
compliant
section vide
inspection
report dated
31-12-2015
Alfa-D
(Platinum)
GMP
compliant
section vide
inspection
report dated
31-12-2015
WHO
recommended
formulation
Kilin -Linear
GMP
compliant
section vide
inspection
report dated
31-12-2015
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Product
Deferred as
under
product is
review as under
waiting for review and
reply
of sent
for
WHO.
views
of
WHO.
235
345.
M/s Highnoon
Laboratories
Ltd, 17.5 km ,
Multan Road,
Lahore
Tablet Ivahi 7.5mg
Each film coated tablet
contains:
Ivabradine HCl eq to
Ivabradine 7.5mg
Priority # 2629
(Anti angina )
04-11-2013
form 5-D
Rs.50000/(Photocopy)
MHRA
approved
Procoralan –
Servier
Pack size
10s  Rs. 2500/20s  Rs. 5000/-
GMP
compliant
section vide
inspection
report dated
09-03-2015
USP specification
346.
M/s Highnoon
Laboratories
Ltd, 17.5 km ,
Multan Road,
Lahore
Tablet Ivahi 5mg
Each film coated tablet
contains:
Ivabradine HCl eq to
Ivabradine 5mg
Priority # 2628
(Anti angina )
04-11-2013
form 5-D
Rs.50000/(Photocopy)
Pack size
10s  Rs. 1500/20s  Rs. 3000/-
GMP
compliant
section vide
inspection
report dated
09-03-2015
USP specification
347.
M/s Life
Pharmaceutical
company, 24-III
Industrial Estate
Multan
Priority # 1992
Caliz Dry suspension
Each 5ml of reconstituted
suspension contains:
Azithromycin Dihydrate
eq to Azithromycin
200mg
20-11-2012 Form 5
20000/- (Photocopy)
Pack size
15ml  Rs. 300/25 ml  Rs. 480/-
USP specification
M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Tablet Desotin 5mg
Each film coated tablet
contains:
Desloratadine 5mg
(Antihistamine)
Priority # 810
Manufacture specification
Minutes for 260th Meeting Registration Board
Deferred for
provison of
stability
data as per
guidelines
provided in
251st
RB
meeting and
fee challan.
Stability
data
required as
per
guidelines
provided in
251st
RB
meeting.
Deferred for
provision of
stability
data
required as
per
guidelines
provided in
251st
RB
meeting and
fee challan.
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
MHRA
approved brand
of Sandoz
Azomax –
Novartis
GMP
compliant
section
(Antibiotics )
348.
Stability
data
required as
per
guidelines
provided in
251st
RB
meeting.
11-01-2011
Dy.No.90 Form 5
Rs.12,000/05-02-2013
(Photocopy)
Pack size
10s  as per PRC
MHRA
approved brand
of Consilient
Alenor –
Macter
GMP
compliant
section vide
236
inspection
report dated
31-08-2015
349.
M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Tablet Alfadol 1mcg
Each tablet contains:
Alfacalcidol 1.0 mcg
(Vitamin D Analogue)
Manufacture specification
Priority # 803
350.
351.
M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Spasno 40mg Injection
Each 4ml contains:Hydrated
Phloroglucinol.40mg
Trimethylphloroglucinol
0.04mg
Priority # 1060
(Anti Spasmodic)
Manufacture Specification
M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Laxolac 3.35gm Syrup
Each 5ml contains:Lactulose USP 3.35gm
(osmotic lexative)
USP Specification
Priority # 806
11-01-2011
Dy.No.87 Form 5
Rs.8000/Rs.12,000/05-02-2013
(Photocopy)
Pack size
10s  as per PRC
11-01-2011
Dy.No.87 Form 5
Rs.8000/Rs.12,000/05-02-2013
(Photocopy)
Pack size
10s  as per PRC
11-01-2011
Dy.No.117 Form 5
Rs.8000/Rs.12,000/05-02-2013
(Photocopy)
Pack size & price
as per SRO
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Deferred as
product is
under
review and
fee challan
Adela - getz
GMP
compliant
section vide
inspection
report dated
31-08-2015
Spasfon –
France
Spasfon –
Himont
GMP
compliant
section vide
inspection
report dated
31-08-2015
MHRA.
Duphalac
3.35g/5ml By
M/s BGP
Local.
Duphalac
3.35g/5ml by
M/s Highnoon
Product
under
review.
Source of
Lactulose
required
along with
fee
and
documents.
GMP
compliant
section vide
Minutes for 260th Meeting Registration Board
237
Deferred for
Source of
lactulose,
fee, GMP,
stability
data,
fee
challan.
inspection
report dated
31-08-2015
352.
M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Priority # 975
353.
] M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Priority # 1030
354.
M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Priority # 1101
Tablet Lufid 20mg
Each film coated tablet
contains:Leflunomide 20mg
(Anti rheumatic)
USP Specification
Ironate 800mg/15ml Syrup
12-04-2011
Dy # 883 Form 5
Rs.8000/Rs.12,000/05-02-2013
(Photocopy)
MHRA.AravaSanofi
Pack size of 30s 
as per SRO
GMP
compliant
section vide
inspection
report dated
31-08-2015
Each 15ml contains:Iron Protein Succinylate
800mg eq to elemental iron
40mg
12-04-2011
Dy # 883 Form 5
Rs.8000/Rs.12,000/05-02-2013
(Photocopy)
(Anti anemic)
USP Specification
Pack size of 30s 
as per SRO
Tablet CartiPLUS
31-5-2011
Dy.No.1435 Form 5
Rs.8000/Rs.12,000/05-02-2013
(Photocopy)
Each film coated tablet
contains:Glucosamine Sulphate
750mg
Chondroitin Sulphate
600mg
(Musculo-skeletal product)
Manufacture Specification
Minutes for 260th Meeting Registration Board
Pack size of 30s 
as per SRO
Adira Wilshire
EMICO-NOA
HEMIS
GMP
compliant
section vide
inspection
report dated
31-08-2015
Cartigen plus –
Getz
GMP
compliant
section vide
inspection
report dated
31-08-2015
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Me
too Deferred for
needs
confirmatio
confirmatio n
of
n
approval
status
by
reference
regulatory
authorities
and
Pakistan
and
fee
238
challan
355.
356.
M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Injection Cefot 2gm
Priority # 217
(Antibiotics)
Manufacture Specification
M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Tablet Rapral 10mg
Priority # 968
357.
M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Priority # 805
swapped
Each vial contains:Cefoperazone Sodium USP
eq to Cefoperazone 1gm
Salbactam sodium eq to
salbactam 1 gm
11-01-2011
Dy.No.89 Form 5
Rs.12,000/05-02-2013
(Photocopy)
Pack size of 1s 
as per SRO
Each enteric coated tablet
contains:Rabeprazole (as sodium)
10mg
12-04-2011
Dy.No.885 Form 5
Rs.8000/Rs.12,000/05-02-2013
(Photocopy)
(Proton Pump Inhibitor)
Manufacture Specification
Pack size of 10s 
as per SRO
Tablet Swiss Mether 40/240
30-7-2010
Dy.No.1512 Form 5
Rs.8000/Rs.12,000/05-09-2013
(Photocopy)
Each tablet contains:Artemether 40mg
Lumefantrine 240mg
(antimalarial)
Manufacture Specification
Minutes for 260th Meeting Registration Board
Pack size of 1 x 16s
 as per SRO
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
Cebac -Bosch
GMP
compliant
section vide
inspection
report dated
31-08-2015
MHRA
approved Pariet
– Eisai
Rabecid Highnoon
GMP
compliant
section vide
inspection
report dated
31-08-2015
WHO
recommended
formulation
Artem -Hilton
GMP
compliant
section vide
inspection
report dated
31-08-2015
239
358.
359.
M/s Swiss
Pharmaceuticals
(Pvt.) Ltd,
A/159, S.I.T.E,
Super Highway,
Karachi
Tablet Swiss Mether
80/480
Priority # 809
swapped
(antimalarial)
Manufacture
Specification
M/s Amarant
Pharmaceuticals
(Pct.) Ltd, 158D, Tora Gadap
Road, Super
Highway,
Karachi
Amate 7.5mg Tablet
Each tablet contains:Artemether 80mg
Lumefantrine 480mg
Each film coated tablet
contains:
Calcium 1-5methyltetrahydrofolate
eq. to 1methylfolate….7.5 mg
30-7-2010
Dy.No.1511 Form
5
Rs.8000/Rs.12,000/05-09-2013
(Photocopy)
19-10-2012
Dy.No.1305 Form 5D
Rs.20,000/(Photocopy)
Tablet LMethylfolate
7.5mg – Virtus
Pharmaceutical
s, USA
(Adjunctive use in major
depressive and
schizophrenia)
M/s Amarant
Pharmaceuticals
(Pct.) Ltd, 158D, Tora Gadap
Road, Super
Highway,
Karachi
Amate 15mg Tablet
Each film coated tablet
contains:
Calcium 1-5methyltetrahydrofolate
eq. to 1methylfolate….15 mg
Minutes for 260th Meeting Registration Board
Artem -Hilton
Pack size of 1 x 6s
 as per SRO
Priority # 1926
360.
WHO
recommended
formulation
GMP
compliant
section vide
inspection
report dated
31-08-2015
Pack size of 10s &
30s  as per SRO
19-10-2012
Dy.No.1306 Form 5D
Rs.20,000/(Photocopy)
Pack size of 10s &
30s  as per SRO
issuance of
registration
letter
Approved.
Photocopy
fee
challanswill
be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Deferred for
 Remaini
ng fee
for
prescrib
ed Form
5-D.
 Stability
data as
per
guidelin
es
provided
in 251st
RB
meeting.
 Fee
challan
GMP
compliant
section vide
inspection
report dated
31-08-2015
Tablet LMethylfolate
15mg – Virtus
Pharmaceutical
s, USA
GMP
compliant
 Firm
needs to
submit
remainin
g fee for
prescrib
ed Form
5-D.
 Firm
needs to
submit
stability
data as
per
guidelin
es
provided
in 251st
RB
meeting.
Deferred for
 Firm
needs to
 Remaini
submit
ng fee
remainin
for
g fee for
prescrib
prescrib
ed Form
ed Form
5-D.
240
section vide
inspection
report dated
31-08-2015
Priority # 1927
(Adjunctive use in major
depressive and
schizophrenia)
361.
M/s Linear
Pharma, Plot #
18, Street S-4,
National
Industrial Zone,
Rawat.
Priority # 485
362.
M/s Linear
Pharma, Plot #
18, Street S-4,
National
Industrial Zone,
Rawat.
Priority # 484
363.
Tablet Betalin 16mg
Each tablet contains:
Betahistine 16mg
Antihistamine
Manufacture
Specification
Tablet Betalin 8mg
Each tablet contains:
Betahistine 8mg
Antihistamine
Manufacture
Specification
M/s Linear
Pharma, Plot #
18, Street S-4,
National
Industrial Zone,
Rawat.
Tablet Linakast 10mg
Priority # 513
Antihistamine
Manufacture
Specification
Each film coated tablet
contains:
Montelukast (as sodium)
10mg
Minutes for 260th Meeting Registration Board
17-12-2013
Rs. 12000/Dy.No.846
Form 5
02-11-2010
Rs.12,000/-
MHRA
approved brand
of Aurobindo.
Pack size & price
as per SRO
Inspection
report dated
19-01-2016
17-12-2013
Rs. 12000/Dy.No.8140
Form 5
02-11-2010
Rs.12,000/-
MHRA
approved brand
of Aurobindo.
Pack size & price
as per SRO
17-12-2013
Rs. 12000/Dy.No.8133
Form 5
02-11-2010
Rs.12,000/-
5-D.
 Firm
needs to
submit
stability
data as
per
guidelin
es
provided
in 251st
RB
meeting.
 Stability
data as
per
guidelin
es
provided
in 251st
RB
meeting.
 Fee
challan
Approved
Serc-Abbott
Approved
Serc-Abbott
GMP
compliant
section
MHRA
approved brand
of Accord
Approved
Serc-Abbott
Pack size & price
as per SRO
241
364.
M/s Linear
Pharma, Plot #
18, Street S-4,
National
Industrial Zone,
Rawat.
Priority # 484
365.
M/s Linear
Pharma, Plot #
18, Street S-4,
National
Industrial Zone,
Rawat.
Priority # 515
366.
M/s Linear
Pharma, Plot #
18, Street S-4,
National
Industrial Zone,
Rawat.
Priority # 514
367.
M/s Linear
Pharma, Plot #
18, Street S-4,
National
Industrial Zone,
Rawat.
Priority # 483
Tablet Heam 500 mcg
Each sugar coated tablet
contains:
Mecobalamin 500 mcg
Vitamin
Manufacture
Specification
Tablet Melix 15mg
Each uncoated tablet
contains:
Meloxicam USP 15mg
NSAID
Manufacture
Specification
Tablet Melix
Each uncoated tablet
contains:
Meloxicam USP 7.5mg
NSAID
Manufacture
Specification
Tablet Liprazole 15mg
Each oro-dispersible
tablet contains:
Aripiprazole 15mg
Dopamine Partial agonist
Psychotic drug
Manufacture
Specification
Minutes for 260th Meeting Registration Board
17-12-2013
Rs. 12000/Dy.No.8147
Form 5
06-10-2010
Rs.12,000/-
Methycobal –
Eisai, Japan
Approved
Anemovit Pharmacare
Pack size & price
as per SRO
17-12-2013
Rs. 12000/Dy.No.8136
Form 5
06-10-2010
Rs.12,000/-
Pack size & price
as per SRO
17-12-2013
Rs. 12000/Dy.No.8138
Form 5
06-10-2010
Rs.12,000/-
USFDA
MOBIC Boehringer
Approved
ALOXI ALSON
USFDA
MOBIC Boehringer
Approved
ALOXI ALSON
Pack size & price
as per SRO
17-12-2013
Rs. 12000/Dy.No.8138
Form 5
06-10-2010
Rs.12,000/-
MHRA
approved
Abilify –
Otsuka
Zedan -Surge
Pack size & price
as per SRO
Proof
of
segregated
facility for
psychotropi
c
manufacturi
ng
not
provided.
242
Approved
368.
369.
M/s Reko
Pharmacal
(Pvt.) Ltd, 13th
km, Multan
Road, Lahore
Epafen Ophthalmic
Solution
Priority # 2850
Anti inflammatory
Manufacture
Specification
M/s Reko
Pharmacal
(Pvt.) Ltd, 13th
km, Multan
Road, Lahore
Each ml contains:
Nepafenac 1mg
Olopine Ophthalmic
Drops
Each ml contains:
Olopatadine (as HCl)
USP 2mg
Priority # 2849
370.
M/s Genome
Pharmaceuticals
(Pvt.) Ltd, 16/1,
Phase IV,
Industrial
Estate, Hattar,
Haripur
Priority # 2343
371.
M/s Apex
Pharmaceuticals
(Pvt.) Ltd, D-21,
A/1, S.I.T.E,
Super Highway,
Karachi
Priority # 42
Anti inflammatory
Manufacture
Specification
Ranast 112.5mg Capsules
Each capsule contains:Pranlukast (as
hemihydrate) 112.5mg
(cysteinyl leukotriene
receptor-1 antagonist)
Manufacture specification
Apdinir Suspension
50mg/5ml
Each 5ml of reconstituted
suspension contains:Cefdinir 50mg
30-12-2013
Rs. 20,000/Dy.No. 1424
Form 5
MHRA
approved
NevanacAlcon
Pack size
5ml  Rs. 315/-
Fenap –Valor
GMP
Compliant
section vide
inspection
report dated
30-03-2016
30-12-2013
Rs. 20,000/Dy.No. 1423
Form 5
Pack size
5ml  Rs. 306/-
FDA approved
Pataday- Alcon
Pack size & price
as per pRC
10-06-2010
Dy # 1158 Form 5
Rs.8000/Rs.12,000/28-03-2014
Photocopy
Approved
Aptadine Barrett
31-05-2013
Rs. 20,000/Dy.No. 471
Form 5
Pack size of 60ml
(Antibiotics)
& price as per pRC
Manufacture specification
Minutes for 260th Meeting Registration Board
Approved
ZaplyWislhire
Proof
of
approval
status
of
same
dosage form
in reference
countries
and
Pakistan not
provided.
Following
documents
not found in
application
 Latest
inspectio
n report
conducte
d within
one
year.
 Proof of
approval
243
Deferred for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
and
Pakistan.
Deferred for
 Latest
inspectio
n report
conducte
d within
one
year.
 confirma
tion of
approval
status by
referenc
372.
373.
10-06-2010
Dy # 1162 Form 5
Rs.8000/Rs.12,000/28-03-2014
M/s Apex
Pharmaceuticals
(Pvt.) Ltd, D-21,
A/1, S.I.T.E,
Super Highway,
Karachi
Danvar capsule
Priority # 39
(Antibiotics)
USP specification
Pack size 12s  as
per PRC
M/s Apex
Pharmaceuticals
(Pvt.) Ltd, D-21,
A/1, S.I.T.E,
Super Highway,
Karachi
Apedroxile capsule
10-06-2010
Dy # 1162 Form 5
Rs.8000/Rs.12,000/28-03-2014
Priority # 33
(Antibiotics)
USP specification
Each capsule contains:Cefaclor (as
monohydrate) USP
500mg
Each capsule contains:Cefadroxil (as
monohydrate) USP
500mg
Minutes for 260th Meeting Registration Board
Photocopy
Photocopy
Pack size 12s  as
per PRC
status of
e
same
regulator
dosage
y
form in
authoriti
referenc
es and
e
Pakistan
countrie
.
s
and  Commit
PAKIST
ment as
AN.
per
decision
 Commit
ment as
of 251st
per
RB
decision
meeting.
st
of 251
 Fee
RB
challan
meeting.
MHRA
Following
Deferred for
approved
documents
 Latest
Distaclor not found in
inspectio
Flynn
application
n report
conducte
 Latest
Ceclor -AGP
inspectio
d within
n report
one
conducte
year.
d within  Commit
one
ment as
year.
per
 Commit
decision
ment as
of 251st
per
RB
decision
meeting.
st
of 251
 Fee
RB
challan
meeting.
MHRA
Following
Deferred for
approved brand documents
 Latest
of Sandoz
not found in
inspectio
application
n report
Neucef - Sami
conducte
 Latest
inspectio
d within
n report
one
conducte
year.
d within  Commit
one
ment as
year.
per
244
374.
M/s Davis
Pharmaceuticals
Laboratories,
121, Industrial
Triangle Area,
Kahuta Road,
Islamabad.
Priority # 1228
Tricold plus Sachet
Each Sachet Contains
Paracetamol 500mg
Mepyramine Maleate
13mg
Pheniramine maleate
13mg
Pseudoephedrine HCl
30mg
30-07-2011
Form 5
Rs.8000/Rs.12,000/30-07-2013
Flu Eze Werrick
Pack size 12s  as
per PRC
Analgesic / Anti allergic
Manufacture
Specification
375.
M/s Davis
Pharmaceuticals
Laboratories,
121, Industrial
Triangle Area,
Kahuta Road,
Islamabad.
Priority # 1228
Tricold plus Sachet
Each Sachet Contains
Paracetamol 500mg
Mepyramine Maleate
13mg
Pheniramine maleate
13mg
Pseudoephedrine HCl
30mg
Analgesic / Anti allergic
Minutes for 260th Meeting Registration Board
30-07-2011
Form 5
Rs.8000/Rs.12,000/30-07-2013
Pack size 12s  as
per PRC
Flu Eze Werrick
decision
 Commit
of 251st
ment as
RB
per
meeting.
decision
of 251st  Fee
RB
challan
meeting.
Following
Deferred for
documents
 Latest
not found in
inspectio
application
n report
 Latest
conducte
inspectio
d within
n report
one
conducte
year.
d within  Proof of
one
approval
year.
status of
same
 Commit
ment as
dosage
per
form in
decision
referenc
of 251st
e
RB
countrie
meeting.
s
and
PAKIST
 Proof of
AN.
approval
status of  Commit
same
ment as
dosage
per
form in
decision
referenc
of 251st
e
RB
countrie
meeting.
s.
Following
Deferred for
documents
 Latest
not found in
inspectio
application
n report
conducte
 Latest
inspectio
d within
n report
one
conducte
year.
d within  Confirm
one
ation of
year.
approval
245
Manufacture
Specification
376.
M/s Getz
Pharma (Pvt.)
Ltd, 29-30,
Sector 27,
Korangi
Industrial Area,
Karachi
Daxin 30mg Tablet
Each film coated tablet
contains:
Dapoxetine
Hydrochloride eq. to
Dapoxetine…………..30
mg
Priority # 1102
377.
378.
M/s Allmed Pvt.
Ltd.
(Formerly,
EverGreen
Pharmaceuticals,
Pvt. Ltd.
Plot.No.590,
Sundar Industrial
Estate Lahore.
Priorty # 196
M/s Allmed Pvt.
Ltd.
(Formerly,
EverGreen
Pharmaceuticals,
Pvt. Ltd.
Plot.No.590,
Sundar Industrial
Estate Lahore.
Priorty # 195
(SSRI)
Calso
Tablet
Each tablet contains:
Calcium Acetate B.P
….667mg eq.to
Elemental Calcium
169mg
Calcium Supplement
(Manfacturer’s Specs)
Everpol
Infusion
Each 100ml contains:
Paracetamol B.P…..1g
Analgesic / Antipytic
(Manfacturer’s Specs)
Minutes for 260th Meeting Registration Board
30-07-2011
Form 5
Rs.8000/Rs.12,000/30-07-2013
priligy
Pack size 12s  as
per PRC
28-07-2010
Form 5
Rs.8000/Rs.12,000/30-07-2013
Pack size 10x10’s
 as per PRC
28-07-2010
Form 5
Rs.8000/Rs.12,000/30-07-2013
Pack size
1’sx100ml  as
per PRC
 Commit
ment as
per
decision
of 251st
RB
meeting.
 Proof of
approval
status of
same
dosage
form in
referenc
e
countrie
s.
Approval
status
of
dosage form
in Pakistan
not
provided.
Phoslo by M/s
NabiBioPharmaceut
ical USA
status by
referenc
e
regulator
y
authoriti
es and
Pakistan
.
 Commit
ment as
per
decision
of 251st
RB
meeting.
Deferred for
application
on Form5D
as it is not
registered in
Pakistan
Approved
Lophos by M/s
Getz Pharma
Approved
Perfalgan by
M/s B-Braun
Germany
Falgan by M/s
Bosch Pharma
246
379.
M/s Indus
Pharma Karachi.
Priorty # 1197
Parazol
Tablet
Each tablet contains:
Paracetamol…..500mg
Analgesic / Antipytic
Minutes for 260th Meeting Registration Board
25-06-2011
Form 5
Rs.8000/Rs.12,000/06-06-2013
Paracetamol by
M/s Johnsan &
Johnsan
Canada
Pack size 20’s 
Rs.200/-
Panadol by M/s
GSK
Approved
247
Evaluator-IV Mr. Salateen Wasim Philip
Veterinary Routine cases :S/
N
380.
Name and Brand Name
address of
manufacture (Proprietary name
Form
r / Applicant Dosage
Strength)
International
Remarks /
status
in Observation
+ Initial date, diary
stringent
s
regulatory
+
Fee
including agencies
differential fee
Me-too status
Composition
Demanded Price /
GMP status as
Pharmacological Group Pack size
depicted
in
inspection
Finished
product
report (dated)
Specification
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Toltrastar Oral Solution
Each ml contains
Toltrazuril (I.H.S) 25 mg
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Priority #
372
18-06-2013
Dy.No.708
Form 5
Rs.20.000/-
Antibiotics
Manufacture
Specification
Pack size of
100ml, 150ml, 500ml
& 1000ml 
decontrolled
Tilmisin Oral Solution
18-06-2013
Dy.No.705
Form 5
Rs.20.000/-
Priority #
371
381.
Type of Form
Each ml contains
Tilmicosin (as phosphate)
USP 250mg
Antibiotics
Manufacture
Specification
Pack size of
100ml, 150ml, 500ml
& 1000ml 
decontrolled
Minutes for 260th Meeting Registration Board
Emicide - nawal
Decision
Approved
Firm is GMP
compliant as
per inspection
dated 21-092015
Motil - Breeze
Approved
Firm is GMP
compliant as
per inspection
dated 21-092015
248
382.
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Priority #
372
383.
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Closan 500mg Bolus
Each bolus contains
Clonastel (as Sodium)
500mg
Anthelmintic
Manufacture
Specification
19-04-2013
Dy.No.334
Form 5
Rs.20.000/-
Pack size of
Glass bottle 
decontrolled
Each ml contains
Ciprofloxacin BP 200mg
31-01-2014
Dy.No.101
Form 5
Rs.20.000/-
Antibiotics
Manufacture
Specification
Pack size of
Glass bottle 50m 
decontrolled
Leva 20% Oral Powder
04-07-2013
Dy.No.792
Form 5
Rs.20.000/-
Cipvet-200 injection
Flukinil Selmore
Approved
Firm is GMP
compliant as
per inspection
dated 21-092015
Floxacin - Leads
Firm is GMP
compliant as
per inspection
dated 21-092015
To follow
policy
decision on
this
veterinary
formulation.
Priority #
372
384.
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Priority #
378
385.
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Priority #
369
Each gram contains
Levamisole HCl BP
200mg
Anthelmentics
Manufacture
Specification
Florfenic Oral Solution
Each ml contains
Florfenicol 100mg
Antibiotics
Manufacture
Specification
Pack size of
100gm, 500gm,
1000gm & 2.5kg
18-06-2013
Dy.No.210
Form 5-D
Rs.50.000/-
Levabak Attabak
The Board
also advised
to
issue
show cause
to
the
companies
with
registered
ciprofloxaci
n.
Approved
Firm is GMP
compliant as
per inspection
dated 21-092015
Florobak Attabak
Firm is GMP
compliant as
Pack size of
100ml, 150ml, 250ml, per inspection
dated 21-09450ml, 1 litre
2015
Minutes for 260th Meeting Registration Board
Rejected
Firm applied
on Form 5D but now
product is
me too and
accordingly
firm
has
submitted
Form 5.
249
Approved
386.
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Tablet Carpropain
Each chewable tablet
contains
Carprofen USP 50mg
NSAID
USP Specification
08-06-2013
Dy.No.706
Form 5-D
Rs.50.000/-
Pack size 
decontrolled
Priority #
367
387.
388.
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Tablet Prazistar
Priority #
369
Anthemintic
Manufacture
Specification
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Priority #
366
Each film coated tablet
contains
Pyraziquantel BP 20mg
Pyrantel Pamoate BP
230mg
Tablet Prazistar plus
Each film coated tablet
contains
Pyraziquantel BP 50mg
Pyrantel Pamoate BP
144mg
Febantel BP 150mg
18-06-2013
Dy.No.706
Form 5-D
Rs.50.000/-
Pack size 
decontrolled
FDA approved
Rimadyl
chewable tablet –
Zoetis USA
Firm is GMP
compliant as
per inspection
dated 21-092015
Cazitel 230/20
falvoured film
coated tablet –
Chanelle
Pharmaceuticals,
Ireland
Drontal –BayerUK
Stability
studies
required as
it is a new
molecule to
be registered
in Pakistan.
Deferred for
provision of
stability
studies
as
per
guidelines
approved in
251st
meeting.
Stability
studies
required as
it is a new
molecule to
be registered
in Pakistan.
Deferred for
provision of
stability
studies
as
per
guidelines
approved in
251st
meeting.
Stability
studies
required as
it is a new
molecule to
be registered
in Pakistan.
Deferred for
provision of
stability
studies
as
per
guidelines
approved in
251st
meeting.
Firm is GMP
compliant as
per inspection
dated 21-092015
18-06-2013
Dy.No.711
Form 5-D
Rs.50.000/-
Well plus
flavoured tablet –
Divasa Spain
Pack size 
decontrolled
Drontal plus
flavoured tablet –
Bayer-UK
Anthemintic
Manufacture
Specification
Minutes for 260th Meeting Registration Board
Firm is GMP
compliant as
per inspection
dated 21-092015
250
389.
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Diclavet Oral Solution
Each 100 ml contains
Diclazuril BP 1gm
Anthemintic
Manufacture
Specification
18-06-2013
Dy.No.711
Form 5-D
Rs.50.000/-
Pack size 
decontrolled
Firm is GMP
compliant as
per inspection
dated 21-092015
Priority #
370
390.
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Bamberstar Powder
Each 100 gm contains
Bambermycin 4gm
Antbiotics
Manufacture
Specification
18-06-2013
Dy.No.801
Form 5-D
Rs.50.000/-
Pack size 
decontrolled
Priority #
380
391.
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Priority #
379
392.
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
Priority #
381
Wormflash Deworming
Capsules
Each capsule contains
Piperazine Citrate BP
390mg
18-06-2013
Dy.No.800
Form 5-D
Rs.50.000/-
Pack size 
decontrolled
Anthelmintic
Manufacture
Specification
Micostar medicated
shampoo
Each 100ml contains
Miconazole Nitrate BP
2gm
Chlorhexidine Gluconate
BP 2gm
18-06-2013
Dy.No.802
Form 5-D
Rs.50.000/-
Pack size 
decontrolled
Flavomycin –
Intervet-USA
Firm is GMP
compliant as
per inspection
dated 21-092015
Firm is GMP
compliant as
per inspection
dated 21-092015
Malaseb – Bayer
-UK
Firm is GMP
compliant as
per inspection
dated 21-092015
Product in
proposed
strength
doesn’t exist
in Pakistan
and
reference
countries.
Stability
studies
required as
it is a new
molecule to
be registered
in Pakistan.
Product in
proposed
strength
doesn’t exist
in Pakistan
and
reference
countries.
Stability
studies
required as
it is a new
molecule to
be registered
in Pakistan.
Antimicrobial
Manufacture
Specification
Minutes for 260th Meeting Registration Board
251
Deferred for
confirmation
of approval
status
of
same
formulation
by reference
regulatory
authorities
and
Pakistan.
Deferred for
provion of
stability
studies
as
per
guidelines
provided in
251st
RB
meeting.
Deferred for
confirmation
of approval
status
of
same
formulation
by reference
regulatory
authorities
and
Pakistan.
Deferred for
provion of
stability
studies
as
per
guidelines
provided in
251st
RB
meeting.
393.
394.
Doxygenta Powder
Priority #
381
Antibacterial
Manufacture
Specification
M/s Inshall
Pharmaceuti
cal
Industries,
Plot # 2,
Street SS2,
RCCI
Industrial
area, Rawat
Islamabad.
Hepasoul Liquid
Each 100ml contains
L.Cartinine……5%
Magnesium Sulphate.
USP…….1%
Sorbitol…………20%
Choline Chloride
BP….10%
Betain……….2%
Inositol BP………..0.7%
Hepatoprotective,
(Multivitamins. Immune
booster )
10-07-2013
Dy.No.4234
Form-5
Rs.20,000/-
Coolant Powder
Each 1000 g contains
Vitamin
C……………200g
Acetyl Salicylic
Acid….67g
Calcium
Carbonate…...50g
Sodium Chloride……40g
Magnesium
Sulphate….40g
Sodium citrate……0.7g
(NSAID)
10-07-2013
Dy.No.4235
Form-5
Rs.20,000/-
Priority #
384
395.
18-06-2013
Dy.No.803
Form 5-D
Rs.50.000/-
M/s Star
Laboratories
, 23-km,
Multan
Road,
Ghung,
Lahore
M/s Inshall
Pharmaceuti
cal
Industries,
Plot # 2,
Street SS2,
RCCI
Industrial
area, Rawat
Islamabad.
Priority #
384
Each gram contains
Doxycycline Hyclate BP
100mg
Gentamicin Sulphate
USP 50mg
Pack size 
decontrolled
Gentadox 10/5,
Agrar Holland,
The Netherland
Firm is GMP
compliant as
per inspection
dated 21-092015
Stability
studies
required as
it is a new
formulation
to
be
registered in
Pakistan. .
Heptic Solution
by M/s Evergreen
Pharma Lahore
Reg#072689
Deferred for
provion of
stability
studies
as
per
guidelines
provided in
251st
RB
meeting..
Approved
Pack size
Firm is GMP
100ml,150ml,250ml,5
compliant as
00ml,1Liter,2.5Liter
per inspection
decontrolled
dated 04-122015
Pack size
30g,50g,100g,250g,
500g,1kg,5kg,10kg,
25kg
decontrolled
Minutes for 260th Meeting Registration Board
Acelyte water
Soluble Powder
by M/s Decent
Pharma Rawat
Reg#079821
Approved
Firm is GMP
compliant as
per inspection
dated 04-122015
252
Evaluator-IV Mr. Salateen Wasim Philip
Deferred cases :S.No
.
396.
Name and
address of
manufactu
rer /
Applicant
M/s
Novartis
Pharma
(Pakistan)
Limited,
Petaro
Road,
Jomshoro.
Brand Name
(Proprietary
name + Dosage
Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price /
Pack size
Decision of
meeting of
Registration
Board
Remarks
Decision
Registration
Board in its 257th
meeting deferred
for evaluation as
per decision of
250th Registration
Board meeting.
Firm
has Approved
submitted
the
prescribed fee Rs.
20,000/- on 1406-2016, for form
5.
Deferred 257th for
clarification of
NCE as per
DRAP’s Policy
Board decision
Firm
has
submitted
Stability Studies
conducted as per
decision of 251st
meeting of the
Board.
Approval status
international /
national
Nocid 40mg/5ml Form 5
Rs. 20,000/- vide
Each 5 ml of
Dy. No. 2629
reconstituted
dated 11-12-2015
suspension
contains
Pack size of 60ml
Famotidine BP
amber color glass
40mg
bottle
Histamine H2
receptor
antagonist
(Manufacture
Specification)
397.
M/s CCL
Pharmace
utical
Lahore.
Famotidine
40mg/5ml –FDA
Zepsin (Cirin)
Sita-Met XR Tab
Form-5-D
50/500
Dy. No: Not
Tablet
mentioned
Each tablet contains: Dated.08-04-2013
Sitagliptin
Rs.50,000/phosphate
As per SRO
monohydrate eq.
10’s,14’s,30’s
to
USFDA Approved.
Sitagliptin…......... JANUMET XR
........50mg
By MERCK
Metformin
SHARP DOHME
HCI………..500
mg
(Anti Diabetic)
Priority 2252
Minutes for 260th Meeting Registration Board
253
Registration
Board
referred for
on
site
verification
of stability
data by panel
comprising
of Director
DTL,
Peshawar,
Lahore and
area
FID,
DRAP.
398.
M/s CCL
Pharmace
utical
Lahore
Sita-Met XR Tab
Form-5-D
50/1000
Dy. No: Not
Tablet
mentioned
Each tablet contains: Dated.08-04-2013
Sitagliptin
Rs.50,000/phosphate
As per SRO
monohydrate eq.
10’s,14’s
to
USFDA Approved.
Sitagliptin…......... JANUMET XR
........50mg
By MERCK
Metformin
SHARP DOHME
HCI……..…..100
0mg
(Anti Diabetic)
Deferred 257th for
clarification of
NCE as per
DRAP’s Policy
Board decision
Firm
has
submitted
Stability Studies
conducted as per
decision of 251st
meeting of the
Board.
Registration
Board
referred for
on
site
verification
of stability
data by panel
comprising
of Director
DTL,
Peshawar,
Lahore and
area
FID,
DRAP.
Deferred 257th for
clarification of
NCE as per
DRAP’s Policy
Board decision
Firm
has
submitted
Stability Studies
conducted as per
decision of 251st
meeting of the
Board.
Registration
Board
referred for
on
site
verification
of stability
data by panel
comprising
of Director
DTL,
Peshawar,
Lahore and
area
FID,
DRAP.
Priority 2251
399.
M/s CCL
Pharmace
utical
Lahore
Sita-Met XR Tab
Form-5-D
100/1000
Dy. No: Not
Tablet
mentioned
Each tablet contains: Dated.08-04-2013
Sitagliptin
Rs.50,000/phosphate
As per SRO
monohydrate eq.
10’s,14’s
to
USFDA Approved.
Sitagliptin…......... JANUMET XR
........100mg
By MERCK
Metformin
SHARP DOHME
HCI……..…..100
0mg
(Anti Diabetic)
Priority 2253
Minutes for 260th Meeting Registration Board
254
400.
M/s CCL
Pharmace
utical
Lahore
Urocon + Tablets
Tablet
Each tablet
contains:
Solifenacin
succinate
……….6mg
Tamsulosin HCl
(as SR
pellets)…..0.4mg
(Alpha-1
adrenoceptor
antagonists)
Priority 2745
Form-5-D
Dy. No: Not
mentioned
Dated.03-12-2013
Rs.50,000/As per SRO
30’s
Vesomni (UK),
MHRA
Deferred 257th for
clarification
of
NCE
as
per
DRAP’s
Policy
Board decision
401.
M/s Elko
Organizati
on
(Private)
Limited,
27 & 28,
Sector
12/B,
North
Karachi,
Industrial
Area,
Karachi
Carbo Vet
Injection
Form 5-D vide Dy.
# 2670 dated
24-05-2013
Registration
Board in 258th RB
meeting deferred
the case and
advised to apply
on
prescribed
Form 5-D along
with
required
documents
because
same
formulation is not
yet registered in
Pakistan.
Firm has now
submitted
application
on
prescribed Form
5-D in which
following
shortcomings
needs
to
be
rectified : Stability data
of the product
as
per
guidelines
provided
in
251st
RB
meeting.
 Prescribed fee
of Form 5-D.
Registration
Board in 258th RB
meeting deferred
the case and
advised to apply
on
prescribed
Form 5-D along
with
required
documents
because
same
formulation is not
yet registered in
Firm has now
submitted
application
on
prescribed Form
5-D in which
following
shortcomings
needs
to
be
rectified : Stability data
of the product
as
per
guidelines
Each ml
contains:Carbetocin………
..0.07mg/ml
Pack size –10ml,
50ml, 100ml, Decontrolled
Oxytocic, antihem
orrhagic and utero
tonic
drug
BP Spec’s
Priority #
359
402.
M/s Elko
Organizati
on
(Private)
Limited,
27 & 28,
Sector
12/B,
North
Karachi,
Industrial
Area,
Gamocin Injection Form 5-D vide Dy.
# 2669 dated 24Each ml
05-2013
contains:Gamithromycin…
……..150mg/ml
Pack size –10ml,
50ml, 100ml,
(Antibioric).
250ml, 500ml,
1000ml vials
Decontrolled
Minutes for 260th Meeting Registration Board
Registration
Board
referred for
on
site
verification
of stability
data by panel
comprising
of Director
DTL,
Peshawar,
Lahore and
area
FID,
DRAP.
255
Deferred for
provision of
following
information/
documents
 Stability
data
of
the
product
as
per
guideline
s
provided
in 251st
RB
meeting.
 Prescribe
d fee of
Form 5D.
Deferred for
provision of
following
information/
documents
 Stability
data
of
the
product
as
per
guideline
s
provided
Karachi
Pakistan.
Priority #
361
403.
M/s UDL
Pharmaceut
icals, Plot #
E-44& E45, North
Western
Industrial
Zone, Port
Qasim
Authority,
Karachi.
TENZOLID
100mg/5ml
granules
for oral
suspension
Each 5ml of
reconstituted
suspension
contains:
Linezolid BP
100 mg
(Antibiotics)
USP
Specification
Source of
pellets:Benovo Labs
private limited,
Plot # 97 & 98,
Kolhar
Industrial Area,
Bidar, Karnatka,
India
404.
M/s
Uniferoz
PVT. Ltd.
32/8 Sector
15, Korangi
Industrial
Area,
Karachi.
(1840)
Form 5
20,000/Dy. No. 4278
(07/07/2015)
Pellet fee Rs.
80,000/- vide Dy
# nil dated 24-052016
Pack of
10’s and 30’s as
per SRO
FDA approved
Avodart (GSK)
Avodart (GSK)
Saniplast Aqua
Bandage First Aid
Bandage
Form-5
Dy. No: 1442
Dated. 21.06.2012
Rs.8,000/Each Bandage
Dated.05.09.2013
contains:
Rs.12000/Polyurethane (PU) Rs.41/10’s
Tape
(25x72mm),
Bezalkonium
40.50/10’s
Chloride Pad
(38x38mm)
………………..0. 40.57/10’s,
Minutes for 260th Meeting Registration Board
provided
in
251st
RB
meeting.
 Prescribed fee
of Form 5-D.
in 251st
RB
meeting.
 Prescribe
d fee of
Form 5D.
Photocopies
of Approved.
Registration
COA
,
GMP
Firm
will
Board
certificate.
provide
deferred the
legalized
case in 258th
GMP, CoA,
meeting of RB for
stability data
provision of
of Zone IVA
Source of
and
coated taste
Chairman,
masked
RB
will
linezolid
permit
pellets along
issunce
of
registration
with GMP
letter.
certificate of
the source,
Stability data
and required
fee if source
is outside of
Pakistan.
Deferred in 257th
RB meeting
for clarification for
registration of the
same strength /
composition.
Reply of the firm Approved
mentioned below
256
5%w/w.
(First Aid
Bandage)
(Mfg. specs)




(5’s x25x72mm &
5’sx38x38mm)
40.57/20’s,
(10’s x25x72mm &
10’s x38x38mm)
BAND-AID
(Johnson &
Johnson) made in
Brazile, distributed
in canada.
Nexcare Clear by
3M consumer
Health Care USA.
Saniplast Ultra first
aid Bandage (with
Poluethylene Base)
by M/sUniferoz.
It is water proof bandage, thus the wound area is protected from getting wet.
It completely seals the applied area on the skin and help protect the small wound from dust and germs.
The consumer will appreciate availability of this new improved variant once it is available in Pakistan,
as this is available abroad, and they do purchase this vairiant abroad.
Introduction of this variant will help in introducing this new improved first aid bandages for domestic
and export markets, improve utilization of our capacity and adapt modern technology.

They further explained that Board has already granted export registration of saniplast aqua bandage. However
when we apply for registration abroad they require free sale certificate in the country of manufacturer, which
they couldn’t provide to importing country due to non-registration in Pakistan.
405.
-do-
Dermapore Non
Woven Fabric
Surgical Tape for
(Surgical
Dressing &
Bandage)
Form 5
10 cmx10m
5 cm x 10m
2.5 cm x10
Demanded price
has not been
mentioned
Rs.8000/(27/07/2010)
Rs.12,000/(23/07/2013)
Fee challans are
duplicate
Total
Rs.20,000/Dy. No. not
available /
Duplicate
dossier
Deferred for the
confirmation
of
approval status in
reference countries.
Reply of the
firm
mentioned
below
GMP
inspection
Minutes for 260th Meeting Registration Board
257
report dated
15-07-2014.
Overall GMP
compliance
level rated as
good.




406.
We already manufacture Dermapore Non Woven Paper Surgical Tapes for domestic and export
markets and has registration from DRAP. Non-Woven fabric surgical tapes would be manufactured
by using the same manufacturing capacity to introduce a new varient.
Dermapore Non Woven Fabric Surgical tapes export registration was granted by board earlier, now
we are seeking registration to sell the same product in domestic market for utilization of capacity and
modern technology.
For export registrations in foreign countries we required free sale certificate which can only be
applied when we have local registration.
Non registered similar tapes are already being used in local hospitals. We on the other hand are
seeking registration to manufacture a better product locally by utilizing our hand are seeking
registration to manufacture a better product locally by utilizing our ideal capacity, and meeting the
demand of the market.
Importer
M/s.
UM
Enterpri
ses,
Karachi,
18-C, 3rd
floor,
Dolmen
Estate
Building
, Block
7-8,
Shaheed
-eMillat
Road,
Karachi
Gentadox Water
Soluble powder
Each gm contains:Gentamycin Sulphate
160mg equivalent to
Gentamycin 100mg
Doxycycline HCl
100mg
Antibiotic
Specifications:Manufacturer
Form 5 with fee Rs
100,000/- vide Dy.
# 411 dated 13-052013
Pack size of
100gm, 500gm,
1kg & 5kg 
decontrolled
The Board deferred
the
case
for
provision
of
approval status of
same formulation
in Pakistan and
reference
regulatory
authorities.
Registration
Board
rejected the
proposed
formulation,
being
irrational.
Zygosis-Nigeria
Jovet-Jordan
Not yet registered
in Pakistan
Manufa
cturer:
M/s.
Arab
Veternia
ry
Industri
Minutes for 260th Meeting Registration Board
Registration
Board
referred the
proposed
product for
comments of
ECMD.
258
es CO,
(AVICO
), P.O
Box
150906
Amman,
11115,
Jordan
407.
Importer
M/s.
UM
Enterpri
ses,
Karachi,
18-C, 3rd
floor,
Dolmen
Estate
Building
, Block
7-8,
Shaheed
-eMillat
Road,
Karachi
Diclacox Liquid
Each ml contains:Diclazuril 10mg
Anticoccidal
Specifications:Manufacturer
Form 5 with fee Rs
100,000/- vide Dy.
# 380 dated 08-052013
Pack size of 100ml,
500ml, 1L & 5L 
decontrolled
The Board deferred
the
case
for
provision
of
approval status of
same dosage form
in
reference
regulatory
authorities and in
Pakistan.
Registration
Board
deferred the
case
for
provision of
following
documents/i
nformation: Product
Developm
ent data in
liquid
dosage
form.
 Stability
data for
real time
studies
and
accelerate
d
time
studies.
 Complete
master
formulatio
n along
with
active and
inactive
ingrdients
.
however in powder
from available.
Reg # 021258
Manufa
cturer:
M/s.
Arab
Veternia
ry
Industri
es CO,
(AVICO
), P.O
Box
150906
Amman,
11115,
Jordan
Deferred cases of new licensed manufacturers
Minutes for 260th Meeting Registration Board
259
408.
409.
M/s
Linta
Pharmac
euticals
(Pvt.)
Ltd, Plot
# 3,
Street #
S-5,
National
Industri
al Zone,
Rawat
-do-
Ospra capsule 20mg
Each Capsule
Contains:
Omeprazole
(enteric coated pellets)
eq. to Omeprazole...
20mg
(Proton Pump
Inhibitor)
(USP Spec.s)
{Source of pellets: M/s
. Lee Pharma Ltd., Sy.
No. 199, Plot No. 3 &
4, D.No. 5-9-265/1 &
2, Rajeevgandhinagar,
Prasanthinagar I.E,
Kukatpally, Ranga
Reddy District,
Telangana State, India}
Ospra capsule 40mg
Each Capsule
Contains: Omeprazole
(enteric coated pellets)
eq. to Omeprazole...
40mg
(Proton Pump
Inhibitor)
(USP Spec.s)
{Source of pellets: M/s
. Lee Pharma Ltd., Sy.
No. 199, Plot No. 3 &
4, D.No. 5-9-265/1 &
2, Rajeevgandhinagar,
Prasanthinagar I.E,
Kukatpally, Ranga
Reddy District,
Telangana State, India}
410.
-do-
Rush capsule 20mg
Each Capsule
Contains:Esomeprazole( as
Esomeprazole
Form 5
17-04-2015
(977)
Rs.1,00,000/As per SRO/
2 x 7’s
BNF: Losec
(AstraZeneca)
Deferred in 249th
RB meeting for
submission of
legalized GMP
certificate of
pellet’s
manufacturer, COA
and stability studies
data of pellets.
Firm has now Approved
change the source
of pellets and
submitted
new
source documents
as under:Source
of
Omeprazole
ECP
pellets
22.5%:M/s
Vision
Pharmaceuticals,
Plot # 22-23,
Industrial
Triangle, Kahuta
Road, Islamabad.
Deferred in 249th
RB meeting for
submission of
legalized GMP
certificate of
pellet’s
manufacturer, COA
and stability studies
data of pellets.
Firm has now
change the source
of pellets and
submitted
new
source documents
as under:Source
of
Omeprazole
ECP
pellets
22.5%:M/s
Vision
Pharmaceuticals,
Plot # 22-23,
Industrial
Triangle, Kahuta
Road, Islamabad.
Approved
Deferred in 249th
RB meeting for
submission of
legalized GMP
certificate of
pellet’s
Firm has now
change the source
of pellets and
submitted
new
source documents
as under:-
Approved
with change
of
brand
name.
RISEK 20mg
Capsule
Getz Pharma (Pvt.)
Ltd
Grant For
registration of
drugs of new
license dated 0204-2015
Form 5
17-04-2015
(978)
Rs.1,00,000/As per SRO/
2 x 7’s
BNF: Losec
(AstraZeneca)
RISEK 40mg
Capsule
Getz Pharma (Pvt.)
Ltd
Grant For
registration of
drugs of new
license dated 0204-2015
Form 5
17-04-2015
(984)
Rs.1,00,000/As per SRO/
2 x 7’s
Minutes for 260th Meeting Registration Board
260
411.
-do-
magnesium trihydrate
enteric
coated pellets) (USP)
…20 mg
NEXIUM Capsule
(AstraZeneca)
(Proton Pump
Inhibitor)
(USP Spec.s)
E-CAP 40mg
Capsules
((Brookes
Pharmaceuticals
(Pvt) Limited))
{Source of pellets: M/s
. Lee Pharma Ltd., Sy.
No. 199, Plot No. 3 &
4, D.No. 5-9-265/1 &
2, Rajeevgandhinagar,
Prasanthinagar I.E,
Kukatpally, Ranga
Reddy District,
Telangana State, India}
Grant For
registration of
drugs of new
license dated 0204-2015
Rush capsule 40mg
Each Capsule
contains
Esomeprazole( as
Esomeprazole
magnesium trihydrate
enteric
coated pellets) eq. to
Esomeprazole…40 mg
Form 5
17-04-2015
(985)
Rs.1,00,000/As per SRO/
2 x 7’s
NEXIUM Capsule
(AstraZeneca)
(Proton Pump
Inhibitor)
(USP Spec.s)
E-CAP 40mg
Capsules
(Brookes
Pharmaceuticals
(Pvt) Limited)
{Source of pellets: M/s
. Lee Pharma Ltd., Sy.
No. 199, Plot No. 3 &
4, D.No. 5-9-265/1 &
2, Rajeevgandhinagar,
Prasanthinagar I.E,
Kukatpally, Ranga
Reddy District,
Telangana State, India}
Grant For
registration of
drugs of new
license dated 0204-2015
Minutes for 260th Meeting Registration Board
manufacturer, COA
and stability studies
data of pellets as
per Zone IVA.
Source
of
Esomeprazole
Mg ECP pellets
22.5%:M/s
Vision
Pharmaceuticals,
Plot # 22-23,
Industrial
Triangle, Kahuta
Road, Islamabad.
Deferred in 249th
RB meeting for
submission of
legalized GMP
certificate of
pellet’s
manufacturer, COA
and stability studies
data of pellets as
per Zone IVA.
Firm has now
change the source
of pellets and
submitted
new
source documents
as under:Source
of
Esomeprazole
Mg ECP pellets
22.5%:M/s
Vision
Pharmaceuticals,
Plot # 22-23,
Industrial
Triangle, Kahuta
Road, Islamabad.
261
Approved
with change
of brand
name.
412.
-do-
Votsa capsule 30mg
Form 5
17-04-2015
Each Capsule
(986)
Contains: Lansoprazole Rs.1,00,000/(enteric coated pellets) As per SRO/
eq. to Lansoprazole
2 x 7’s
(USP) ... 30mg
FDA: Prevacid
(Proton Pump
(Novartis
Inhibitor)
Pharmaceuticals)
(USP Spec.s)
{Source of pellets: M/s Inhibitol 30mg
. Lee Pharma Ltd., Sy. Capsule
No. 199, Plot No. 3 &
(Highnoon
4, D.No. 5-9-265/1 &
Laboratories
2, Rajeevgandhinagar, Limited)
Prasanthinagar I.E,
Kukatpally, Ranga
Grant For
Reddy District,
registration of
Telangana State, India} drugs of new
license dated 0204-2015
Deferred in 249th
RB meeting for
submission of
legalized GMP
certificate of
pellet’s
manufacturer, COA
and stability studies
data of pellets.
Firm has now Approved
change the source
of pellets and
submitted
new
source documents
as under:Source
of
Lansoprazole
ECP
pellets
22.5%:M/s
Vision
Pharmaceuticals,
Plot # 22-23,
Industrial
Triangle, Kahuta
Road, Islamabad.
413.
M/s
Hamaz
Pharmac
euticals
(Pvt.)
Ltd, 13km,
Bosan
Road,
Luftaba
d,
Multan
Montilak 4mg sachet
Deferred in 244th
RB meeting for
clarification of
manufacturing
process for
granules.
All shortcomings Approved
rectified.
Each sachet contains:granules of
Montilukast (as
sodium) 4mg
Leukotriene receptor
antagonist
Manufacture
Specification
Form-5
18-2-2014
Dy # 619 R&I
Rs.20,000/Rs.225.00/14‟s
sachet
MHRA approved
Deferred cases of pendency list
414.
M/s
Himont
Pharmac
euticals
(Pvt.)
Ltd, 17km,
Ferozpu
r Road,
Lahore
Priority
# 2655
Deproset Capsule
20mg
Form 5 with fee Rs.
20,000/- vide Dy.
# 592 dated 06-092013
Each capsule contains:Duloxetine HCl enteric
coated pellets eq. to Pack size
Duloxetine 20 mg
14’s  Rs.447/SSRI
Manufactures
specification
Cymbalta-Eli LillyFDA
Llario-Wilshire
Source of pellets:-
Minutes for 260th Meeting Registration Board
The Board deferred
the case in 258th
RB meeting, for
provision source of
pellets along with
relevant documents
Firm
has
submitted source
of
pellets
as
under:Source
of
Duloxetine HCl
ECP 19.0%
M/s
Vision
Pharmaceuticals,
Plot
#
22,
Industrial
Trinagle, Kahuta
Road, Islamabad.
262
Approved
415.
416.
417.
M/s
Himont
Pharmac
euticals
(Pvt.)
Ltd, 17km,
Ferozpu
r Road,
Lahore
Priority
# 2654
M/s
Himont
Pharmac
euticals
(Pvt.)
Ltd, 17km,
Ferozpu
r Road,
Lahore
Priority
# 2654
M/s
Getz
Pharma,
2930/27,
Korangi
Industri
al Area,
Karachi
2053
Deproset Capsule
30mg
Form 5 with fee Rs.
20,000/- vide Dy.
# 591 dated 21-102013
Each capsule contains:Duloxetine HCl enteric
coated pellets eq. to
Duloxetine 30 mg
Pack size
10’s  Rs.415/SSRI
Manufactures
Cymbalta-Eli Lillyspecification
FDA
Source of pellets:Deproset Capsule
60mg
Llario-Wilshire
Form 5 with fee Rs.
20,000/- vide Dy.
# 591 dated 21-102013
Each capsule contains:Duloxetine HCl enteric
coated pellets eq. to
Duloxetine 60 mg
Pack size
10’s  Rs.415/SSRI
Manufactures
Cymbalta-Eli Lillyspecification
FDA
Source of pellets:Lyta 40mg Capsule
Each capsule contains:
Enteric coated pellets
of Duloxetine HCl eq
to Duloxetine……….
40mg
(Selective serotonin
Norepinephrine
reuptake inhibitor)
(Mfg. Specification)
Duloxetine is indicated
for women for the
treatment of moderate
to severe stress urinary
incontinence.
Llario-Wilshire
Form-5-D
Dy. No: 114
dated. 19.02.2011
Rs.15,000/19.09.2013
Rs.5,000/Rs. 645/14’s,
925/20’s
Duloxetine 20mg &
40mg gastric
resistant capsules
(Consilient Health
Ltd) MHRA
Dulan –Hilton
Reg# 067169
Minutes for 260th Meeting Registration Board
The Board deferred
the case for
provision source of
pellets along with
relevant
documents.
The Board deferred
the case for
provision source of
pellets along with
relevant
documents.
Deferred for
Balance fee of form
5 D,
Legalized
documents of the
source and
Fee for source.
Stability studies as
per 251st meeting of
RB.
Firm
has Approved
submitted source
of
pellets
as
under:Source
of
Duloxetine HCl
ECP 19.0%
M/s
Vision
Pharmaceuticals,
Plot
#
22,
Industrial
Trinagle, Kahuta
Road, Islamabad.
Firm
has
Approved
submitted source
of
pellets
as
under:Source
of
Duloxetine HCl
ECP 19.0%
M/s
Vision
Pharmaceuticals,
Plot
#
22,
Industrial
Trinagle, Kahuta
Road, Islamabad.
Firm has rectified
Approved
all shortcomings.
 Product
is
already
registered in
Pakistan.
 Firm
submitted
fresh Form 5.
 Firm
has
submitted
legalized
documents of
GMP and free
sale certificate
of Source of
Duloxetine
Delayed
released
pellets
17.65% w/w:M/s
Alphamed
Formulations Pvt
Ltd, Sy. No. 225,
263
Sampanhole
Village,
Shameerpet
Mandal,
Ranga
Reddy
District
500
078,
Telangana state,
India
418.
419.
420.
M/s
Pharmac
are Labs
(Pvt)
Ltd,
129/1,
Industri
al
Estate,
Kotlakh
pat,
Lahore.
1462
Lexxel Tablet
Anti-depressant
USP Specification
MHRA Cipralex
20mg f/c tablet
Cipralex 20mg by
M/s Lundbeck
M/s
Allmed
Pvt.
Ltd.
(Former
ly,
EverGre
en
Pharmac
euticals,
Pvt. Ltd.
Plot.No.
590,
Sundar
Industri
al
Estate
Lahore.
-do-
Reevo
Injection
Each ml contains:
Levocarnitine……
……..200 mg
4.Anti infective
systematic
.Form5
2.Routine
3.Rs.5mlx10‟s/ As
per SRO
4.23-08-2010
Rs.8000/11-10-2012
Rs.12,000/-
Each film coated tablet
contains:Escitalopram Oxalate
USP eq.to
Escitalopram 20mg
Form 5
Dy No.1166
Rs.8000 dated 2812-2011 & Rs.
12,000 dated 3107-2013.
As per SRO
Deferred 254th RB
All shortcomings
for
rectified.
 Raw material and
finished product
specifications
need to be
submitted.
 Outline of
manufacturing
method needs to
be provided.
 Description of
the dosage form
is not provided.
 Fresh inspection
require to be
submitted.
Deferred 244th for
confirmation of
pharmacological
group as applied by
firm.
Deferred for
correct
pharmacolog
ical
group
and
submission
of stability
data as per
251st
RB
meeting
Deferred 244th for
confirmation
of
international
Registration
Board
deferred the
FDA: Carnitor
Kefei Injection by
M/s RG Pharma
Metoril
Tablet
Each tablet contains:
1.Form5
2.Routine
3.100‟s/As per
Minutes for 260th Meeting Registration Board
Approved
264
Nitrogen
Contents…36mg
Calcium .0.5gm
Aminoacids
SRO
4.06-08-2010
Rs.8000/11-10-2012
Rs.12,000/
availability
and
facilty
for processing of
nitrogen
preparations
case
for
provision of
complete
master
formulation
and
confirmation
of approval
status
in
Pakistan
Ketosteril by M/s
Fresenius Kabi
Pharma Germany.
Ketosteril by M/s
Medipak Pharma
DDC PEC-I Dr. Hafsa Karam Ellahi
Sr. No
421.
Name and
address of
manufacturer
/ Applicant
M/s Irza
Pharma (Pvt)
Ltd. 10.2 K.M
Lahore –
Sheikhupura
Road, P.O.Kot
Abdul Malik,
Distt:
Sheikhupura.
1378
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Remarks by
Evaluator
/Decision
Decision
Fee including
differential fee
Demanded Price
/ Pack size
Remarks on the
formulation (if any)
including
International status in
stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report (with
date) by the Evaluator
Dephan Syrup
Each 5ml contains:
Dextromethorphan
HBr ….13.5mg
(Antitussive)
Protocol Applied: USP
Form 5
Dairy No. 705
dated 04.10.11
Rs.8,000/dated 29.07.2013
Rs.12,000/As per SRO
120ml
International availability
not confirmed
De xtromethrphan
HBr 13.5 mg of
Neutropharma
Last GMP inspection
was conducted on 2804-2014
Deferred in 255th
meeting of DRB
Deferred
for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
Initial date, diary
 for latest
cGMP
inspection
report.
 availability
in SRA is
not
confirmed.
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
Minutes for 260th Meeting Registration Board
265
422.
M/s Irza
Pharma (Pvt)
Ltd. 10.2 K.M
Lahore –
Sheikhupura
Road, P.O.Kot
Abdul Malik,
Distt:
Sheikhupura.
1379
Dephan Syrup
Each 5ml contains:
Dextromethorphan
HBr …..10mg
Chlorpheniramine
Maleate……2mg
(Antitussive /
Antihistamine)
Protocol Applied: USP
Form 5
Dairy No. 706
dated 04.10.11
Rs:8,000/dated 29.07.2013
Rs.12,000/As per SRO
120ml
International availability
not confirmed
Deferred in 255th
meeting of DRB
BUCKLEYS JACK &
JILL (Pacific
Phararmaceutical
 for latest
cGMP
inspection
report.
Last GMP inspection
was conducted on 2804-2014
 availability
in SRA is
not
confirmed.
Deferred
for
confirmatio
n
of
approval
status
by
reference
regulatory
authorities
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
423.
424.
425.
M/s Irza
Pharma (Pvt)
Ltd. 10.2 K.M
Lahore –
Sheikhupura
Road, P.O.Kot
Abdul Malik,
Distt:
Sheikhupura.
1010
R-Din Injection
Each 2ml contains:
Ranitidine HCl
equivalent to
Ranitidine………50m
g
(H 2 Blocker)
M/s Irza
Pharma (Pvt)
Ltd. 10.2 K.M
Lahore –
Sheikhupura
Road, P.O.Kot
Abdul Malik,
Distt:
Sheikhupura.
1008
Irzaline Injection
Each 1ml contains:
Lincomycin
Hydrochloride
equivalent to
Lincomycin………300
mg
(Lincosamide)
M/s Irza
Pharma (Pvt)
Ltd. 10.2 K.M
Lahore –
Sheikhupura
Road, P.O.Kot
Abdul Malik,
Irzaline Injection
Each 2ml contains:
Lincomycin
Hydrochloride
equivalent to
Lincomycin…. 600mg
(Lincosamide)
Form 5
Dairy No. 4831
dated 28.04.11
Rs.8,000/dated 29.07.2013
Rs.12,000/As per SRO
5’s
International availability
FDA approved Zantac
Eq to 25MG Ranitidine
Base/Ml
Concordia Pharms Inc
Deferred in 255th
meeting of DRB
Approved
 for latest
cGMP
inspection
report.
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
Form 5
Dairy No. 4829
dated 28.04.11
Rs.8,000/dated 29.07.2013
Rs.12,000/As per SRO
12’s
Form 5
Dairy No. 4827
dated 28.04.11
Rs.8,000/dated 29.07.2013
Rs.12,000/As per SRO
Minutes for 260th Meeting Registration Board
International availability
FDA: Lincocin
Lincomycin HCl Eq.
300mg base per ml
(Pharmacia and Upjohn)
Lincocin (pfizer
laboratories
ltd. (Lincomycin HCl),
equivalent to
Lincomycin……..300m
g
Last GMP inspection
was conducted on 2804-2014
International availability
FDA: Lincocin
Lincomycin HCl Eq.
300mg base per ml
(Pharmacia and Upjohn)
Lincocin (pfizer
laboratories
Deferred in 255th
meeting of DRB
Approved
 for latest
cGMP
inspection
report.
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
Deferred in 255th
meeting of DRB
 for latest
cGMP
inspection
266
Approved
12’s
Distt:
Sheikhupura.
1011
426.
427.
M/s Irza
Pharma (Pvt)
Ltd. 10.2 K.M
Lahore –
Sheikhupura
Road, P.O.Kot
Abdul Malik,
Distt:
Sheikhupura.
1099
M/s Irza
Pharma (Pvt)
Ltd. 10.2 K.M
Lahore –
Sheikhupura
Road, P.O.Kot
Abdul Malik,
Distt:
Sheikhupura.
1007
Asmolin Injection
Each ml contains:
Aminophylline……..2
5mg
(Antiasthmatic)
Jantolin Injection
Each 1ml contains:
Salbutamol Sulphate
equivalent to
Salbutamol…. 0.5mg
(Selective Beta 2
Agonist)
Form 5
Dairy No. 618
dated 28.05.11
Rs.8,000/dated 29.07.2013
Rs.12,000/As per SRO
5’s
Form 5
Dairy No. 4828
dated 28.04.11
Rs.8,000/dated 29.07.2013
Rs.12,000/As per SRO
5’s
ltd. (Lincomycin HCl),
equivalent to
Lincomycin………600
mg/2ml
Last GMP inspection
was conducted on 2804-2014
Aminophylline
25mg/ml
Mercury pharma UK
Aminophylline Hydrate
25mg/ml Sol for Inj of
USFDA
Aminophylline
25mg/ml
GD SEARLE LLC
(Discontinued)
Aminophylline
25mg/ml of LCPW
Last GMP inspection
was conducted on 2804-2014
International availability
Ventolin Injection
(0.5mg) in 1ml
Glaxo Wellcome UK
Ltd
Me too : ventral
Akson
Last GMP inspection
was conducted on 2804-2014
report.
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
Deferred in 255th
meeting of DRB
 for latest
cGMP
inspection
report.
Approved
with
change of
brand
name
 Change of
name
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
Deferred in 255th
meeting of DRB
 for latest
cGMP
inspection
report.
Approved
with
change of
brand
name
 Change of
mame
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
428.
M/s Irza
Pharma (Pvt)
Ltd. 10.2 K.M
Lahore –
Sheikhupura
Road, P.O.Kot
Abdul Malik,
Distt:
Sheikhupura.
1012
I-Menate Injection
Each 1ml contains:
Dimenhydrinate…….5
0mg
(Antihistamine)
Form 5
Dairy No. 4825
dated 28.04.11
Rs.8,000/dated 29.07.2013
Rs.12,000/As per SRO
25’s
Minutes for 260th Meeting Registration Board
DIMENHYDRINATE
50MG/ML
INJECTION OF
FRESENIUS KABI
USFDA
Gravinate injection
Searl pharma
Last GMP inspection
was conducted on 2804-2014
Deferred in 255th
meeting of DRB
 for latest
cGMP
inspection
report.
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
267
Approved
429.
M/s Irza
Pharma (Pvt)
Ltd. 10.2 K.M
Lahore –
Sheikhupura
Road, P.O.Kot
Abdul Malik,
Distt:
Sheikhupura.
1013
I-Cobal Injection
Each 1ml contains:
Mecobalamin…….500
mcg
(Coenzyme type
vitamin B12)
Form 5
Dairy No. 4824
dated 28.04.11
Rs.8,000/dated 29.07.2013
Rs.12,000/As per SRO
10’s
Methycobal amine of
Eisai Co. Ltd. Japan
Mabil Injection (Sami
Pharma, Karachi).
Last GMP inspection
was conducted on 2804-2014
Deferred in 255th
meeting of DRB
Approved
with
change of
brand
name
 for latest
cGMP
inspection
report.
 Change of
name
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
Import Case of M/s Atco Pharma was deferred in 255th meeting of RB.
Sr. No
430.
Name and
address of
manufacture
r / Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Micopirox, Nail Lacquer
Atco
Cyclopirox 8mg/100g
pharma
BP Specification
Internationa
l
(PVT.)LTD
B-18,
S.I.T.E,
Karachi75700
Name and
address of
Manufactur
er;
Laboratorio
Pablo
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price
/ Pack size
Form 5-A
Rs. 15000 dt 1904-2011
Rs. 85000 dt 0406-2013
Rs. 600
Minutes for 260th Meeting Registration Board
Remarks on the
formulation (if
any) including
International
status in stringent
drug regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Penlac,8%
Topical solution of
(Valeant
Bermuda)
USFDA
Remarks by
Evaluator
/Decision
Decision
Deferred in 255th
meeting for the
following reasons;
Approved as per
Import Policy for
Finished Drugs
 CPP issued on
Feb 2011 and
is valid for 12
months.
 Last GMP
certificate was
issued on Nov
2010 and is in
local language.
Latest
268
Cassar’a
S.R.L
Carhue
1096.
(C.P.1408)
City:
Buenos
Aires
Country:
Argentina
52
Minutes for 260th Meeting Registration Board
legalized
Certificate
with English
translation
required.
 Sole
agreement of
Laboratory
Pablo Cassara
with Atco is
valid till
December
2015.
Extension in
the agreement
is required.
269
Routine Cases.
S. No
431.
432.
433.
Name and
address of
manufacture
r / Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
M/s. Friends
Pharma (Pvt)
Limited,
31Km
Ferozpure
Road, Lahore
1092
Bactriol
infusion
Each 250ml contains:
Moxifloxacin……400m
g
Form 5
Dy.No.561
28-05-2011
Rs:8,000/14.05.2013
Rs.. 12000/As per SRO
M/s. Friends
Pharma (Pvt)
Limited,
31Km
Ferozpure
Road, Lahore
1091
Cipfen
infusion
Each 100ml contains:
Ciprofloxacin …200mg
M/s
Remington
Pharma
Lahore
846
Zylofixim Capsule
Oral Capsules
Each Capsule contains:
Cefixime Trihydrate
U.S.P equivalent to
Cefixime…..200mg
(Antibiotic).
Manufacturer’s
Specification
(Anti-biotic)
(Anti-biotic)
Minutes for 260th Meeting Registration Board
Initial date, diary
Fee including
differential fee
Demanded Price
/ Pack size
Remarks on the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
Avelox I.V by
M/s. Bayer Inc.
US FDA
Avilox Infusion
by M/s. Baeyer
(Pvt) Limited,
Karachi
Form 5
Dy.No.522
03-05-2011
Rs:8,000/14.05.2013
Rs.. 12000/As per SRO
Ciprofloxacin
2mg / ml by
Pharmathen
MHRA
Form 5
Dy.No.3898
28-03-2011
Rs:8,000/Dy. No. 9276
30.07.2013
Rs.. 12000/Leader Price
Applied
formulation is
not available in
reference
SRA’s.
Cefim by M/s
Getz Pakistan
Remarks by
Evaluator
/Decision
Decision
Approved
Approved
cipesta Infusion
by M/s. Getz
Pharma
Applied
formulation
is
not available in
reference SRA’s.
The firm also
fails to provide
the same.
270
Deferred for
confirmation
of approval
status
by
reference
regulatory
authorities
434.
M/s
Remington
Pharma
Lahore
1544
Nilol 10mg
Tablet
Each tablet contains:
Nebivolol Hcl eq to
Nebivolol……10mg
Beta Blocker
Manufacturer’s
Specification
Form 5
Dy.No.136
23-2-2016
Rs:20,000/As per PRC
As per PRC
Bystolic Tablet
of Forest Labs
US FDA
435.
M/s
Remington
Pharma
Lahore
853
Malfan 80/480
Dispersible
Oral dispersible Tablet
Each dispersible tablet
contains:
Artemether……80mg
Lumefantrine……480m
g
(Anti Malarial)
Manufacturer’s
Specification
Form 5
Dy.No.1500
04-8-2011
Rs:8,000/Dy. No. 9296
30.07.2013
Rs12000/Leader Price
Applied
formulation is
not available in
reference
SRA’s.
Alar
once
Dispersible by
M/s
Searle
Pharma
Applied
formulation
is
not available in
reference SRA’s.
The firm also
fails to provide
the same.
Deferred for
confirmation
of approval
status
by
reference
regulatory
authorities /
WHO
436.
M/s
Remington
Pharma
Lahore
852
Malfan 40/240
Dispersible
Oral Tablet
Each tablet contains:
Artemether……40mg
Lumefantrine……240m
g
Form 5
Dy.No.1501
04-8-2011
Rs:8,000/Dy. No. 9289
30.07.2013
Rs12000/Leader Price
Applied
formulation is
not available in
reference
SRA’s.
Alar
once
Dispersible by
M/s
Searle
Pharma
Applied
formulation
is
not available in
reference SRA’s.
The firm also
fails to provide
the same.
Deferred for
confirmation
of approval
status
by
reference
regulatory
authorities
/WHO
Form 5
Dy.No.1500
04-8-2011
Rs:8,000/Dy. No. 9296
30.07.2013
Rs12000/Leader Price
Applied
formulation is
not available in
reference
SRA’s.
Me too status is
not confirmed
Applied
formulation
is
not available in
reference SRA’s.
The firm also
fails to provide
the same.
Rejected
being
irrational
formulation
and
not
approved by
ant
reference
regulatory
authoritity
(Anti Malarial)
Manufacturer’s
Specification
437.
M/s
Remington
Pharma
Lahore
945
Nebra-D
Ophthalmic suspension
Each ml contains:
Tobramycin
U.S.P……3.0 mg
Dexamethasone
U.S.P……1.0mg
Boric Acid B.P….5mg
Manufacturer’s
Specification
(antibacterial,
corticosteroid)
Manufacturer’s
Specification
Minutes for 260th Meeting Registration Board
Approved
ByscardTablet
Searle Pakistan
271
438.
M/s
Remington
Pharma
Lahore
1818
Remflox 750
Oral Tablet
Each film coated tablet
contains:
Levofloxacin
Hemihydrates eq. to
Levofloxacin U.S.P
(Antibiotic, quinolones)
Manufacturer’s
Specification
Form 5
Dy.No.
21-05-2012
Rs:8,000/Dy. No.
30.07.2013
Rs12000/Leader Price
Levaquin Tablet
of
Janssen
Pharms
US FDA
Leflox by M/s
Getz Pharma
Shelf
life
provided by the
firm is three years
whereas 2 years
are allowed by the
Board.
Approved
439.
M/s
Remington
Pharma
Lahore
842
Zincure
Oral Syrup
Each 5ml contains:
Zinc Sulphate
Monohydrate U.S.P
equivalent to Elemetal
Zinc………20mg
Form 5
Dy.No. 5853
29-06-2012
Rs:8,000/30.07.2013
Rs12000/Leader Price
Applied
formulation is
not available in
reference
SRA’s.
Deferred
for
opinion/commen
ts of
WHO as per
decision of the
board in 250th
meeting. Dosage
recommendation
(UNICEF/
WHO): Tablets
may
contain
either 10 or 20 mg
of zinc and the
concentration of
zinc
in
oral
solutions may be
10mg/5mL.
Decisions about
the best strength
to be used should
depend on better
adherence
to
treatment
by
patient,
taking
into consideration
other issues as
well, such as
price,
medicine
delivery,
and
duration
of
treatment (10- or
14-day treatment).
Preferably, in any
given
country,
only one strength
of tablets or oral
solution should be
available to avoid
dosing errors. If
10-mg zinc tablets
are chosen, it will
mean that older
children will have
to take two tablets
Deferred for
opinion/com
ments of
WHO as per
decision of
the board in
250th
meeting.
(Zinc Supplement)
Manufacturer’s
Specification
Minutes for 260th Meeting Registration Board
272
440.
M/s
Remington
Pharma
Lahore
841
Remisole-P Syrup
Each 5ml contains:
Ammonium Chloride
B.P….100mg
Sodium Citrate
B.P….60mg
Chlorpheniramine
Maleate B.P……2mg
Phenylephrine HCl
B.P…..5mg
Menthol B.P…..1.0mg
(Expectorant)
Manufacturer’s
Specification
Minutes for 260th Meeting Registration Board
Form 5D
Dy.No. 5852
29-06-2012
Rs:15,000/30.07.2013
Rs35000/Rs. 45/60ml
Rs. 65/120ml
Rs. 200/450ml
Applied
formulation is
not available in
reference
SRA’s.
each day; if 20mg
zinc tablets are
chosen, it will
mean that for
younger infants
only half a tablet
will be given each
day and therefore
tablets will have
to be scored to
facilitate
this.
With
oral
solutions, because
it is difficult to
accurately
measure half a
teaspoon
of
solution, it is
recommended that
oral solution of
zinc contain 10mg
of elemental zinc
per 5 mL, that is
to say per one
teaspoon.
It
means that infants
below 6 months
of age will receive
one
teaspoon,
while
older
children will need
2 teaspoons of
oral solution per
day.
(Ref:
UNICEF/ WHO)
Applied
formulation
is
not available in
reference SRA’s.
The firm also
fails to provide
the same.
273
Deferred for
confirmation
of approval
status
by
reference
regulatory
authorities
and Pakistan
441.
M/s
Remington
Pharma
Lahore
840
Moxidex
Each ml contains:
Moxifloxacin
Hydrochloride B.p
Equivalent to
Moxifloxacin…..5mg
Dexamethasone Sodium
Phosphate U.S.P eq. to
Dexamethasone
Phosphate…..1mg
(Antibiotic &
Corticosteroid)
Manufacturer’s
Specification
Form 5
Dy.No. 1465
23-04-2012
Rs:8,000/30.07.2013
Rs 12,000/Leader Price
Applied
formulation is
not available in
reference
SRA’s.
Oxcin-D by M/s
Atco Pharma
Applied
formulation
is
not available in
reference SRA’s.
The firm also
fails to provide
the same.
Deferred for
confirmation
of approval
status
by
reference
regulatory
authorities
442.
M/s
Remington
Pharma
Lahore
791
Moxear-Pain otic drops
Each ml contains:
Moxifloxacin HCL B.P
Equivalent to
Moxifloxacin…..5mg
Lignocaine HCL B.P
equivalent to Lignocaine
base ……50mg
(Antibiotic and local
Anaesthetic)
Manufacturer’s
Specification
Form 5
Dy.No. 1465
23-04-2012
Rs:8,000/30.07.2013
Rs 12,000/Leader Price
Applied
formulation is
not available in
reference
SRA’s.
Me too status is
not confirmed
Applied
formulation
is
not available in
reference SRA’s.
The firm also
fails to provide
the same.
Deferred for
confirmation
of approval
status
by
reference
regulatory
authorities
and pakistan
443.
M/s
Remington
Pharma
Lahore
1772
Valpin-H 5/160/25
Oral Tablet
Each film coated tablet
contains:
Amlodipine (as
Besylate) B.P…..5mg
Valsartan
U.S.P…..160mg
Hydrochlorothazide
U.S.P…..25mg
(Calcium Channel
Blocker, Angiotensin-II
Receptor Antagonist &
Thiazide Diuretic )
Manufacturer’s
Specification
Duplicate Dossier
Form 5
02-02-2011
Rs:8,000/30.07.2013
Rs 12,000/Leader Price
Exforge HCT
Novartis
US
FDA
Valam-H
5/160/25by M/s.
CCL Pharma
Minutes for 260th Meeting Registration Board
Approved
274
444.
M/s
Remington
Pharma
Lahore
1777
Valpin 10/80
Oral Tablet
Each film coated tablet
contains:
Amlodipine (as
Besylate) B.P…..10mg
Valsartan
U.S.P…..80mg
(Calcium Channel
Blocker, AngiotensinUII Receptor Antagonist
& Thiazide Diuretic )
Manufacturer’s
Specification
Duplicate Dossier
Form 5
02-02-2011
Rs:8,000/30.07.2013
Rs 12,000/Leader Price
Applied
formulation is
not available in
reference
SRA’s.
Valam
10/80 by M/s.
CCL Pharma
445.
M/s
Remington
Pharma
Lahore
1773
Valpin-H 10/160/25
Oral Tablet
Each film coated tablet
contains:
Amlodipine (as
Besylate) B.P…..10mg
Valsartan
U.S.P…..160mg
Hydrochlorothazide
U.S.P…..25mg
(Calcium Channel
Blocker, AngiotensinUII Receptor Antagonist
& Thiazide Diuretic )
Manufacturer’s
Specification
Duplicate Dossier
Form 5
02-02-2011
Rs:8,000/30.07.2013
Rs 12,000/Leader Price
Exforge HCT
Novartis
US
FDA
M/s
Remington
Pharma
Lahore
1774
Valpin-H 10/320/25
Oral Tablet
Each film coated tablet
contains:
Amlodipine (as
Besylate) B.P…..10mg
Valsartan
U.S.P…..320mg
Hydrochlorothazide
U.S.P…..25mg
(Calcium Channel
Blocker, AngiotensinUII Receptor Antagonist
& Thiazide Diuretic )
Manufacturer’s
Specification
Duplicate Dossier
Form 5
02-02-2011
Rs:8,000/30.07.2013
Rs 12,000/Leader Price
Exforge HCT
Novartis
US
FDA
446.
Applied
formulation
is
not available in
reference SRA’s.
The firm also
fails to provide
the same.
Deferred for
confirmation
of approval
status
by
reference
regulatory
authorities
Approved
Valam-H
10/160/25by
M/s.
CCL
Pharma
Approved
Valam-H
10/320/25by
M/s.
CCL
Pharma
Following products of M/s. Friends Pharma (Pvt.) ltd were deferred in 257 th meeting of Drug registration board for
approval status of same formulation in reference regulatory authorities and for finished product specification. Now
the firm has submitted the evidence of same formulation in reference regulatory authorities and for finished product
specification. Submitted for consideration of Board.
Minutes for 260th Meeting Registration Board
275
S/N
Name
and
address
of
manufact
urer
/
Applican
t
Brand Name
(Proprietary name +
Dosage
Form
+
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial
date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
447.
M/s.
Friends
Pharma
(Pvt)
Limited,
31Km
Ferozpure
Road,
Lahore
1095
Ferifend
Injection
Each
ml
contains:
Piroxicam……….20mg
Form-5
Dy. No: 547
dated.
28-052011 Rs.8000/Rs.12,000/As per SRO
M/s.
Friends
Pharma
(Pvt)
Limited,
31Km
Ferozpure
Road,
Lahore
1089
Nootrofil Injection
Injection
Each
ml
contains:
Piracetam……..200mg
448.
(Analgesic)
(Nootropic Drug)
Form-5 Dy. No:
553 dated. 2805-2011
Rs.8000/Rs.12,000/- As
per
SRO/200mg/ml
Minutes for 260th Meeting Registration Board
Remarks on the
formulation (if
any) including
International
status
in
stringent drug
regulatory
agencies
/
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by
the Evaluator
International
availability is not
confirmed
pcam
By
M/sMerck
Laboratories.
Remarks
Evaluator
Availability
SRA
is
confirmed
Piracetam
is
a
cyclic
derivative
of GABA. In the
United States, it is
not approved by
the US Food and
Drug
Administration for
any medical use and
it is not permitted to
be sold as a dietary
supplement. In the
UK, piracetam is
prescribed mainly
for myoclonus, but
is used off-label for
other
conditions.
Evidence to support
its use for many
conditions
is
unclear.
in
not
Nootropil
injection
by
Glaxosmithkline,
Pakistan 1G/ 5ml
International
availability is
confirmed
by
not
276
Decision
Deferred
for
confirmatio
n
of
approval
status by
reference
regulatory
authorities
Deferred
for
confirmatio
n
of
approval
status by
reference
regulatory
authorities
DDC PEC-II Muhammad Amin.
Sofosbuvir Cases.
S/N
Name
and
address
of
manufacturer /
Applicant
Brand Name
(Proprietary name + Dosage
Form + Strength)
Composition
Pharmacological Group
Finished
product
Specification
Type of Form
Initial date, diary
Fee
including
differential fee
Demanded Price /
Pack size
449.
M/s NovaMed
Pharmaceuticals
(Pvt) Ltd,
Lahore.
Ledinil Tablet
Tablet
Each tablet contains:Sofosbuvir……400mg
Ledipasvir……90mg
(Manufacturer’s Specs)
Form 5-D
Dairy No. 1928
dated 20-04-2014
Rs.50,000/14’s, 28’s
Rs.630,000/Rs.11,97,000/-
M/s Barrett
Hodgson
Pakistan (Pvt)
Ltd. Karachi.
Hepgard Plus
Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
Ledipasvir……90mg
(Direct-acting antiviral agent
against the hepatitis C virus)
(Mnf Specs)
Form 5-D
Dairy No. 5335
dated 21-08-2015
Rs.50,000/7’s,10’s,14’s,20’s,
28’s,30’s
Rs.24,500/Rs.35,000/Rs.49,000/Rs.70,000/Rs.1,05,000/-
450.
Minutes for 260th Meeting Registration Board
Remarks on
the
formulation (if
any) including
International
status
in
stringent drug
regulatory
agencies
/
authorities
Me-too status
GMP status as
depicted
in
latest
inspection
report (with
date) by the
Evaluator
Harvoni, FDA.
Harvoni,
Ferozsons,
Pakistan.
Harvoni, FDA.
Harvoni,
Ferozsons,
Pakistan.
Remarks
Evaluator
by
 Stability
studies not
submitted.
 Last
Inspection
report
required. \
 Undertaking
as per new
format.
 Stability
studies not
submitted.
 Last
Inspection
report
required.
 Undertaking
as per new
format
277
Decision
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
451.
452.
453.
M/s Barrett
Hodgson
Pakistan (Pvt)
Ltd. Karachi.
Hepgard
Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
(Direct-acting antiviral agent
against the hepatitis C virus)
(Mfg Specs)
Form 5
Dairy No. 5336
dated 24-08-2015
Rs.20,000/7’s,10’s,14’s,20’s,
28’s,30’s
Rs.17,500/Rs.25,000/Rs.35,000/Rs.50,000/Rs.70,000/Rs.75,000/-
Sovaldi, USA.
M/s Indus
Pharma (Pvt.)
Ltd.,
Indovir 400mg
Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
(Anti-Viral)
Form 5-D
Dairy No. 264
dated 17-09-2014
Rs.20,000/As per SRO]
As per SRO
Sovaldi, USA.
M/s Nawan
Laboratories Pvt
Ltd. Karachi.
Virosof
Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
(Antihepatitis ATC Code:
JO5AB)
(Manufacturer’s Specs)
Form 5
Dairy No. 402
dated 22-03-2016
Rs.20,000/As per SRO
As per SRO
Sovaldi, USA.
Sovaldi,
Ferozsons,
Pakistan
Sovaldi,
Ferozsons,
Pakistan
Sovaldi,
Ferozsons,
Pakistan
 Stability
studies not
submitted.
 Last
Inspection
report
required.
 Undertaking
as per new
format
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Stability
studies not
submitted.
 Last
Inspection
report
required.
 Undertaking
as per new
format not
submitted.
 Stability
studies not
submitted.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Last
Inspection
report
required.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Undertaking
as per new
format not
submitted.
454.
M/s Helix
Pharma (Pvt)
Ltd Karachi.
Sofoled 90mg/400mg
Tablet
Each film coated tablet
contains:Ledipasvir……90mg
Sofosbuvir……400mg
(Direct Acting Antiviral)
Minutes for 260th Meeting Registration Board
Form 5-D
Dairy No. 512
dated 11-04-2016
Rs.50,000/As per SRO
As per SRO
Harvoni, FDA.
Harvoni,
Ferozsons,
Pakistan.
 Stability
studies not
submitted.
 Undertaking
as per new
format
278
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
455.
M/s Paramount
Pharmaceutical
Islamabad.
Savior
Tablet
Each tablet contains:Sofosbuvir……400mg
(Anti-infective, Antiviral)
Form 5
Dairy No. 1201
dated 09-10-2015
Rs.20,000/As per SRO
Sovaldi, USA.
Sovaldi,
Ferozsons,
Pakistan
 Stability
studies not
submitted.
 Last
Inspection
report
required.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Undertaking
as per new
format
456.
M/s Rotex
Pharma
Islamabad.
Sonata
Tablet
Each film coated tablet
contains:Ledipasvir…….90mg
Sofosbuvir……400mg
(Nucleotide Analog NSB
Polymerase Inhibitor &
Nucleotide NS5B Inhibitor Anti
viral)
Form 5
Dairy No. 78
dated 11-01-2016
Rs.50,000/28’s
As per SRO
Harvoni, FDA.
Harvoni,
Ferozsons,
Pakistan.
 Stability
studies not
submitted.
 Undertaking
as per new
format.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Inspection
report states
that firm has
limited
capacity of
production.
457.
M/s Pharmix
Laboratories Pvt
Ltd, Lahore
Alvir
Tablet
Each film coated tablet
contains:Ledipasvir…….90mg
Sofosbuvir……400mg
(Antiviral Agent)
Form 5-D
Dairy No.1452
dated 13-11-2015
Rs.50,000/28’s
Rs.100,000/-
Harvoni, FDA.
Harvoni,
Ferozsons,
Pakistan.
 Stability
studies
not
submitted.
 Last Inspection
report
required.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Undertaking as
per new format
458.
M/s Nexus
Pharma Karachi.
Sofonex
Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
(Hepatitis C virus (HCV)
Nucleotide analog
Minutes for 260th Meeting Registration Board
Form 5-D
Dairy No.2299
dated 25-11-2015
Rs.50,000/As per SRO
Sovaldi, USA.
Sovaldi,
Ferozsons,
Pakistan
 Stability
studies not
submitted.
 Last
Inspection
279
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
report
required.
 Undertaking
as per new
format
459.
460.
M/s Bosch
Pharmaceutical
Karachi.
M/s Siam
Pharmaceuticals
Islamabad.
Lesovir
Tablet
Each film coated tablet
contains:Ledipasvir……90mg
Sofosbuvir……400mg
(Hepatitis C virus (HCV)
nucleotide analog NSB
polymerase inhibitor)
Form 5
Dairy No.87
dated 20-01-2016
Rs.20,000/28’s
As per SRO
Sovaldi, USA.
Sifos Plus
Tablet
Each film coated tablet
contains:Ledipasvir……90mg
Sofosbuvir……400mg
(Antiviral)
Form 5-D
Dairy No.1272
dated 03-03-2016
Rs.20,000/As per SRO
Sovaldi, USA.
Sovaldi,
Ferozsons,
Pakistan
 Stability
studies not
submitted.
 Undertaking
as per new
format not
submitted.
Sovaldi,
Ferozsons,
Pakistan
 Stability
studies not
submitted.
 Last
Inspection
report
required..
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Undertaking
as per new
format not
submitted.
461.
M/s Crystolite
Pharmaceuticals,
Islamabad.
Hepled
Tablet
Each film coated tablet
contains:Ledipasvir……90mg
Sofosbuvir……400mg
(Antiviral against Hepaptis C)
(Manufacturer’s Specs)
Minutes for 260th Meeting Registration Board
Form 5-D
Dairy No.3099
dated 30-12-2015
Rs.50,000/As per SRO
Harvoni, FDA.
Harvoni,
Ferozsons,
Pakistan.
 Stability
studies not
submitted.
280
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
462.
463.
464.
465.
466.
M/s Medisave
Pharmaceuticals
Lahore.
Sobovir
Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
(Antivirals for systemic use)
Form 5
Dairy No.1092
dated 12-10-2015
Rs.20,000/As per SRO
Sovaldi, USA.
M/s Global
Pharmaceutical
Pvt. Ltd
Islamabad.
Cure-C Plus
Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
Ledipasvir…..90mg
(Anti-viral agent)
Manufacturer’s Specs
Form 5-D
Dairy No.1035
dated 18-02-2016
Rs.50,000/As per SRO
Harvoni, FDA.
M/s Jenner
Pharmaceuticals
Pvt. Ltd.
Sobovir
Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
(Direct-acting antiviral)
Manufacturer’s Specs
Form 5
Dairy No.1205
dated 20-10-2015
Rs.20,000/28’s
As per SRO
Sovaldi, USA.
M/s Martin Dow
Karachi.
Osvir Plus
Film coated Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
Ledipasvir…….90mg
(Antiviral)
Manufacturer’s Specs
Form 5-D
Dairy No.795
dated 04-11-2015
Rs.50,000/7’s,14’s,28’s
Rs.21,000/Rs.42,000/Rs.84,000/-
Harvoni, FDA.
Ziqar Plus
Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
Ledipasvir…….90mg
(Antiviral)
Form 5-D
Dairy No.795
dated 04-11-2015
Rs.50,000/1’s,5’s,10’s,30’s,
50’s
As per SRO
Harvoni, FDA.
M/s Wilshire
Laboratories
(Pvt) Ltd.
Lahore.
Sovaldi,
Ferozsons,
Pakistan
Harvoni,
Ferozsons,
Pakistan.
Sovaldi,
Ferozsons,
Pakistan
Harvoni,
Ferozsons,
Pakistan.
 Stability
studies not
submitted.
 Last
Inspection
report
required.
 Undertaking
as per new
format not
submitted.
 Stability
studies not
submitted.
 Undertaking
as per new
format not
submitted.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Stability
studies not
submitted.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Stability
studies not
submitted.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Undertaking
as per new
format not
submitted.
Harvoni,
Ferozsons,
Pakistan.
 Stability
studies
not
submitted.
 Last Inspection
report
required.
 Undertaking as
Minutes for 260th Meeting Registration Board
281
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
per new format
467.
468.
469.
470.
M/s Saffron
Pharmaceutical
Faisalabad.
Viraldi
Tablet
Each tablet contains:Sofosbuvir……400mg
Ledipasvir…….90mg
(HCV NS5A Inhibitor and
Nucleotide analog inhibitor of
Hcv NS5B Polymerase.)
Form 5-D
Dairy No.185
dated 07-12-2015
Rs.50,000/30’s
Rs.60,000/-
Harvoni, FDA.
M/s Seatle Pvt
Limited, Lahore.
Isuvir Plus
Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
Ledipasvir…….90mg
(Antiviral.)
Form 5-D
Dairy No.1361
dated 04-11-2015
Rs.50,000/7’s,14’s,28’s
Rs.21,000/Rs.42,000/Rs.84,000/-
Harvoni, FDA.
M/s OBS
Pakistan,
Karachi.
Viratron-Plus
Film coated Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
Ledipasvir…….90mg
(Antiviral.)
Manufacturer’s Specs
Form 5-D
Dairy No.214
dated 03-06-2015
Rs.50,000/28’s
Rs.364,000/-
Harvoni, FDA.
M/s Hilton
Pharma, Karachi
Sofoled
Film coated Tablet
Each film coated tablet
contains:Sofosbuvir……400mg
Ledipasvir…….90mg
(Antiviral.)
Manufacturer’s Specs
Form 5-D
Dairy No.273
dated 06-03-2015
As per DPC
Rs.364,000/-
Harvoni, FDA.
Minutes for 260th Meeting Registration Board
Harvoni,
Ferozsons,
Pakistan.
Harvoni,
Ferozsons,
Pakistan.
 Stability
studies not
submitted.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Stability
studies not
submitted.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
 Undertaking
as per new
format not
submitted.
Harvoni,
Ferozsons,
Pakistan.
Harvoni,
Ferozsons,
Pakistan.
 Stability
studies not
submitted.
 Last
Inspection
report
required.
 Undertaking
as per new
format not
submitted.
 Stability
studies not
submitted.
 Last
Inspection
report
required.
282
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
471.
472.
473.
474.
475.
M/s Tabros
Pharma, Karachi
M/s Sami,
Karachi
M/s Sami,
Karachi
M/s Hilton
Pharma, Karachi
M/s Hilton
Pharma, Karachi
Concerta 400/90 mg Tablets
Each Film coated tablets
contain:
Sofosbuvir….400 mg
Ledipasvir…….90 mg
Form 5-D
Dairy No.273
dated 06-03-2015
As per DPC
Rs.3392.85 per
tablet.
Pack 2 × 14: Rs
95000/-
Harvoni, FDA.
Daclavir 30 mg tablets
Each
film
coated
tablet
contains:
Daclatasvir (as dihydrochloride)
30 mg
Mfg Specs
Form 5-D
Dy no: 1241 dated:
14.6.2016
Rs: 50,000
Price: 6500/ 28
Tablets
Deklinza
of
M/s BMS, UK.
Daclavir 60 mg tablets
Each
film
coated
tablet
contains:
Daclatasvir (as dihydrochloride)
60 mg
Mfg Specs
Form 5-D
Dy no: 1240 dated:
14.6.2016
Rs: 50,000
Price: 13000/ 28
Tablets
Deklinza
of
M/s BMS, UK.
Clavir tablets 30 mg
Each film coated Tablet :
Daclatasvir
…………30mg
(equivalent to 33mg daclatasvir
dihydrochloride)
Form 5-D
Dy. No. 403
dated: 14.09.2015
Rs: 50,000
As Per DPC
Deklinza
of
M/s BMS, UK.
Clavir tablets 60 mg
Each film coated Tablet :
Daclatasvir
…………60mg(equivalent to
66mg
daclatasvir
dihydrochloride)
Form 5-D
Dy. No 402
dated: 14.09.2015
Rs: 50,000
As Per DPC
Deklinza
of
M/s BMS, UK.
Minutes for 260th Meeting Registration Board
Harvoni,
Ferozsons,
Pakistan.
New Molecule
 Stability
studies not
submitted.
 Last
Inspection
report
required.
 Undertaking
as per new
format not
submitted.
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
Stability data of 06
months accelerated
and real time is
required
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
-do-
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
Stability data of 06
months accelerated
and real time is
required
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
-do-
Deferred for
rectification
of mentioned
deficiencies
and
submission of
stability data
New Molecule
New Molecule
New Molecule
283
Deferred Cases:
Following cases of M/s Selmore Pharmaceutical Lahore were deferred in M-258th due to me too
status now the firm has submitted the deficiencies.
S/N
Name
and
address
of
manufacturer /
Applicant
Brand Name
(Proprietary name + Dosage Form
+ Strength)
Composition
Pharmacological Group
Finished product Specification
Type of Form
Initial date, diary
Fee
including
differential fee
Demanded Price / Pack
size
476.
M/s. Selmore
Pharmaceuticals
(Pvt) Limited,
36 Km, Multan
Road, Lahore.
Novacin intra-Mammary Suspension
Liquid Injectable
Each 5ml contains:Penicillin G
Sodium…………..200,000IU
Novobiocin Sodium eq. to
Novobiocin ………………….400mg
(2 years)
Form-5
Dy. No.138
Dated.28-01-2016
Rs.20,000/Decontrolled
10ml,10ml x 12’s
10mlx24’s
477.
M/s. Selmore
Pharmaceuticals
(Pvt) Limited,
36 Km, Multan
Road, Lahore.
Speclimox Oral Dry Powder
Oral Dry Powder
Each Kg powder contains:Amoxicillin Trihydrate (BP) eq. to
Amoxicillin…………….......200mg
Lincomycin HCI (BP) eq. to
Lincomycin…..88mg
Spectinomycin Sulphate (BP VET).
eq. to Spectinomycin……........88mg
(Board Spectrum Antibiotics
(Penicillin/ Aminoglycosides)
02 years
Form-5
Dy. No.133
Dated.28-01-2016
Rs.20,000/Decontrolled
100gm,250gm
500gm,1Kg
Minutes for 260th Meeting Registration Board
Remarks on
the
formulation
(if
any)
including
International
status
in
stringent
drug
regulatory
agencies
/
authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
Me-too
not
available
Decision
Me-too
available
Rejected on
the grounds
that me-too
of the drug
is
not
available
not
Rejected on
the grounds
that me-too
of the drug
is
not
available
284
Minutes for 260th Meeting Registration Board
285
Grant of Registration to New Drug Manufacturing Licenses
DDC-PEC-I Dr.Hafsa Karam Ellahi
S/N
Name and address of
manufacturer / Applicant
478.
Scilife Pharma
(Private)
Limited
Plot # FD57/58-A2,
Korangi Creek
Industrial
park (KCIP)
Karachi
479.
480.
Tablet
(General)
approved in
247st meeting
of Central
Licensing
Board held on
29-04-2016.
-do-
-do-
Brand Name
(Proprietary
name + Dosage
Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
Tablet (General)
Leflo Tablet 250 mg
Form 5
Each film coated
Rs. 20,000/tablet contains:
Dy. No.1156
Levofloxacin 250 mg 08-06-2016
(as hemihydrates)
10’s,30’s
(Scilife Spec)
As Per SRO
Quinolone
Antibiotics
Leflo Tablet 500 mg
Each film coated
tablet contains:
Levofloxacin 500 mg
(as hemihydrates)
(Scilife Spec)
Quinolone
Antibiotics
Form 5
Rs. 20,000/Dy. No.1155
08-06-2016
10’s,30’s
As Per SRO
Leflo Tablet 750 mg
Each film coated
tablet contains:
Levofloxacin 750 mg
(as hemihydrates)
(Scilife Spec)
Quinolone
Antibiotics
Form 5
Rs. 20,000/Dy. No. 1154
08-06-2016
10’s,30’s
As Per SRO
Minutes for 260th Meeting Registration Board
International
status in
reference drug
agencies /
authorities
Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Remarks
FDA approved
Tablet Levaquin
250 mg
manufactured by
Janssen Pharms
Decision
Approved
Tablet
Dynaquin 250
mg by Barrett
Hodgson
FDA approved
Tablet Levaquin
500 mg
manufactured by
Janssen Pharms
Approved
Tablet
Dynaquin 500
mg by Barrett
Hodgson
FDA approved
Tablet Levaquin
750 mg
manufactured by
Janssen Pharms
Approved
Leflox by M/s
Getz Pharma
286
481.
482.
483.
484.
485.
-do-
-do-
-do-
-do-
-do-
Amstan Tablet 5/80
mg
Each film coated
tablet contains:
Amlodipine: 5 mg (as
Amlodipine Besylate)
Valsartan: 80 mg
(Scilife Spec)
Anti-Hypertensive
Form 5
Dy. No. 1206
Dated.08-06-2016
Rs. 20,000/Pack of 14’s,28’s /as
per SRO
Amstan Tablet 5/160
mg
Each film coated
tablet contains:
Amlodipine: 5 mg (as
Amlodipine Besylate)
Valsartan: 160 mg
(Scilife Spec)
Anti-Hypertensive
Form 5
Rs. 20,000/Dy. No.1207
Dated.08-06-2016
14’s,28’s
As Per SRO
Amstan Tablet
10/160 mg
Each film coated
tablet contains:
Amlodipine: 10 mg
(as Amlodipine
Besylate)
Valsartan: 160 mg
(Scilife Spec)
Anti-Hypertensive
Form 5
Rs. 20,000/Dy. No.1208
Dated.08-06-2016
14’s,28’s
As Per SRO
Co-Amstan Tablet
5/160/12.5 mg
Each film coated
tablet contains:
Amlodipine: 5 mg (as
Amlodipine Besylate)
Valsartan: 160 mg
Hydrochlorothiazide
USP: 12.5 mg
(Scilife Spec)
Anti-Hypertensive
Co-Amstan Tablet
10/160/12.5 mg
Each film coated
tablet contains:
Amlodipine: 10 mg
(as Amlodipine
Besylate)
Valsartan: 160 mg
Hydrochlorothiazide
Form 5
Rs. 20,000/Dy. No. 1209
08-06-2016
14’s,28’s
As Per SRO
Minutes for 260th Meeting Registration Board
FDA approved
Tablet
Exforge 5/80 mg
manufactured by
Novartis
Approved
Tablet
Avsar 5/80 mg
manufactured by
Pharmevo
FDA approved
Tablet
Exforge 5/160
mg
manufactured by
Novartis
Approved
Tablet
Avsar 5/160 mg
manufactured by
Pharmevo
FDA approved
Tablet
Exforge 10/160
mg
manufactured by
Novartis
Approved
Tablet
Avsar 10/160
mg
manufactured by
Pharmevo
FDA approved
Tablet
Exforge HCT
5/160/12.5 mg
manufactured by
Novartis
Approved
Tri-Valsan by
M/s Hilton
Pharma
Form 5
Rs. 20,000/Dy. No.1173
08-06-2016
14’s,28’s
As Per SRO
FDA approved
Tablet
Exforge HCT
10/160/12.5 mg
manufactured by
Novartis
Approved
Tri-valsan by
Hilton Pharma
287
486.
487.
488.
489.
-do-
-do-
-do-
-do-
USP: 12.5 mg
(Scilife Spec)
Anti-Hypertensive
Co-Amstan Tablet
5/160/25 mg
Each film coated
tablet contains:
Amlodipine: 5 mg (as
Amlodipine Besylate)
Valsartan: 160 mg
Hydrochlorothiazide
USP: 25 mg
(Scilife Spec)
Anti-Hypertensive
Co-Amstan Tablet
10/160/25 mg
Each film coated
tablet contains:
Amlodipine: 10 mg
(as Amlodipine
Besylate)
Valsartan: 160 mg
Hydrochlorothiazide
USP: 25 mg
(Scilife Spec)
Anti-Hypertensive
Co-Amstan Tablet
10/320/25 mg
Each film coated
tablet contains:
Amlodipine: 10 mg
(as Amlodipine
Besylate)
Valsartan: 320 mg
Hydrochlorothiazide
USP: 25 mg
(Scilife Spec)
Anti-Hypertensive
Cowaldi Tablet 400
mg
Each film coated
tablet contains:
Sofosbuvir 400 mg
(Scilife Spec)
Anti-Hepatitis C
Minutes for 260th Meeting Registration Board
Form 5
Rs. 20,000/Dy. No. 1172
08-06-2016
14’s,28’s
As Per SRO
FDA approved
Tablet
Exforge HCT
5/160/25 mg
manufactured by
Novartis
Approved
Tri-Valsan by
M/s Hilton
Pharma
Form 5
Rs. 20,000/Dy. No. 1169
08-06-2016
14’s,28’s
FDA approved
Tablet
Exforge HCT
10/160/25 mg
manufactured by
Novartis
Approved
Tri-Valsan by
M/s Hilton
Pharma
Form 5
Rs. 20,000/Dy. No.1157
08-06-2016)
14’s,28’s
As Per SRO
FDA approved
Tablet
Exforge HCT
10/320/25 mg
manufactured by
Novartis
Approved
Tri-Valsan by
M/s Hilton
Pharma
Form 5
Rs. 20,000/Dy. No. 1186
08-06-2016
30’s As Per SRO
FDA approved
Tablet Sovaldi
400 mg
manufactured by
Gilead science
Stability
data is
required.
Tablet Sofos
400 mg by
Genix Pharma
288
Deferred
for
submissio
n
of
stability
data as per
guidelines
approved
by
registratio
n Board in
251st
meeting
490.
-do-
Arixa Tablet 10 mg
Each film coated
tablet contains:
Rivaroxaban 10 mg
(Scilife Spec)
Anti-Coagulant
Form 5
Rs. 20,000/Dy. No.1153
08-06-2016
14’s,28’s
As Per SRO
FDA approved
Tablet Xarelto
10 mg
manufactured by
Janssen Pharms
Approved
Tablet
Xarelto 10 mg
manufactured by
Bayer
491.
-do-
Arixa Tablet 15 mg
Each film coated
tablet contains:
Rivaroxaban 15 mg
(Scilife Spec)
Anti-Coagulant
Form 5
Rs. 20,000/Dy. No.1152
08-06-2016
14’s,28’s
As Per SRO
FDA approved
Tablet Xarelto
15 mg
manufactured by
Janssen Pharms
Approved
Tablet
Xarelto 15 mg
manufactured by
Bayer
492.
493.
494.
-do-
-do-
-do-
Arixa Tablet 20 mg
Each film coated
tablet contains:
Rivaroxaban 20 mg
(Scilife Spec)
Anti-Coagulant
Form 5
Rs. 20,000/Dy. No.1189
08-06-2016
14’s,28’s
FDA approved
Tablet Xarelto
20 mg
manufactured by
Janssen Pharms
Wilda-M Tablet
50/500 mg
Each film coated
tablet contains:
Vildagliptin
50 mg
Metformin HCl 500
mg
(Scilife Spec)
Anti-Diabetic
Form 5
Rs. 20,000/Dy. No.1192
08-06-2016
14’s,28’s
As Per SRO
Tablet
Xarelto 20 mg
manufactured by
Bayer
TGA & EMA
approved Tablet
Eucreas 50/500
mg
manufactured by
Novartis
Wilda-M Tablet
50/850 mg
Each film coated
tablet contains:
Vildagliptin
50 mg
Metformin HCl 850
mg
(Scilife Spec)
Anti-Diabetic
Form 5
Rs. 20,000/Dy. No.1188
08-06-2016
Minutes for 260th Meeting Registration Board
Approved
Approved
Tablet
Galvus Met
50/500 mg
manufactured by
Novartis
14’s,28’s
As Per SRO
TGA & EMA
approved Tablet
Eucreas 50/850
mg
manufactured by
Novartis
Tablet
Galvus Met
50/850 mg
manufactured by
Novartis
Approved
289
495.
496.
497.
498.
-do-
-do-
-do-
-do-
Wilda-M Tablet
50/1000 mg
Each film coated
tablet contains:
Vildagliptin
50 mg
Metformin HCl 1000
mg
(Scilife Spec)
Anti-Diabetic
Form 5
Rs. 20,000/Dy. No.1187
03-06-2016
Pack of 14’s/as per
DPC
28’s / as per DPC
Dolobid-P Tablet
325/37.5 mg
Each film coated
tablet contains:
Paracetamol
325 mg
Tramadol HCL 37.5
mg
(Scilife Spec)
Analgesic
Form 5
Rs. 20,000/Dy. No.1190/08-06-2016
10’s,30’s
As Per SRO
Omitax Tablet 10/10
mg
Each enteric coated
tablet contains
Doxylamine
Succinate 10 mg
Pyridoxine
Hydrochloride 10 mg
(Scilife Spec)
Anti-emetic
Form 5
Rs. 20,000/Dy. No. 1185
08-06-2016
10’s,30’s
Romilast Tablet 500
mcg
Each tablet contains:
Roflumilast
500 mcg
(Scilife Spec)
Phosphodiesterase
Inhibitor
Form 5-D
Rs. 50,000/Dy. No.
08-06-2016
10’s,20’s,30’s
As Per SRO
Minutes for 260th Meeting Registration Board
TGA & EMA
approved Tablet
Eucreas 50/1000
mg
manufactured by
Novartis
Approved
Tablet
Galvus Met
50/1000 mg
manufactured by
Novartis
FDA approved
Tablet Ultracet
325/37.5 mg
manufactured by
Janssen Pharm
Approved
with
change of
brand
name
Tablet
Tramal Plus
325/37.5 mg
manufactured by
Searle Pharma
FDA approved
Tablet Diclegis
10/10 mg
manufactured by
Duche Snay
Approved
Tablet
Envepe 10/10
mg
manufactured by
RG Pharma
FDA approved
Tablet
Daliresp 500
mcg
manufactured by
Astrazeneca
Pharms
Stability
data is
required.
290
Deferred
for
submissio
n
of
stability
data as per
guidelines
approved
by
registratio
n Board in
251st
meeting
499.
500.
501.
502.
-do-
Scimox Tablet 400
mg
Each Film coated
tablet contains:
Moxifloxacin…400
mg (as
Hydrochloride)
(Scilife Spec)
Quinolones
Antibiotic
Scilife Pharma
(Private) Limited
Plot # FD-57/58-A2,
Korangi Creek
Industrial park (KCIP)
Karachi
Capsule (General)
approved in 247st
meeting of Central
Licensing Board held
on 29-04-2016.
-do-
-do-
Form 5
Rs. 20,000/Dy. No. 1191
08-06-2016
5’s/ As Per SRO
FDA approved
Tablet Avelox
400 mg
manufactured by
Bayer Health
care
Approved
Tablet
Moxiget 400
mg
manufactured by
Getz Pharma
Capsule (General)
Dolobid Capsule
Form 5
50mg
Rs. 20,000/Dy. No.1183
Each capsule
08-06-2016
contains
10’s,30’s
Tramadol HCl 50mg As Per SRO
TGA Approved
Zydol by M/s
Arrow Pharma
Approved
with
change of
brand
name
Tamadol 50 mg
(Highnoon
Pharma)
Analgesic (Scilife
Spec)
Duloxa Capsule
20mg
Each capsule
contains
Duloxetine HCL
17.65% enteric
coated pellets
equivalent to 20 mg
Duloxetine
Serotonin/Nor
epinephrine Reuptake Inhibitor
(Scilife Spec)
Source of pellets
M/s Surge
laboratories Private
Limited,
Sheikhupura
Duloxa Capsule
30mg
Each capsule
contains
Duloxetine HCL
17.65% enteric
coated pellets
equivalent to 30 mg
Duloxetine
Serotonin/Nor
epinephrine Re-
Minutes for 260th Meeting Registration Board
Form 5
Rs. 20,000/Dy. No.1182
08-06-2016
14’s,28’s
FDA approved
capsule
Cymbalta 20 mg
manufactured by
Lilly
Approved
Dulan 20 mg
(Hilton Pharma)
Form 5
Rs. 20,000/Dy. No.1181
08-06-2014
14’s,28’s
As Per SRO
FDA approved
capsule
Cymbalta 30 mg
manufactured by
Lilly
Approved
Dulan 30 mg
(Hilton Pharma)
291
503.
504.
-do-
-do-
uptake Inhibitor
(Scilife Spec)
Source of pellets
M/s Surge
laboratories Private
Limited,
Sheikhupura
Duloxa Capsule
60mg
Each capsule
contains
Duloxetine HCL
17.65% enteric
coated pellets
equivalent to 60 mg
Duloxetine
Serotonin/Nor
epinephrine Reuptake Inhibitor
(Scilife Spec)
Source of pellets
M/s Surge
laboratories Private
Limited,
Sheikhupura
Timsol Capsule 0.4
mg
Each capsule
contains
Tamsulosin HCl
0.2% Pellets
equivalent to 0.4 mg
Tamsulosin
Form 5
Rs. 20,000/Dy. No.1180
08-06-2016
14’s, 28’s As
Per SRO
FDA approved
capsule
Cymbalta 60 mg
manufactured by
Lilly
Dulan 60 mg
(Hilton Pharma)
Approved
Form 5
Rs. 20,000/Dy. No.1178
08-06-2016
20’s,30’s
As Per SRO
FDA approved
capsule Flomax
0.4 mg
manufactured by
Boehringer
Ingelheim
Approved
Tamsolin 0.4 mg
(Getz Pharma)
Peripherally acting
anti-adrenergic
(Scilife Spec)
505.
-do-
Source of pellets
M/s Vision
Pharmaceuticals,
Islamabad
Ozon Capsule 20
mg
Each capsule
contains
Omeprazole 12.5%
Enteric coated
Pellets equivalent to
20 mg Omeprazole
Form 5
Rs. 20,000/Rs.80000/- Dy.
No.1177 0806-2016
FDA approved
capsule Prilosec
20 mg
manufactured by
Astrazeneca
Pharma
Approved
14’s,28’s
Risek 20 mg
(Getz Pharma)
Proton Pump
Inhibitor
(Scilife Spec)
Minutes for 260th Meeting Registration Board
292
Source of pellets
M/s Spansules
Formulation, India
506.
-do-
Ozon Capsule 40
mg
Each capsule
contains
Omeprazole 12.5%
Enteric coated
Pellets equivalent to
40 mg Omeprazole
Proton Pump
Inhibitor
(Scilife Spec)
507.
-do-
Source of pellets
M/s Spansules
Formulation, India
Mebrin MR Capsule
200 mg
Each capsule
contains
Mebeverine HCl
MR 80% Pellets 200
mg
Form 5
Rs. 20,000/Rs.80000/- Dy.
No.1176 0806-2016
Pack of
14’s / as per
DPC
28’s / as per
DPC
Form 5
Rs. 20,000/Rs.80,000/Dy. No.1179
08-06-2016
10’s,20’s As
Per SRO
508.
-do-
Each gastro resistant
Capsule contains:
Dexlansoprazole
22.5% Enteric
Coated Pellets……
30 mg
Approved
Risek 40 mg
(Getz Pharma)
MHRA
approved
capsule Colofac
MR
manufactured by
Abbott
Approved
Mebever MR
200 mg
(Getz Pharma)
Anti-Spasmodic
(Scilife Spec)
Source of pellets
M/s Spansules
Formulation, India
Dexlanz Capsule 30
mg
FDA approved
capsule Prilosec
40 mg
manufactured by
Astrazeneca
Pharma
Form 5
Rs. 20,000/Rs.80,000
Dy. No.1205
08-06-2016
14’s / As Per
SRO
USFDA
approved
capsule
Dexilant 30 mg
manufactured by
Takeda Pharma
Me too
needs to
be
verified.
Proton pump
Inhibitor
(Scilife Spec)
Source of pellets
M/s Spansules
Formulation, India
Minutes for 260th Meeting Registration Board
293
Deferred
for
submissio
n
of
applicatio
n on Form
5D,
requisite
fee
and
stability
data as per
guidelines
approved
by
registratio
509.
-do-
Dexlanz Capsule 60
mg
Each gastro resistant
Capsule contains:
Dexlansoprazole
22.5% Enteric
Coated Pellets….60
mg
Proton pump
Inhibitor
(Scilife Spec)
Source of pellets
M/s Spansules
Formulation, India
Form 5
Rs. 20,000/Rs.80,000/-Dy.
No.1204
08-06-2016
14’s As Per
SRO
USFDA
approved
capsule
Dexilant 60 mg
manufactured by
Takeda Pharma
Me too needs to
be verified.
Me too
needs to
be
verified.
Invalid
GMP
certificat
e
attached.
n Board in
251st
meeting
Deferred
for
submissio
n
of
applicatio
n on Form
5D,
requisite
fee
and
stability
data as per
guidelines
approved
by
registratio
n Board in
251st
meeting
Sachet (General)
510.
511.
Scilife Pharma (Private)
Limited
Plot # FD-57/58-A2,
Korangi Creek
Industrial park (KCIP)
Karachi
Sachet (General)
approved in 247st
meeting of Central
Licensing Board held
on 29-04-2016.
-do-
Asthiven 4mg
Sachet
Each Sachet
contains
Montelukast
Sodium eq. to
Montelukast 4 mg
Leukotriene
receptor antagonist
(Scilife Spec)
Form 5
Rs. 20,000/Dy. No.1203
08-06-2016
14’s,28’s
As Per SRO
FDA Approved
Singular
Merck (FDA)
Solo Powder 4
mg
manufactured by
(Atco)
Ozon Insta Powder
20 mg Sachet
Form 5
Rs. 20,000/Dy. No.1196
08-06-2016
10’s,30’s
As Per SRO
FDA Approved
Zegerid
Santarus INC
Form 5
Rs. 20,000/-
FDA Approved
Zegerid
Each Sachet
contains
Omeprazole
20 mg
Sodium
Bicarbonate 1680
mg (as buffer)
512.
-do-
Proton Pump
Inhibitor
(Scilife Spec)
Ozon Insta Powder
40 mg Sachet
Minutes for 260th Meeting Registration Board
Risek Insta
Powder 20 mg
manufactured by
(Getz Pharma)
Approved
In
review in
250th
meeting
Deferred
as
formulatio
n is under
Internati
onal
Deferred
as
294
513.
514.
-do-
-do-
Each Sachet
contains
Omeprazole
40 mg
Sodium
Bicarbonate 1680
mg (as buffer)
Proton Pump
Inhibitor
(Scilife Spec)
Dy. No.1195
03-06-2016
10’s,30’s
As Per SRO
Santarus INC
Risek Insta
Powder 40 mg
manufactured by
(Getz Pharma)
Forlax Sachet
Each Sachet
contains
PEG 3350
…..13.125 g
Sodium Chloride….
0.3507 g
Sodium
bicarbonate….
0.1785 g
Potassium
chloride…
0.0466 g
Form 5
Rs. 20,000/Dy. No.1201
08-06-2016
TGA & MHRA
Approved
Movicol Sachet
Somatically acting
laxatives (Scilife
Spec)
Forlax Junior
Sachet
Each Sachet
contains
PEG 3350
…..6.563 g
Sodium Chloride….
0.1754 g
Sodium
bicarbonate….
0.0893 g
Potassium
chloride…
0.0251 g
Somatically acting
laxatives (Scilife
Spec)
Minutes for 260th Meeting Registration Board
10’s,20’s
As Per SRO
Form 5
Rs. 20,000/Dy. No.1200
08-06-2016)
10’s,20’s
As Per SRO
availabili
ty
discontin
ue from
market.
In
review in
250th
meeting
formulatio
n is under.
Also
confirmati
on
regarding
approval
status by
reference
regulatory
authorities
Approved
Composi
tion API
in me
too is
Norgine Limited different
from the
Movcol
manufactured by product
(Genix Pharma)
applied
for
Deferred
for
confirmati
on
of
compositi
on as per
me too
Norgine Limited
Movcol
manufactured by
(Genix Pharma)
TGA & MHRA
Approved
Movicol Junior
Sachet
Sodium
Chloride…
.
350.7mg
Sodium
bicarbonat
e….
178.5mg
Potassium
chloride…
46.6mg
295
515.
-do-
Hydro Sachet
Each Sachet
contains
Anhydrous Glucose
13.50 g
Tri sodium citrate
Dihydrate 2.90 g
Sodium Chloride
2.60 g
Potassium Chloride
1.50 g
Form 5
Rs. 20,000/Dy. No.1199
08-06-2016
NonProprietary Oral
Rehydration
Salt BP
20’s,30’s As
Per SRO
WHO
Recommended
Formulation
Cellchem
Pharmaceutical
Incorporation,
Canada
Electrolyte Solution
(Anti-diarrheal)
Peditral Sachet
by M/s Searl
Pharma
(Scilife Spec)
516.
-do-
One soda Sachet
Each Sachet
contains
Sodium Bicarbonate
1.716 g
Sodium citrate
0.613g
Citric acid
0.702 g
Tartaric acid 0.858
g
Form 5
Rs. 20,000/Dy. No.1197
08-06-2016
20’s
As Per SRO
-do-
Mehvisk Sachet
Each Sachet contains
Mebeverine HCl 135
mg
Isaphagul husk 3.5 g
Antispasmodic, Anti
Constipative
(Scilife Spec)
Minutes for 260th Meeting Registration Board
Approved
Anhydrous
Glucose 20
g
sodium
citrate
2.90g
Sodium
Chloride
3.5g
TGA Approved
Ural sachet
Aspen Pharma
Composi
tion of
API in
ural
Citro soda
manufactured by sachet is
(Abbott)
different
from the
product
applied
for
Urinary and gastric
alkaliniser
(Scilife Spec)
517.
Composi
tion API
in me
too is
different
from the
product
applied
for
Deferred
for
confirmati
on
of
compositi
on as per
me too
Sodium
Bicarbonat
e 1.76 g
Sodium
citrate
0.63g
Citric acid
0.72 g
Tartaric
acid 0.89 g
Form 5
Rs. 20,000/- Dy.
No.1198 08-062016
10’s,20’s
As Per SRO
MHRA Approved
Fybogel
Mebeverine
Forum Health
Product Limited
Approved
Musk-MSachet
manufactured by
Genix Pharma )
296
Evaluator-I Muhammad Ansar
Additional Sections.
Additional section Veterinary
S/N
Name
and
address
of
manufacturer
/ Applicant
Brand Name
(Proprietary name +
Dosage Form + Strength)
Type of Form
Composition
Fee
including
differential fee
Initial date, diary
Pharmacological Group
Finished
Specification
product
Demanded Price / Pack
size
Remarks on the
formulation (if
any) including
International
status
in
stringent drug
regulatory
agencies
/
authorities
Remarks
Evaluator/
Decision
by
Decision
Me-too status
GMP status as
depicted
in
latest inspection
report
(with
date) by the
Evaluator
518.
M/s
Sanna
Laboratories,
1019-B, PSIE,
Sargodha
Road,
Faisalabad.
ATC-Forte Oral
Soluble Powder
water
Each 100gm contains:Amoxicillin
Trihydrate……50gm
Colistin
Sulphate…….50MIU
Form 5
Dy No.442 dated 20-052016 Rs.20,000.
Decontrolled/100gm,
300gm, 500gm, 1kg,
5kg, 10kg & 25kg.
Approved
Local. Amox-C
Maarson
by
Attabak.
Antibacterial
519.
-do-
Manufacturer’s
Specifications
Himox-50
Oral
Soluble Powder
water
Each 1000gm contains:Amoxicillin Trihydrate eq
to Amoxicillin……500gm
Antibacterial
520.
-do-
Lincosac-200 Oral water
Soluble Powder
Each 1000gm contains:Amoxicillin
Trihydrate
……20gm
Lincomycin
HCl……….8.8gm
Form 5
Dy No.446 dated 20-052016 Rs.20,000.
Approved
Local. Amoxi-50
by M/s Symans.
Decontrolled/100gm,
300gm, 500gm, 1kg,
5kg, 10kg & 25kg.
Form 5
Dy No.440 dated 20-052016 Rs.20,000.
Approved
Local.
Amoxy
L.S
by
M/s
Inshall.
Decontrolled/100gm,
300gm, 500gm, 1kg,
5kg, 10kg & 25kg.
Minutes for 260th Meeting Registration Board
297
Spectinomycin
2HCl…….8.8gm
Antibacterial
521.
-do-
Manufacturer’s
Specifications
Clavmox-Forte Oral water
Soluble Powder
Each 100gm contains:Amoxicillin as Amoxicillin
Trihydrate ……16gm
Clavulanic
Acid
as
Potassium
Clavulanate……4gm
Bromhexine
HCl…………….0.5gm
Form 5
Dy No.445 dated 20-052016 Rs.20,000.
Approved
Local. WealmoxPlus by M/s Prix.
Decontrolled/100gm,
300gm, 500gm, 1kg,
5kg, 10kg & 25kg.
Antibacterial
522.
-do-
Manufacturer’s
Specifications
Clavmox-200 Oral water
Soluble Powder
Each 100gm contains:Amoxicillin as Amoxicillin
Trihydrate ……16gm
Clavulanic
Acid
as
Potassium
Clavulanate……4gm
Form 5
Dy No.441 dated 20-052016 Rs.20,000.
Approved
Local. PrimoxPlus by M/s Prix.
Decontrolled/100gm,
300gm, 500gm, 1kg,
5kg, 10kg & 25kg.
Antibacterial
523.
-do-
Himox-70
Oral
Soluble Powder
water
Each 100gm contains:Amoxicillin
Trihydrate
80gm eq to Amoxicillin
……70gm
Form 5
Dy No.443 dated 20-052016 Rs.20,000.
Approved
Local.
Primox
70% by M/s Prix.
Decontrolled/100gm,
300gm, 500gm, 1kg,
5kg, 10kg & 25kg.
Antibacterial
524.
-do-
GP-80 Oral water Soluble
Powder
Each 1000gm contains:Zinc Bacitracin ……52gm
Procaine
Penicillin
……..12gm
Streptomycin
Sulphate……36gm
Form 5
Dy No.444 dated 20-052016 Rs.20,000.
Approved
Local. PSB-100
by M/s Epla.
Decontrolled/100gm,
300gm, 500gm, 1kg,
5kg, 10kg & 25kg.
Antibacterial
Minutes for 260th Meeting Registration Board
298
M/s Vision Pharma Human Additional section
S/N
Name
and
address
of
manufacturer /
Applicant
Brand Name
(Proprietary name
Form + Strength)
Type of Form
+
Dosage
Initial
diary
date,
Composition
Pharmacological Group
Fee including
differential
fee
Remarks on the
formulation
(if
any)
including
International
status in stringent
drug
regulatory
agencies
/
authorities
Remarks
by
Evaluator/
Decision
Decision
Finished product Specification
Demanded
Price / Pack
size
525.
526.
M/s
Vision
Pharmaceuticals,
Plot No. 22 &
23,
Industrial
Triangle Kahuta
Road,
Islamabad.
“Liquid
Vial
General
approved
in
247th meeting of
CLB.”
-do-
Linzy 600mg Infusion
Form 5
Each vial of 300ml contains:Linezolid……….…..600mg
Dy No. 2713
dated 16-062016
Rs.20,000.
Antibiotic
Manufacturer’s Specifications
As
SRO/1’s
Linzy 400mg Infusion
Form 5
Each vial of 200ml contains:Linezolid……….…..400mg
Dy No. 2715
dated 16-062016
Rs.20,000.
Antibiotic
Manufacturer’s Specifications
527.
-do-
Linzy 200mg Infusion
Each vial of 100ml contains:Linzolid……….…..200mg
Antibiotic
Manufacturer’s Specifications
528.
-do-
Katafast 500mg Injection
Each vial of 10ml contains:Ketamine hydrochloride equivalent
to ketamine……….…..500mg
Anesthetic
Minutes for 260th Meeting Registration Board
As
SRO/1’s
Form 5
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
MHRA. Linzolid
2mg/ml by M/s
Pfizer
Local.
600mg
Bosch.
by
Approved
Lezol
M/s
per
MHRA.
2mg/ml
Pfizer
Local.
400mg
Bosch.
Linzolid
by M/s
by
Approved
Lezol
M/s
per
Dy No. 2714
dated 16-062016
Rs.20,000.
As
SRO/1’s
Form 5
Me-too status
MHRA.
2mg/ml
Pfizer
Local.
200mg
Bosch.
Linzolid
by M/s
by
Approved
Zolrest
M/s
per
Dy No. 2704
dated 16-062016
Rs.20,000.
MHRA.
Ketalar
50mg/ml by M/s
Pfizer
Local.
500mg
Global
Approved
Ketarol
by M/s
299
529.
530.
531.
-do-
M/s
Vision
Pharmaceuticals,
Plot No. 22 &
23,
Industrial
Triangle Kahuta
Road,
Islamabad.
“Liquid
Ampoule
General
approved
in
247th meeting of
CLB.”
-do-
USP Specifications
As
SRO/1’s
Odimox 400mg Infusion
Form 5
Each vial of 100ml contains:Moxifloxacin
hydrochloride
equivalent
to
Moxifloxacin……….…..400mg
Dy No. 2706
dated 16-062016
Rs.20,000.
Antibiotic
As
SRO/1’s
Manufacturer’s Specifications
Artip 40mg Injection
Each ampoule contains:Artemether……….…..40mg
Antimalarial
Dy No. 2703
dated 16-062016
Rs.20,000.
Approved
Local. Artem 40mg
by M/s Holton
Pharma
(PVT)
Limited
Each ampoule of 1 ml contains:Artemether……….…..80mg
Dy No. 2702
dated 16-062016
Rs.20,000.
Local. Artem 80mg
by M/s Holton
Pharma
(PVT)
Limited
Manufacturer’s Specifications
-do-
Form 5
WHO approved
NSAID
Doston 4mg Injection
Each ampoule of 2ml contains:Ondansetron
hydrochloride
equivalent
to
Ondansetron…….…..4mg
5-HT3 Receptor Antagonist
USP Specifications
Minutes for 260th Meeting Registration Board
Advised
to
apply Form 5
with 250ml
per
Form 5
Feldex 20mg Injection
Approval status
in
reference
countries
not
provided.
Local.
Barimox
400mg by M/s
Barrett Hodgson.
Artip 80mg Injection
Each ampoule contains:Piroxicam……….…..20mg
533.
MHRA. Avelox by
M/s
Bayer
400mg/250ml
As
per
SRO/1x5’s &
1x10’s
Manufacturer’s Specifications
-do-
Pharmaceuticals
Manufacturer’s Specifications
Antimalarial
532.
per
As
per
SRO/1x5’s &
1x10’s
Form 5
Dy No. 2705
dated 16-062016
Rs.20,000.
As
per
SRO/1x5’s &
1x10’s
Form 5
Dy No. 2771
dated 20-062016
Rs.20,000.
As
per
SRO/1x5’s &
1x10’s
Local. Pcam 20mg
by M/s Merck (Pvt)
Limited
Approved
Approval status
in
reference
countries is not
provided.
MHRA. Zofran by
M/s GSK
Deferred for
confirmation
of
approval
status
by
reference
regulatory
authorities.
Approved
Local. Ondiemetic
4mg by M/s Zafa
Pharmaceuticals
300
534.
535.
-do-
-do-
Doston 8mg Injection
Form 5
Each ampoule 0f 4ml contains:Ondansetron
hydrochloride
equivalent
to
Ondansetron…….…..8mg
Dy No. 2770
dated 20-062016
Rs.20,000.
5-HT3 Receptor Antagonist
As
per
SRO/1x5’s &
1x10’s
Form 5
USP Specifications
Tramax 50mg Injection
Each ampoule of 1ml contains:Tramadol hydrochloride equivalent
to Tramadol…….…..50mg
Dy No. 2710
dated 16-062016
Rs.20,000.
Opioid analgesic
USP Specifications
536.
-do-
Spasmax Plus Injection
Each ampoule contains:Phloroglucinol
dehydrate
equivalent
to
Phloroglucinol…….40mg
Trimethylphloroglucinol….0.04mg
Antispasmodic
537.
-do-
Manufacturer’s Specifications
Zytec 25mg Injection
Each ampoule of 1ml contains:Ranitidine
hydrochloride
equivalent to Ranitidine…….25mg
Dy No. 2774
dated 20-062016
Rs.20,000.
538.
-do-
Pyritec 150mg Injection
Each ampoule 1ml contains:Paracetamol………….150mg
Analgesic & antipyretic
Manufacturer’s Specifications
539.
-do-
MHRA. Tramadol
by M/s Beacon
Approved
Local. Tramal
50mg
by
M/s
Searle
Pakistan
(Pvt) Limited.
The product is
under review.
Local. Spadix by
M/s
Tabros
Pharma.
Deferred
as
product
is
under review.
As
per
SRO/1x5’s &
1x10’s
Form 5
Dy No. 2702
dated 16-062016
Rs.20,000.
As
per
SRO/1x5’s &
1x10’s
Form 5
Dy No. 2712
dated 16-062016
Rs.20,000.
MHRA. Ranitidine
25mg/ml by M/s
Amdipharm
Approved
Local. Ranitidine
injection 25mg by
M/s
Glaxosmithkline
Deferred for
confirmation
of
approval
status
by
reference
regulatory
authorities.
Local.
Pravos
150mg injection by
M/s
Sami
Pharmaceuticals
(Pvt) Limited.
Etorac 10mg Injection
As
per
SRO/1x5’s &
1x10’s
Form 5
MHRA
Each ampoule of ml contains:Ketorolac tromethamine equivalent
to Ketorolac………….10mg
Dy No. 2049
dated 26-052016
Local.
Toradol
10mg injection by
M/s Roche Pakistan
Minutes for 260th Meeting Registration Board
Approved
Local. Ondiemetic
8mg by M/s Zafa
Pharmaceuticals
As
per
SRO/1x5’s &
1x10’s
Form 5
Histamine H2 receptor blocker
USP Specifications
MHRA. Zofran by
M/s GSK
Deferred for
confirmation
of
approval
status
by
reference
301
Rs.20,000.
Limited.
regulatory
authorities.
MHRA. Ketoralac
30mg/ml by M/s
Beacon
Approved
NSAID
USP Specifications
540.
-do-
Etorac 30mg Injection
Each ampoule of 1ml contains:Ketorolac tromethamine equivalent
to Ketorolac………….30mg
As
per
SRO/1x5’s &
1x10’s
Form 5
Dy No. 2048
dated 26-052016
Rs.20,000.
NSAID
Drotin 40mg Injection
As
per
SRO/1x5’s &
1x10’s
Form 5
Each ampoule of 2ml contains:Drotaverine
hydrochloride
equivalent
to
Drotaverine.……….40mg
Dy No. 2709
dated 16-062016
Rs.20,000.
Antispasmodic
As
per
SRO/1x5’s &
1x10’s
Form 5
USP Specifications
541.
542.
-do-
-do-
Manufacturer’s Specifications
Osteo-D 5mg Injection
Each ampoule of 1ml contains:Cholecalciferol….……….5mg
544.
Local.
NO-SPA
40mg injection by
M/s Sanofi Aventis
(Pakistan) Limited.
Approved
Local.
Calciferol
5mg injection by
M/s
Global
Pharmaceuticals.
Indocin 1mg Injection
As
per
SRO/1x5’s &
1x10’s
Form 5
FDA approved
Each vial contains:Indomethacin sodium ready to fill
powder
equivalent
to
Indomethacin….……….1mg
Dy No. 2711
dated 16-062016
Rs.20,000.
NSAID
As
SRO/1’s
BP Specifications
M/s
Vision
Pharmaceuticals,
Plot No. 22 &
23,
Industrial
Triangle Kahuta
Road,
Islamabad.
“Sterile
Dry
Powder
Inectable Vials
General
approved
in
240th meeting of
CLB.”
-do-
Approved
Dy No. 2047
dated 26-052016
Rs.20,000.
Vitamin
543.
Local.
Toradol
30mg injection by
M/s Roche Pakistan
Limited.
Deferred
as
product
is
more than 10.
Local. Liometacen
Injection by M/s
Chiesi
Pharmaceuticals
(Pvt) Limited.
per
USP Specifications
Viscortin 100mg Injection
Form 5
FDA approved
Each vial contains:Hydrocortisone sodium succinate
ready to fill powder equivalent to
Hydrocortisone ….……….100mg
Dy No. 2050
dated 26-052016
Rs.20,000.
Local. Hy-cortisone
100mg Injection by
M/s
Cirin
Pharmaceuticals
(Pvt) Limited.
Minutes for 260th Meeting Registration Board
Approved
302
Glucocorticoid
As
SRO/1’s
per
USP Specifications
545.
546.
547.
-do-
-do-
-do-
Viscortin 250mg Injection
Form 5
FDA approved
Each vial contains:Hydrocortisone sodium succinate
ready to fill powder equivalent to
Hydrocortisone ….……….250mg
Dy No. 2051
dated 26-052016
Rs.20,000.
Local. Hy-cortisone
250mg Injection by
M/s
Cirin
Pharmaceuticals
(Pvt) Limited.
Glucocorticoid
As
SRO/1’s
per
USP Specifications
Viscortin 500mg Injection
Form 5
FDA approved
Each vial contains:Hydrocortisone sodium succinate
ready to fill powder equivalent to
Hydrocortisone ….……….500mg
Dy No. 2052
dated 26-052016
Rs.20,000.
Local. Hy-cortisone
500mg Injection by
M/s
Cirin
Pharmaceuticals
(Pvt) Limited.
Glucocorticoid
As
SRO/1’s
549.
-do-
-do-
USP Specifications
Vanacin 500mg Injection
Form 5
Each vial contains:Vancomycin hydrochloride ready
to fill powder equivalent to
Vancomycin….. ….……….500mg
Dy No. 2056
dated 26-052016
Rs.20,000.
Antibiotic
As
SRO/1’s
per
Vanacin 1g Injection
Form 5
Each vial contains:Vancomycin hydrochloride ready
to fill powder equivalent to
Vancomycin….. ….……….1g
Dy No. 2055
dated 26-052016
Rs.20,000.
Antibiotic
As
SRO/1’s
USP Specifications
Methlone 500mg Injection
Each vial contains:Methylprednisolone
sodium
succinate ready to fill powder
equivalent to Methylprednisolone
….……….500mg
Glucocorticoid
USP Specifications
Minutes for 260th Meeting Registration Board
per
Form 5
Dy No. 2053
dated 26-052016
Rs.20,000.
As
SRO/1’s
Approved
per
USP Specifications
548.
Approved
per
MHRA.
Vancomycin
500mg by
Actavis
Approved
M/s
Local.
Vinjec
500mg Injection by
M/s
Bosch
Pharmaceuticals
(Pvt) Limited.
MHRA.
Vancomycin 1g by
M/s Actavis
Approved
Local. Vinjec 1g
Injection by M/s
Bosch
Pharmaceuticals
(Pvt) Limited.
MHRA.
Methylprednisolone
Powder
for
injection by M/s
Beacon.
Approved
Local. Methylpred
500mg Injection by
M/s Haji medicine
co.
303
550.
551.
552.
553.
-do-
-do-
M/s
Vision
Pharmaceuticals,
Plot No. 22 &
23,
Industrial
Triangle Kahuta
Road,
Islamabad.
“Tablet General
approved
in
240th meeting of
CLB.”
-do-
Methlone 1g Injection
Form 5
Each vial contains:Methylprednisolone
sodium
succinate ready to fill powder
equivalent to Methylprednisolone
….……….1g
Dy No. 2054
dated 26-052016
Rs.20,000.
Glucocorticoid
As
SRO/1’s
USP Specifications
Tigelin 50mg Injection
Form 5
Each vial contains:Tigecycline ready to fill powder
equivalent
to
Tigecycline…….……….50g
Dy No. 2708
dated 16-062016
Rs.20,000.
Antibiotic
As
SRO/1’s
Manufacturer’s Specifications
Galmet 50mg/500mg Tablet
Each film coated tablet contains:Vildagliptin….………...50mg
Metformin
hydrochloride
equivalent
to
Metformin………..…500mg
-do-
per
Form 5
Dy No. 2714
dated 16-062016
Rs.20,000.
Antidiabetic
As
per
SRO/2x7’s
Manufacturer’s Specifications
Galmet 50mg/850mg Tablet
Form 5
Each film coated tablet contains:Vildagliptin….………...50mg
Metformin
hydrochloride
equivalent
to
Metformin………..…850mg
554.
per
Dy No. 2717
dated 16-062016
Rs.20,000.
Antidiabetic
As
per
SRO/2x7’s
Manufacturer’s Specifications
Galmet 50mg/1000mg Tablet
Form 5
Each film coated tablet contains:Vildagliptin….………...50mg
Metformin
hydrochloride
equivalent
to
Metformin………..…1000mg
Antidiabetic
Dy No. 2716
dated 16-062016
Rs.20,000.
As
per
SRO/2x7’s
MHRA.
Methylprednisolone
Powder
for
injection by M/s
Beacon.
Approved
Local. Methylpred
1g Injection by M/s
Haji medicine co.
MHRA.
Tygacil
50mg Powder for
infusion by M/s
Pfizer
Approved
Local. Tigecycline
50mg Injection by
M/s
Wyeth
Pakistan Limited.
TGA. Sobrea by
M/s Novartis
Approved
Local. Galvusmet
50mg/500mg
Tablet by M/s
Novartis
Pharma
(Pak) Limited.
MHRA. Eucrease
by M/s Novartis
Approved
Local. Galvusmet
50mg/500mg
Tablet by M/s
Novartis
Pharma
(Pak) Limited.
MHRA. Eucrase by
M/s Novartis
Approved
Local. Galvusmet
50mg/1000mg
Tablet by M/s
Novartis
Pharma
(Pak) Limited.
Manufacturer’s Specifications
Minutes for 260th Meeting Registration Board
304
555.
-do-
Valent-H 80mg/12.5mg Tablet
Form 5
Each film coated tablet contains:Valsartan….………...80mg
hydrochlorothiazide…….…12.5mg
Dy No. 2773
dated 20-062016
Rs.20,000.
Calcium
Diuretic
556.
-do-
Channel
Blocker
+
As
per
SRO/2x7’s
USP Specifications
Valent-H 160mg/12.5mg Tablet
Form 5
Each film coated tablet contains:Valsartan….………...160mg
hydrochlorothiazide…….…12.5mg
Calcium
Diuretic
557.
-do-
Channel
Blocker
+
As
per
SRO/2x7’s
USP Specifications
Valent-H 160mg/25mg Tablet
Form 5
Each film coated tablet contains:Valsartan….………...160mg
Hydrochlorothiazide…….…25mg
Calcium
Diuretic
558.
-do-
Channel
Blocker
USP Specifications
Co-Valzaar 5mg/80mg Tablet
Angiotensin Receptor Blocker +
Calcium Channel Blocker
559.
USP Specifications
Co-Valzaar 5mg/160mg Tablet
Each film coated tablet contains:Amlodipine….………...5mg
Valsartan………….…160mg
Angiotensin Receptor Blocker +
Calcium Channel Blocker
560.
-do-
USP Specifications
Co-Valzaar 5mg/320mg Tablet
Each film coated tablet contains:Amlodipine….………...5mg
Valsartan………….…320mg
Minutes for 260th Meeting Registration Board
Dy No. 2775
dated 20-062016
Rs.20,000.
+
Each film coated tablet contains:Amlodipine….………...5mg
Valsartan………….…80mg
-do-
Dy No. 2772
dated 20-062016
Rs.20,000.
MHRA. Co-Diovan
by M/s Novartis.
Approved
Local. Co-Diavan
80mg/12.5mg
Tablet by M/s
Novartis
Pharma
(Pak) Limited.
MHRA. Co-Diovan
by M/s Novartis
Approved
Local. Co-Diavan
160mg/12.5mg
Tablet by M/s
Novartis
Pharma
(Pak) Limited.
MHRA. Co-Diovan
by M/s Novartis
Approved
Local. Co Valtec
160mg/25mg
Tablet by M/s
Tabros Pharma.
As
per
SRO/2x7’s
Form 5
Dy No. 2768
dated 20-062016
Rs.20,000.
As
per
SRO/2x7’s
Form 5
Dy No. 2766
dated 20-062016
Rs.20,000.
As
per
SRO/2x7’s
MHRA. Exforge by
M/s Novartis
Approved
Local.
Amstan
5mg/80mg Tablet
by
M/s
Getz
Pharma
(Pvt)
Limited.
MHRA. Exforge by
M/s Novartis
Approved
Local.
Amstan
5mg/160mg Tablet
by
M/s
Getz
Pharma
(Pvt)
Limited.
Form 5
Dy No. 2767
dated 20-062016
Rs.20,000.
Deferred for
confirmation
of
approval
status
by
reference
regulatory
Local.
Amstan
5mg/320mg Tablet
by
M/s
Getz
Pharma
(Pvt)
305
Angiotensin Receptor Blocker +
Calcium Channel Blocker
Limited.
authorities
MHRA. Exforge by
M/s Novartis
Approved
As
per
SRO/2x7’s
USP Specifications
561.
-do-
Co-Valzaar 10mg/160mg Tablet
Form 5
Each film coated tablet contains:Amlodipine….………...10mg
Valsartan………….…160mg
Dy No. 2769
dated 20-062016
Rs.20,000.
Angiotensin Receptor Blocker +
Calcium Channel Blocker
562.
USP Specifications
Co-Valzaar 10mg/320mg Tablet
-do-
Each film coated tablet contains:Amlodipine….………...10mg
Valsartan………….…320mg
Angiotensin Receptor Blocker +
Calcium Channel Blocker
563.
-do-
-do-
Dy No. 2848
dated 23-062016
Rs.20,000.
Antispasmodic
As
per
SRO/1x5’s &
1x10’s
Form 5
Nalfy Injection 20mg
(Manufacturer’s Specifications )
Nalfy Injection 10mg
Each 01ml ampoule contains:
Nalbuphine Hydrochloride eq. to
Nalbuphine………10mg
Opioid
(Manufacturer’s Specifications )
Minutes for 260th Meeting Registration Board
Deferred for
confirmation
of
approval
status
by
reference
regulatory
authorities
Local.
Amstan
10mg/320mg
Tablet by M/s Getz
Pharma
(Pvt)
Limited.
As
per
SRO/2x7’s
Each ampoule of 4ml contains:Phloroglucinol
dehydrate
equivalent
to
Phloroglucinol…….40mg
Opioid
-do-
Dy No. 2765
dated 20-062016
Rs.20,000.
Form 5
Each 01ml ampoule contains:
Nalbuphine Hydrochloride eq. to
Nalbuphine………20mg
565.
Form 5
USP Specifications
Spasmax 40mg Injection
Manufacturer’s Specifications
564.
As
per
SRO/2x7’s
Local.
Amstan
10mg/160mg
Tablet by M/s Getz
Pharma
(Pvt)
Limited.
Dy No. 2849
dated 23-062016
Rs.20,000.
As
per
SRO/1x5’s &
1x10’s
Form 5
Dy No. 2850
dated 23-062016
Rs.20,000.
The product is
under review
Local. Spasfon by
M/s Hilton Pharma
(Pvt) Limited.
FDA Nubail by M/s
Endo
Deferred
as
the product is
under review
Approved
Local. Nalbin 20mg
by M/s Global
Pharmaceuticals.
FDA Nubail by M/s
Endo
Approved
Local. Nalbin 10mg
by M/s Global
Pharmaceuticals.
As
per
SRO/1x5’s &
1x10’s
306
Remaining applications of M/s Sami Pharma, Karachi
566.
567.
M/s SAMI
Pharmaceuticals
(Pvt.) Limited,
F-95, Off. Hub
River Road,
S.I.T.E.,
Karachi-75730
ROSERA 5mg Tablets
Form 5
Each film coated tablet contains:
Rosuvastatin Calcium MS
equivalent to
Rosuvastatin
………………………..5mg
Rs. 20,000/(06-01-2014)
(Tablet
General)
HMG Reductase Inhibitor
M/s SAMI
Pharmaceuticals
(Pvt.) Limited,
F-95, Off. Hub
River Road,
S.I.T.E.,
Karachi-75730
(Tablet
General)
568.
M/s SAMI
Pharmaceuticals
(Pvt.) Limited,
F-95, Off. Hub
River Road,
S.I.T.E.,
Karachi-75730
(Tablet
General)
569.
M/s SAMI
Pharmaceuticals
(Pvt.) Limited,
F-95, Off. Hub
River Road,
S.I.T.E.,
Karachi-75730
(Freeze Dried
Products
General)
Manufacturer’s Specs.
ROSERA 10mg Tablets
Each film coated tablet contains:
Rosuvastatin Calcium MS
equivalent to
Rosuvastatin
………………………..10mg
EMA: Crestor
(AstraZeneca)
FDA: Crestor
(AstraZeneca)
As per SRO
Rovista Regn.
No. 044043
(M/s Getz)
Form 5
Rs. 20,000/(06-01-2014)
EMA: Crestor
(AstraZeneca)
FDA: Crestor
(AstraZeneca)
Fee
Rs
20,000 is a
photocopy.
Fee
Rs
20,000 is a
photocopy.
As per SRO
Rovista Regn.
No. 044044
(M/s Getz)
HMG Reductase Inhibitor
Manufacturer’s Specs.
ROSERA 20mg Tablets
Each film coated tablet contains:
Rosuvastatin Calcium MS
equivalent to
Rosuvastatin
………………………..20mg
Form 5
Rs. 20,000/(06-01-2014)
EMA: Crestor
(AstraZeneca)
FDA: Crestor
(AstraZeneca)
Fee
Rs
20,000 is a
photocopy.
As per SRO
Rovista Regn.
No. 044045
(M/s Getz)
HMG Reductase Inhibitor
Manufacturer’s Specs.
Lenor 8mg Injection
Each combination pack contain:
Vial:
Lornoxicam MS……….…8mg
Ampoule:
Water for Injection
USP……….2ml
Form 5
Dy No.206
dated 01-062015 Rs.
20,000/-
Acabel Reg. No.
061605 (M/s
Continental
Pharma)
Approval
status
in
reference
countries is
not
provided.
As per SRO
HMG Reductase Inhibitor
Manufacturer’s Specs.
Minutes for 260th Meeting Registration Board
307
Approved. Fee
will be verified
by Budget and
Accounts,
DRAP
&
Chairman
Registration
Board
will
permit issuance
of registration
letter.
Approved. Fee
will be verified
by Budget and
Accounts,
DRAP
&
Chairman
Registration
Board
will
permit issuance
of registration
letter.
Approved. Fee
will be verified
by Budget and
Accounts,
DRAP
&
Chairman
Registration
Board
will
permit issuance
of registration
letter.
Deferred
for
confirmation of
approval status
by
reference
regulatory
authorities.
Evaluator-IV Salateen Waseem Philp
New License & New Sections Cases.
New License
S/N
570.
Name and
address of
manufactur
er /
Applicant
SURGILIN
E
A business
division of
the licensed
unit
M/s Vikor
Healthcare
(Pvt.) Ltd,
Plot # C-126
to C-135,
LIEDA, Hub
District,
Lasbella,
Balouchistan
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price /
Pack size
Silk Braided
Form 5 with fee Rs
20,000/- vide Dy. #
580 dated 16-062016
Silk Braided sterile non
absorbable surgical
suture (all sizes with all
types of needles as per
USP)
International
status in
stringent
regulatory
agencies
Remarks /
Observations
Decision
Me-too status
GMP status
Pack size of 12
pieces 
Sutures, Non absorbable
silk
USP Specification
Mersilk –
Ethicon, UK
Deferred
for
following
Ethicon
clarificatio
mersilkn:
Johnson &
Source of needles :Johnson
Enova® 300 needles,  Docum
entary /
(import)
a brand of Suturex &
regulat
RenodexSurgical
ory
DML # 000834 Needles, France
referen
Silk Suture
Section
Sterilization :ces for
By
Gamma
source
irradiations
of
braided
silk
and
needle.
 Metho
d
of
gamma
radiati
ons
and
agreem
ent.
 Sterilit
y
testing
facility
Source of Raw
braided silk
Pearsalls Limited,
London
Demanded Price & Pack size
Minutes for 260th Meeting Registration Board
308
#
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)
18)
19)
20)
21)
22)
23)
24)
25)
26)
27)
28)
29)
30)
31)
32)
33)
34)
35)
36)
37)
38)
39)
40)
41)
42)
43)
44)
Siz
e/
Ga
uge
s
2
1
1
1
1
0
0
0
0
0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
Length
Curvature
Length
Point
Unit
price
Pack size
Price
per
pack
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
1m
76 cm
45 cm
76 cm
76 cm
76 cm
45 cm
76 cm
76 cm
1m
1m
45 cm
76 cm
45 cm
45 cm
76 cm
45 cm
45 cm
76 cm
76 cm
76 cm
76 cm
45 cm
76 cm
76 cm
76 cm
45 cm
76 cm
76 cm
45 cm
1m
45 cm
45 cm
45 cm
45 cm
76 cm
½ circle
½ circle
Curved
½ circle
Straight
½ circle
½ circle
Straight
Straight
Curved
Curved
½ circle
½ circle
Curved
½ circle
½ circle
Curved
Straight
Straight
Curved
Curved
½ circle
Curved
Curved
Curved
3/8 circle
½ circle
½ circle
½ circle
5/8 circle
½ circle
½ circle
½ circle
Curved
Curved
Straight
Curved
Curved
Straight
Curved
Curved
Curved
Curved
Curved
40 mm
35 mm
60 mm
30 mm
60 mm
30 mm
50 mm
60 mm
75 mm
45 mm
26 mm
26 mm
30 mm
16 mm
22 mm
40 mm
35 mm
75 mm
55 mm
26 mm
35 mm
25 mm
26 mm
16 mm
25 mm
26 mm
16 mm
25 mm
30 mm
25 mm
22 mm
35 mm
20 mm
20 mm
15 mm
60 mm
35 mm
20 mm
75 mm
16 mm
19 mm
22 mm
26 mm
35 mm
Round bodies heavy
Taper point
Curved cutting
Round bodies heavy
Cutting
Taper point
Cutting
Cutting
Cutting
Reverse cutting
Reverse cutting
Taper point
Taper point
Curved cutting
cutting
Taper point
Reverse cutting
Cutting
Cutting
Precision cutting
Precision cutting
taper point
Reverse cutting
Curved cutting
Slim blade
Conventional cutting
Taper point
Taper point
Taper point
Cutting
Cutting
Taper point
Taper point
Taper point
Slim blade
Straight cutting
Reverse cutting
Slim blade
Cutting
Precision cutting
Precision cutting
Precision cutting
Precision cutting
Precision cutting
191.59
181.82
181.82
181.82
181.82
175.95
175.95
175.95
175.95
175.95
166.18
166.18
166.18
166.18
166.18
166.18
166.18
166.18
166.18
166.18
166.18
166.18
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
2299.08
2181.78
2181.78
2181.78
2181.78
2111.40
2111.40
2111.40
2111.40
2111.40
1994.10
1994.10
1994.10
1994.10
1994.10
1994.10
1994.10
1994.10
1994.10
1994.10
1994.10
1994.10
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
Minutes for 260th Meeting Registration Board
309
45)
46)
47)
48)
49)
50)
51)
52)
53)
54)
55)
56)
3/0
4/0
4/0
4/0
4/0
4/0
4/0
4/0
4/0
4/0
4/0
4/0
45 cm
45 cm
76 cm
45 cm
45 cm
76 cm
76 cm
76 cm
45 cm
45 cm
45 cm
45 cm
½ circle
Curved
Curved
½ circle
Curved
½ circle
Curved
½ circle
Curved
Curved
Curved
Curved
16 mm
19 mm
16 mm
15 mm
25 mm
16 mm
16 mm
20 mm
15 mm
20 mm
13 mm
16 mm
Taper point
Reverse cutting
Curved cutting
Slim blade
Slim blade
Taper point
Taper point
Taper point
Slim blade
Slim blade
Reverse cutting
Precision cutting
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
150.54
12
12
12
12
12
12
12
12
12
12
12
12
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
1806.42
57)
58)
4/0
4/0
45 cm
45 cm
Curved
curved
19 mm
26 mm
Precision cutting
Precision cutting
150.54
150.54
12
12
1806.42
1806.42
571. SURGILINE
A business
division of the
licensed unit
M/s Vikor
Healthcare (Pvt.)
Ltd, Plot # C-126
to C-135,
LIEDA, Hub
District, Lasbella,
Balouchistan
Surgigut plain
Plain sterile
absorbable surgical
sutures (all sizes)
Catgut plain sterile
absorbable surgical
sutures
USP Specification
Form 5 with fee Rs
20,000/- vide Dy. #
559 dated 16-062016
Pack size of 12
pieces 
Softcat plain
BBRAUN
USA
Catgut –
Ethicon
(Import)
Source of Catgut
Deferred
plain string
for
Locally manufactured following
at Vikor Healthcare
clarificatio
(Pvt.) Ltd under
n:
license of basic
manufacturing DML  Docum
entary /
# 000835.
DML # 000834
Catgut sutures Source of needles :Enova® 300 needles,
(absorbable)
a brand of Suturex &
Section
RenodexSurgical
Needles, France
Sterilization :-
By
Gamma
irradiations



Minutes for 260th Meeting Registration Board
310
regulat
ory
referen
ces for
source
of
needle.
Metho
d
of
gamma
radiati
ons
and
agreem
ent.
Sterilit
y
testing
facility
.
Source
of
catgut
materia
l
#
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)
18)
19)
20)
21)
22)
23)
572.
Size /
Gauges
1
1
1
0
0
0
0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
4/0
4/0
SURGILI
NE
A business
division of
the
licensed
unit
M/s Vikor
Healthcare
(Pvt.) Ltd,
Plot # C126 to C135,
LIEDA,
Hub
District,
Lasbella,
Balouchista
n
Length
Curvature
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
½ circle
½ circle
½ circle
½ circle
½ circle
Curved
½ circle
½ circle
½ circle
½ circle
½ circle
Curved
Straight
½ circle
½ circle
½ circle
Curved
½ circle
Curved
Curved
½ circle
Curved
Curved
Demanded Price & Pack size
Length
Point
40 mm
40 mm
30 mm
36 mm
35 mm
26 mm
40 mm
30 mm
30 mm
25 mm
35 mm
26 mm
38 mm
30 mm
20 mm
26 mm
22 mm
16 mm
26 mm
16 mm
30 mm
16 mm
16 mm
Surgigut Chromic
Catgut chromic sterile
absorbable surgical
suture (all sizes)
Catgut sterile absorbable
surgical sutures
USP Specification
Pack size
211.14
211.14
211.14
211.14
191.59
191.59
191.59
191.59
181.82
181.82
181.82
181.82
181.82
181.82
168.13
168.13
168.13
168.13
168.13
168.13
168.13
168.13
168.13
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
Reverse Cutting
Taper point
Taper point
Taper point
Taper point
Curved cutting
Taper point
Taper point
Taper point
Taper point
Taper point
Curved cutting
Straight cutting
cutting
Taper Point
Taper point
Curved cutting
Cutting
Curved Cutting
Curved cutting
Taper point
Curved cutting
Taper point
Form 5 with fee Rs
20,000/- vide Dy. #
558 dated 16-062016
Pack size of 12
pieces 
Minutes for 260th Meeting Registration Board
Unit price
Price per
pack
2533.68
2533.68
2533.68
2533.68
2299.08
2299.08
2299.08
2299.08
2181.78
2181.78
2181.78
2181.78
2181.78
2181.78
2017.56
2017.56
2017.56
2017.56
2017.56
2017.56
2017.56
2017.56
2017.56
Softcan Chrom
– BBRAUN,
USA
Source of Catgut
Deferred
plain string
for
Locally manufactured following
at Vikor Healthcare
clarificatio
Catgut –
(Pvt.) Ltd under
n:
Ethicon
license of basic
(Import)
manufacturing DML  Docum
entary /
# 000835.
regulat
DML # 000834 Source of needles :ory
Catgut sutures Enova® 300 needles,
referen
a brand of Suturex &
(absorbable)
RenodexSurgical
Section
ces for
Needles, France
source
Sterilization :of
By
Gamma
irradiations

311
needle.
Metho
d
of
gamma
radiati


#
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)
18)
19)
20)
21)
22)
23)
24)
25)
26)
27)
28)
29)
30)
31)
Size /
Gauges
2
2
2
2
2
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Length
Curvature
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
½ circle Heavy
½ circle Heavy
½ circle Heavy
½ circle Heavy
½ circle
½ circle
½ circle
½ circle
½ circle Heavy
½ circle Heavy
½ circle Heavy
Curved
½ circle
½ circle
Curved
Curved
½ circle Heavy
½ circle Heavy
½ circle
½ circle
½ circle Heavy
½ circle Heavy
Curved
½ circle
½ circle
½ circle
½ circle
½ circle Heavy
½ circle Heavy
½ circle Heavy
½ circle Heavy
Demanded Price & Pack size
Length
Point
35 mm
45 mm
40 mm
45 mm
50 mm
40 mm
50 mm
65 mm
40 mm
45 mm
80 mm
45 mm
50 mm
38 mm
63 mm
85 mm
35 mm
45 mm
40 mm
30 mm
30 mm
45 mm
30 mm
40 mm
40 mm
50 mm
65 mm
30 mm
35 mm
40 mm
45 mm
Minutes for 260th Meeting Registration Board
Taper cut
Taper cut
Taper point
Taper point
Taper point
Reverse cutting
Reverse cutting
Taper point
Trocar point
Trocar point
Taper cut
Taper point
Taper point
Taper point
Blunt pint round bodied
Blunt pint round bodied
Taper cut
Taper cut
Taper cut
Taper cut
Taper point
Taper point
Taper point
Taper point
Reverse cutting
Reverse cutting
Taper point
Trocar point
Trocar point
Trocar point
Trocar point
Unit
price
232.65
232.65
232.65
232.65
232.65
232.65
232.65
232.65
232.65
232.65
232.65
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
220.92
Pack size
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
312
ons
and
agreem
ent.
Sterilit
y
testing
facility
.
Source
of
catgut
materia
l
Price per
pack
2791.74
2791.74
2791.74
2791.74
2791.74
2791.74
2791.74
2791.74
2791.74
2791.74
2791.74
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
2650.98
32)
33)
34)
35)
36)
37)
38)
39)
40)
41)
42)
43)
44)
45)
46)
47)
48)
49)
50)
51)
52)
53)
54)
55)
56)
57)
58)
59)
60)
61)
62)
63)
64)
65)
66)
67)
68)
69)
70)
71)
72)
73)
74)
75)
76)
77)
78)
79)
80)
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
2/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
3/0
4/0
4/0
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
76 cm
½ circle Heavy
Straight
Curved
Curved
Curved
Curved
½ circle
½ circle
½ circle
½ circle
5/8 circle
½ circle
½ circle
½ circle
½ circle
½ circle
Hook needle
Straight
Straight
Curved
Curved
Curved
Curved
Curved
½ circle
½ circle
½ circle
½ circle
½ circle
½ circle
½ circle
5/8 circle
½ circle
½ circle
½ circle heavy
½ circle
½ circle heavy
½ circle heavy
½ circle
Straight
Curved
½ circle
½ circle
5/8 circle
½ circle
½ circle
Hook needle
½ circle
Curved
80 mm
40 mm
30 mm
40 mm
45 mm
65 mm
35 mm
45 mm
50 mm
60 mm
35 mm
35 mm
30 mm
30 mm
40 mm
45 mm
35 mm
40 mm
50 mm
30 mm
40 mm
45 mm
55 mm
65 mm
25 mm
30 mm
40 mm
25 mm
45 mm
50 mm
60 mm
60 mm
35 mm
35 mm
45 mm
30 mm
25 mm
50 mm
26mm
50mm
45mm
20mm
25mm
25mm
30mm
30mm
25mm
20mm
16mm
Minutes for 260th Meeting Registration Board
Taper cut
Taper point
Taper point
Taper point
Taper point
Taper point
Taper point
Taper point
Taper point
Taper point
Taper point
Taper cut
Taper cut
Taper point
Taper point
Cutting
Round bodied
Taper point
Taper point
Taper point
Taper point
Taper point
Taper point
Taper point
Taper cut
Taper point
Taper point
Taper point
Taper point
Taper point
Taper point
Taper point
Taper point
Taper cut
Taper cut
Taper cut
Taper cut
Taper point
Reverse cutting
Taper point
Taper point
Taper point
Taper point
Taper cut
Taper cutting
Taper point
Round bodied
Taper point
Taper point
220.92
211.14
211.14
211.14
211.14
211.14
211.14
211.14
211.14
211.14
211.14
211.14
211.14
211.14
211.14
211.14
211.14
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
191.59
172.04
172.04
172.04
172.04
172.04
172.04
172.04
172.04
172.04
168.13
168.13
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
313
2650.98
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2533.68
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2299.08
2064.48
2064.48
2064.48
2064.48
2064.48
2064.48
2064.48
2064.48
2064.48
2017.56
2017.56
573. M/s
MEDIPAK
LIMITED,
554, Sundar
Industrial
Estate,
Lahore.
(Intravenous
infusion)
approved in
247 th meeting
of CLB held
on 29.04.16
574.
-do-
Medisol NS IV
Infusion- B.PEach 100ml contains.
Sodium Chloride…..
0.9g
Water for Injection q.s
100ml
Electrolytes
(B.P Specification)
Medisol NS IV
Infusion- B.PEach 100ml contains.
Sodium Chloride......
0.9g
Water for Injection q.s
100ml
Electrolytes
FORM 5
Rs 20,000/24.05.16
-do-
Medisol NS IV
Infusion- B.PEach 100ml contains.
Sodium
Chloride.......0.9g
Water for Injection q.s
100ml
Electrolytes
FORM 5
Rs 20,000/24.05.16 ,
Pack size 250ml
-do-
Medisol NS IV
Infusion- B.PEach 100ml contains.
Sodium
Chloride......0.9g
Water for Injection q.s
100ml
Electrolytes
Sodium
Chloride 0.9%
IV infusion BP
(Baxter Health
care Limited
(UK)
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatory
authorities.
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Sterifluid NS
(FDL Limited)
FORM 5
Rs 20,000/24.05.16 ,
DML
Inspection
dated 16.03.16
Sodium
Chloride 0.9%
IV infusion BP
(Baxter Health
care Limited
(UK)
Pack size 500ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Sterifluid NS
(FDL Limited)
FORM 5
Rs 20,000/24.05.16 ,
DML
Inspection
dated 16.03.16
Sodium
Chloride 0.9%
IV infusion BP
(Baxter Health
care Limited
(UK)
(B.P Specs)
576.
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatory
authorities.
Pack size 100ml
plus Eurocap price
with single & double Sterifluid NS
injection ports
(FDL Limited)
Price As per SRO
DML
Inspection
dated 16.03.16
(B.P Specs)
575.
Sodium
Chloride 0.9%
IV infusion BP
(Baxter Health
care Limited
(UK)
Pack size 1000ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Approved
Approved
Sterifluid NS
(FDL Limited)
DML
Minutes for 260th Meeting Registration Board
314
(B.P Specs)
577.
578.
-do-
-do-
Ciprofena IV Infusion
B.P
Pack size 100ml
Antibiotic
(B.P Specs)
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Ciprofena IV Infusion
B.P
FORM 5
Rs 20,000/24.05.16 ,
Ciprofloxacin
solution for
Infusion
(MHRA)
DML
Inspection
dated 16.03.16
Ciprofloxacin
solution for
Infusion
(MHRA)
Ciproxin IV
Infusion (Bayer
Healthcare)
Aquasteril -water for
injection)BP-
FORM 5
Rs 20,000/24.05.16 ,
Each 100ml contains.
Water for Injection
100ml
Diluent for Admixing
Pack size 100ml
Water for
Injection
Antigen
International
Ltd AucklandNew Zeeland
(MHRA)
(BP Specs)
Aquasteril -water for
injection)BP-
Price =As per SRO
plus Eurocap price
with single & double
injection ports
FORM 5
Rs 20,000/24.05.16 ,
Each 100ml contains.
Minutes for 260th Meeting Registration Board
Approved
Ciproxin IV
Infusion (Bayer
Healthcare)
Pack size 250ml
plus Eurocap price
with single & double
injection ports
Price =As per SRO
Antibiotic
(B.P Specs)
580.
FORM 5
Rs 20,000/24.05.16 ,
Each 100ml contains.
Ciprofloxacin as
lactate....200mg
Each 100ml contains.
Ciprofloxacin as
lactate....200mg
Water for Injection q.s
....100ml
579.
Inspection
dated 16.03.16
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatory
authorities
and
Pakistan.
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatory
authorities
and
Pakistan
and
with
intended
use in this
pack size.
Deferred
for
provision
of approval
DML
Inspection
dated 16.03.16
Water for
injection
(Otsuka Pvt
Limited)
Water for
Injection
Antigen
International
315
Water for Injection
100ml
Diluent for Admixing
(BP Specs)
581.
Aquasteril (water for
injection)BPEach 100ml contains.
Water for Injection
100ml
Diluent for Admixing
(BP Specs)
582.
Aquasteril (water for
injection)BPEach 100ml contains.
Water for Injection
100ml
Diluent for Admixing
Pack size 250ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
FORM 5
Rs 20,000/24.05.16 ,
Pack size 500ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
FORM 5
Rs 20,000/24.05.16 ,
Pack size 1000ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
(BP Specs)
Minutes for 260th Meeting Registration Board
Ltd AucklandNew Zeeland
(MHRA)
status
of
formulation
in
same
pack size
by
reference
regulatory
authorities
and
Pakistan
and
with
intended
use in this
pack size.
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatory
authorities
and
Pakistan
and
with
intended
use in this
pack size.
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatory
authorities
and
Pakistan
and
with
intended
use in this
pack size.
Water for
injection
(Otsuka Pvt
Limited)
Water for
Injection
Antigen
International
Ltd AucklandNew Zeeland
(MHRA)
Water for
injection
(Otsuka Pvt
Limited)
Water for
Injection
Antigen
International
Ltd AucklandNew Zeeland
(MHRA)
Water for
injection
(Otsuka Pvt
Limited)
316
583.
Medisol 5% IV
Infusion—B.P
Each 100ml contains.
Dextrose
Anhydrous....5g
Water for Injection q.s
....100ml
Carbohydrates
FORM 5
Rs 20,000/24.05.16 ,
Dextrose IV
Infusion
(B. Braun)
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan.
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan.
Approved
Pack size 100ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Sterifluid -5
(FDL Limited)
DML
Inspection
dated 16.03.16
FORM 5
Rs 20,000/24.05.16 ,
Dextrose IV
Infusion
(B. Braun)
(B.P Specs)
584.
Medisol 5% IV
Infusion—B.P
Each 100ml contains.
Dextrose
Anhydrous....5g
Water for Injection q.s
....100ml
Carbohydrates
(B.P Specs)
585.
Medisol 5% IV
Infusion—B.P
Each 100ml contains.
Dextrose
Anhydrous....5g
Water for Injection q.s
....100ml
Carbohydrates
586.
(B.P Specs)
Medisol 5% IV
Infusion—B.P
Each 100ml contains.
Dextrose
Anhydrous....5g
Water for Injection q.s
....100ml
Carbohydrates
Pack size 250ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
FORM 5
Rs 20,000/24.05.16 ,
Sterifluid -5
(FDL Limited)
Dextrose IV
Infusion
(B. Braun)
Pack size 500ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
FORM 5
Rs 20,000/24.05.16 ,
Sterifluid -5
(FDL Limited)
DML
Inspection
dated 16.03.16
Dextrose IV
Infusion
(B. Braun)
Approved
Pack size 1000ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
(B.P Specs)
Minutes for 260th Meeting Registration Board
Sterifluid -5
(FDL Limited)
DML
Inspection
dated 16.03.16
317
587.
Medigyl Injection B.P –
Each 100ml contains.
Metronidazole....0.5g
Water for Injection q.s
....100ml
Anti amoebic
(B.P Specs)
588.
Medigyl Injection B.P –
Each 100ml contains.
Metronidazole....0.5g
Water for Injection q.s
....100ml
Anti amoebic
(B.P Specs)
FORM 5
Rs 20,000/24.05.16 ,
Metronidazole
Infusion
AFT Pharma
New Zeeland
Approved
Pack size 100ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
FORM 5
Rs 20,000/24.05.16 ,
Flagyl
Injection
(Sanofi)
DML
Inspection
dated 16.03.16
Metronidazole
Infusion
AFT Pharma
New Zeeland
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan.
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan.
Pack size 250ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Flagyl
Injection
(Sanofi)
DML
Inspection
dated 16.03.16
589.
Medisol-S IV
Infusion—B.P
Each 100ml contains.
1. Sodium
Chloride...0.9g
2. Dextrose
Anhydrous...5g
3. Water for Injection
Q.S.
FORM 5
Rs 20,000/24.05.16 ,
Pack size 100ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Electrolytes +
carbohydrates
Sterifluid 0.9%
Glucose 5%
Baxter
Healthcare LtdUK)
Sterifluid DS
(FDL)
DML
Inspection
dated 16.03.16
B.P specs
Minutes for 260th Meeting Registration Board
318
590.
Medisol-S IV
Infusion—B.P
Each 100ml contains.
1. Sodium
Chloride...0.9g
2. Dextrose
Anhydrous...5g
3. Water for Injection
Q.S.
FORM 5
Rs 20,000/24.05.16 ,
Pack size 250ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Sterifluid DS
(FDL)
FORM 5
Rs 20,000/24.05.16
Sterifluid 0.9%
Glucose 5%
Baxter
Healthcare LtdUK)
Electrolytes +
carbohydrates
591.
B.P specs
Medisol-S IV
Infusion—B.P
Each 100ml contains.
1. Sodium
Chloride...0.9g
2. Dextrose
Anhydrous...5g
3. Water for Injection
Q.S.
Pack size 500ml
B.P specs
Medisol-S IV
Infusion—B.P
Each 100ml contains.
1. Sodium
Chloride...0.9g
2. Dextrose
Anhydrous...5g
3. Water for Injection
Q.S.
Sterifluid DS
(FDL)
FORM 5
Rs 20,000/24.05.16 ,
Sterifluid 0.9%
Glucose 5%
Baxter
Healthcare LtdUK)
Pack size 1000ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Electrolytes +
carbohydrates
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan.
DML
Inspection
dated 16.03.16
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Electrolytes +
carbohydrates
592.
Sterifluid 0.9%
Glucose 5%
Baxter
Healthcare LtdUK)
Approved
DML
Inspection
dated 16.03.16
Approved
Sterifluid DS
(FDL)
DML
Inspection
dated 16.03.16
B.P specs
Minutes for 260th Meeting Registration Board
319
593.
Medisol Hartmann’s
(Compound Sodium
Lactate)
IV Infusion—B.P
FORM 5
Rs 20,000/24.05.16 ,
Pack size 100ml
Each 100ml contains.
1. Sodium Chloride...
0.6g
2. Potassium Chloride...
0.04g
3. Calcium Chloride.
2H2O.. 0.027g
4. Sodium Lactate (50%
solution).. 0.64g
5. Water for Injection
Q.S..100ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Compound
Sodium Lactate
solution for
Infusion
(Baxter
Healthcare LtdUK)
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan
and
clarificatio
n for use
of sodium
lactate in
50%
solution
form
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan
and
clarificatio
n for use
of sodium
lactate in
50%
solution
form
Sterifluid –RL
(FDL Limited)
DML
Inspection
dated 16.03.16
Electrolytes
(B.P Specs)
594.
Medisol Hartmann’s
(Compound Sodium
Lactate)
IV Infusion—B.P
FORM 5
Rs 20,000/24.05.16 ,
Pack size 250ml
Each 100ml contains.
1. Sodium Chloride...
0.6g
2. Potassium Chloride...
0.04g
3. Calcium Chloride.
2H2O.. 0.027g
4. Sodium Lactate (50%
solution).. 0.64g
5. Water for Injection
Q.S..100ml
Electrolytes
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Compound
Sodium Lactate
solution for
Infusion
(Baxter
Healthcare LtdUK)
Sterifluid –RL
(FDL Limited)
DML
Inspection
dated 16.03.16
(B.P Specs)
Minutes for 260th Meeting Registration Board
320
595.
Medisol Hartmann’s
(Compound Sodium
Lactate)
IV Infusion—B.P
FORM 5
Rs 20,000/24.05.16 ,
Pack size 500ml
Each 100ml contains.
1. Sodium Chloride...
0.6g
2. Potassium Chloride...
0.04g
3. Calcium Chloride.
2H2O.. 0.027g
4. Sodium Lactate (50%
solution).. 0.64g
5. Water for Injection
Q.S..100ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Compound
Sodium Lactate
solution for
Infusion
(Baxter
Healthcare LtdUK)
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan
and
clarificatio
n for use
of sodium
lactate in
50%
solution
form
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan
and
clarificatio
n for use
of sodium
lactate in
50%
solution
form
Sterifluid –RL
(FDL Limited)
DML
Inspection
dated 16.03.16
Electrolytes
(B.P Specs)
596.
Medisol Hartmann’s
(Compound Sodium
Lactate)
IV Infusion—B.P
Each 100ml contains.
FORM 5
Rs 20,000/24.05.16 ,
Each 100ml contains.
1. Sodium Chloride...
0.6g
2. Potassium Chloride...
0.04g
3. Calcium Chloride.
2H2O.. 0.027g
4. Sodium Lactate (50%
solution).. 0.64g
5. Water for Injection
Q.S..100ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Pack size 1000ml
Compound
Sodium Lactate
solution for
Infusion
(Baxter
Healthcare LtdUK)
Sterifluid –RL
(FDL Limited)
DML
Inspection
dated 16.03.16
Electrolytes
(B.P Specs)
Minutes for 260th Meeting Registration Board
321
597.
Medisol Paeds IV
Infusion B.P
Each 100ml contains.
1. Sodium
Chloride...0.18g
2. Dextrose
Anhydrous...4.3g
3. Water for Injection
Q.S...100ml
FORM 5
Rs 20,000/24.05.16 ,
Pack size 100ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
598.
FORM 5
Rs 20,000/24.05.16 ,
Pack size 250ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Electrolytes +
carbohydrates
599.
B.P Specs
Medisol Paeds IV
Infusion B.P
Each 100ml contains.
1. Sodium
Chloride...0.18g
2. Dextrose
Anhydrous...4.3g
3. Water for Injection
Q.S...100ml
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan.
Sterifluid
Paeds (FDL
Limited)
DML
Inspection
dated 16.03.16
Electrolytes +
carbohydrates
B.P Specs
Medisol Paeds IV
Infusion B.P
Each 100ml contains.
1. Sodium
Chloride...0.18g
2. Dextrose
Anhydrous...4.3g
3. Water for Injection
Q.S...100ml
0.18% sodium
chloride ,
4% glucose
B Braun
Germany.
0.18% sodium
chloride ,
4% glucose
B Braun
Germany.
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan.
Approved
Sterifluid
Paeds (FDL
Limited)
DML
Inspection
dated 16.03.16
FORM 5
Rs 20,000/24.05.16 ,
Pack size 500ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Electrolytes +
carbohydrates
0.18% sodium
chloride ,
4% glucose
B Braun
Germany.
Sterifluid
Paeds (FDL
Limited)
DML
Inspection
dated 16.03.16
B.P Specs
Minutes for 260th Meeting Registration Board
322
600.
Medisol Paeds IV
Infusion B.P
Each 100ml contains.
1. Sodium
Chloride...0.18g
2. Dextrose
Anhydrous...4.3g
3. Water for Injection
Q.S...100ml
FORM 5
Rs 20,000/24.05.16 ,
Pack size 1000ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
601.
Each 100ml contains.
Sodium Chloride............
0.45g
Water for Injection q.s
....100ml
Approved
Sterifluid
Paeds (FDL
Limited)
DML
Inspection
dated 16.03.16
Electrolytes +
carbohydrates
B.P Specs
Medisol ½ NS (Sodium
Chloride 0.45%)
Injection USP
0.18% sodium
chloride ,
4% glucose
B Braun
Germany.
FORM 5
Rs 20,000/24.05.16 ,
Pack size 100ml
Sodium
Chloride
Injection
0.45% (Hospira
USA)
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Nisf Normal
Saline
(Otsuka
Limited)
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan.
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan.
Electrolytes
602.
(USP Specs)
Medisol ½ NS (Sodium
Chloride 0.45%)
Injection USP
Each 100ml contains.
Sodium Chloride............
0.45g
Water for Injection q.s
....100ml
Pack size 250ml
DML
Inspection
dated 16.03.16
Sodium
Chloride
Injection
0.45% (Hospira
USA)
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Nisf Normal
Saline
(Otsuka
Limited)
FORM 5
Rs 20,000/24.05.16 ,
Electrolytes
(USP Specs)
Minutes for 260th Meeting Registration Board
DML
Inspection
dated 16.03.16
323
603.
Medisol ½ NS (Sodium
Chloride 0.45%)
Injection USP
FORM 5
Rs 20,000/24.05.16 ,
Each 100ml contains.
Sodium Chloride............
0.45g
Water for Injection q.s
....100ml
Pack size 500ml
Sodium
Chloride
Injection
0.45% (Hospira
USA)
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Nisf Normal
Saline
(Otsuka
Limited)
Approved
Electrolytes
Medisol ½ NS (Sodium
Chloride 0.45%)
Injection USP
FORM 5
Rs 20,000/24.05.16 ,
Each 100ml contains.
Sodium Chloride............
0.45g
Water for Injection q.s
....100ml
Pack size 1000ml
DML
Inspection
dated 16.03.16
Sodium
Chloride
Injection
0.45% (Hospira
USA)
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Nisf Normal
Saline
(Otsuka
Limited)
(USP Specs)
604.
Approved
Electrolytes
(USP Specs)
605.
Medilact-D Solution for
Injection-USP
Each 100ml contains.
1. Sodium Chloride...
0.6g
2. Potassium Chloride ...
0.03g
3. Calcium Chloride.
2H2O... 0.02g
4. Sodium Lactate (50%
solution)... 0.620g
5. Dextrose
Monohydrate... 5.0g
6. Water for Injection
Q.S...100ml
FORM 5
Rs 20,000/24.05.16 ,
Pack size 100ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
DML
Inspection
dated 16.03.16
Lactated
Ringer &
Dextrose
Injection
Baxter
Healthcare
CorporationUSA
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan
and
clarificatio
n for use
of sodium
lactate in
50%
solution
form
Sterifluid RLD
(FDL Limited)
DML
Inspection
dated 16.03.16
Electrolytes +
carbohydrates
USP Specs
Minutes for 260th Meeting Registration Board
324
606.
Medilact-D Solution for
Injection-USP
Each 100ml contains.
1. Sodium Chloride...
0.6g
2. Potassium Chloride ...
0.03g
3. Calcium Chloride.
2H2O... 0.02g
4. Sodium Lactate (50%
solution)... 0.620g
5. Dextrose
Monohydrate... 5.0g
6. Water for Injection
Q.S...100ml
FORM 5
Rs 20,000/24.05.16 ,
Pack size 250ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Lactated
Ringer &
Dextrose
Injection
Baxter
Healthcare
CorporationUSA
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan
and
clarificatio
n for use
of sodium
lactate in
50%
solution
form
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan
and
clarificatio
n for use
of sodium
lactate in
50%
solution
form
Sterifluid RLD
(FDL Limited)
DML
Inspection
dated 16.03.16
Electrolytes +
carbohydrates
USP Specs
607.
Medilact-D Solution for
Injection-USP
Each 100ml contains.
1. Sodium Chloride...
0.6g
2. Potassium Chloride ...
0.03g
3. Calcium Chloride.
2H2O... 0.02g
4. Sodium Lactate (50%
solution)... 0.620g
5. Dextrose
Monohydrate... 5.0g
6. Water for Injection
Q.S...100ml
FORM 5
Rs 20,000/24.05.16 ,
Pack size 500ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Lactated
Ringer &
Dextrose
Injection
Baxter
Healthcare
CorporationUSA
Sterifluid RLD
(FDL Limited)
DML
Inspection
dated 16.03.16
Electrolytes +
carbohydrates
USP Specs
Minutes for 260th Meeting Registration Board
325
608.
Medilact-D Solution for
Injection-USP
Sodium Chloride 0Each
100ml contains.
1. Sodium Chloride...
0.6g
2. Potassium Chloride ...
0.03g
3. Calcium Chloride.
2H2O... 0.02g
4. Sodium Lactate (50%
solution)... 0.620g
5. Dextrose
Monohydrate... 5.0g
6. Water for Injection
Q.S...100ml
FORM 5
Rs 20,000/24.05.16 ,
Pack size 1000ml
Price =As per SRO
plus Eurocap price
with single & double
injection ports
Lactated
Ringer &
Dextrose
Injection
Baxter
Healthcare
CorporationUSA
Deferred
for
provision
of approval
status
of
formulation
in
same
pack size
by
reference
regulatories
authorities
and
Pakistan
and
clarificatio
n for use
of sodium
lactate in
50%
solution
form
Sterifluid RLD
(FDL Limited)
DML
Inspection
dated 16.03.16
Electrolytes +
carbohydrates
USP Specs
609. M/s Jupiter
Pharma
Plot # 25, St#
S6 RCCI
Rawat
Rawalpindi.
Tablet Anatrin
Each tablet contains
Nitrofurantoin 100 mg
(BP).
Antibacterial
BP Specification
Tablet
(General)
Approved in
247th meeting
of central
licensing
board held on
29-04-2016
610.
-doTablet Jucip 250
Each film coated tablet
contains
Ciprofloxacin (as
HCl.2H2O) 250mg.
Tablet (General)
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2653
Pack of 10 x 10’s
 as per DPC
MHRA
approved
Aratoin – Dr.
Reddy, UK
Approved
Furadin
(Ferozsons)
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2652
MHRA
approved brand
of Dr. Reddy,
UK
Pack of 1x 10’s 
as per DPC
Novidat - Sami
Approved
Antibiotics
(USP Specification)
Minutes for 260th Meeting Registration Board
326
611. -do-
Tablet Jucip 500
Each film coated tablet
contains
Ciprofloxacin (as
HCl.2H2O) 500mg
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2650
MHRA
approved brand
of Dr. Reddy,
UK
Pack of 1x 10’s
 as per DPC
Novidat - Sami
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2649
MHRA
approved
Evoxil –
Beacon
Pack of 1x 10’s
 as per DPC
Leflox-Getz
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2651
MHRA
approved
Evoxil –
Beacon
Approved
Antibiotics
(USP Specification)
612. -do-
Tablet Julin 250
Each film coated tablet
contains
Levofloxacin (as
hemihydrate ) 250mg
Approved
Quinolones
(Jupiter’s Specs)
613. -do-
Tablet Julin -500
Each film coated tablet
contains
Levofloxacin (as
hemihydrate) 500mg
Quinolones
(Jupiter’s Specs)
614. -do-
Tablet Jukast 5
Each chewable tablet
contains
Montelukast (as sodium)
5mg
Approved
Leflox-Getz
Pack of 1x 10’s
 as per DPC
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2647
MHRA
approved brand
of Aurobindo
Approved
Montika-Sami
Pack of 2x 7’s
 as per DPC
Anti-asthmatic
(Jupiter’s Specs)
615. -do-
Tablet Jukast -10
Each film coated tablet
contains
Montelukast (as
sodium) 10mg
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2648
MHRA
approved
Singulair –
Merck
Pack of 2x 7’s
 as per DPC
Singulair OBS
Approved
(Jupiter’s Specs)
Anti-asthmatic
Minutes for 260th Meeting Registration Board
327
616. -do-
Tablet Mozter 400mg
Each film coated tablet
contains
Moxifloxacin HCl USP
eq. to Moxifloxacin 400
mg
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2642
MHRA
approved
Avelox
Approved
Moxiget -Getz
Pack of 1x 5’s
 as per DPC
quinolone antibiotic
(Manufacture Specs)
617. -do-
Tablet Resjun-1
Each film coated tablet
contains
Risperidone 1mg
618. -do-
Tablet Resjun -2
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2646
MHRA
approved
Risperdal –
Janssen
Pack of 2x 10’s
 as per DPC
Benzisox Highnoon
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2645
MHRA
approved
Risperdal –
Janssen
Pack of 2x 10’s
 as per DPC
Benzisox Highnoon
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2644
MHRA
approved
Risperdal –
Janssen
Pack of 2x 10’s
 as per DPC
Benzisox Highnoon
Tablet Resjun -3
Each film coated tablet
contains
Riperidone 3mg
Benzisoxazole
derivatives (USP Specs)
Tablet Resjun-4
Each film coated tablet
contains
Riperidone 4mg
Benzisoxazole
derivatives (USP Specs)
Minutes for 260th Meeting Registration Board
Approved
Benzisox Highnoon
Pack of 2x 10’s
 as per DPC
Benzisoxazole
derivatives (USP Specs)
620. -do-
MHRA
approved
Risperdal –
Janssen
Benzisoxazole
derivatives
(USP Specs)
Each film coated tablet
contains
Riperidone 2mg
619. -do-
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2643
Approved
Approved
Approved
328
621. -do-
Tablet Pirujin
Each tablet Contains
Piroxicam B
cyclodextrin 191.2mg eq
to Piroxicam 20mg
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2665
Tablet Brexine
20mg –Chiesi –
France
Approved
Brexin -Chiesi
Pack of 2x 10’s
 as per DPC
Analgesics, antipyretics
(Jupiter’s specs)
622. -do-
Tablet Marlin
Each tablet contains
Artemether ..20mg
Lumefentrine 120mg
623. -do-
Pack of 2x 8’s
 as per DPC
Tablet Marlin Fort
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2635
(Jupiter’s specs)
Antimalarial
Tablet Marlin DS
Each tablet contains
Artemether ..80mg
Lumefentrine 480mg
(Jupiter’s specs)
Antimalarial
625. -do-
Tablet J-Rox CR 12.5
Each enteric film coated
controlled released
tablet contains
Paroxetin as HCl
12.5mg
WHO
recommended
formulation
Approved
Artem -Hilton
(Jupiter’s specs)
Antimalarial
Each tablet contains
Artemether ..40mg
Lumefentrine 240mg
624. -do-
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2636
WHO
recommended
formulation
Approved
Artem -Hilton
Pack of 1x 8’s
 as per DPC
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2662
WHO
recommended
formulation
Approved
Artem -Hilton
Pack of 1x 6’s
 as per DPC
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2654
USFDA
Paxil SR-GSK
Approved
Seroxat CRGSK
Pack of 1x 10’s
 as per DPC
(Jupiter’s specs)
SSRIs
Minutes for 260th Meeting Registration Board
329
626. -do-
Tablet J-Rox CR 25
Each enteric film coated
controlled released
tablet contains
Paroxetin as HCl 25mg
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2663
USFDA
Paxil SR-GSK
Approved
Seroxat CRGSK
Pack of 1x 10’s
 as per DPC
(Jupiter’s specs)
SSRI
627. -do-
Tablet Amlodine 5/80
Each film coated tablet
contains Amlodipine (as
besylate) 5mg
Valsartan 80mg
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2659
MHRA
approved
ExforgeNovartis
Pack of 14’s
 as per DPC
Exforge –
Novartis
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2660
MHRA
approved
ExforgeNovartis
Approved
(Jupiter’s specs)
Calcium channel
blocker.
Angiotensis II (AT1)
receptor antagonist
628. -do-
629. -do-
Tablet Amlodine 5/160
Each film coated tablet
contains
Amlodipine (as besylate)
5mg
Valsartan 160mg
Pack of 14’s
 as per DPC
(Jupiter’s specs)
Calcium channel
blocker.
Angiotensis II (AT1)
receptor antagonist.
Tablet Amlodine 10/160 Form 5
Rs. 20000/Each film coated tablet
(13-06-2016)
contains
Dy.No 2657
Amlodipine (as besylate)
10mg
Valsartan 160mg
Pack of 14’s
 as per DPC
(Jupiter’s specs)
Calcium channel
blocker.
Angiotensis II (AT1)
receptor antagonist.
Minutes for 260th Meeting Registration Board
Approved
Exforge –
Novartis
MHRA
approved
ExforgeNovartis
Approved
Exforge –
Novartis
330
630. -do-
Tablet Judol
631. -do-
Each tablet contains
Alfacalcidol 0.5mcg
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2650
(Jupiter’s specs)
Vitamin –D Analogue
Pack of 1 x 10’s
 as per DPC
Mides
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2655
Each film coated tablet
contains
Desloratadine 5mg
( Jupiter’s specs).
Antihistamine
632. -do-
Tablet Jubal
Each sugar coated tablet
contains
Mecobalamin 500 mcg
Vitamin B-12
Manufacture
Specification
633. M/s Jupiter
Pharma
Plot # 25, St#
S6 RCCI
Rawat
Rawalpindi.
Capsule
(General)
Approved in
247th meeting
of central
licensing
Pack of 1 x 10’s
 as per DPC
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2658
Deferred as
10
molecules
per section
has already
been
approved
MHRA
approved brand
of Consilient
Deferred as
10
molecules
per section
has already
been
approved
Alenor –
Macter
Methycobal –
Eisai, Japan
Deferred as
10
molecules
per section
has already
been
approved
Anemovit Pharmacare
Pack of 3x 10’s
 as per DPC
Capsule (General)
Form 5
Rs. 20000/Each capsule contains
(13-06-2016)
Fluconazole 150mg
Dy.No 2641
Capsule Jutrazole
Synthetic
azole/Systemic
antifungal agent
(Jupiter’s Specs)
Adela - getz
MHRA
approved
Azocan-P,
FDC
Approved
Axicon - Axis
Pack of 1x 1’s
 as per DPC
Minutes for 260th Meeting Registration Board
331
board held on
29-04-2016
634.
-do-
Capsule J-Baline-50
Each capsule contains
Pregabalin 50mg
(Jupiter’s specs)
anti-epileptic drug, also
called an anticonvulsant
agent.
635.
-do-
Capsule J-Baline -75
Each capsule contains
Pregabaline 75mg
636.
-do-
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2621
Pack of 3x 10’s
 as per DPC
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2622
(Jupiter’s specs)
anti-epileptic drug, also
called an anticonvulsant
agent.
Pack of 3x 10’s
 as per DPC
Capsule J-Baline-100
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2629
Each capsule contains
Pregabaline 100mg
(Jupiter’s specs)
anti-epileptic drug, also
called an anticonvulsant
agent.
US FDA
LYRICA
Capsules (25,
50, 75, 100,
150,200, 225
and 300mg)
Approved
ZEEGAP
Capsules (25,
50, 75, 100 and
150mg)
Hilton
US FDA
LYRICA
Capsules (25,
50, 75, 100,
150,200, 225
and 300mg)
Approved
ZEEGAP
Capsules (25,
50, 75, 100 and
150mg)
Hilton
Pack of 3x 10’s
 as per DPC
Minutes for 260th Meeting Registration Board
US FDA
LYRICA
Capsules (25,
50, 75, 100,
150,200, 225
and 300mg)
Approved
ZEEGAP
Capsules (25,
50, 75, 100 and
150mg)
Hilton
332
637.
-do-
Capsule Tamsel 400mcg
Each capsule contains
Tamsulosin HCl (as
modified released
pellets 0.2 %) eq to
Tamsulosine 0.4mg
Form 5
Rs. 20000+30000=
50000
(13-06-2016)
(17-06-2016)
Dy.No 2630
MHRA
approved
TabphynGenus
Approved
Alfamax Platinum
(Jupiter’s Specs)
Pack of 1x 10’s
α1-Adrenergic blocking
 as per DPC
agent with selectivity for
α1A-adrenergic receptors
Source of pellets:M/s Vision
Pharmaceuticals, Kahuta
road, Islamabad.
638. -do-
Capsule Azoter
Each capsule contains
Azithromycin (as
dehydrate) 250mg
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2631
MHRA
approved
Zithromax –
Pfizer
Approved
Azelide-Hygeia
639. -do-
(USP Specs)
Macrolide Antibiotic
agent.
Pack of 1x 10’s
 as per DPC
Capsule Mebal
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2637
Each capsule contains
Mecobalamine 500mcg
(Jupiter’s specs)
Antianemic agent
640. -do-
Capsule Jucam
Each capsule contains
Piroxicam 20mg
Innovit Werrick
Proof of approval
status of same dosage
form in reference
countries not given.
Pack of 2x 10’s
 as per DPC
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2633
MHRA
approved
feldene-Pfizer
Approved
Feldene -Pfizer
(USP Specs)
NSAID
Pack of 2x 10’s
 as per DPC
Minutes for 260th Meeting Registration Board
Deferred
for
approval
status
of
same
dosage
form
in
reference
countries.
333
641. -do-
Capsule Judep Plus
Each capsule contains
Fluoxetine (as HCl) 25
mg Olanzopine 6mg
642. -do-
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2623
(USP specs)
Antidepressent
Pack of 2x 10’s
 as per DPC
Capsule Lansjup 30mg
Form 5
Rs. 50000/(13-06-2016)
Dy.No 2624
Each capsule contains
Lansoprazole (as enteric
coated pellets 8.5% ) eq
to Lansoprazole 30mg
(USP Specs)
Proton Pump Inhibitor
USFDA
SYMBAX
Approved
Co-Depricap,
NabiQasim
MHRA
approved brand
of Consilient
Approved
Doudcer-nil Global
Pack of 14’s
 as per DPC
Source of pellets:M/s Vision
Pharmaceuticals, Kahuta
Road, Islamabad.
643. -do-
Capsulr Esojup-20
Each capsule contains
Esomeprazol(as
Megnesium trihydrate
enteric coated pellet
22.5% ) eq to
Esomeprazole 20mg
Form 5
Rs. 50000/(13-06-2016)
Dy.No 2628
MHRA
approved
EmozulConsilient
Approved
ESSO-Shaigan
Pack of 14’s
 per DPC
(Jupiter’s Specs)
Proton Pump Inhibitor
Source of pellets:M/s Vision
Pharmaceuticals, Kahuta
Road, Islamabad.
Minutes for 260th Meeting Registration Board
334
644. -do-
Capsule Esojup- 40
Each capsule contains
Esomeprazole (as
Megnesium trihydrate
enteric coated pellet
22.5% ) eq to
Esomeprazole 40mg
Form 5
Rs. 50000/(13-06-2016)
Dy.No 2625
Capsule Jumep -20
Each capsule contains
omeprazol(enteric
coated pellet 8.5 ) eq to
omeprazole 20mg
(USP Specs)
Proton Pump Inhibitor
Approved
ESSO-Shaigan
Pack of 14’s
 as per DPC
(Jupiter’s Specs)
Proton Pump Inhibitor
645. -do-
MHRA
approved
EmozulConsilient
Form 5
Rs. 50000/(13-06-2016)
Dy.No 2627
Source of
pellets:M/s Vision
Pharmaceutical
s, Kahuta
Road,
Islamabad.
MHRA
approved
Losec –
AstraZeneca
Approved
Risek-Getz
Pack of
14’s  as per DPC
Source of pellets:M/s Vision
Pharmaceuticals, Kahuta
Road, Islamabad.
646. -do-
Capsule Jumep- 40
Each capsule contains
omeprazole (enteric
coated pellet 8.5) eq to
omeprazole 40mg
(USP Specs)
Proton Pump Inhibitor
Form 5
Rs. 50000/(13-06-2016)
Dy.No 2626
MHRA
approved
Losec –
AstraZeneca
Approved
Risek-Getz
Pack of 14’s
 per DPC
Source of pellets:M/s Vision
Pharmaceuticals, Kahuta
Road, Islamabad.
Minutes for 260th Meeting Registration Board
335
647. M/s Jupiter
Pharma
Plot # 25, St#
S6 RCCI
Rawat
Rawalpindi.
Oral Dry Powder Suspension
Azoter Dry Powder for
Form 5
Suspension
Rs. 20000/(13-06-2016)
Each 5ml of
Dy.No 2634
reconstituted suspension
contains Azithromycin
(as dehydrate) 200mg
Pack of 15ml
 as per DPC
( USP Specs)
Macrolide Antibiotic
agent.
Dry Powder
Suspension
(General)
Approved in
247th meeting
of central
licensing
board held on
29-04-2016
648. -doMarlin Suspension
15/90
Each 5ml of
reconstituted suspension
contains Artemether
15mg Lumefentrine
90mg
649. -do-
(jupiter’s specs)
Anti malarial
Marlin DS Suspension
30/180
Each 5ml of
reconstituted suspension
contains Artemether
30mg Lumefentrine
180mg
650. -do-
(jupiter’s specs)
Anti malarial
Clariter Oral Drops
Each 5ml of
reconstituted suspension
contains
Clarithromycin 125mg
Granules for suspension
Macrolide Antibiotic
agent.
(USP Specs)
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2661
MHRA
approved brand
of Sandoz
Approved
Azomax Novartis
WHO
recommended
formulation
Approved
Artem - Hilton
Pack of 60ml  as
per DPC
Form 5
Rs. 20000/(13-06-2016)
Dy.No
WHO
recommended
formulation
Approved
Artem - Hilton
Pack of 60ml
 as per DPC
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2637
MHRA
approved brand
of Sandoz
Approved
Klaricid –
Abbott
Pack of 60ml
 as per DPC
Minutes for 260th Meeting Registration Board
336
651. -do-
J-Linz Suspension
Each 5ml reconstituted
suspension contains
Linezolid 100 mg
Powder for suspension
(Jupiter’s Specs)
synthetic antibiotic, the
first of the
oxazolidinone class
652. -do-
Jutrazole Dry
Suspension
Each 5ml reconstituted
suspension contains
Fluconazole 50 mg
(USP Specs)
Synthetic
azole/Systemic
antifungal agent.
653. -do-
Zincter Suspension
Each 5ml reconstituted
suspension contains
Zinc sulphate
monohydrate eq to
Elemental Zinc 20 mg
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2638
USFDA Zyvox
–Pharmacia
upjouhn
Approved
Nezocin brookes
Pack of 60ml
 as per DPC
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2639
MHRA
Diflucan –
Pfizer
Approved
Diflucan Pfizer
Pack of 35ml
 as per DPC
Form 5
Rs. 20000/(13-06-2016)
Dy.No 2640
WHO
recommended
formulation
Product under review
as waiting for reply
from WHO.
Zincat
Pack of 60ml
 as per DPC
Deferred as
Product is
under
review and
sent
for
comments
of WHO.
(Jupiter’s Specs)
Zinc supplement
Evaluator-IV Salateen Waseem Philp
New License of M/s Regal Pharmaceuticals, Plot # 2-A, Street # S-5 National industrial zone RawatIslamabad
S/N
Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded Price
/ Pack size
Minutes for 260th Meeting Registration Board
International
status in reference
drug agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Remarks
Decision
337
Evaluator
Tablet (General)
654.
M/s Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
Regcam Tablet 4 mg
Each film coated
tablet contains:
Lornoxicam 4 mg
(Regal Spec)
NSAID.
Pack of
10’s/as per DPC
20’s / as per DPC
30’s / as per DPC
Regcam Tablet 8 mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2462
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
655.
-do-
Each film coated
tablet contains:
Lornoxicam 8 mg
656.
-do-
(Regal Spec)
NSAID.
Pack of 10’s/as
per DPC
20’s / as per DPC
30’s / as per DPC
Regoxin CR Tablet
12.5 mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2457
Each enteric coated
controlled release
tablet contains:
Paroxetine Hcl eq to
Paroxetine 12.5mg
(USP Spec)
SSRI
657.
-do-
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2460
Regoxin CR Tablet
25 mg
Each enteric coated
controlled release
tablet contains:
Paroxetine Hcl eq to
Paroxetine 25mg
EMA approved
Brand Xefo
Approved
Loricam - Saffron
EMA approved
Brand Xefo
Approved
Loricam - Saffron
FDA approved
Paxil CR - GSK
Approved
Tablet Deroxat
12.5 mg by
Gobal pharma
Pack of 10’s/as
per DPC
20’s / as per DPC
30’s / as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2461
Pack of 10’s/as
per DPC
20’s / as per DPC
30’s / as per DPC
FDA approved
Paxil CR- GSK
Approved
Tablet Deroxat
12.5 mg by
Gobal pharma
(USP Spec)
SSRI
Minutes for 260th Meeting Registration Board
338
658.
Dinac Tablet 50 mg
-do-
Each Delayed release
tablet contains:
Diclofenac sodium
50mg +
Misoprostol 200mcg
(Regal Spec)
Pain reliever
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2458
FDA approved
Arthrotec – health
care UK.
Proof of Double
punch
compression
machine.
Erwin –Sami
Complete
description of
dosage form
required.
Pack of 10’s/as
per DPC
20’s / as per DPC
Firm needs to
follow innovator
brand
formulation.
659.
-do-
Dinec Tablet 75 mg
Each delayed release
tablet contains:
Diclofenac sodium
50mg
Misoprostol 200mcg
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2455
FDA approved
Arthrotec – health
care UK.
Complete
manufacturing
method
including
procedure of
outer core of
misoprostol, on
diclofenac
sodium tablet
before enteric
coating.
Proof of Double
punch
compression
machine.
Erwin –Sami
Pack of
10’s/as per DPC
20’s / as per DPC
(Regal Spec)
Pain reliever
Complete
description of
dosage form
required.
Firm needs to
follow innovator
brand
formulation.
Complete
manufacturing
method
including
procedure of
outer core of
misoprostol, on
diclofenac
sodium tablet
before enteric
coating.
Minutes for 260th Meeting Registration Board
Deferred for
 Confirmation
by FID for
double punch
compression
machine.
 Complete
description of
dosage form
required.
 Firm needs to
follow
innovator
brand
formulation.
 Complete
manufacturing
method
including
procedure of
outer core of
misoprostol,
on diclofenac
sodium tablet
before enteric
coating.
Deferred for
 Confirmation
by FID for
Double punch
compression
machine.
 Complete
description of
dosage form
required.
 Firm needs to
follow
innovator
brand
formulation.
 Complete
manufacturing
method
including
procedure of
outer core of
misoprostol,
on diclofenac
sodium tablet
before enteric
coating.
339
660.
Pesom Tablet 50 mg
-do-
Each sugar coated
tablet contains:
Eperisone Hcl 50mg
(Regal Spec)
Anticholinergic
661.
Epiwell CR Tablet
250
-do-
Each Controlled
release tablet
contains:
Divalproex sodium
250mg
(USP Spec)
Antiepileptic
662.
663.
664.
Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
-do-
-do-
Epiwell CR Tablet
500
Each Controlled
release tablet
contains:
Divalproex sodium
500mg
(USP Spec)
Antiepileptic
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2449
Approved
Qulax – Myonal
Pack of
10’s/as per DPC
20’s / as per DPC
30’s / as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2473
Pack of 10’s/as
per DPC
30’s / as per DPC
100’s / as per
DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2465
Pack of 10’s/as
per DPC
30’s / as per DPC
100’s / as per
DPC
Radol-P Tablet
325/37.5 mg
Each Film coated
tablet contains:
Paracetamol
325mg
Tramadol 37.5mg
(Regal Spec)
Opiod analgesic
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2453
Zolid Tablet 600 mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2450
Each Film coated
tablet contains:
Linezolid 600mg
Myonal – Eisai
Pack of 10’s/as
per DPC
20’s / as per DPC
100’s / as per
DPC
Minutes for 260th Meeting Registration Board
USFDA Depakote
Deferred as more
than 10 molecules
Local
Tablet Leptil at
250 mg by
Donvalley
pharmaceuticals
USFDA Depakote
Deferred as more
than 10 molecules
Local
Tablet Leptil at
250 mg by
Donvalley
pharmaceuticals
MHRA
Tablet Tramacet
325/37.5mg
manufactured by
Grunenthal
Approved
Local
Tablet Tronoflex P
325/37.5 mg
by
Sami pharma
MHRA
Tablet Zyvox
600mg
manufactured by
340fizer
Approved
340
665.
-do-
(Regal Spec)
Oxazolidone
Antibiotic
Pack of
10’s/as per DPC
20’s / as per DPC
100’s / as per
DPC
Local
Tablet Nezolide
600 mg
by
Searl pharma
Solfine Tablet 5 mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2459
MHRA
Vesicare –Astellas
UK
Each Film coated
tablet contains:
Solifenacin succinate
5mg
(Regal Spec)
Antimuscarinic
666.
667.
668.
-do-
Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
-do-
Solfine Tablet
10 mg
Each Film coated
tablet contains:
Solofinacin succinate
5mg
(Regal Spec)
Antimuscarinic
Qupixan Tablet 25
mg
Each Film coated
tablet contains:
Quetapine 25mg
as Quetapine
Fumarate
-do-
Fenaso – Highnoon
Pack of
10’s/as per DPC
20’s / as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2469
Pack of 10’s/as
per DPC
20’s / as per DPC
MHRA
Vesicare Astellas
Approved
Tablet Vezitic
5mg
By CCL
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2457
MHRA
Quetapine –
Sandoze UK
Pack of
10’s/as per DPC
20’s / as per DPC
30’s / as per DPC
Q-Par – Helix
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2472
MHRA
Quetapine –
Sandoze UK
Pack of 10’s/as
per DPC
20’s / as per DPC
30’s / as per DPC
Q-Par – Helix
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2467
MHRA
Quetapine –
Sandoze UK
Approved
(USP Spec)
Dibenzothiazepine
Qupixan Tablet 50
mg
Each Film coated
tablet contains:
Quetapine 50mg as
Quetapine Fumarate
669.
Approved
(USP Spec)
Dibenzothiazepine
Qupixan Tablet 100
mg
Each Film coated
tablet contains:
Minutes for 260th Meeting Registration Board
Approved
Approved
341
Quetapine 100mg as
Quetapine Fumarate
670.
-do-
(USP Spec)
Dibenzothiazepine
Brudex Tablet 400
mg
Each Film coated
tablet contains:
Dexibuprofen
400mg
Pack of 10’s/as
per DPC
20’s / as per DPC
30’s / as per DPC
Q-Par – Helix
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2470
Seractil
(Genus
Pharmaceuticals
UK) BNF-67
Deferred as more
than 10 molecules
Dexib –Tabros
Pack of 10’s/as
per DPC
50’s / as per DPC
(Manufacture Spec)
Propionic acid
671.
672.
Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
Re-SPA Tablet
80 mg
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
-do-
(Regal Spec)
Each Film coated
tablet contains:
Drotaverine 80mg
as Drotaverine Hcl
NO-SPA FORTE
Deferred as more
than 10 molecules
Himont
Pack of 10’s/as
per DPC
50’s / as per DPC
Anti-Spasmodic
Repram Tablet 10 mg
Each Film coated
tablet contains:
Escitalopram 10mg
as Escitalopram
Oxalate
673.
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2468
(USP Spec)
Anti depressant
Repram Tablet 20 mg
Each Film coated
tablet contains:
Escitalopram 20mg
as Escitalopram
Oxalate
(USP Spec)
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2466
Pack of 10’s/as
per DPC
14’s / as per DPC
28’s / as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2451
Pack of 10’s/as
per DPC
14’s / as per DPC
28’s / as per DPC
MHRA
Cipralex
Lundback
Approved
Product of
NabiQasim pharma
MHRA
Cipralex
Lundback
Approved
Product of
NabiQasim pharma
Anti depressant
Minutes for 260th Meeting Registration Board
342
674.
-do-
O-Mox Tablet 400
mg
Each Film coated
tablet contains:
Moxifloxacin 400mg
as Moxifloxacin Hcl
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2463
MHRA Avelox
Bayer
Deferred as more
than 10 molecules
Moxiget – Getz
Pack of 5’s/as per
DPC
(Regal Spec)
FlouroQuinolone
Antibiotic
675.
676.
M/s Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
DML of firm
approved in 247th
meeting of
Central
Licensing Board
held on 29-042016.
-do-
Mograll Fort Tablet
Each Film coated
tablet contains:
Orphenadrine Citrate
50mg + Paracetamol
450mg+ Caffeine
30mg
(Regal Spec)
Rostin Tablet 5mg
(Regal Spec)
Lipid regulating
agent
Rostin Tablet 10mg
Each Film coated
tablet contains:
Rosuvastatin 10mg
as Rosuvastatin
Calcium
678.
Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
Rawat-
Approved status in
Pakistan reference
countries not
approved
Pack of 30’s/as
per DPC
50’s/as per DPC
Local
Tablet Medigesic
Fort
By
Wilshire pharma
100’s/as per DPC
Deferred as more
than 10 molecules
Analgesic / Central
anti cholinergic /
Xanthine
Each Film coated
tablet contains:
Rosuvastatin 5mg
as Rosuvastatin
Calcium
677.
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2471
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2456
Pack of
10’s/as per DPC
20’s/as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2454
Pack of 10’s/as
per DPC
(Regal Spec)
20’s/as per DPC
Lipid regulating
agent
CAPSULE (GENERAL)
Resold Capsule
Form 5
20mg
Rs. 50,000/08-06-2016
Each Capsule
Dy. No. 2493
contains:
Enteric coated pallets Pack of
Minutes for 260th Meeting Registration Board
MHRA
Crestor 5mg
Astrazeneca UK
Approved
Local
Tablet Loster
By
Helix pharma
MHRA
Crestor
Astrazeneca UK
Approved
Local
Tablet Loster
By
Helix pharma
MHRA approved
Emozul
Approved
Esso – Shaigan
343
Islamabad
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
of Esomeprazole
20mg
as Esomeprazole
magnesium
344olymalto
10’s/as per DPC
14’s/as per DPC
(USP Spec)
Proton Pump
Inhibitor
Source of
Esomeprazole Mg
ECP pellets 22.5%:M/s Vision
Pharmaceuticals, Plot
# 22-23, Industrial
Triangle, Kahuta
Road, Islamabad.
679.
M/s Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
680.
Resold Capsule
40mg
Each Capsule
contains:
Enteric coated pallets
of Esomeprazole
40mg
as Esomeprazole
magnesium dehydrate
MHRA
Emozul
Approved
Esso – Shaigan
Pack of 10’s/as
per DPC
(USP Spec)
Protin pump Inhibitor
Source of
Esomeprazole Mg
ECP pellets 22.5%:M/s Vision
Pharmaceuticals, Plot
# 22-23, Industrial
Triangle, Kahuta
Road, Islamabad.
Thicosid 4mg
Capsule
Each Capsule
contains:
Thiocolchicoside
4mg
681.
Form 5
Rs. 50,000/08-06-2016
Dy. No. 2496
(Regal Spec)
Skeletal muscle
relaxant
Regastat 120mg
Capsule
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2491
Muscoril – Sanofi,
France
Approved
Muscoril –Searle
Pack of
20’s / as per DPC
14’s/as per DPC
Form 5
Rs. 50,000/08-06-2016)
Minutes for 260th Meeting Registration Board
FDA approved
Xenical
Approved
344
Each Capsule
contains immediate
release pallets of
Olrlistat 120mg
Dy. No. 2513
Pack of 20’s /
as per DPC
Local
Capsule Febical
By
Highnoon
Laboratories
(USP Spec)
Lipase inhibitor
Source of Orlistat
IR pellets 50%:M/s Vision
Pharmaceuticals, Plot
# 22-23, Industrial
Triangle, Kahuta
Road, Islamabad.
682.
-do-
Regalin 50mg
Capsule
Each Capsule
contains:
Pregabalin 50mg
Alli 120mg
GSK consumer
health care USA
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2506
FDA approved
Lyrica Pfizer
Approved
Gabalin - CCL
Pack of 14’s /
as per DPC
(Regal Spec)
GABA Analogue
683.
-do-
Regalin 75mg
Capsule
Each Capsule
contains:
Pregabalin 75mg
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2498
FDA approved
Lyrica Pfizer
Approved
Gabalin - CCL
Pack of 14’s /
as per DPC
(Regal Spec)
GABA Analogue
684.
-do-
Regalin 100mg
Capsule
Each Capsule
contains:
Pregabalin 100mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2489
FDA approved
Lyrica Pfizer
Approved
Gabalin - CCL
Pack of 14’s /
as per DPC
(Regal Spec)
GABA Analogue
685.
-do-
Olanzin – F 3/25mg
Capsule
Each Capsule
contains:
Olanzapine 3mg
Fluoxetine 25mg
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2497
USFDA SYMBAX
Approved
Co-Depricap,
NabiQasim
Pack of
14’s / as per DPC
30’s / as per DPC
(USP Spec)
Minutes for 260th Meeting Registration Board
345
Thienobenzodiazepin
e /SSRI
686.
-do-
Capsule Olanzin – F
6/25
Each Capsule
contains:
Olanzapine 6mg
Fluoxetine 25mg
(USP Spec)
Thienobenzodiazepin
e /SSRI
Olanzin – F 12/25mg
Capsule
687.
Each Capsule
contains:
Olanzapine 12mg
Fluoxetine 25mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2514
USFDA SYMBAX
Approved
Co-Depricap,
NabiQasim
Pack of 14’s /
as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2488
USFDA SYMBAX
Me too needs
confirmation
Approved
Co-Depricap,
NabiQasim
Pack of 14’s /
as per DPC
(USP Spec)
Thienobenzodiazepin
e /SSRI
688.
M/s Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
689.
Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
Recoxib 200mg
Capsule
Each Capsule
contains:
Celecoxib 200mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2502
MHRA approved
Celebrex – Pfizer
Approved
Artiflex –
Standpharm
Pack of 10’s /
as per DPC
20’s / as per DPC
30’s / as per DPC
(Regal Spec)
COX -2 Inhibitor
Tamsuger 0.4mg
Capsule
Each Capsule
contains:
Tamsulosin HCl SR
pellets 0.2% eq to
Tamsulosin 0.4mg
Form 5
Rs. 50,000/08-06-2016
Dy. No. 2494
FDA approved
Contiflo XL
E.Lilly and
company
Pack of 10’s /
as per DPC
20’s / as per DPC
Local
Capsule Proset
By
Synchro pharma
Approved
(USP Spec)
Slective alpha-1
blocker
Source of pellets :-
Minutes for 260th Meeting Registration Board
346
690.
-do-
M/s Vision
Pharmaceutcals ,
Kahuta rOad,
Islamabad.
Venflax XR 37.5mg
Capsule
Each Capsule
contains:
Extended release
pallets of
Vanlafaxine 37.5mg
as Vanlafaxine Hcl
Form 5
Rs. 50,000/08-06-2016
Dy. No. 2595
Proof
of
approval status
of same dosage
form
in
reference
countires
and
Pkaistan
not
provided.
Pack of 10’s /
as per DPC
Deferred
for
confirmation
of
approval status of
formulation
by
reference regulatory
authorities
and
Pakistan.
14’s / as per DPC
(USP Spec)
Serotonin &
noradrenaline
reuptake inhibitor
Source of Venlafaxine
HCl SR pellets 33% :M/s Vision
Pharmaceuticals, Plot #
22-23, Industrial
Triangle, Kahuta Road,
Islamabad.
691.
-do-
Venflax XR 75mg
Capsule
Each Capsule
contains:
Extended release
pallets of
Vanlafaxine 75mg as
Vanlafaxine Hcl
Form 5
Rs. 50,000/08-06-2016)
Dy. No. 2492
Pack of 10’s /
as per DPC
FDA approved
Efexor XL
Pfizer Ltd
USA
Approved
Venalax – Stand
pharm
14’s / as per DPC
(USP Spec)
Serotonin &
noradrenaline
reuptake inhibitor
Source of Venlafaxine
HCl SR pellets 33% :M/s Vision
Pharmaceuticals, Plot #
22-23, Industrial
Triangle, Kahuta Road,
Islamabad.
692.
M/s Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
Erox 60mg Capsule
Each Capsule
contains:
Etroricoxib 60mg
(Regal Spec)
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2499
Pack of 10’s /
as per DPC
Minutes for 260th Meeting Registration Board
The proposed
formulation is in
tablet form in
reference
countries and
not in capsule
form.
Rejected
as
proposed
formulation
is
approved in tablet
dosage form by
reference regulatory
authorities
347
Cyclooxygenase
inhibitor
693.
-do-
Rethro 250mg
Capsule
Each Capsule
contains:
Azithoromycin
250mg as
Azithromycin
dehydrate
694.
-do-
(USP Spec)
Macrolide antibiotic
Mervin- MR 200mg
Capsule
Each Capsule
contains:
Mebeverine HCl SR
pellets 50% eq to
Mebeverine Hcl
200mg
20’s / as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2487
FDA approved
Azisara 250mg
Piramal healthcare
10’s / as per DPC
Local
Capsule Bactizith
250mg
By
Woodwards
Form 5
Rs. 50,000/(21-06-2016)
Dy. No. 2464
MHRA
Clofac MR
BGP Ltd
UK
Pack of 10’s /
as per DPC
20’s / as per DPC
30’s / as per DPC
Local
Capsule
Mebeverine MR
By
Getz pharma
Pack of 6’s /
as per DPC
Approved
Innovator brand
contains
modified release
granules.
Deferred
for
confirmation
whether granules of
M/s Vision Pharma
are modified release
or otherwise
(Regal Spec)
Antispasmodic
Source of pellets:M/s Vision
Pharmaceuticals,
Kahuta Road,
Ilsambad.
ORAL DRY POWDER (GENERAL)
695.
M/s Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
Rethrocin 125mg
/5ml
oral drops
Each 5ml of
reconstituted
suspension contains:
Clarithromycin
27.5% EC Taste
Masked pellets eq to
Clarithromycin
125mg
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2528
FDA approved
Claricid
125mg/5ml
Abbott laboratories
Pack of 60ml /
as per DPC
Local
Claritek
125mg/5ml
By
Getz pharma
The innovator
brand is in
granules
formulation.
Approved
(USP Spec)
Macrolide antibiotic
Minutes for 260th Meeting Registration Board
348
Source of pellets :M/s Vision
Pharmaceuticals,
Kahuta rOad,
Islamabad.
696.
Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
Rethrocin 250mg
/5ml
oral suspension
Each 5ml of
reconstituted
suspension contains:
Clarithromycin
27.5% EC Taste
Masked pellets eq to
Clarithromycin
250mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2530
FDA approved
Claricid
250mg/5ml
Abbott laboratories
Pack of 60ml /
as per DPC
Local
Claritek
250mg/5ml
By
Getz pharma
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2524
MHRA approved
brand of 349andoz
The innovator
brand is in
granules
formulation.
Approved
(USP Spec)
Macrolide antibiotic
Source of pellets :M/s Vision
Pharmaceuticals,
Kahuta rOad,
Islamabad.
697.
-do-
Azocine 200mg /5ml
oral Dry Suspension
Each 5ml
(reconstituted)
contains:
Azithromycin
200mg
(USP Spec)
698.
-do-
Macrolide antibiotic
Remal 15/90mg /5ml
oral Dry suspension
Each 5ml
(reconstituted)
contains:
Artimether 15mg
Lumefantrine 90mg.
699.
-do-
(Manufacture Spec)
Anti-malarial
Remal 20/120mg
/5ml
oral D/S
Pack of 30ml /
as per DPC
Approved
Local
Zithrosan
200mg/5ml
By
Sante pharma
15ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2525
WHO
recommended
formulation
Approved
Artem – Hilton
Pack of 30ml /
as per DPC
60ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2531
Each 5ml
Minutes for 260th Meeting Registration Board
Local
Arceva
Proof provided
by firm for
proposed
formulation
availability in
Rejected
as
proposed
formulation
is
neither approved by
reference regulatory
349
(reconstituted)
contains:
Artimether 20mg
Lumefantrine
120mg.
Pack of 30ml /
as per DPC
60ml /
as per DPC
20/120mg/5ml
By
Sami
pharmaceuticals
reference
countires and
Pakistan is not
correct.
authorities
recommended
WHO.
nor
by
(Manufacture Spec)
Anti-malarial
700.
701.
Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
-do-
Zolid 100mg /5ml
oral D/S
Each 5ml
(reconstituted)
contains:
Linzolide 100mg
Powder for
suspension
Pack of 60ml /
as per DPC
Zincal 10mg /5ml
oral D/S
(Regal Spec)
Zinc Supplement
R – Flucon 50mg
/5ml
oral D/S
Each 5ml contains:
Fluconazole 50mg
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2527
Pack of 60ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2526
Pack of 35ml /
as per DPC
(Regal Spec)
Anti-Fungal
703.
-do-
FDA approved
100mg/5ml
Approved
change of
name.
with
brand
Local
Nezilide
100mg/5ml
By
Searle
pharmaceuticals
(Regal Spec)
Antibiotic
Each 5ml contains:
Zinc Sulphate 10mg.
702.
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2490
Re – Dos 175mg
/5ml
oral Dry suspension
Each 5ml of
reconstituted
suspension contains:
Erdosterine 175mg
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2785
Pack of 35ml /
as per DPC
Local
Rite-Zinc
10mg/5ml
By
Fynk
pharmaceuticals
The proposed
formulation in
dry
powder
forms
while
WHO
recommended
formulation is
oral solution.
MHRA
DiFlucan one
50mg/5ml
Jhonson & Jhonson
Newsland
Deferred
for
confirmation
of
approval status by
reference regulatory
authorities or WHO
in
dry powder
suspension.
Approved
change of
name
Local
Zolanix
By
GSK
pharmaceuticals
Local
Dostin
By
Brooks
pharmaceuticals
The product is
not available in
the
proposed
formulation in
reference
countires.
Deferred
for
confirmation
of
approval status of
formulation
by
reference regulatory
authorities
and
Pakistan.
(Regal Spec)
Minutes for 260th Meeting Registration Board
with
brand
350
Mucolytic agent
704.
Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
Resar 100mcg /5ml
oral D/S
Each 5ml contains:
Formoterol fumarate
100mcg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2787
MHRA
Foradil
Novartis Uk Ltd
UK
Pack of 60ml /
as per DPC
Local
Easair
By
Platinum
pharmaceuticals
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2786
FDA approved
Alinia
Lupin pharma
USA
Pack of 60ml /
as per DPC
Local
Izato
By
Sami
pharmaceuticals
(Regal Spec)
705.
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
-do-
Mucolytic
Re-Zox 100mg /5ml
oral D/S
Each 5ml contains:
Nitazoxanide 100mg
(Regal Spec)
706.
-do-
Nitrothiazolylsalicylamide prodrug
Regsan
500mg /30ml
oral D/S
Each dose of 30ml
contains:
Secnidazole 500mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2783
Liviat –Siza
Firm doesn’t
possess
segregated
licensed
manufacturing
facility for
Capsule
(Steroid)
Deferred
for
confirmation
of
approval status of
formulation
by
reference regulatory
authorities
and
Pakistan in dry
powder suspension.
Moreover status of
product will also be
verified as steroid
or otherwise
Approved
Reference
countries
approval status
required
Deferred
for
confirmation
of
approval status of
formulation
by
reference regulatory
authorities
and
Pakistan.
Reference
countries
approval status
required.
Deferred
for
confirmation
of
approval status of
formulation
by
reference regulatory
authorities
and
Pakistan.
The product not
dound in
reference
countires.
Deferred
confirmation
approval status
formulation
Pack of 30ml /
as per DPC
(Regal Spec)
707.
-do-
Nitoimidazole
Regsan 750mg /30ml
oral Dry suspension
Each dose of 30ml
contains:
Secnidazole 750mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2784
Eknit – Hilton
Pack of 30ml /
as per DPC
(Regal Spec)
Nitoimidazole
708.
Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
ORAL LIQUID SYRUP/SUSPENSION (GENERAL)
Metrozole Plus Oral
Form 5
suspension
Rs. 20,000/Metrodil –Sharex
08-06-2016)
Each 5ml contains:
Dy. No. 2518
Minutes for 260th Meeting Registration Board
351
for
of
of
by
industrial zone
RawatIslamabad
709.
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
-do-
Metronidazole as
Benzoate 200mg
Diloxanide furoate
250mg
(Regal Spec)
Nitoimidazole ,
Amoebicide
Metrozole Oral
Liquid suspension
Each 5ml contains:
Metronidazole (as
Benzoate) 200mg
(BP Spec)
Nitoimidazole
710.
-do-
Dom – V Oral Liquid
suspension
Each 5ml contains:
Domperidone
Maleate 5mg
711.
-do-
DML of firm
approved in 247st
meeting of
Central
MHRA
Flygl, SanofiAventis UK
Pack of
60ml /as per DPC
120ml /as per
DPC
450ml / as per
DPC
Flgyl SanofiAventis
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2517
MHRA-UK
Approved product
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2519
Each 5ml contains:
Ibuprofen 100mg
(USP Spec)
Analgesic /
Antipyretic
Approved
Motillium – J & J
Sucralate Oral Liquid
suspension
Brofenac Oral liquid
suspension
Approved
Pack of
60ml / as per DPC
120ml / as per DPC
(Regal Spec)
Anti-ulcerant/
mucoprotactant
M/s Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2522
(Regal Spec)
Anti-dopaminergic
Each 5ml contains:
Sucralfate 1gm
712.
reference regulatory
authorities
and
Pakistan.
Pack of 90ml /
as per DPC
Pack of
60ml / as per DPC
120ml /as per DPC
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2521
MHRA
Antepsin 1gm
Merk Barcelona
spain
Approved
Ulsonic –
Highnoon
MHRA approved
brand UK
Approved
Brufen – Abbott
Pack of 90ml /
as per DPC
Minutes for 260th Meeting Registration Board
352
713.
714.
Licensing Board
held on 29-042016.
-do-
-do-
Brofenac DS
Oral liquid
suspension
Each 5ml contains:
Ibuprofen 200mg
(USP Spec)
Analgesic /
Antipyretic
Levocine oral
solution
Each 5ml contains:
Levocetirizine as dihydro chloride 2.5mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2529
MHRA approved
brand UK
Approved
Brufen – Abbott
Pack of 90ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2477
FDA approved
Xyzal oral solution
UCB pharma
USA
Pack of 60ml /
as per DPC
Local
Ocitra
By
Searle laboratories
(Regal Spec)
Approved
Anti-Histamine
715.
-do-
Epiwell 250mg
Oral Liquid syrup’
Each 5ml contains:
Sodium valproate
250mg
(USP Spec)
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2516
Reference
countires and
Pakistan
approval status
not given.
Deferred
for
confirmation
of
approval status of
formulation
by
reference regulatory
authorities
and
Pakistan.
Reference
countires and
Pakistan
approval status
not given.
Deferred
for
confirmation
of
approval status of
formulation
by
reference regulatory
authorities
and
Pakistan.
Deferred
for
confirmation
of
approval status of
formulation
by
reference regulatory
authorities.
Pack of 60ml /
as per DPC
Anti-Epileptic
716.
717.
-do-
-do-
Epiwell 500mg
Oral Liquid syrup
Each 5ml contains:
Divalproex 500mg
(USP Spec)
Anti-Epileptic
Regadryl Oral Liquid
syrup
Each 5ml contains:
Amiophylline 32mg
Diphanhydramin
8mg.
Ammonium chloride
30mg
Menthol 0.98mg
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2512
Pack of 60ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2523
Approved status in
Pakistan, reference
from other
counteriesd not
available
Pack of 120ml /
as per DPC
Local
Hydralline
By
Searle pharma
(Regal Spec)
AntiHistamine/Xanthine/
Expectorant.
Minutes for 260th Meeting Registration Board
353
718.
-do-
Regtus Oral Liquid
suspension
Each 5ml contains:
Paracetamol 80mg
Pseudoephiderine Hcl
15mg.
Chlorphenaramine
maleate 1mg
719.
M/s Regal
Pharmaceuticals,
Plot # 2-A, Street
# S-5 National
industrial zone
RawatIslamabad
DML of firm
approved in 247st
meeting of
Central
Licensing Board
held on 29-042016.
720.
-do-
(Regal Spec)
Anti-Tussive /
Antipyretic
Regofer – F Oral
Liquid
Form 5
Rs. 20,000/08-06-20162478
Dy. No.
Local
Reltus CF
By
Pharmatec
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2511
722.
-do-
Approved
Local
Approved vide
registration
No.055272
Rubifer-F- AGP
(Regal Spec)
Haematinic .
Regacal Oral Liquid
suspension
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2520
MHRA
Almus Paracetamol
BCM. Nottingham
UK
Pack of 120ml /
as per DPC
Local
Calpol
By
GSK
(BP Spec)
Anti-pyretic
-do-
Approved status in
Pakistan, reference
from
other
counteries
not
available
Pack of 120ml /
as per DPC
Folic Acid 0.35mg
Each 5ml oral
suspension contains:
Paracetamol 120mg
721.
Deferred
for
confirmation
of
approval status of
formulation
by
reference regulatory
authorities.
Pack of 120ml /
as per DPC
Each 5ml contains:
Iron Ш hydroxide
354olymaltose
complex eq. To
elemental Iron 50mg
Approved status in
Pakistan, reference
from
other
counteries
not
available
Approved
LIQUID VIAL INJECTION (GENERAL)
Ciprocin Infusion
Form 5
FDA approved
Rs. 20,000/Cipro
Each 100ml contains:
08-06-2016
Bayer corporation
Ciprofloxacin as
Dy. No. 2474
pharmaceutical
lactate 200mg
division USA
Pack of 100ml /
(USP Spec)
as per DPC
Local
Novidate
Quinolone Antibiotic
By
Sami
pharmaceutical
Ciprocin
Liquid vial injection
(Infusion)
Form 5
Rs. 20,000/08-06-2016
Minutes for 260th Meeting Registration Board
Qilox –Bosch
Approved
Reference
countires
approval status
Deferred
for
confirmation
of
approval status of
354
Dy. No. 2475
Each 100ml contains:
Ciprofloxacin as
lactate 400mg
required
for
proposed dosage
form.
Pack of 100ml /
as per DPC
formulation
by
reference regulatory
authorities.
(USP Spec)
Quinolone Antibiotic
723.
-do-
Metrozole Infusion
Each 100ml contains:
Metronidazole
500mg
(USP Spec)
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2481
MHRA approved
brand of Baxter
Approved
Flagyl –Sanofi
Pack of 100ml /
as per DPC
Nitroimidazole / Anti
protozoal
724.
-do-
O – Mox Infusion
Each 250ml contains:
Moxifloxacin (as
HCl) 400 mg
(Regal Spec)
Quinolone Antibiotic
725.
-do-
WEFLOX Infusion
Each 100 ml
contains:
Levofloxacin 500 mg
(5mg/ml)
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2484
FDA approved
Avelox –Bayer \
Approved
Moxiget – Getz
Pack of 250ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2476
MHRA Evoxil –
Beacon
Approved
Leflox – Getzs
Pack of 100ml /
as per DPC
(Regal Spec)
726.
-do-
Floro Quinolone
Antibiotic
Zolid Infusion 200mg
Each 100ml contains:
Linzolid 200mg
(Regal Spec)
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2479
Pack of 1200ml /
as per DPC
Oxazolidinone
Antibacterial
727.
-do-
Zolid Infusion 600mg
Each 300ml contains:
Linzolid 600mg
FDA approved
Zyvox
Pharmacia Upjohn
pharmaceutical
Newyork
USA
Approved
change of
name
with
brand
Approved
change of
name
with
brand
Local
Ecasil
By
Sami
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2482
Minutes for 260th Meeting Registration Board
FDA approved
Zyvox
Pharmacia Upjohn
pharmaceutical
Newyork
355
(Regal Spec)
Pack of 100ml /
as per DPC
Oxazolidinone
Antibacterial
728.
-do-
Zolid Infusion 400mg
Each 200ml contains:
Linzolid 400mg
(Regal Spec)
Local
Ecasil
By
Sami
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2483
Pack of 100ml /
as per DPC
Oxazolidinone
Antibacterial
729.
730.
-do-
-do-
PARAMOL Infusion
FDA approved
Zyvox
Pharmacia Upjohn
pharmaceutical
Newyork
USA
Approved
change of
name
with
brand
Approved
change of
name
with
brand
Local
Ecasil
By
Sami
Each 100ml contains:
Paracetamol 1gm
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2480
(USP Spec)
Antipyretic
Pack of 300ml /
as per DPC
Amikan Liquid
injection
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2505
Each 2ml vial
contains:
Amikacin (as
Sulphate) 250mg
USA
MHRA approved
product of Actavis
Provas - Sami
FDA amikasinTeva 250mg/ml
Srasil – Sami
Pack of 2ml /
as per DPC
Proof of
approval of
same dosage
form in strength
250mg/2ml in
reference
countires is not
correct.
Deferred for proof
of approval of same
formulation
(250mg/2ml)
by
reference regulatory
authorities.
(BP Spec)
Aminoglycoside
Antibacterial
731.
-do-
Amikan injection
500mg
Each 2ml contains:
Amikacin (as
Sulphate) 500mg
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2486
Pack of 2ml /
as per DPC
FDA approved
Amikasin Teva
Approved
change of
name
with
brand
Srasil
By
Sami
(BP Spec)
Aminoglycoside
Antibacterial
LIQUID AMPOULE INJECTABLE (GENERAL)
732.
-do-
V-REN Liquid
injection
Each 3ml ampoule
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2508
Minutes for 260th Meeting Registration Board
FDA approved
Dyloject –
Hospira
Approved
356
Contains:
Diclofenac sodium
75mg
733.
-do-
(Regal Spec)
NSAID
Ondis injection
Each 4ml Ampoule
Contains:
Ondansetron 8mg
(USP Spec)
Anti-emetic (5HT3
antagonist)
734.
-do-
Ibro injection 3ml
Each 3ml ampoule
contains
Ibandronate
monosodium
monohydrate salt BP
eq to ibandronic acid
3mg
Dyclo – Indus
Pack of 3ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2510
Pack of 5 x 4ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2504
Pack of 3ml /
as per DPC
MHRA
Ondansteron
USA
Approved
Local
Onset injection
By
Pharmedic
laboratories
FDA approved
Ibandronate
Sodium Injection
vial - Sun
Pharmaceutical
India
Approved
Bonviva – Roche
Biophosphonate
Specification:Manufacture
735.
-do-
Calcirol injection
Each 1ml Ampoule
Contains:
Calcitriol 1mcg
(USP Spec)
Vitamin D Analogue
736.
-do-
Calcvit injection
Each 1ml Ampoule
Contains:
Cholicalciferol 5mg
(Regal Spec)
Vitamin D Analogue
737.
Re-lac injection
Each 1ml Ampoule
Contains:
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2500
Pack of 10 x 1ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2515
FDA approved
Calitriol
Americal Regent
pharmaceutical
USA
Approved
Local
Calciwins injection
By
Winsfield pharma
Vit D3 B.O.N,
France
Approved
Indrop D – Neutro
Pack of 1X1ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2485
Minutes for 260th Meeting Registration Board
USFDA Toradol –
Roche
Approved
Molac – Linear
357
Ketorolac
Trometamol 30mg
Pack of 5 x 1ml /
as per DPC
(USP Spec)
NSAID
738.
-do-
Iron-C injection
Each 5ml Ampoule
Contains:
Iron sucrose complex
equivalent to
elemental iron 100mg
739.
-do-
(USP Spec)
Hematinic
Regamin injection
Each 1ml amber glass
ampoule Contains:
Mecobalamin
500mcg
740.
-do-
(Regal Spec)
Vitamin B12 coenzyme
Regadol injection
Each 2ml Ampoule
Contains:
Tramadol Hcl 100mg
(Regal Spec)
Opiate Analogue
741.
-do-
Remol injection
Each 2ml Ampoule
Contains:
Paracetamol 300mg
Lidocain Hcl 20mg
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2503
FDA approved
Venofer
100mg/5ml
Ampoule
Pack of 5X5ml /
as per DPC
Local
Bislery-S injection
By
Sami pharma
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2507
Methycobal –
Eisai, Japan
Approved
Approved
Mabil – Sami
Pack of 10 x 1ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016)
Dy. No. 2509
Pack of10X1ml /
as per DPC
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2501
Pack of10X1ml /
as per DPC
MHRA Tramol –
CSL
Approved
Lamadol – Brooks
pharma
Paygone
injection
By
Fynk
pharmaceuticals
Proof of
approval status
of same dosage
form in
reference
countires not
provided.
Deferred
for
confirmation
of
approval status of
formulation
by
reference regulatory
authorities.
(Regal Spec)
NSAID / Local
anesthetic
742.
-do-
AQUA-R
Liquid Ampoule
injection
5ml Ampolue
Form 5
Rs. 20,000/08-06-2016
Dy. No. 2788
Each 5ml Ampoule
Contains:
Sterile water for
injection
Pack of
100 X5ml / as per
DPC
Minutes for 260th Meeting Registration Board
FDA approved
Sterile water for
injection
Americal Regent
pharmaceutical
USA
Approved
Local
Aqua -P injection
By
358
(BP Spec)
Ipram pharma
Vehicle/solvent/Dilue
nt for parental
administration
Evaluator-IV Salateen Waseem Philp
New Veterinary Licensed Unit M/s Vantage Pharmaceutical, 54/ R.B SARHALI, 6-KM
SANGLA HILL ROAD SHAHKOT, FAISALABAD.
S/N
Name and
address of
manufacture
r / Applicant
Brand Name
(Proprietary name +
Dosage Form + Strength)
Composition
Pharmacological Group
Finished product
Specification
M/s Vantage
Pharmaceuti
cal, 54/R.B
Sarhali, 6km Sangla
Hill Road,
Shahkot,
Faisalabad.
Bromodil oral Liquid
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price /
Pack size
International
status in
reference drug
agencies /
authorities
Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Remarks
Decision
Veterinary Oral Liquid (General)
743.
Each 100 ml contains:
Tylosin Tartrate 10gm
Doxycycline HCl 20gm
Bromhexine 1gm
(Manufcature Specification)
Antibiotics
Form 5
Rs. 20,000/21-06-2016
Dy. No. 254
Pack size 100ml,
500ml & one litre
Price decontrolled
744.
-do-
Micotil 250 oral liquid
Each ml contains:
Tilmicosin 250mg
745.
-do-
Form 5
Rs. 20,000/21-06-2016
Dy. No. 258
(Manufcature Specification)
Antibiotics
Pack size 100ml,
250ml, 500ml, one
litre & 5 litre
Price decontrolled
ENROX TAGE 20% oral
liquid
Form 5
Rs. 20,000/21-06-2016
Minutes for 260th Meeting Registration Board
Doctyl Super
Solution –
Alina
Approved
DML of firm
approved in
247st meeting
of Central
Licensing
Board held on
29-04-2016.
Tilcosin 25% Nawan
Approved
ENROCK -IPL
Approved
359
Each ml contains:
Enrofloxacin 200 mg
(Manufcature Specification)
Antibiotics
746.
-do-
FOXIN TAGE oral liquid
Each ml contains:
Florfenicol 230mg
Colistin Sulphate 50 MIU
(Manufcature Specification)
Antibiotics
747.
-do-
TAGE TRIL 10% oral
liquid
Each 100 ml contains:
Enrofloxacin 10gm
(100 mg/ml)
748.
-do-
(Manufcature Specification)
Antibiotics
SULFATRIN TAGE oral
liquid
Each ml contains:
Sulphadiazine 400mg
Trimethoprim 80 mg
749.
-do-
(Manufcature Specification)
Antibiotics
TIVERDOX oral liquid
Each 100ml contains:
Doxycyclin HCl 20gm
Tylosin Tartrate 10gm
(Manufcature Specification)
Antibiotics
750.
-do-
FLORFEN 23 oral liquid
Each 100ml contains:
Florfenicol 23gm
(Manufcature Specification)
Antibiotics
751.
-do-
MICROMUTIN oral liquid
Each 100ml contains:
Dy. No. 259
Pack size 100ml,
250ml, 500ml, one
litre & 5 litre
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 256
FLORICOL –
DECENT
Approved
FLORICOL –
DECENT
Approved
TRISTAR BIOGEN
Approved
MEDIDOX MEDIVET
Approved
BAFLOR 23 BAARIQ
Approved
Tylo biotech –
grand
Approved
Pack size 100ml,
250ml, 500ml, one
litre & 5 litre
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 257
Pack size 100ml,
250ml, 500ml, one
litre & 5 litre
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 262
Pack size 100ml,
250ml, 500ml, one
litre & 5 litre
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 250
Pack size 100ml,
250ml, 500ml, one
litre & 5 litre
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 251
Pack size 100ml,
250ml, 500ml, one
litre & 5 litre
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Minutes for 260th Meeting Registration Board
360
Tylosin Tartrate 10gm
Doxycycline HCl 20gm
Colistin Sulphate 50000 IU
Bromhexine 0.5gm
752.
-do-
(Manufcature Specification)
Antibiotics
EAFLEXIN TAGE oral
liquid
Each 100ml contains:
Enrofloxacin 10gm
Colistin Sulphate
50,000,000 IU
753.
754.
M/s Vantage
Pharmaceuti
cal, 54/R.B
Sarhali, 6km Sangla
Hill Road,
Shahkot,
Faisalabad.
-do-
DOXY TAGE Oral Powder
(Manufcature Specification)
Antibiotics
-do-
COLI TAGE 48 Oral
Powder
Each gm contains:
Colistin Sulphate 48000000
IU
(Manufcature Specification)
Antibiotics
756.
-do-
Pack size 100ml,
250ml, 500ml, one
litre & 5 litre
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 252
TYL-D600 Oral Powder
Each 100 gm contains:
Tylosin tartrate 20gm
Doxycycline HCl 40gm
ENROCOL
10% - LEADS
Approved
E-COX ORAL
POWDER BIOGEN
Approved
Pack size 100ml,
250ml, 500ml, one
litre & 5 litre
Price decontrolled
(Manufcature Specification)
Antibiotics
Veterinary Oral Powder
Vantage ESB 30% Oral
Form 5
Powder
Rs. 20,000/21-06-2016
Each 100 gm contains:
Dy. No. 266
Sulphaclozine sodium
monohydrate 30gm
Pack size 100gm,
(Manufcature Specification) 250gm, 500gm,
Antibiotics
1kg & 5kg
Price decontrolled
Each 100 gm contains:
Tylosin tartrate 10gm
Doxycycline HCl 20gm
755.
Dy. No. 251
Form 5
Rs. 20,000/21-06-2016
Dy. No. 261
DML of firm
approved in
247st meeting
of Central
Licensing
Board held on
29-04-2016.
DOXYTYL
ORAL
POWDER NAWAL
Approved
Pack size 100gm,
250gm, 500gm,
1kg & 5kg
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 260
Deferred
for
confirmation
of
approval status of
same formulation in
Pakistan.
Pack size 100gm,
250gm, 500gm,
1kg & 5kg
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 263
REOCIN TD DELUX
Approved
Pack size 100gm,
Minutes for 260th Meeting Registration Board
361
757.
-do-
(Manufcature Specification)
Antibiotics
250gm, 500gm,
1kg & 5kg
Price decontrolled
OXYTAGE Oral Powder
Form 5
Rs. 20,000/21-06-2016
Dy. No. 263
Each 100 gm contains:
Oxytetracycline HCl 25gm
Neomycin Sulphate 25gm
Colistin Sulphate 30 MIU
(Manufcature Specification)
Antibiotics
758.
-do-
VANTAGE ASPER-C Oral
Powder
Each 100 gm contains:
Vitamin C 20gm
Acetylsalicylic acid 6.7gm
(Manufcature Specification)
Vitamin / antipyretic / anti
inflammatory
759.
-do-
SPECLIN TAGE Oral
Powder
Each gm contains:
Lincomycin HCl 222mg
Spectinomycin HCl 444 mg
(Manufcature Specification)
Antibiotics
760.
-do-
TYLOSTIN Oral Powder
Each 1000 gm contains:
Tylosin Tartrate 100gm
Doxycyclin HCl 200gm
Colistin Sulphate 480 MIU
Bromhexine HCl 3 gm
(Manufcature Specification)
Antibiotics
NEOCHLOR ALINA
Approved
Pack size 100gm,
250gm, 500gm,
1kg & 5kg
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 264
Approved
SB – ASPERSB PHARMA
Pack size 100gm,
250gm, 500gm,
1kg & 5kg
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 265
The product in
proposed
strength is not
yet registered in
Pakistan.
Deferred
for
submission
of
registration
application
on
prescribed Form 5D as product in
proposed strength is
not yet registered in
Pakistan.
The local
availability is in
liquid form
while firm has
applied for fwy
powder.
Deferred for
submission of
registration
application on
prescribed Form 5D as product in
proposed strength is
not yet registered in
Pakistan.
Deferred
for
confirmation
of
approval status of
same formulation in
Pakistan
and
reference regulatory
authorities
as
already approved
formulation are in
liquid form while
firm has applied for
dry powder.
Pack size 100gm,
250gm, 500gm,
1kg & 5kg
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 268
Pack size 100gm,
250gm, 500gm,
1kg & 5kg
Price decontrolled
Minutes for 260th Meeting Registration Board
Bronchodil –
Attabak
362
761.
-do-
CHLOR NEC Oral Powder
Each 1000 gm contains:
Chlortetracyclin 80gm
Neomycin Sulphate 70gm
Colistin Sulphate 4 gm
(Manufcature Specification)
Antibiotics
762.
-do-
SPECLINX Oral Powder
Each 100 gm contains:
Lincomycin HCl 5gm
Spectinomycin HCl 7.5gm
Spiramycin adipose 2.5gm
Bromhexine HCl 0.5 gm
(Manufcature Specification)
Antibiotics
Form 5
Rs. 20,000/21-06-2016
Dy. No. 269
Approved
STRIKER WIMITS
Pack size 100gm,
250gm, 500gm,
1kg & 5kg
Price decontrolled
Form 5
Rs. 20,000/21-06-2016
Dy. No. 267
Spiralin –B
(Attabak)
import 249th
meeting and
254th meeting
Approved
Pack size 100gm,
250gm, 500gm,
1kg & 5kg
Price decontrolled
Evaluator-IV Salateen Waseem Philp
New Section:S/N
Name
and Brand Name
Type of Form
address
of
manufacturer (Proprietary name + Initial date, diary
Dosage
Form
+
/ Applicant
Fee
including
Strength)
differential fee
Composition
Demanded Price /
Pharmacological
Pack size
Group
Finished
product
Specification
International
status
stringent
regulatory
agencies
Remarks /
in Observation
s
Decision
Me-too status
GMP status as
depicted
in
inspection report
(dated)
Following cases of Azilsartan containing formulations were deferred in 259th meeting of the
board:
Decision (259th meeting):
Registration Board noticed that significant changes in the assay of the
API have been occurred in Azilsartan formulations applied by different applicants.
Therefore, all cases of azilsartan preparations were deferred for further deliberation in
next board meeting.
Minutes for 260th Meeting Registration Board
363
1. Azil tablets (Azilsartan Medoxomil 20mg,40mg, 80mg), M/s Helix Pharma Karachi.
Drug
Source
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Meeting
Azil tablets (Azilsartan Medoxomil 20mg,40mg, 80mg)
Jiangxi Synergy Pharmaceutical CO., Ltd. China
Real Time: 30°C and 65% RH
Accelerated: 40°C and 75% RH
Real Time: 6 months
Accelerated: 6 months
0, 3, 6 months
400 Tablets, 400 Tablets, 400 Tablets,
03
25 tablets



Remarks
Deferred 245th
meeting of Registration
Board for stability data as per WHO
guidelines.
Deferred in 255th meeting of registration
board for evaluation by committee.
Significant change noticed in assay.
Documents / Data provided by the applicant (M/s Helix Pharma Karachi)
Sr. No.
Documents to be provided
Status
1.
COA of API
2.
Yes (Photocopy
Approval of API by regulatory authority of country of
provided)
origin or GMP certificate of API manufacturer issued by
regulatory authority of country of origin.
Yes
Protocols followed for conduction of stability study and
details of tests.
Data of 03 batches will be supported by attested Yes
respective documents like chromatograms, laboratory
reports, data sheets etc.
Yes (By courier only)
Documents confirming import of API etc.
Partially attested
All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
Yes
Commitment to continue real time stability study till
assigned shelf life of the product.
3.
4.
5.
6.
7.
Decision:
Yes
Registeration Board deliberated on the matter of significant changes in the assay of
the API and decided to call technical team of firm for presentation on
aforementioned point before the Board.
Minutes for 260th Meeting Registration Board
364
2. Azil tablets 80 mg, Co-Azil 40/25 mg, M/s OBS Karachi.
Drug
1. Azil tablets 80 mg, (Azilsartan Kamedoximil)
2. Co-Azil 40/25 mg (Azilsartan Kamedoximi +
Chlorothalidone)
Source
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
parameters
Meeting
Remarks
Sr. No.
1.Jiangxi Synergy Pharma Co. Ltd, China
2.Trichem Life Sciences India.
Real Time: 25°C and 60% RH
Accelerated: 30°C and 65% RH
Real Time: 6 months
Accelerated: 6 months
0, 3, 6 months
2000 Tablets/ batch
03
50 tablets
Appearance, weight, dissolution, microbiology, assay,
Deferred 245th meeting of Registration Board for
stability as per WHO guidelines.
Firm has submitted a request for grant of registration of
Azil 40mg tablets and Co-Azil 40/12.5 mg based upon
above data.
Storage conditions not as per ICH Zone IV-A.
Significant change noticed in assay.
Documents / Data provided by the applicant
Documents to be provided
Status
1.
COA of API
2.
Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of
country of origin.
Protocols followed for conduction of stability study and details of tests.
Yes (Photocopies
provided)
Data of 03 batches will be supported by attested respective documents
like chromatograms, laboratory reports, data sheets etc.
Documents confirming import of API etc.
Yes
3.
4.
5.
6.
7.
Decision:
All provided documents will be attested (name, sign and stamp) for
ensuring authenticity of data / documents.
Commitment to continue real time stability study till assigned shelf life
of the product.
Yes
Yes
Yes (photocopy invoice
submitted)
Yes
Yes
Registeration Board deliberated on the matter of significant changes in the assay of
the API and decided to call technical team of firm for presentation on
aforementioned point before the Board
Minutes for 260th Meeting Registration Board
365
3.
M/s Genix Pharma Pvt Ltd.
Drug
Source
Lalap Syrup 10mg/per m l (Lacosamide)
Nutra Specialties pvt Ltd 69, chandrapadiya
village vinjamur mandal Nellore DT-524228
Indraspardash, India
Accelerated: 40°C±2°C/ 75% ±5% RH
Long Term: 30°C±2°C/ 65% ±5% RH
Accelerated: 06 months
Long Term: 24 months
1,3,6,9,12,18,24months
5Liters / batch
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Meeting
03
18 Packs
Deferred in 252nd meeting of registration board
for stability data
Documents / Data provided by the applicants (M/s Genix Pharma Pvt Ltd, Karachi.)
Sr. No.
Documents to be provided
Status
1.
2.
COA of API
Approval of API by regulatory authority of country of origin or
GMP certificate of API manufacturer issued by regulatory
authority of country of origin.
Protocols followed for conduction of stability study and details
of tests.
Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data sheets
etc.
Documents confirming import of API etc.
Yes
All provided documents will be attested (name, sign and stamp)
for ensuring authenticity of data / documents.
Commitment to continue real time stability study till assigned
shelf life of the product.
Yes
3.
4.
5.
6.
7.
Decision:
Yes
Yes
Yes
Yes
Yes
Registration Board decided to constituted following panel for onsite investigation to
confirm genuineness/ authenticity of stability data and associated documents,
import of API, quality, specification, test analysis, facilities etc.
 Director DTL Quetta (Chairman),
 Director DTL, Karachi;
 Area FID, DRAP (Member/Convener).
Minutes for 260th Meeting Registration Board
366
M/s CCL Labs, Lahore
4
M/s CCL Labs,
Lahore
Diyacon Tablets
Each
tablet
contains:
Dapagliflozin
5mg
Form-5-D
Duplicate
New
file
Molecule
Rs.50,000/As
per
SRO
5
M/s CCL Labs,
Lahore
Diyacon Tablets
Each
tablet
contains:
Dapagliflozin 10
mg
Form-5-D
Duplicate
New
file
Molecule
Rs.50,000/As
per
SRO
Drug
Diyacon Tablets
Each tablet contains:
Dapagliflozin 5mg
Source
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Diyacon Tablets
Each tablet contains:
Dapagliflozin 10 mg
Beijing Huikang boyuan chemical company ltd, China
Real Time: 30°C and 75% RH
Accelerated: 40°C and 75% RH
Real Time: 6 months
Accelerated: 6 months
0,3,6
3,000 Tablets per batch
3
50 tablets per batch
Documents / Data provided by the applicants
(M/s CCL Pharma Pvt Ltd, Lahore.)
Sr. No.
Documents to be provided
Status
1.
2.
COA of API
Approval of API by regulatory authority of country of origin
or GMP certificate of API manufacturer issued by regulatory
authority of country of origin.
Protocols followed for conduction of stability study and
details of tests.
Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data
Yes
3.
4.
Minutes for 260th Meeting Registration Board
Yes
(Photocopy)
Yes
Yes
367
5.
6.
7.
Decision:
sheets etc.
Documents confirming import of API etc.
All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
Commitment to continue real time stability study till assigned
shelf life of the product.
Yes
(Commercial invoice not
attested)
Yes
Yes
Registration Board decided to constituted following panel for onsite investigation to
confirm genuineness/ authenticity of stability data and associated documents,
import of API, quality, specification, test analysis, facilities etc.
 Director DTL Peshawar (Chairman),
 Director DTL, Lahore;
 Area FID, DRAP (Member/Convener).
6
7
Drug
M/s CCL Labs,
Lahore
Dacvir
Tablets
Each film coated tablet
contains:
Daclatasvir
Dihydrochloride
equivalent
to
Daclatasvir
……30mg
Mfg Specs
Form-5-D
Duplicate
file
Rs.50,000/As per SRO
M/s CCL Labs,
Lahore
Dacvir
Tablets
Each film coated tablet
contains:
Daclatasvir
Dihydrochloride
equivalent
to
Daclatasvir
……60mg
Mfg Specs
Form-5-D
Duplicate
file
Rs.50,000/As per SRO
New
Molecule
New
Molecule
Dacvir
Tablets
Each film coated tablet contains:
Daclatasvir Dihydrochloride equivalent to Daclatasvir
……30mg
Mfg Specs
Dacvir
Tablets
Each film coated tablet contains:
Daclatasvir Dihydrochloride equivalent to Daclatasvir
……60mg
Mfg Specs
Minutes for 260th Meeting Registration Board
368
Source
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Ruyuan HEC pharam Ruyuan county guangdond China
Real Time: 30°C and 75% RH
Accelerated: 40°C and 75% RH
Real Time: 6 months
Accelerated: 6 months
0,3,6
1000 Tablets
3
50 Tablets
Documents / Data provided by the applicants
(M/s CCL Pharma Pvt Ltd, Lahore .)
Sr. No.
1.
2.
3.
4.
5.
6.
7.
Decision:
Documents to be provided
Status
COA of API
Yes
Approval of API by regulatory authority of country of origin The GMP
certificate
or GMP certificate of API manufacturer issued by regulatory provided by the firm
authority of country of origin.
shows
scope
of
inspection for bulk drug
is
(Azithromycin,
Sofosbuvir, Ledipasvir)
Protocols followed for conduction of stability study and
Yes
details of tests.
Data of 03 batches will be supported by attested respective
Yes
documents like chromatograms, laboratory reports, data
sheets etc.
Documents confirming import of API etc.
Yes
(Performa invoice not
attested)
All provided documents will be attessted (name, sign and
Yes
stamp) for ensuring authenticity of data / documents.
Commitment to continue real time stability study till assigned
Yes
shelf life of the product.
Registration Board decided to constitute the following panel for onsite
investigation to confirm genuineness/ authenticity of stability data and
associated documents, import of API, quality, specification, test analysis,
facilities etc.
o Brig. (R) M.H. Najmi, Member Registration Board.
o Dr. Obaidullah, DDG (Reg-I), DRAP, Islamabad.
o Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.
Minutes for 260th Meeting Registration Board
369
M/s Pharmevo, Karachi
8
M/s PharmEvo,
Karachi
Drug
Dakvir tablet
Each film coated tablet
contains:
Daclatasvir
(as
dihydrochloride) 60 mg
Mfg Specs
Form 5-D
Duplicate
file
Rs: 50,000
As per PRC
New
Molecule
Dakvir tablet
Each film coated tablet contains:
Daclatasvir (as dihydrochloride) 60 mg
Mfg Specs
Source
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Virupaksha organics India
Real Time: 30°C and 75% RH
Accelerated: 40°C and 75% RH
Real Time: 6 months
Accelerated: 6 months
0,3,6
2500 Tablets
3
50 Tablets
Documents / Data provided by the applicants
(M/s Pharm Evo Pvt Ltd, Karachi .)
Sr. No.
Documents to be provided
Status
1.
2.
COA of API
Approval of API by regulatory authority of country of origin
or GMP certificate of API manufacturer issued by regulatory
authority of country of origin.
3.
Protocols followed for conduction of stability study and details
of tests.
Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data sheets
etc.
Documents confirming import of API etc.
Yes
Yes
(However the proof of
approval of API not
attached )
No
4.
5.
6.
7.
All provided documents will be attessted (name, sign and
stamp) for ensuring authenticity of data / documents.
Commitment to continue real time stability study till assigned
shelf life of the product.
Minutes for 260th Meeting Registration Board
Yes
Yes
Yes
Yes
370
Decision:
Registration Board decided to constitute the following panel for onsite
investigation to confirm genuineness/ authenticity of stability data and
associated documents, import of API, quality, specification, test analysis,
facilities etc.
o Brig. (R) M.H. Najmi, Member Registration Board.
o Dr. Obaidullah, DDG (Reg-I), DRAP, Islamabad.
o Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.
M/s English Pharma Pvt Ltd, Lahore.
Drug
Source
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Esovir 400mg Tablet (Sofosbuvir)
M/s Pharmagen, Lahore
Real Time: 30°C and 65% RH
Accelerated: 40°C and 75% RH
Real Time: 9 months
Accelerated: 6 months
0,1,3,6
Not provided
3
Not provided
Documents / Data provided by the applicants
(M/s English Pharma Pvt Ltd, Lahore.)
Sr. No.
Documents to be provided
Status
1.
2.
COA of API
Approval of API by regulatory authority of country of origin or
GMP certificate of API manufacturer issued by regulatory
authority of country of origin.
Protocols followed for conduction of stability study and details
of tests.
Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data sheets
etc.
Documents confirming import of API etc.
Yes
Yes
3.
4.
5.
6.
7.
Decision:
All provided documents will be attessted (name, sign and
stamp) for ensuring authenticity of data / documents.
Commitment to continue real time stability study till assigned
shelf life of the product.
No
Not Attested
Not Appied
No
No
Registration Board deferred case for completion of documents as recorded above.
Minutes for 260th Meeting Registration Board
371
M/s Getz Pharma, Karachi
9
10
M/s Getz Pharma,
Karachi
M/s Getz Pharma,
Karachi
Drug
Source
Storage Condition
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Remarks
Verna tablets 30 mg
Each film coated Tablet :
Daclatasvir
dihydrochloride equivalent
to
Daclatasvir…………30mg
Form 5-D
Dy no: 365
dated:
08..09.2015
Rs: 50,000
Price:
30000/ 28
Tablets
Price;
1071.42/per
tablet
Verna tablets 60 mg
Form 5-D
Each film coated Tablet :
Dy no: 364
Daclatasvir…………60mg dated:
08..09.2015
Rs: 50,000
Price:
50000/ 28
Tablets
Price;
1785.42/per
tablet
Verna tablets 30 mg
Each film coated Tablet :
Daclatasvir
dihydrochloride
Daclatasvir…………30mg
New
Molecule
New
Molecule
equivalent
to
Verna tablets 60 mg
Each film coated Tablet :
Daclatasvir…………60mg
Zhejiang apeloa kangyu Pharmaceutical company limited
Zhejiang, China
Real Time: 30°C and 65% RH
Accelerated: 40°C and 75% RH
Real Time: 6 months
Accelerated: 6 months
0,1,2,3,6
Not available
3
Not available
The firm has informed that they have developed
daclatasvir 60mg tablet from shanghai forefront pharma
company Ltd China (contract development China- R&D
company) and through technology transfer they have
reproduced the same product at their facility. Further,
Getz phama has manufacturer 03batches of the drug using
Minutes for 260th Meeting Registration Board
372
same technology and 03months stability data has been
completed.
Documents / Data provided by the applicants
(M/s Getz Pharma Pvt Ltd, Karachi .)
Sr. No.
Documents to be provided
Status
1.
2.
COA of API
Approval of API by regulatory authority of country of origin
or GMP certificate of API manufacturer issued by regulatory
authority of country of origin.
Yes
3.
4.
5.
6.
7.
Decision:
Protocols followed for conduction of stability study and
details of tests.
Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data
sheets etc.
Documents confirming import of API etc.
All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
Commitment to continue real time stability study till assigned
shelf life of the product.
The GMP certificate
provided by the firm
shows scope of
inspection for bulk drug
(Ofloxacin,
levofloxacin,
rimantadine, Ubenimex)
Yes
Yes
NO
Yes
Yes
Registration Board deferred the case for scientifically rationale lab scale stability
data for six months as per recommendatons of the Board.
M/s CCL Pharma, Lahore
11
Lebriva Tablet
Each Tablet contains:
Ledipasvir……..90mg
Sofosbuvir………400mg
Mfg Specs
Drug
Source
Storage Condition
Form 5-D
Dy
no:
705
08.02.2016
Rs: 50,000
Not applicable
Lebriva Tablet
Each Tablet contains:
Ledipasvir……..90mg
Sofosbuvir………400mg
Mfg Specs
Ruyuan HEC pharam Ruyuan county guangdond China
Jiangxi Synergy Pharmaceutical Company limited China
Real Time: 30°C and 75% RH
Accelerated: 40°C and 75% RH
Minutes for 260th Meeting Registration Board
373
dated:
Time Period
Frequency
Batch Size
No. of Batches
Sample Size
Real Time: 6 months
Accelerated: 6 months
0,3,6
1000 tablets
3
50 Tablets
Documents / Data provided by the applicants
(M/s CCL Pharma Pvt Ltd, Lahore .)
Documents to be provided
Sr. No.
1.
COA of API
2.
Approval of API by regulatory authority of country of origin
or GMP certificate of API manufacturer issued by regulatory
authority of country of origin.
Protocols followed for conduction of stability study and
details of tests.
Data of 03 batches will be supported by attested respective
documents like chromatograms, laboratory reports, data sheets
etc.
Documents confirming import of API etc.
3.
4.
5.
6.
7.
Decision:
All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
Commitment to continue real time stability study till assigned
shelf life of the product.
Status
Yes
(The firm has provided
COA of two different
companies )
Yes
(Photocopy Provided)
Yes
Yes
Yes
(not clear from the
invoice that from which
source the firm has
imported the API)
Yes
Yes
Registeration Board deferred the case for clarification regarding source of
API used for conducting stability studies.
Minutes for 260th Meeting Registration Board
374
Registration of Aprovasc Range (Irbesartan + Amlodipine).
Following case of M/s Sanofi Aventis, Karachi was discussed in 257th meeting and decided as
follows:
Registration Board in its 245th meeting discussed following products of M/s Sanofi Aventis,
Karachi and advised the firm to provide status about availability of products in SRAs and provide safety
and efficacy data of the drugs along with complete clinical trial data of these formulations.
S. No
I.
II.
III.
IV.
Name of drug(s) & Composition
Aprovasc 300/10mg Tablet
Each tablet contains:
Irbesartan……….300 mg
Amlodipine besylate.14 mg eq. to amlodipine…10 mg
(Antihypertensive, angiotensin II receptor antagonist)
Aprovasc 150/10mg Tablet
Each tablet contains:
Irbesartan……….150 mg
Amlodipine besylate.14 mg eq. to amlodipine…10 mg
(Antihypertensive, angiotensin II receptor antagonist)
Aprovasc 150/5mg Tablet
Each tablet contains:
Irbesartan……….150 mg
Amlodipine besylate.7 mg eq. to amlodipine……5 mg
(Antihypertensive, angiotensin II receptor antagonist)
Aprovasc 300/5mg Tablet
Each tablet contains:
Irbesartan……….300 mg
Amlodipine besylate.7 mg eq. to amlodipine……5 mg
(Antihypertensive, angiotensin II receptor antagonist)
In response, the firm had submitted that the fixed dose combination of Irbesartan + Amlodipine
(in the strength of Irbesartan 100mg /Amlodipine 5mg and Irbesartan 100mg /Amlodipine 10 mg) is
registered with PMDA Japan by the name of AIMIX by Daipinppon Suitomo Pharma. They have
submitted that as the dosing in Japan is considerably lower than the USA or Europe therefore the fixed
dose combinations are of lower strength.
They have informed that that three Bioequivalence studies have been conducted for Aprovasc and
the results of these had been submitted to DRAP for review and these studies show that the combination
of Irbesartan + Amlodipine versus free individual molecule is safe and well tolerated. Apart from these 2
Minutes for 260th Meeting Registration Board
375
randomized, open-label, multicenter, phase III trials were conducted and published in peer reviewed index
Journal, Clinical therapeutics (2012) and no untoward side effects were observed with this combination
other than those already reported for the individual drugs.
Registration Board in its 249th meeting discussed the case in view of the submission made by the firm and
following decision was taken:
“Registration Board referred the clinical data to Pharmacy Services Division for evaluation.”
 Division of Pharmacy Services has now submitted evaluation report as under:
“The clinical study data attached by the company have been studied. The pharmacokinetic,
Pharmacovigilance, safety, efficacy data provided by the company was evaluated. The representatives of
the company who are involved in clinical research were asked to explain the need of combination
medicines and their beneficial effects on hypertension patients.
The research articles, studies carried out on the above combination medicine provided by the company
and the discussion made with the expert reveals that the products could be approved for registration. Such
combination products with Amlodipine and valsartan are already available in the market. The products
may be considered by the Registration Board after completing other required codal formalities”
Decision (257th meeting): Registration Board deferred the case for detailed deliberation in the
light of report of Pharmacy Services Division.
Decision:
Registeration
Board
deferred
Minutes for 260th Meeting Registration Board
the
case
for
further
deliberation.
376
Item No.III: Biological Drugs Division.
Case No.01:
Cases of imported human biological drugs from non reference countries.
”In 255th meeting of Registration Board it was apprised that registration
applications for finished imported products are submitted with Certificate of Pharmaceutical Products
(CoPP) and in some cases, CoPP is without any expiry date. The Board decided to consider such CoPP
valid for 05 years from date of issuance. Moreover, Registration Board also decided to consider
registration applications of those imported products whose CoPPs was valid at time of submission of
application and later on expired during processing of the application. In such cases, application will be
considered by Registration Board and firm will be advised to provide valid CoPP. Registration letter will
be issued after submission of legalized CoPP after approval of chairman, RB. Accordingly the following
cases require consideration by the Registration Board”
S.#.
Name of
Importer &
Manufacturer
Brand Name &
Composition
1.
M/s Medibid
First floor,
Shafi Court
Merewether
Road, Civil
Lines, Karachi.
KXING-GCSF
300ug/ml PFS
Shandong
Kexing
Bioproducts
Co., Ltd.
Mingshui
development
Zone,
Zhangqiu,
Shandong,
China.
Recombinant
human
granulocyte
colonystimulating
factor injection
Strength of
active
ingredients:
300ug/ml/Pre
Filled Syringe
Type of Form
Dy No & Date of
application
Fee submitted
Pack size/
Demanded Price
Form 5-A
Dy No. 2232 R&I
dated 15-4-2013
Fee deposited Rs.
15000/- dated 19-42012 + Rs. 35000/dated 13-11-2013 +
Rs. 50000/- dated
12-1-2015
Shelf life: 24
months
Pack size: 300ug/ml
Pre filled
syringe/small
carton, 10
syringes/middle
carton, 320
syringes/big carton
Minutes for 260th Meeting Registration Board
Document
Remarks
details (CoPP)
Me too
status/New
molecule
Decision
COPP No.
WHO-CPPCERT-JN131211 dated
17-2-2013
from Republic
of China
Deferred for
expert opinion
of following
and valid
legalized
COPP/FSC &
GMP:
Product
License No.
GYZZ
S20103004
dated 29-42010
Free Sale
Certificate No.
2013-023
dated 17-22013 valid for
two years
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
a. Brig. Tariq
Satti,
AFBMTC,
Islamabad.
Brig.
Qamar-unNisa,
AFBMTC,
Islamabad
c. Dr Shamsi,
Karachi
Condition
of
inspection abroad
as per import
policy.
b.
377
2.
M/s Medinet
Pharmaceutical
s, Rawalpindi
Probiomed S.A
de C.V.
San Esteban
No.88, Col.
Santo Tomas,
C.P. 02020,
Deleg,
Azcapotzalco,
D.F., Mexico.
FILATIL
Prefilled Syringe
300MCG/1ML
(Filgrastim)
Active
ingredient:
Filgrastim……3
00MCG/1ML
Demanded Price.
Rs.4500/- per vial.
Dy. No. 1798 (R&I)
DRAP (TF)
Dated 21-11-2014
Fee deposited: Rs.
50000/- dated 1711-2014 +
Rs.50000/- dated
15-3-2016
Antineoplastic
Shelf life : 24
months
GMP
Certificate No.
113300IT0114
73 dated 05-72011
Product
Registration
No.
101M2001S.S.
A.
Free sale
certificate No.
113300516B1
305 dated 238-2011 valid
until 24
months
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Deferred for
expert opinion
of following
and valid
legalized
COPP/FSC &
GMP:
a. Brig. Tariq
Satti,
AFBMTC,
Islamabad.
Brig.
Qamar-unNisa,
AFBMTC,
Islamabad.
c. Dr Shamsi,
Karachi
Condition
of
inspection abroad
as per import
policy.
b.
Sanitary
License No. 09
002 02 0001
Date of expiry
30-1-2009
Date of
translation 27
July, 2011
3.
M/s Medinet
Pharmaceutical
s, Rawalpindi
Probiomed S.A
de C.V.
San Esteban
No.88, Col.
Santo Tomas,
C.P. 02020,
Deleg,
Azcapotzalco,
BIOYETIN
Multi dose
10,000IU
(Recombinant
Human
Erythropoietin)
Each 2ml vial
contains:
Recombinant
Human
Erythropoietin---
Dy No. 1164 (R&I)
DRAP (TF) dated
26-2-2015
Fee deposited: Rs.
50000/- dated 26-22015 + Rs.50000/dated 15-3-2016
As per DRAP policy
Minutes for 260th Meeting Registration Board
GMP
Certificate No.
113300IT0114
73 dated 05-72011
Free sale
certificate No.
093300516B1
213 dated 025-2009 valid
until 24months
from the
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Condition
of
inspection abroad
as per import
policy.
Deferred for
expert opinion
of following
and valid
legalized
COPP/FSC &
GMP:
a. Dr. Ghias
But, PIMS,
Islamabad.
378
D.F., Mexico.
--10,000IU
country of
origin.
Product
Registration
No. 306M98
S.S.A.
:
Anti anemic
agent
Hematopoietic
Growth Factor
b. Maj. Gen.
Sohail
Sabir, MH,
Rawalpindi.
c. Dr.Sami
siraj, KMU,
Peshawar.
Sanitary
License No. 09
002 02 0001
Date of expiry
30-1-2009
Date of
translation 27
July, 2011
4.
M/s Medinet
Pharmaceutical
s, Rawalpindi
Probiomed S.A
de C.V.
San Esteban
No.88, Col.
Santo Tomas,
C.P. 02020,
Deleg,
Azcapotzalco,
D.F., Mexico.
BIOYETIN
PFS 4000IU
(Recombinant
Human
Erythropoietin)
Strength &
Active
ingredients:
One pack of
Bioyetin 4000IU
PFS Contains:
Pre Filled
Syringes of
0.30ML Each.
Dy No. 1165 (R&I)
DRAP (TF) dated
26-2-2015
Fee deposited:
Rs. 50000/- dated
26-2-2015 +
Rs.50000/- dated
15-3-2011.
Recombinant
Human
Erythropoietin…
…4000IU
Pharmacological
group:
Antianemic
agent
Hematopoietic
Growth Factor
Minutes for 260th Meeting Registration Board
GMP
Certificate No.
113300IT0114
73 dated 05-72011
Free sale
certificate
letter
No.093300516
B1213 dated
02-5-2009
valid until 24
months from
the country of
origin.
Product
Registration
No. 306M98
S.S.A.
Sanitary
License No. 09
002 02 0001
Date of expiry
30-1-2009
Date of
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Deferred for
expert opinion
of following
and valid
legalized
COPP/FSC &
GMP:
Condition
of
inspection abroad a. Dr. Ghias
as per import
But, PIMS,
policy.
Islamabad.
b. Maj. Gen.
Sohail, MH,
Rawalpindi.
c. Dr.Sami
siraj, KMU,
Peshawar.
379
5.
M/s Medinet
Pharmaceutical
s, Rawalpindi
Probiomed S.A
de C.V.
San Esteban
No.88, Col.
Santo Tomas,
C.P. 02020,
Deleg,
Azcapotzalco,
D.F., Mexico.
BIOYETIN
PFS 2000IU
(Recombinant
Human
Erythropoietin)
Strength &
Active
ingredients:
One pack of
Bioyetin 2000IU
PFS Contains:
Pre Filled
Syringes of
0.30ML Each.
Dy No. 1166 (R&I)
DRAP (TF)
Dated 26-2-2015
Fee deposited: Rs.
50000/- dated 26-22015 + Rs. 50000/dated 15-3-2016.
Recombinant
Human
Erythropoietin…
…2000IU
Pharmacological
group:
Antianemic
agent
Hematopoietic
Growth Factor
6.
M/s La-Vie
(Pvt) Ltd.,
Lahore
Manufacturer
M/s xiamen
Innovax
Biotech Co.,
Ltd.,
130.Xinyuan
Road, Haicang
District,
Hecolin ®
0.5ml/dose PFS
Each 0.5ml dose
contains:30 ug of purified
recombinant
Hepatitis E virus
antigen
translation 27
July, 2011
GMP
Certificate No.
113300IT0114
73 dated 05-72011
Free sale
certificate
letter
No.093300516
B1213 dated
02-5-2009
valid until 24
months from
the country of
origin.
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
a. Dr.
GhiasBut,
PIMS,
Islamabad.
Maj Gen.
Sohail, MH,
Rawalpindi.
Condition
of
inspection abroad
as per import
policy.
b.
c. Dr.Sami
siraj,,
KMU,
Peshawar
Product
Registration
No. 306M98
S.S.A.
Dy. No. 2224 (R&I)
DRAP (TF)
Dated 12-5-2016
Fee deposited: Rs.
50000/- dated
10.5.2016
Shelf life : 36
months
Minutes for 260th Meeting Registration Board
Sanitary
License No. 09
002 02 0001
Date of expiry
30-1-2009
Date of
translation 27
July, 2011
New molecule
GMP
Certificate No.
CN20120056
dated 09-72012 valid
upto 08-72017
Free Sale
Certificate No.
Deferred for
expert opinion
of following
and valid
legalized
COPP/FSC &
GMP:
The
new
molecule
for
treatment
of
hepatitis
E
require
expert
evaluation from
hepatalogists.
Condition
of
inspection abroad
as per import
policy
will
Deferred
for
confirmation of
approval status
by
reference
regulatory
authorities and
expert opinion
of
following
pertaining
to
requirement of
Hepatitis
E
380
Exiamen,
Fujian
Province, PR
China.
7.
8.
2016002 dated
8.1.2016
M/s La-Vie
(Pvt) Ltd.,
Lahore
Hirax Injection
Each 0.5 ml
(vial) contains:-
Dy. No.886 (R&I)
DRAP (TF)
Dated 15-2-2016
Manufacturer
M/s BMI Korea
Co., Ltd., 11,7
Gill, Chedanro,
Jeju-si, Jeju-do,
690,140 Korea.
Hyaluronidase…
…. 750 IU
Fee deposited: Rs.
50000/- dated
08.2.2016.
M/s La-Vie
(Pvt) Ltd.,
Lahore
Hirax Injection
Each 1ml (vial)
contains:Hyaluronidase…
…. 1500 IU
Manufacturer
M/s BMI Korea
Co., Ltd., 11,7
Enzyme
(Enhance
permeation of
Subcutanious or
Intramuscular
Injections, local
anesthetics and
subcutaneous
infusions.)
(Enhance
Dy. No.4666 (R&I)
DRAP (TF)
Dated 28-7-2015
Fee deposited: Rs.
50000/- dated
09.7.2015
Minutes for 260th Meeting Registration Board
New molecule
CoPP No.
2014-F1-0121
dated
24.4.2014
(validity not
mentioned)
GMP
Certificate No.
2014-F1-0172
dated 07-72014
Free Sale
Certificate No.
2014-F1-0120
dated
24.4.2014
New molecule
CoPP No.
2014-F1-0121
dated
24.4.2014
GMP
prevail.
Evidence
of
availability
in
reference
drug
agencies
is
required.
Product
is
available
internatioally in
reference
agencies
under
the
name
of
HYLASE
of
virus vaccine in
country,
keeping in view
its
prevelance,epid
emiology,
domestic
requirement etc.
a. Dr. Huma
Qureshi,
PHRC,
Islamabad
b. Prof,
Dr.
Umar, Holy
Family
Hospital,
Islamabad
Deferred
for
confirmation of
approval status
by
reference
regulatory
authorities
including
indications.
Deferred
for
confirmation of
approval status
by
reference
regulatory
authorities
381
9.
Gill, Chedanro,
Jeju-si, Jeju-do,
690,140 Korea.
permeation of
Subcutanious or
Intramuscular
Injections, local
anesthetics and
subcutaneous
infusions.)
Venture
Pharmaceutical
s (Pvt) Ltd,
Karachi.
RHOCLONE
300 MCG
Bharat Serums
and Vaccines
Limited
Plot No. K-27,
Anand Nagar,
Additional
M.I.D.C.
Ambernath
(East), India
Anti Rho-D
Immuno
globulin
Injection
(Monoclonal)
(Liquid
Injection)
Certificate No.
2014-F1-0172
dated 07-72014
Free Sale
Certificate No.
2014-F1-0120
dated
24.4.2014
Form-5A
Dy. No. 1218 (R&I)
DRAP dated 25-22016
Fee Deposited:
Rs.100000/- dated
03-2-2016
vial
Each ml
contains:
Anti Rho-D
Immunoglobulin
….300mcg/
1500 IU
Water for
Injection
U.S.P…q.s
Immune Sera
and
Immunoglobulin
Anti-D (Rh)
Immunoglobulin
ATC code: J06B
B01
Shelf life: 24
months
Minutes for 260th Meeting Registration Board
Legalized
Valid COPP
No.
COPP/CERT/
KD/42264/201
6/11/14803/73
243 valid up to
01-10-2016
Product
License No.
KD5 in Form
28E
Dated 07-22011
Legalized
GMP
Certificate No.
NEW-WHOGMP/CERT/K
D/12788/2014/
11/6320 dated
04-4-2014
Wockhardt UK as
freeze
dried
formulation
(powder)
in
ampoule,
however
tha
applied product is
solution in vial.
The lyphollized
formulation
is
included in BP.
The product was
discussed in the
257th meeting and
deferred
for
submission
of
vaild
legalized
CoPP. Now the
Firm
has
submitted Valid
legalized CoPP
valid upto 01-102016.
including
indications.
Deferred for
a. Confirmation
of
approval
status
by
reference
regulatory
authorities.
b. References
pharmacopias
c. Importability
Evidence
of as per import
availability
in policy
order
reference
drug from India
agencies
is
required as the
Pharmacopieal
preparation (BP)
contains specific
antibodies against
erythrocyte
Dantigen and may
also contain small
quantities
of
other blood-group
antibodies.
However
the
applied
formulation
contains only IgG
antibodies.
d.
Safety
profile, clinical
efficacy,
and
clarification as
the
Pharmacopieal
preparation
(BP) contains
specific
antibodies
against
erythrocyte Dantigen
and
may
also
contain small
382
Condition
of quantities
of
inspection abroad other
bloodas per import group
policy.
antibodies.
However
the
applied
formulation
contains only
IgG antibodies.
10.
M/s Opulent
International
Karachi.
M/s Reliance
Life Sciences,
of Dhirubhai
Ambani Life
Sciences Center
(DALC),Plant
No. 4B, Plot
No. R-282,
TTC Area of
MIDC, Rabale
Thane Belapur
Road Navi
Mumbai India.
ALBUREL
(Human Normal
Albumin IP
20%)
Form-5A
Each 100 ml vial
contains:
Total
protein….200g/
L
Sodium
Caprylate…..6.6
5g/ L
Na+ not more
than…160mM/L
K+ not more
than…..2mM/ L
Aluminum…..≤
200µg/ L
Rs.100000 dated 2806-2013
Dy. No 1120 dated
28-05-2014
Legalized
CoPP/CERT/
KD/42047/201
6/11/14718/72
804 dated 304-2016 valid
upto 31-122017
As per COPP, the
product
is
licensed to be
placed in the
market for use in
the
exporting
country; however
product is not
available in the
market in the
country of origin.
Legalized
CoPP/CERT/
KD/42047/201
6/11/14718/72
804 dated 304-2016 valid
upto 31-122017
As per COPP, the
product
is
licensed to be
placed in the
market for use in
the
exporting
country; however
product is not
60USD / vial
Deferred
for
clarification
about
non
abailability of
product in the
country
of
origin and valid
reason thereof
by
the
regulatory body
and
Condition
of confirmation of
inspection abroad availability of
as per import similar products
policy.
in country.
Human Albumin
–Plasma protein
11.
M/s Opulent
International
Karachi.
M/s Reliance
Life Sciences,
of Dhirubhai
Ambani Life
Shelf life : 36
months
ALBUREL
(Human Normal
Albumin IP
20%)
Each 50 ml vial
contains:
Total
Form-5A
Dy. No 1119 dated
28-05-2014
Rs. 100000 dated
28-06-2013
Minutes for 260th Meeting Registration Board
Deferred
for
clarification
about
non
abailability of
product in the
country
of
origin and valid
reason thereof
383
Sciences Center
(DALC),Plant
No. 4B, Plot
No. R-282,
TTC Area of
MIDC, Rabale
Thane Belapur
Road Navi
Mumbai India.
protein….200g/
L
Sodium
Caprylate…..6.6
5g/ L
Na+ not more
than…160mM/L
K+ not more
than…..2mM/ L
Aluminum…..≤
200µg/ L
30USD / vial
available in the by
the
market in the regulatory body
country of origin. and
confirmation of
Condition
of
availability of
inspection abroad
similar products
as per import
in country.
policy.
Human Albumin
–Plasma protein
12.
M/s Opulent
International
Karachi.
M/s Reliance
Life Sciences,
Pvt Limited,
Plant-1 Sandhra
Textile Mills
Compound,
Ground and
First Floor C.S.
No. 1621 Plot
No. 3 Plan 1
Pandurang
Budhkar, Marg
Worli Mumbai.
Shelf life : 36
months
IMMUNOREL
(Human Normal
Immunoglobulin
for Intravenous
Administration)
Each 50ml
contains:
Form-5A
Legalized
CoPP
Dy. No 11198 dated /CERT/MD/26
28-05-2014
507/2015/11/1
0485/48262
100000 dated 28-06- dated 28-42013
2015 valid
upto 09-398 USD / vial
2017
Protein…..50g/
L
IgG…..2.5g
Stabilizer
Maltose…..100g
/L
IgA content≤
80mg/L
IgG
subclases……N
ormal
distribution
As per COPP, the
product
is
licensed to be
placed in the
market for use in
the
exporting
country; however
product is not
available in the
market in the
country of origin.
Deferred
for
clarification
about
non
abailability of
product in the
country
of
origin and valid
reason thereof
by
the
regulatory body
and
Condition
of confirmation of
inspection abroad availability of
as per import similar products
policy.
in country.
Immunoglobulin
s
Shelf life: 36
months
Minutes for 260th Meeting Registration Board
384
13.
14.
M/s Hakim
sons (Impex)
Pvt Limited,
Hakim sons
Building, 19
West Warf
Road, Karachi
Pakistan
HuCoG- 5000
HP
M/s Bharat
Serum and
Vaccines
Limited, Plot
No K-27 Anaa
nd Nagar,
Additional
MIDC
Ambernath
(East) India.
Gonadotropins
M/s Hakim
sons (Impex)
Pvt Limited,
Hakim sons
Building, 19
West Warf
Road, Karachi
Pakistan
BSV HUMOG
75 HP
M/s Bharat
Serum and
Vaccines
Limited, Plot
No K-27 Anaa
nd Nagar,
Additional
MIDC
Each vial
contains:
Chorionic
Gonadotropin
BP……5000 I.U
Form-5A
Dy No. 279 R&I
dated 15-01-16
Fee Rs.100000/dated 12-01-2016
Legalized
CoPP No:
CoPP/ CERT/
KD/ 16870/
2014/ 11/
6610/ 292156/
valid up to 0104-2016
Legalized
GMP No:
New-WHOGMP/ CERT/
KD/ 12788/
2014/ 11/ 6320
valid up to 0104-2016
Indications:
An ovulatory
Fertility,
Hypogonadism
and
Cryptorchidism
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Deferred
for
submission of
valid legalized
COPP,
confirmation of
availability of
similar products
in country and
Condition
of expert opinion
inspection abroad of following:
as per
policy.
import
Shelf life: 24
months
Each vial
contains:
Menotropin BP
equivalent to
activity of
Follicle
Stimulating
Hormone……75
IU
Luteinizing
Hormone……75
IU
Form-5A
Dy No. 280 R&I
dated 14-01-16
Fee Rs.100000/dated 12-01-2016
Hormone
Minutes for 260th Meeting Registration Board
a. Brig.
Muzamil
Hussain
Najmi,
Member
Registration
Board
b. Brig, Aamir
Ikram,
AFIP,
Rawalpindi.
c. Dr. Masudur-Rehman,
DDG,
DRAP
Deferred
for
submission of
valid legalized
COPP,
confirmation of
availability of
similar products
in country and
expert opinion
of following:
Legalized
CoPP No:
CoPP/ CERT/
KD/ 26812/
2015/ 11/
10547/ 48878/
valid up to 0104-2016
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Legalized
GMP No:
New-WHOGMP/ CERT/
KD/ 12788/
2014/ 11/ 6320
valid up to 0104-2016
Condition
of
inspection abroad
as per import
a. Brig.
policy.
Muzamil
Hussain
Najmi,
Member
Registration
385
Ambernath
(East) India.
15.
Hospital
Services &
Sales 13-C
Annexe, Block
6, P.E.C.H.S,
Shahrah-eFaisal, Karach
75400.
Manufacturer:
M/s. Reliance
Life Sciences,
Limited
Dhirubhai
Ambani Life
Sciences Center
(DALC),
R-282, TTC
Industrial Area,
Thane Belapur
Road, Rabale,
Navi Mumbai,
Maharashtra,
India
16.
Hospital
Services &
Sales 13-C
Annexe, Block
6, P.E.C.H.S,
Shahrah-eFaisal, Karach
75400.
Board
b. Brig, Aamir
Ikram,
AFIP,
Rawalpindi.
c. Dr. Masudur-Rehman,
DDG,
DRAP
Deferred for
submission of
valid legalized
COPP and
expert opinion
of following:
Shelf Life: 36
months
EPOREL-10,000 Form 5A
I.U PFS
10-10-2014
Each 1.0ml
contains:
Fee Rs.100000/Erythropoietin
dated 10-10-2014
concentrated
(rhEPO) Ph Eur
Rs. 6086/- pack of
……10,000
1’s
Blood Forming
Agent
Shelf life: 24
months
EPOREL-2000
I.U PFS
Legalized
CoPP
provided, valid
up to 19-032014
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
a. Dr. Toqeer
Raza,
Condition
of
NUST,
inspection abroad
Islamabad
as per import b. Dr. Huma
policy.
Qureshi,
PMRC,
Islamabd
c. Dr. Sami J
Khan
Product
License No.
KD/7
Dated 28-042014
Form 5A
10-10-2014
Each 0.5ml
contains:
Erythropoietin
concentrated
(rhEPO) Ph Eur
……2000
Legalized Free
Sale
Certificate No.
D&C/841/201
110/-00525-4
Dated 09-112011
Fee Rs.100000/dated 10-10-2014
Rs. 1383/- pack of
1’s
Manufacturer:
Minutes for 260th Meeting Registration Board
Legalized
GMP
provided, valid
up to 19-032014.
Legalized Free
Sale
Certificate No.
D&C/841/201
110/-00525-4
Dated 09-112011
Legalized
CoPP
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Condition
Deferred for
submission of
valid legalized
COPP and
expert opinion
of following:
a. Dr. Toqeer
Raza,
of
NUST,
386
17.
M/s. Reliance
Life Sciences,
Limited
Dhirubhai
Ambani Life
Sciences Center
(DALC),
R-282, TTC
Industrial Area,
Thane Belapur
Road, Rabale,
Navi Mumbai,
Maharashtra,
India
Blood Forming
Agent
Hospital
Services &
Sales 13-C
Annexe, Block
6, P.E.C.H.S,
Shahrah-eFaisal, Karach
75400.
EPOREL-4000
I.U PFS
Manufacturer:
M/s. Reliance
Life Sciences,
Limited
Dhirubhai
Ambani Life
Sciences Center
(DALC),
R-282, TTC
Industrial Area,
Thane Belapur
Road, Rabale,
Navi Mumbai,
Maharashtra,
India
18.
Hospital
Services &
Sales 13-C
Annexe, Block
provided, valid
up to 19-032014
Shelf life: 24
months
Form 5A
Fee Rs.100000/dated 10-10-2014
Rs. 2856/- pack of
1’s
Blood Forming
Agent
Shelf life: 24
months
APIGRAST
300µg PFS
PMRC,
Islamabd
c. Dr. Sami J
Khan
Product
License No.
KD/7
Dated 28-042014
10-10-2014
Each 0.4 ml
contains:
Erythropoietin
concentrated
(rhEPO) Ph Eur
……4000
inspection abroad
Islamabad
as per import b. Dr. Huma
Qureshi,
policy.
Legalized
GMP
provided, valid
up to 19-032014.
Legalized Free
Sale
Certificate No.
D&C/841/201
110/-00525-4
Dated 09-112011
Legalized
CoPP
provided, valid
up to 19-032014
Product
License No.
KD/7
Dated 28-042014
Form-5A
02-09-2014
Each 0.5ml
Minutes for 260th Meeting Registration Board
Legalized
GMP
provided, valid
up to 19-032014.
Legalized Free
Sale
Certificate No.
D&C/841/201
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Deferredfor
submission of
valid legalized
COPP and
expert opinion
of following:
Valid
and
legalized COPP/
FSC along with
GMP Certificate
Defered for
expert opinion
of following
and valid
a. Dr. Toqeer
Raza,
Condition
of
NUST,
inspection abroad
Islamabad
as per import b. Dr. Huma
policy.
Qureshi,
PMRC,
Islamabd
c. Dr. Sami J
Khan
387
6, P.E.C.H.S,
Shahrah-eFaisal, Karach
75400.
Manufacturer:
M/s. Reliance
Life Sciences,
Pvt Limited
Dhirubhai
Ambani Life
Sciences Center
(DALC),
R-282, TTC
Industrial Area,
Thane Belapur
Road, Rabale,
Navi Mumbai,
Maharashtra,
India
19.
Hospital
Services &
Sales 13-C
Annexe, Block
6, P.E.C.H.S,
Shahrah-eFaisal, Karach
75400.
Manufacturer:
M/s. Reliance
life sciences
Pvt. Ltd.,
Dhirubhai
Ambani Life
Sciences Center
(DALC),
R-282, TTC
Industrial Area,
Thane Belapur
Road, Rabale,
Navi Mumbai,
Maharashtra,
contains:
Filgrastim
concentrated
solution Ph.
Eur… 300µg
Fee Rs.100000/dated 02-09-2014
Rs.4910/- Pack of
1’s
Antineoplastic
and
Immunomodulat
or
Each vial
contains:
Reteplase
(Recombinant
Tissue
Plasminogen
Activator)
…….…. 18mg
Tranexamic
acid... 8.32mg.
Legalized
CoPP
provided, valid
up to 19-032014
need
to
be legalized
submitted as per COPP/FSC &
above decision of GMP:
255th meeting.
a. Brig. Tariq
Satti,
AFBMTC,
Islamabad.
Brig.
Qamar-unNisa,
AFBMTC,
Islamabad.
c. Dr Samsi
Karachi
Condition
of
inspection abroad
as per import
b.
policy.
Product
License No.
KD/7
Dated 28-042014
Shelf life: 24
months
CARDIRAL
18mg/ 10Units
Per Vial (Sterile
lyophilized
powder for
injection)
110/-00525-4
Dated 09-112011
Legalized
GMP
provided, valid
up to 19-032014
Form 5A
Legalized Free
Sale
100000 dated 02-09- Certificate No.
2014
D&C/841/201
110/-00525-4
Dated 09-1147188/- pack of 2
2011
single use vials, 2
Legalized
ampoules of 10ml
CoPP
sterile water of
provided, valid
injection, 2 single
up to 19-03use 10 ml syringes,
2014
4 sterile needles.
Product
License No.
KD/7
Dated 28-042014
Antithrombotic
Shelf life: 24
months
Minutes for 260th Meeting Registration Board
Legalized
GMP
provided, valid
up to 19-03-
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Deferred
for
confirmation of
approval status
by
reference
regulatory
authorities,
local
availability of
Condition
of similar products
inspection abroad and provision
valid
as per import of
policy.
legalized
COPP/FSC &
GMP.
Tranexamic acid
is
used
as
excipient
in
formulation
which
require
clarification from
the firm.
388
20.
INDIA.
Hospital
Services &
Sales 13-C
Annexe, Block
6, P.E.C.H.S,
Shahrah-eFaisal, Karachi
75400.
Manufacturer:
M/s. Reliance
life sciences
pvt. Ltd.,
Dhirubhai
Ambani Life
Sciences Center
(DALC),
R-282, TTC
Industrial Area,
Thane Belapur
Road, Rabale,
Navi Mumbai,
Maharashtra,
INDIA.
21.
Hospital
Services &
Sales 13-C
Annexe, Block
6, P.E.C.H.S,
Shahrah-eFaisal, Karachi
75400.
Manufacturer:
M/s. Reliance
life sciences
pvt. Ltd.,
Dhirubhai
Ambani Life
Sciences Center
(DALC),
R-282, TTC
APFERON
5MIU vial
Each 0.5ml
contains:
rH Interferon
alfa 2b Ph. Eur.
…………..… 5
MIU
2014
Form 5A
Legalized Free
Sale
100000 dated 02-09- Certificate No.
2014
D&C/841/201
110/-00525-4
Rs. 1936/- Pack of
Dated 09-111’s
2011
Legalized
CoPP
provided, valid
up to 19-032014
Cytokines and
Immunomodulat
or
Shelf life :
2years
APFERON
3MIU vial
Each 0.5ml
contains:
rH Interferon
alfa 2b Ph. Eur.
…………..… 3
MIU
Product
License No.
KD/7
Dated 28-042014
Legalized
GMP
provided, valid
up to 19-032014
Form 5A
Legalized Free
Sale
100000 dated 02-09- Certificate No.
2014
D&C/841/201
110/-00525-4
Rs. 1134/- Pack of
Dated 09-111’s
2011
Cytokines and
Immunomodulat
or
Shelf life :
2years
Minutes for 260th Meeting Registration Board
Legalized
CoPP
provided, valid
up to 19-032014
Product
License No.
KD/7
Dated 28-04-
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Deferred for
submission of
valid legalized
COPP and
expert opinion
of following:
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Defered for
submission of
valid legalized
COPP and
expert opinion
of following:
a. Prof. Dr.
Muhammad
Condition
of
Umar, Holy
inspection abroad
Family
as per import
Hospital,
policy.
Islamabad.
b. Dr. Huma
Qureshi,
PMRC,
Islamabad.
c. Dr. Nasir
Jalal,
NUST,
Islamabad.
a. Prof. Dr.
Muhammad
Condition
of
Umar, Holy
inspection abroad
Family
as per import
Hospital,
policy.
Islamabad.
b. Dr. Huma
Qureshi,
PMRC,
Islamabad.
c. Dr. Nasir
389
Industrial Area,
Thane Belapur
Road, Rabale,
Navi Mumbai,
Maharashtra,
INDIA.
22.
Hospital
Services &
Sales 13-C
Annexe, Block
6, P.E.C.H.S,
Shahrah-eFaisal, Karach
75400.
Manufacturer:
M/s. Reliance
life sciences
pvt. Ltd.,
Dhirubhai
Ambani Life
Sciences Center
(DALC),
R-282, TTC
Industrial Area,
Thane Belapur
Road, Rabale,
Navi Mumbai,
Maharashtra,
INDIA.
23.
The Searle
Company Ltd
First floor
NICL Building
Abbasi
Shaheed Road ,
Karachi 75530
Product
License Holder
Address
2014
RELIBETA
30µg – 0.5ML
PFS (
Form-5A
Each 0.5ml in
PFS contains:
Recombinant
Interferon beta
1a ……………
30µg
Deposited fee
100000
10-10-2014
Legalized
GMP
provided, valid
up to 19-032014
Legalized Free
Sale
Certificate No.
D&C/841/201
110/-00525-4
Dated 09-112011
30430/- Pack of 1’s
Legalized
CoPP
provided, valid
up to 19-032014
Cytokines
Shelf life: 2
years
Product
License No.
KD/7
Dated 28-042014
Legalized
GMP
provided, valid
up to 19-032014
CoPP letter No
.20132019
000140 dated
17-4-2015
valid for
twelve months.
TUXIMAB
Injection
100mg/10ml
09 -6-2015
Each vial
contain
100mg/10ml of
Rituximab
Rs.100000/- vide
challan No.
0233078 dated 18-52015
Prod Reg No.
57.279 date of
Balance fee
issuance 16th
October, 2013.
Nil
Issued by
Indication:
Non-Hodgkin’s
Fee Deposited
Minutes for 260th Meeting Registration Board
Jalal,
NUST,
Islamabad.
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Defered for
submission of
valid legalized
COPP and
expert opinion
of following:
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Deferred for
submission
valid legalized
COPP and
expert opinion
of following:
a. Prof. Dr.
Muhammad
Condition
of
Umar, Holy
inspection abroad
Family
as per import
Hospital,
policy.
Islamabad.
b. Dr. Huma
Qureshi,
PMRC,
Islamabad.
c. Dr. Nasir
Jalal,
NUST,
Islamabad.
Condition
of a. Gen.
inspection abroad
Iftikhar,
CMH,
as per import
390
Laboratorio
ELEA
S.A.C.I.F.y.A..
Sanabria No
2353
C1417AZE
Ciudad
Autonoma de
Buenos Aires,
Republica
argentina
API
Manufacturing
Site:
Pharm ADN
Carlos Villate
5148, Buenos
aires, Argentina
24.
Finished
Manufacturing
& Packaging
site:
SINERGIUM
BIOITECH
S.A.
Ruta 9km 38.7
– Grain – Prov.
De, Buenos
Aires,
Republica
argentina
The Searle
Company Ltd
First floor
NICL Building
Abbasi
Shaheed Road ,
Karachi 75530
Product
License Holder
Lymphoma
Chronic
Lymphocytic
Leukemia
Rhematoid
Arthritis
Granulomatosis
with Polyangitis
(previously
termed wegner’s
Granulomatosis)
and microscopic
polyangitis.
anmat
Argentina.
policy.
Rawalpindi.
b. Dr. Humera
Mehmood,
Consultant
of
Oncolologis
t NORI,
Islamabad.
Pharm ADN
GMP
Certificate No.
20132014
000791 14
dated 09-62014
c. Dr. Saleem
Siddique,
Shifa
Internationa
l,
Islamabad.
SINERGIUM
BIOITECH
S.A.
GMP
Certificate No.
20132014
001894 14
dated 14-22015
Documents
Legalized and
notarized.
TUXIMAB
Injection
500mg/50ml
09 -6-2015
Each vial
contain
500mg/50ml of
Rituximab
Rs.100000/- vide
challan No.
0233077 dated 18-52015
Prod Reg No.
57. 279 dated
Balance fee
16-10-2013
Fee Deposited
Minutes for 260th Meeting Registration Board
COPP letter
No.
20132019
000142 15
dated 17-42015
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Condition
Deferred for
submission
valid legalized
COPP and
expert opinion
of following:
of a. Gen.
391
Address
Indication:
Laboratorio
ELEA
S.A.C.I.F.y.A..
Sanabria No
2353
C1417AZE
Ciudad
Autonoma de
Buenos Aires,
Republica
argentina
Non-Hodgkin’s
Lymphoma
Chronic
Lymphocytic
Leukemia
Rhematoid
Arthritis
Granulomatosis
with Polyangitis
(previously
termed wegner’s
Granulomatosis)
and microscopic
polyangitis.
Nil
API
Manufacturing
Site:
Pharm ADN
Carlos Villate
5148, Buenos
aires, argentina
25.
Finished
Manufacturing
& Packaging
site:
SINERGIUM
BIOITECH
S.A.
Ruta 9km 38.7
– Grain – Prov.
De, Buenos
Aires,
Republica
argentina
M/s Hakimsons
(Impex) Pt Ltd
Karachi
M/s
SOVEREIGN
PHARMA
PVT.LTD, S
Issued by
anmat
Argentina.
inspection abroad
as per import
policy.
Iftikhar,
CMH,
Rawalpindi.
b. Dr. Humera
Mehmood,
Consultant
of
Oncolologis
t NORI,
Islamabad.
Pharm ADN
GMP
Certificate No.
20132014
000791 14
dated 09-62014
c. Dr. Saleem
Siddique,
Shifa
Internationa
l,
Islamabad.
SINERGIUM
BIOITECH
S.A.
GMP
Certificate No.
20132014
001894 14
dated 14-22015
Documents
Legalized and
notarized.
Sterilezed water
for Injection for
VaxiRab-N
(Purified Chick
Embryo Cell
Culture Rabies
Vaccine.
Form 5-A
Dy No. 768 Dir
(BD) dated 24-12-213
Fee deposited
Rs.50000/- dated
Minutes for 260th Meeting Registration Board
Legalized
COPP NO.
DD449/1/D/2011
valid upto 2911-2013
submitted
Valid
and
legalized COPP/
FSC along with
GMP Certificate
need
to
be
submitted as per
above decision of
255th meeting.
Approved
as
diluent
for
exclusive use of
VaxiRab-N
vaccine and as
per
Import
Policy
for
392
urvey no.46/14, Kadaiya
Village nanai
Daman-396210
India
Each 1ml Vial
water for Inj
Diulent
Shelf life 05year
Case No. 02:
Sr.
No
1.
29-10-2013 +
50000/- dt 12-122014
Unit price: Free of
Cost
finished drugs.
Condition
of
inspection abroad The firm will
valid
as per import provide
policy.
legalized COPP
and Chairman
Registration
Board
will
allow
the
issuance
of
registration
letter.
Cases of imported veterinary biological drugs from non reference countries
Name
of Brand Name & Type of Form
Document
Importer & Composition
details (CoPP)
Manufacturer
Dy No & Date of
application
Me
too
status/New
Fee submitted
molecule
Pack size/ Price
M/s Al-Asar MYVAC
Legalized Free
IBD Form-5A
Enterprise,
Sale certificate
V877
Multan
(Infectious Bursal Dy. No. 1916 dated dated
23-12Disease
V877 24-05-16
2015
Malaysian
vaccine)
Vaccines and
Fee Rs. 100000/- Legalized GMP
dose dated 24-05-16
Pharmaceutica Each
dated
27-09contains:
ls, Lot 11182,
2020
Infectious
Batu 20 Jalan
Decontrolled/
1000
bronchitis virus doses per vial, 10 vials Me too
Puchong,
V877 per pack
Kajang, Pulau strain
2.5
Meranti, Off ……..10 EID 50
Cyberjaya
Active
47100
immunization of
Puchong
chickens against
Selangor,
IBD
Malaysia.
Shelf life: 2 years
Route of Adm:
oral via drinking
Minutes for 260th Meeting Registration Board
Remarks
Decision
Condition of
inspection
abroad as per
import policy.
Approved as per
Import Policy for
finished drugs
and valid
legalized COPP.
393
2.
3.
water, Intraocular
and Intranasal
M/s Al-Asar MyVAC NDV Form-5A
Enterprise,
4HR
Multan
(New
Castle Dy. No. 2583 dated
Disease Vaccine) 13-06-16
Malaysian
Vaccines and Each
dose Fee
Rs.100000/Pharmaceutica contains:
dated 13-06-2016
ls, Lot 11182, New
castle
Batu 20 Jalan disease V4 Heat Decontrolled/
1000
Puchong,
resistant
virus doses per vial, 10 vials
Kajang, Pulau strain………106.0 per pack
Meranti, Off EID 50
Cyberjaya
47100
Active
Puchong
immunization of
Selangor,
chickens
anew
Malaysia.
castle
disease
virus
Shelf life: 2 years
Route of Adm:
oral via drinking
water, Intraocular
and Intranasal
M/s Al-Asar MyVAC Fowl Form-5A
Enterprise,
Pox
Multan
(Beaudette strain Dy. No. 2582 dated
vaccine)
13-06-16
Malaysian
Each
dose
Vaccines and contains:
Rs.100000/Pharmaceutica Fowl Pox live dated 13-06-2016
ls, Lot 11182, virus Beaudette
Batu 20 Jalan Strain………102.6 Decontrolled/
1000
Puchong,
doses per vial, 10 vials
EID 50
Kajang, Pulau
per pack
Active
Meranti, Off
immunization of
Cyberjaya
chickens against
47100
fowl pox
Puchong
Selangor,
Malaysia.
Legalized Free
Sale certificate
dated
23-122015
Condition of
inspection
abroad as per
import policy.
Approved as per
Import Policy for
finished drugs
and valid
legalized COPP.
Condition of
inspection
abroad as per
import policy.
Approved as per
Import Policy for
finished drugs
and valid
legalized COPP.
Legalized GMP
dated
27-092020
Me too
Legalized Free
Sale certificate
dated
23-122015
Legalized GMP
dated
27-092020
Me too
Shelf life: 2 years
Route of Adm:
wing
web,
Minutes for 260th Meeting Registration Board
394
4.
5.
intraocular,
Intramuscular
M/s Al-Asar IBD UPM93
Form-5A
Enterprise,
(Infectious Bursal
Multan
Disease Vaccine) Dy. No. 2581 dated
13-06-16
Malaysian
Each
dose
Vaccines and contains:
Fee
Rs.100000/Pharmaceutica IBD Live virus dated 13-06-2016
ls, Lot 11182, strain UPM 93
Batu 20 Jalan ………102.5 EID Decontrolled/
1000
Puchong,
doses per vial, 10 vials
50
Kajang, Pulau
per pack
Meranti, Off Active
Cyberjaya
immunization
47100
against IBD in
Puchong
broilers and layer
Selangor,
chickens
Malaysia.
Route of Adm:
Drinking water,
eye drop route
Shelf life: two
years
M/s Al-Asar MYVAC
ND Form-5A
Enterprise,
EMULSION
Multan
Dy. No. 1915 dated
(Inactivated oil
24-05-16
adjuvant
Malaysian
Newcastle
Vaccines and
Fee
Rs.100000/disease vaccine
Pharmaceutica
dated 13-06-2016
B1 Type LaSota)
ls, Lot 11182,
dose Decontrolled/
Batu 20 Jalan Each
1000
contains:
Puchong,
doses per vial, 10 vials
castle per pack
Kajang, Pulau New
disease
virus
Meranti, Off
LaSota strain ≥
Cyberjaya
108.5 EID 50
47100
Puchong
Active
Selangor,
immunization
Malaysia.
against
new
Legalized Free
Sale certificate
dated
23-122015
Condition of
inspection
abroad as per
import policy.
Approved as per
Import Policy for
finished drugs
and valid
legalized COPP.
Condition of
inspection
abroad as per
import policy.
Approved as per
Import Policy for
finished drugs
and valid
legalized COPP.
Legalized GMP
dated
27-092020
Me too
Legalized Free
Sale certificate
dated
23-122015
Legalized GMP
dated
27-092020
Me too
castle disease
Shelf life: 2 years
Minutes for 260th Meeting Registration Board
395
6.
7.
Route of Adm:
SC/ IM
M/s Al-Asar MYVAC 102
Form-5A
Enterprise,
Multan
(New
castle Dy. No. 1917 dated
disease B1 type 24-05-16
Malaysian
LaSota Strain)
Vaccines and
Fee
Rs.100000/Pharmaceutica Each
dose dated 13-06-2016
ls, Lot 11182, contains:
Batu 20 Jalan New
castle Decontrolled/
1000
Puchong,
disease
virus doses per vial, 10 vials
Kajang, Pulau LaSota
per pack
5.5
Meranti, Off strain:…… 10
Cyberjaya
EID 50
47100
Puchong
Active
Selangor,
immunization
Malaysia.
against
new
castle disease
Shelf life: 2 years
Route of Adm:
oral
route,
intraocular route
and intranasal
M/s Al-Asar MYVAC 202
Enterprise,
(Combined New
Multan
castle disease &
Infectious
Malaysian
bronchitis
Vaccines and vaccine)
Pharmaceutica
ls, Lot 11182, Each
dose
Batu 20 Jalan contains:
Puchong,
Kajang, Pulau New
castle
Meranti, Off disease virus B1
Cyberjaya
Type,
LaSota
47100
strain… 105.5 EID
Puchong
50
Selangor,
Infectious
Malaysia.
bronchitis virus
Legalized Free
Sale certificate
dated
23-122015
Condition of
inspection
abroad as per
import policy.
Approved as per
Import Policy for
finished drugs
and valid
legalized COPP.
Condition of
inspection
abroad as per
import policy.
Approved as per
Import Policy for
finished drugs
and valid
legalized COPP.
Legalized GMP
dated
27-092020
Me too
Form-5A
Legalized Free
Sale certificate
Dy. No. 1917 dated dated
23-1224-05-16
2015
Fee
Rs.100000/- Legalized GMP
dated 13-06-2016
dated
27-092020
Decontrolled/
1000
doses per vial, 10 vials Me too
per pack
Minutes for 260th Meeting Registration Board
396
Massachusetts
type
H120
strain….
103.1
EID 50
Active
immunization
against ND and
IBD
8.
Hospital
Services &
Sales 13-C
Annexe, Block
6, P.E.C.H.S,
Shahrah-eFaisal, Karachi
75400.
Parent
Company/Lic.
Holder:
QYH Biotech
Company
Ltd.,
Building. No.
20, Part 11,
ABP, No. 188,
Southwest 4th
Ring Road,
Fengtai
District,
Beijing, China.
Shelf life: 2 years
Route of Adm:
oral
route,
intraocular route
and intranasal
QYH-ND IB
EDS
(Newcastle
Disease,
Infectious
Bronchitis & Egg
Drop Syndrome
Vaccine,
Inactivated)
Each one dose
contains:Inactivated
Newcastle
Disease virus La
Sota strain (the
virus titer is ≥
3x108.0EID50/
22-Dec-10
Deposited fee
100000/Balance Fee
Nil
Pack Sizes:
(250mL / Bottle)
0.1ml before
inactivation),
inactivated
Infectious
Bronchitis
Manufacturin virus M41
g Site:
strain (the
Zhengzhou
virus titer is ≥
Bio6.0
Pharmaceutic 3x10 EID50/
Minutes for 260th Meeting Registration Board
Legalized Free
Sale Certificate
No. (2011)
160132129
Dated 01-062013
Condition of
inspection
abroad as per
import policy.
Deferred for
confirmation of
local availability/
approval of
similar vaccine.
Legalized
CoPP No. 3
Dated 10-122015
Product
License No.
(2010) 01008
Dated 09-032010
Legalized GMP
Certificate No.
(2014) 220
Dated 16-102014
397
al Factory of
QYH Biotech
Co. Ltd.,
Shibalihe,
South Surburb,
Zhengzhou
City, Henan
Provice, P. R.
China.
9.
Tarobina
Corporatin ,
New Garden
Town, Lahore
Choong Ang
Vaccine
Laboratories
co., Ltd. 147637 Yuseongdaero,
Yuseong-gu,
daejeon, Korea
305-348
0.1ml before
inactivation)
and inactivated
Egg Drop
Syndrome
virus AV127
strain (the HA
titer of the
virus is ≥
1:30720 before
inactivation),
(For Veterinary
Use)
Bovishot®
Ephemer
(Bovine
ephemeral fever
virus live
vaccine)
Composition per
dose (2.0ml/dose)
Bovine
ephemeral fever
virus….≥
103.0TCID50/dose
Stablizer…50%
Form-5(A)
Dy No. 4913 (R&I)
DRAP dated 05-82015
Fee deposited
Rs. 100000/- dated
03-8-2015
Dosage:
3doses/bottle
Maximum Retail
Price: Rs. 2115/-
Uses: For control
and preventin of
bovine ephemeral
fever caused by
BEFV in cows.
Legalized FSC
dated 26-62015.
Legalized GMP
Certificate
dated 22-52015
Condition of
inspection
abroad as per
import policy.
Deferred
for
expert
opinion
pertaining
to
prevelance,
epidemiology,
domestic
requirement etc.
from following:
a. Dr. Qurban
Ali, NVL,
Islambad
b. Dr. Masood
Rabbani,
UVAS,
Lahore.
c. Dr. Arif
Awan,
CASVAB
Quetta.
Shelf life:
Twelve(12)
months
Route:
Subcutanously
Injection
Minutes for 260th Meeting Registration Board
398
(For Veterinary
Use)
10. M/s
Vetline
International ,
Lahore,
Pakistan
ITA ND + IB
(Inactivated
Injectable
emulsion Vaccine
for
active
CEVAImmunization of
PHYLAXIA
chickens against
Veterinary
Newcastle
Biologicals
disease (ND) and
Co.
Ltd., infectious
Horog u. 32- Bronchitis (IB).
34.
1107
Budapaest
-50
pd50
of
HUNGARY
Inactivated
Newcastle
disease
Virus,
strain LaSota.
-induced min . 6
log2
HI,
of
Inactivated
Infectious
bronchitis virus,
strain
Pharmacologial
group:
Avian
inactivated
vaccine
Form 5-A
Copy of GMP
Certificate No.
Dy No. 1497 R&I CGDRAP dated 05-5- HU/09V/2014
2016.
DML No. MAFee deposited Rs. HU/04V/2009/
100000/- dated 02-5- M1. Dated 042016
11-2014
Hungary.
Legalized
valid Free sale
certificate
along
with
GMP/ CoPP is
required.
As the firm has
provided
valid
legalized
FSC
((02.2/3442-2/
2016 dated 1006-2016)
and
GMP certificate
(02.2/3442-5/
2016 dated 1006-2016)
and
Registration
Board considerd
the
documents
and approved the
product as per
Import Policy for
finised drugs.
Route
administratin:
Subcutaneously
or
Intramuscularly
Uses: Vaccine is
recommended for
the vaccination of
breeder and lying
type
chikens
flocks, previously
immunization
Minutes for 260th Meeting Registration Board
399
11. M/s Vetline
International ,
Lahore,
Pakistan
CEVAPHYLAXIA
Veterinary
Biologicals
Co. Ltd.,
Horog u. 3234. 1107
Budapaest
HUNGARY
against
Newcastle
disease
and
infectious
bronchitis with
attenuated
live
virus vaccine.
ITA CORYZA
ABC Gel
(Inactivated
Aluminium
Hydrooxide
suspension
Vaccine for the
immunization of
chickens against
infectious
Coryza.
Form 5-A
Dy No. 1495 R&I
DRAP dated 05-52016
Fee deposited:
Rs.100000/- dated 025-2016
Packs: One dose of
0.5ml
Composition:
Active
substances:
Inactivated
antigens:
Avibacterium
paragallinarum
serotypeA……mi
n. 7 log 10 CFU*
before
inactivation
GMP
Certificate No.
CGHU/09V/2014
DML No. MAHU/04V/2009/
M1. Dated 0411-2014
Hungary
Legalized
valid Free sale
certificate
along with
GMP/ CoPP is
required.
As the firm has
provided
valid
legalized
FSC
((02.2/3442-3/
2016 dated 1006-2016)
and
GMP certificate
(02.2/3442-5/
2016 dated 1006-2016)
and
Registration
Board considerd
the
documents
and approved the
product as per
Import Policy for
finised drugs.
Avibacterium
paragallinarum
serotype B……
min. 7 log 10
CFU* before
inactivation
Avibacterium
paragallinarum
serotype C……
min. 7 log 10
CFU* before
inactivation.
Minutes for 260th Meeting Registration Board
400
*CFU – colony
forming unit
Pharmacological
group:
Biologicals –
Avian inactivate
vaccine.
Route of
administration:
one dose of 0.5ml
injected
subcutaneously
or
intramuscularly
12. M/s Marush
Limited,
Lahore
CEVA
PHYLAXIA,
Veterinary
Biological, Co.
Ltd 110 7
budapest
Uses: ITA
CORYZA ABC
Gel is
recommended for
vaccinatin f
breeder and
laying type of
chicken flocks
against infectious
Coryza caused by
Avibacterium
paragallinarum
infection in order
to reduce the
clinical signs and
lesions of
diseases.
CEVAC
Transmune
(Live freeze dried
complex vaccine,
(winterfield 2512
G-61 strain IBD
antibidoes)
Each dose
Form 5-A
Dy No. 271 R&I
DRAP dated 13.5.16
Fee deposited:
Rs.100000/- dated 115-2016
Legalized FSC
No.02.2/72921/2016 dated
08-2-2016
Approved as per
Import Policy for
finished
drugs
and as per valid
legalized COPP.
Legalized GMP
No.02.2/72921/2016 dated
08-2-2016.
Packs: 2000. 4000,
Minutes for 260th Meeting Registration Board
401
Szallas u 5
Hungary.
contains:
Avian infectious
bursal disease
virus strain
winterfield 2512,
G-61……min 0.1
CID 50
8000 doses.
Immunization of
healthy chicjens
against IBD
Route of adm: SC
Shelf life: 24
months
Case No.03:
S.#.
1.
Company
name and
name of
manufacturer
M/s Grand
Pharma (Pvt)
Ltd, Rawat,
Islamabad
(Local
Manufacturer)
Cases of Veterinary Biological Vaccines / Drugs for Local
Manufacturing.
Brand name
/Drug
Composition
GPVAC ND (A)
Injection
Newcastle Disease
Vaccine
Each dose of 0.30
ml contains:
Inactivated
Newcastle Disease
Virus….Inducing≥
4.5 log2 HI uits
Uses:
For the precention
of Newcastle
Disease in poultry
for facster
production of
antibodies
Date of
application/
Fee status/
packs
Form-5
Dy No. 567
ADC(BD)
dated 23-52016
Fee deposited
Rs.20000/dated 20-52016
Price :
Decontrolled
Packs 250ml,
300ml,500ml
,600ml
International
availability
/ Me too status
Remarks
Local
manufacturing of
veterinary
vaccine. In the
254th RB Meeting
on the similar
case the Board
decided
for
product specific
inspection
by
experts focusing
on
processs,
strain
status,
safety
and
potency data.
Decision
Deferred for
products
specification
inspection
by following
experts:
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al),
DRAP
c. Area
Minutes for 260th Meeting Registration Board
402
Shelflife: one year
2.
M/s Grand
Pharma (Pvt)
Ltd, Rawat,
Islamabad
(Local
Manufacturer)
GPVAC H-9
Shield Injection
Avian Influenza
H9 cloned vaccine
Each ml (1000
doses0 contains;
Live rHVT-H9
virus…..3x106
plaque-forming
units (pfu)
Dosage: 3x103 fpu
per bird
Shelf life: Two
years
3.
M/s Grand
Pharma (Pvt)
Ltd, Rawat,
Islamabad
(Local
Manufacturer)
Uses: For the
prevention against
avian influenza
virus serotype H9
and Marek’s
disease virus
serotype-3 in
broilers.
GPVAC
ND+IB+H9
Injection
Combined
Newcastle disease,
Infectious
bronchitis and
avian influenza H9
vaccine
Each dose of
0.30ml contains:
Inactivated
Newcastle disease
virus….inducing
5 log2 HI
FID,
DRAP
Form-5
Dy No.562
ADC (BD)
dated 23-52016
Fee deposited
Rs. 20000/dated 20-52016
Price:
Decontrolled
Local
manufacturing of
veterinary
vaccine. In the
254th RB Meeting
on the similar
case the Board
decided
for
product specific
inspection
by
experts focusing
on
processs,
strain
status,
safety
and
potency data.
Deferred for
products
specification
inspection by
following
experts:
Local
manufacturing of
veterinary
vaccine. In the
254th RB Meeting
on the similar
case the Board
decided
for
product specific
inspection
by
experts focusing
on
processs,
strain
status,
safety
and
potency data.
Deferred for
products
specification
inspection by
following
experts:
Packs,
1000,2000,40
00,5000
doses
Form-5
Dy No. 563
ADC (BD)
dated 23-52016
Fee deposited
Rs. 20000/dated 20-52016
Price :
Decontrolled
Minutes for 260th Meeting Registration Board
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al)
c. Area
FID,
DRAP
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al)
403
units/dose
Infectious
bronchitis virus
(Mass
strain)….inducing
5 log2 HI
units/dose
c. Area
FID,
DRAP
Packs 250ml,
300ml,500ml
, 600ml
Inactivated Avian
Influenza virus
H9….inducing5
log2 HI units/dose.
Shelf life: Two
years
4.
M/s Grand
Pharma (Pvt)
Ltd, Rawat,
Islamabad
(Local
Manufacturer)
GPVAC NDKaseef Injection
New castle
Disease Vaccine
Each dose of
0.20ml contains:
Inactivated
Newcastle Disease
Virus…Inducing
4.5 log2 HI units
Form – 5
Dy No. 564
ADC (BD)
dated 23-52016
Shelf life: Two
years
Price:
Decontrolled
Fee deposited
Rs. 20000/dated 20-52016
Packs 250ml,
300ml,500ml
,600ml
5.
M/s Grand
Pharma (Pvt)
Ltd, Rawat,
Islamabad
(Local
Manufacturer)
GPVAC POLYFLU Injection
Avian Influenza
polyvalent vaccine
Each dose of
0.30ml contains:
Inactivated Avian
Influenza type
Form – 5
Dy No. 565
ADC (BD)
dated 23-52016
Fee deposited
Minutes for 260th Meeting Registration Board
Local
manufacturing of
veterinary
vaccine. In the
254th RB Meeting
on the similar
case the Board
decided
for
product specific
inspection
by
experts focusing
on
processs,
strain
status,
safety
and
potency data.
Deferred for
products
specification
inspection by
following
experts:
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al)
c. Area
FID,
DRAP
Local
Deferred for
manufacturing of products
specification
veterinary
inspection by
vaccine. In the
following
254th RB Meeting experts:
on the similar
case the Board a. Dr.
Muham
decided
for
mad
product specific
404
H5….Inducing5
log2 HI units/dose
Inactivated Avian
Influenza type
H7….inducing5
log2 HI units/dose
Inactivated Avian
Influenza virus
H9….inducing5
log2 HI units/dose.
Rs. 20000/dated 20-52016
Price:
Decontrolled
Packs 250ml,
300ml,500ml
,600ml
inspection
by
Arshad,
Member
experts focusing
Registrat
on
processs,
ion
strain
status,
Board
safety
and b. DDG
potency data.
Biologic
al)
c. Area
FID,
DRAP
Shelf Life: Two
years
6.
M/s Grand
Pharma (Pvt)
Ltd, Rawat,
Islamabad
(Local
Manufacturer)
GPVAC HydroTC Plus Injection
Bivalent HPS-IBH
vaccine
Each 0.30 ml dose
contains:
Inactivated Avian
Adenovirus
serotype-4….7
log10 EID50/dose
Inactivated Avian
Adenovirus
serotype-8….7
log10 EID50/dose.
7.
M/s Grand
Pharma (Pvt)
Ltd, Rawat,
Islamabad
(Local
Manufacturer)
Shelf life: Two
years
GPVAC MGBacterin Injection
Mycoplasma
gallisepticum
vaccine
Each ml contains:
Mycoplasma
gallisepticum……
5 x 107 CFU/ml
Form – 5
Dy No. 561
ADC (BD)
dated 23-52016
Fee deposited
Rs. 20000/dated 20-52016
Price:
Decontrolled
Packs 250ml,
300ml,500ml
,600ml
Form – 5
Dy No. 566
ADC (BD)
dated 23-52016
Fee deposited
Minutes for 260th Meeting Registration Board
Local
manufacturing of
veterinary
vaccine. In the
254th RB Meeting
on the similar
case the Board
decided
for
product specific
inspection
by
experts focusing
on
processs,
strain
status,
safety
and
potency data.
Deferred for
products
specification
inspection by
following
experts:
Local
manufacturing of
veterinary
vaccine. In the
254th RB Meeting
on the similar
case the Board
decided
for
product specific
Deferred for
products
specification
inspection by
following
experts:
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al)
c. Area
FID,
DRAP
a. Dr.
Muham
mad
405
Shelf life: Two
years
Uses: For the
prevention of
mycoplasma
gallisepticmum in
poultry.
8.
M/s Grand
Pharma (Pvt)
Ltd, Rawat,
Islamabad
(Local
Manufacturer)
GPVAC FLU 7+9
(A) Injection
Avian Influenza
virus H7+N9
Aqueous vaccine
Each dose of
0.30ml contains:
Inactivated Avian
Inafluenza virus
H7…Inducing4.5
log2 HI units
Inactivated Avian
Inafluenza virus
H9…Inducing4.5
log2 HI units
9.
M/s SANNA
Laboratories,
Faisalabad
(Local
Manufacturer)
Shelf life: One
year
NIAB (H.S.
VACCINE)
Injectable
Formaline
inactivated
Pasturella
muoltocida oil
adjuvanted
vaccine
Each dose
contains:
….Inactivated oil
emulsified
Pasturella
multocida
Rs. 20000/dated 20-52016
Price:
Decontrolled
Packs 250ml,
300ml,500ml
,600ml
Form – 5
Dy No. 568
ADC (BD)
dated 23-52016
Fee deposited
Rs. 20000/dated 20-52016
Price:
Decontrolled
inspection
by
Arshad,
Member
experts focusing
Registrat
on
processs,
ion
strain
status,
Board
safety
and b. DDG
potency data.
Biologic
al)
c. Area
FID,
DRAP
Local
manufacturing of
veterinary
vaccine. In the
254th RB Meeting
on the similar
case the Board
decided
for
product specific
inspection
by
experts focusing
on
processs,
strain
status,
safety
and
potency data.
Deferred for
products
specification
inspection by
following
experts:
PSI is required by
the panel of
experts.
Deferred for
products
specification
inspection by
following
experts:
Packs 250ml,
300ml,500ml
,600ml
Form – 5
Dy No. 655
R&I DRAP
dated 29-12015
Fee deposited
Rs. 20000/dated 23-122014
Price:
Decontrolled
Minutes for 260th Meeting Registration Board
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al)
c. Area
FID,
DRAP
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
406
Proposed route:
Subcutanous
Injection
Packs 30ml,
90ml,300ml,
900ml
al)
c. Area
FID,
DRAP
Uses: For animals
to protect against
Heamorrhagic
Septicemia
10.
M/s SANNA
Laboratories,
Faisalabad
(Local
Manufacturer
Shelf life: 02 years
PROMAS
Injectable
Each ml contains
an minimum of 6
x 109 m.o of:
Staphylococcus
aureus,
Streptococcus
agalactiae,
Escherichia coli
and
Arcanobacterium
pyogenes oil
adjuvancted
vaccine.
Form -5
Fee deposited
Rs. 60000/dated 20-62013
Dosage: 5ml
Price Decontrolled
Uses: For
prevention of
mastitis in cattle
buffalo, sheep,
goat and camel.
PSI is required by
the panel of
experts.
Deferred for
products
specification
inspection by
following
experts:
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al)
c. Area
FID,
DRAP
Shelf life: One
year
11.
M/s SANNA
Laboratories,
Faisalabad
(Local
Manufacturer
ENTOMIAVAC
(Enterotoxemia
Vaccine)
Formaline
inactivated
clostridium
Form -5
Dy No. 472
R&I, DRAP
dated 22-32016
Minutes for 260th Meeting Registration Board
Deferred for
products
specification
inspection by
following
experts:
a. Dr.
407
perfringeens oil
adjuvanted
vaccine
Each dose
contains:
Inactivated Oil
Emulsified
Clostridium
perfringens… 1 x
109
Shelf Life: One
(01) Year
12.
M/s SANNA
Laboratories,
Faisalabad
(Local
Manufacturer
Uses: For Sheep/
Goat to protect
atainst
Enterotixemia
BQ-VAC (Black
Quarter Vaccine)
Formaline
Inactivated
Clastridium
chavoei oil
adjuvanted
Vaccine
Each dose
contains:
Inactivated Oil
Emulsified
Clostridium
Chavoei.. 1 x 109
Shelf Life: One
Year
Fee deposited
Rs. 20000/dated 22-32016
Dosage: 2ml
Price –
Decontrolled
Packs: 15ml,
30ml ,
300ml,
600ml.
Form -5
Dy No. 476
R&I, DRAP
dated 22-32016
Fee deposited
Rs. 20000/dated 22-32016
Price –
Decontrolled
Packs: 30ml,
90ml ,
300ml,
600ml.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al)
c. Area
FID,
DRAP
Deferred for
products
specification
inspection by
following
experts:
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al)
c. Area
FID,
DRAP
Uses: For large
animals to protect
against Black
Quarter
Minutes for 260th Meeting Registration Board
408
13.
M/s SANNA
Laboratories,
Faisalabad
(Local
Manufacturer
APTHOVAC
(Foot and Mouth
disease Vaccine)
Formaline
inactivate
Aphthovirus oil
adjvanted Vaccine
Each dose
contains:
Inactivated Oil
Emulsified
Aphthovirus
Shelf life: One
year
14.
M/s SANNA
Laboratories,
Faisalabad
(Local
Manufacturer
SANTHRAX
(Anthrax Disease
Vaccine)
Formaline
inactivated
bacillus anthracis
oil adjuvanted
Vaccine
Each dose
contains:
Inactivated Oil
Emulsified
Bacillus anthracis
5 x109
Shelf life: One
year
Form -5
Dy No. 475
R&I, DRAP
dated 22-32016
Fee deposited
Rs. 20000/dated 22-32016
Price –
Decontrolled
Packs: 25ml,
50ml ,
100ml,
200ml.
Form -5
Dy No. 473
R&I, DRAP
dated 22-32016
Fee deposited
Rs. 20000/dated 22-32016
Price –
Decontrolled
Packs: 25ml,
1250ml ,
300ml,
900ml.
Deferred for
products
specification
inspection by
following
experts:
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al)
c. Area
FID,
DRAP
Deferred for
products
specification
inspection by
following
experts:
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board
b. DDG
Biologic
al)
c. Area
FID,
DRAP
Uses: For large
Minutes for 260th Meeting Registration Board
409
animal to protect
against anthrax
15.
M/s SANNA
Laboratories,
Faisalabad
(Local
Manufacturer
GALLIPRO
ND+H9 (ND &
A1 H9 Disease
Vaccine)
Formaline
inactivated New
castle disease
virus lasota &
Influenza A Virus
subtype H9 oil
Each dose
contains:
Inactivated Oil
Emulsified New
castle disease
virus lasota
Influenza A Virus
subtype H9
Form -5
Dy No. 474
R&I, DRAP
dated 22-32016
Fee deposited
Rs. 20000/dated 22-32016
Price –
Decontrolled
Packs:
150ml, ,
300ml,
600ml.
Deferred for
products
specification
inspection by
following
experts:
a. Dr.
Muham
mad
Arshad,
Member
Registrat
ion
Board.
b. DDG
Biologic
al).
c. Area
FID,
DRAP
Shelf life: One
year
Uses: For Poultry
Birds to protect
against New castle
disease and sub
strain H9 of Avian
Influenza disease
Case No.04:
a.
Local Manfacturing Of (Biological Drugs) M/S Macter International, Karachi
Clariclot (Recombinant streptokinase) 1.5MIU Vial of M/S Macter International
Karachi
S.No. Documents
and
required as per
meeting
data Documents and data submitted Remarks
246th by M/s Macter International
Karachi
Minutes for 260th Meeting Registration Board
410
1.
Legalized GMP certificate of
biological drug as an
evidence
that
the
manufacturer
is
an
authorized manufacturer of
that particular biological
drug in its country of origin.
2.
Legalized COPP No. 1919AB(M3A) TS / 2014 valid upto 195-2015 for LIFOKINASE 1.5MIU
(STREPTOKINASE INJECTION
IP)
Manufactured by M/s Shasun
Pharmaceuticals Limited 33&34,
Shasun
Road,
Periyakalapet,
Puducherry – 605014, Mfg at
Vijayapuri North Nagarjunasagar
Nalagonda District India
Structural
similarity
of Not provided
Structural similarity
subject
biological
drug
data is required
product (concentrate/ ready
to fill bulk for further
processing) with reference
biological
product
(innovator)
3.
4.
5.
Firm has submitted the legalized Valid legalized GMP
GMP
certificate
NO. is required.
3753/M3b/2013 dated 20-5-2013
valid upto 2years from date of
issuance of Manufactured by M/s
Shasun Pharmaceuticals Limited
33&34,
Shasun
Road,
Periyakalapet,
Puducherry
–
605014, Mfg at Vijayapuri North
Nagarjunasagar Nalagonda District
India
Manufacturer to manufacture Not provided
the
finished
biological
product for trial studies
Bio-comparability
studies Not provided
including identity testing to
parent molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing
data,
gel
electrophoresis,
WesternBlot and other analytical
techniques) and stability
Minutes for 260th Meeting Registration Board
Bio-comparability
study data is required.
411
studies of finished biological
product
6.
Others
local
data
Specification of streptokinase No
available. Directions
bulk solution provided as under:
from RB is solicited.
 Description






Particular Matter
Identification test
PH
Bacterial endotoxin
Assay (Activated by bioassay
Sterility
Stability
Study
report
streptokinase
bulk
solution
provided
Finished product specifications
submitted
by M/s
Macter
International, Karahci are as
under:
Description, Identification, PH,
Steptodoranse, Streptolysin, Loss
on drying, Bacterial Endotoxin,
Assay (Acitivity by Bioassay),
Sterility, Clarity of solution,
Particulate Matter, Extractable
volume and Uniformity of weight.
Finished
product
submitted
by M/s
Pharmaceuticals India.
stability
Shasun
The submitted data needs to be evaluated in the light of 246th meeting of RB by panel of experts
for geniuness and accuracy.
b.
Sr.
No
Redimab (Rituximab) 100mg/10ml Vial of M/s Macter International, Karachi
Documents
and
required as per
data Documents and data submitted by Remarks
246th M/s Macter International Karachi
Minutes for 260th Meeting Registration Board
412
meeting
1
Legalized GMP certificate of
biological drug as an
evidence
that
the
manufacturer
is
an
authorized manufacturer of
that particular biological
drug in its country of origin.
Legalized GMP Certificate No.
CN20110019 DATED 09-10-2011
valid
until
08-10-2016
M/s
Shanghai
CP
Guojian
Pharmaceutical co., Ltd. China.
2
Structural
similarity
of
subject
biological
drug
product (concentrate/ ready
to fill bulk for further
processing) with reference
biological
product
(innovator)
Charactrization of Primanry and
secrondary structure of redimab and
its comparability analysis with
innovator retuximab sold under
brand name of Rituxan by M/s
Shanghai
CP
Guojian
Pharmaceutical co., Ltd. China
following methods:









Minutes for 260th Meeting Registration Board
N-terminal
amino
acid
sequenced analysis,
C-terminal Lys truncation by
mass peptide maping by
sequence coverage.
Molecule weight by reducing
SDS PAGE.
MALDI-TOF Mass spectrum
performed the test results
demonstrate that the main
components
of
basically
identical, and the molecular
weight of relative to each other
Peptide Mapping by RP-HPLC
which demosntrates that our
products are homogeneioujs and
stable.
Comparison of Methionine
Oxidation
for
Anti-CD20
innovator.
Biological Charatarization was
done
by
biocactivity
determination
and
affinity
comparison
by
immumofluorescence method.
Inpurities by SEC-HPLC, SDSPAGE
413
3
Manufacturer to manufacture
the
finished
biological
product for trial studies
4
Bio-comparability
studies
including identity testing to
parent
molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing
data,
gel
electrophoresis,
WesternBlot and other analytical
techniques) and stability
studies of finished biological
product
Comparitive analysis of finished
drug (Redimab) with Ristova of
Roche:
Identity by SDS Page
Purity:
SDS Page (Silver staining)
Gel Filteration HPLC
Protein content by UV (280nm)
Biological activity
General safety tests :
BET and sterlity
5
Others
Certificateof analyisis of Rituximab
bulk is submitted.
Stability data of finished product
(accelerated and real time ) is
provided.
Clinical Data has also been
submitted.
The submitted data needs to be evaluated in the light of 246th meeting of RB by panel of experts
for geniuness and accuracy.
c.
Redimab (Rituximab) 500mg/50ml Vial of M/s Macter International, Karachi
Sr.
No
1
2
Documents
and
data
required as per 246th
meeting
Legalized GMP certificate of
biological drug as an
evidence
that
the
manufacturer
is
an
authorized manufacturer of
that particular biological
drug in its country of origin.
Structural
similarity
of
subject
biological
drug
product (concentrate/ ready
to fill bulk for further
Documents and data submitted by Remarks
M/s Macter International Karachi
Copy of GMP Certificate No.
CN20110019 DATED 09-10-2011
valid until 08-10-2016 sumbitted.
Charactrization of Primanry and
secrondary structure of redimab and
its comparability analysis with
innovator retuximab sold under
Minutes for 260th Meeting Registration Board
414
3
4
5
processing) with reference brand name of Rituxan by M/s
biological
product Shanghai
CP
Guojian
(innovator)
Pharmaceutical co., Ltd. China
following methods:
 N-terminal
amino
acid
sequenced analysis,
 C-terminal Lys truncation by
mass peptide maping by
sequence coverage.
 Molecule weight by reducing
SDS PAGE.
 MALDI-TOF Mass spectrum
performed the test results
demonstrate that the main
components
of
basically
identical, and the molecular
weight of relative to each other
 Peptide Mapping by RP-HPLC
which demosntrates that our
products are homogeneioujs and
stable.
 Comparison of Methionine
Oxidation
for
Anti-CD20
innovator.
 Biological Charatarization was
done
by
biocactivity
determination
and
affinity
comparison
by
immumofluorescence method.
 Inpurities by SEC-HPLC, SDSPAGE
Manufacturer to manufacture
the
finished
biological
product for trial studies
Bio-comparability
studies Comparitive analysis of finished
including identity testing to drug (Redimab) with Ristova of
parent
molecule, purity Roche:
testing, in vitro biological Identity by SDS Page
activity, potency and toxicity Purity:
with support of iso-electro SDS Page (Silver staining)
focusing
data,
gel Gel Filteration HPLC
electrophoresis,
Western- Protein content by UV (280nm)
Blot and other analytical Biological activity
techniques) and stability General safety tests :
studies of finished biological BET and sterlity
product
Others
Certificateof analyisis of Rituximab
Minutes for 260th Meeting Registration Board
415
bulk is submitted.
Stability data of finished product
(accelerated and real time) is
provided.
Clinical Data has also been
submitted.
The submitted data needs to be evaluated in the light of 246th meeting of RB by panel of experts
for geniuness and accuracy.
d.
Sr.
No
1
2
3
4
5
EPOCAN Injection (Epoetin alpha 2000IU/ml., 4000IU/ml and 10000IU/ml) Vial of M/s
Macter International, Karachi
Documents
and
data
required as per 246th
meeting
Legalized GMP certificate of
biological drug as an
evidence
that
the
manufacturer
is
an
authorized manufacturer of
that particular biological
drug in its country of origin.
Documents and data submitted by Remarks
M/s Macter International Karachi
Legalized GMP Certificate No.
CN20140140 date of issuance 17-32014 valid upto 16-03-2019 M/s
Shandong Kexing Bio – Products
co., Ltd. Tangwangshan Road,
Mingshui
Development
Zone,
Zhangqiu,
Shandong,
China
submitted.
Legalized Free Sale Certificate No.
2015-157 date of issuance 16-112015 valid for two year for date of
issuance for Erythropoietin injection
submitted.
Legalized COPP No. WHO. CPPCERT-ZQ-151116 date of issuance
16-11-2015
Structural
similarity
of Not provided
subject
biological
drug
product (concentrate/ ready
to fill bulk for further
processing) with reference
biological
product
(innovator)
Manufacturer to manufacture
the
finished
biological
product for trial studies
Bio-comparability
studies Comparative
analysis
of
including identity testing to Recombinant
Human
Minutes for 260th Meeting Registration Board
GMP
submitted
reflects
that
manufacturer
is
authorize
to
manufacturer
Recombinant Human
Erythropoietin
injection.
Only
comparative
studies
conducted
locally is submitted
416
parent
molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing
data,
gel
electrophoresis,
WesternBlot and other analytical
techniques) and stability
studies of finished biological
product
Erythropoietin
Vs
RMP
Recormon Roche is submitted
and following test are carried out
by M/s Macter International,
Karachi





SDS-PAGE (Silver staining)
Isoelectric focusing
Purity( By Gel filtration
chromatography)
Sialic Acid (by Resorcinol
Method)
Protein content (By ELISA)
Comparitive analysis of Finished
product VS BRP Erythropoetin
Alfa EDQM is also submitted
and following test are carried out:
6
Others
Identity by ELISA, Potency by
Elisa, Total Protein content (By
Lowry Assay), General Safety Test
(By Bacterial endotixin test by gel
Clot Method (LAL Test), Sterility
Test by membrane filtration
method.
Specification of ready to filled
bulk of M/s Shandong Kexing
bioproducts Co., Ltd, China
Identification test, Physical tests
(Appearance Visible particles),
Chemical tests (pH, Content of
sodium ion content of citrate ion
content of protein Osmolality,
Activity tests (Activity in vitro ,
Activity in vivo), Sterility and BET
, Abnormal toxicity test.
Finished products specification of
M/s Macter International Karachi
as under:
Physical
Appearance,
ParticulateMater,
Extractable
volume, pH, Osmaolality, Immunoidentification, Potency, Content of
Minutes for 260th Meeting Registration Board
417
Protein, BET, Sterility, Abnormal
Toxicity.
The firm has also submitted
accelerated and real time stability
studies
The submitted data needs to be evaluated in the light of 246th meeting of RB by panel of experts
for geniuness and accuracy.
e.
T-Mab (Trastuzumab) 150mg Vial of M/s Macter International, Karachi
Sr.
No
1
2
Documents
and
data
required as per 246th
meeting
Legalized GMP certificate of
biological drug as an
evidence
that
the
manufacturer
is
an
authorized manufacturer of
that particular biological
drug in its country of origin.
Structural
similarity
of
subject
biological
drug
product (concentrate/ ready
to fill bulk for further
processing) with reference
biological
product
(innovator)
Documents and data submitted by Remarks
M/s Macter International Karachi
Legalized GMP Certificate No.
CN20110019 dated 09-10-2011
valid
until
08-10-2016
M/s
Shanghai
CP
Guojian
Pharmaceutical co., Ltd. China.
Charactrization of Primanry and
secondary structure of anti-HER2
rh.MAb and its comparability
analysis with innovator Herceptin
by M/s Shanghai CP Guojian
Pharmaceutical co., Ltd. China
following methods:
 The pimary structure of antiHER2 rhMAb. Similarity in
secondary sturucture by circular
dichroism (CD) and Spectra.
 Similarity in IEF profile.
 Similarity in molecular weight
by reducing SDS-PAGE.
 MALDI-TOF Mass spectrum
performed the test results
demonstrate that the main
components
of
basically
identical, and the molecular
weight of relative to each other.
 Peptide Mapping by RP-HPLC
which demosntrates that our
products are homogeneioujs and
stable.
Minutes for 260th Meeting Registration Board
418


N-Glycosylation Analtysis.
Similarity
in
Biological
Activities and Immunological
Properties

Biological Charatarization was
done
by
biocactivity
determination
and
affinity
comparison
by
immumofluorescence method.
Inpurities by SEC-HPLC, SDSPAGE

3
4
5
Manufacturer to manufacture
the
finished
biological
product for trial studies
Bio-comparability
studies
including identity testing to
parent
molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing
data,
gel
electrophoresis,
WesternBlot and other analytical
techniques) and stability
studies of finished biological
product
Others
Biocomparability of finished drug
the firm has submitted following
data are as under:
Comparative Analysis of Locally
Manufactured Drug Product of TMab 150 mg with Reference
Medicinal Product Harceptin,
Materials, Indentificatin (BySDSPAGE), Purity (By SDS-PAGE),
Reiative Potency (By ELISA),
General Safety Tests (By Bacterial
Endotoxin Test) (By Sterility Test)
(By Abnormal Toxicity Test) (By
Abnormal Toxicity Test).
Stability Studies of Locally
Manufactured Drug Product of TMab 15mg with Reference
Medicinal Product Harceptin.
Real Time stability studies,
Accelerated stability studies
Animal Toxicology study The firm
submitted data are as under:
1. Pharmacology
(Primary pharmacology, Secondary
Pharmacology,
Safety
Pharmacology, Pharmacodynamic
drug interactions).
2. Pharmacokinatics
(Absorption,
distribution,
Minutes for 260th Meeting Registration Board
419
Metabolism,
Excretion,
Pharmacokinetics Drug Interaction)
3. Single-Dose Toxicity
(Acute Single-Dose toxicity for
intravenous injection anti-HER2 rh
MAB of CPGJ into mice)
4. Repeat-Dose toxicity
(Repeat-Dose
toxicity
for
intravenous injection anti-HER2 rh
MAB of CPGJ into rhesus)
5. Genotoxicity
(Genotoxicity of –HER2 rh MAB of
CPGJ)
6. Hepolytic Study
(Hemolytic Study of –HER2 rh
MAB of CPGJ)
The submitted data needs to be evaluated in the light of 246th meeting of RB by panel of experts
for geniuness and accuracy.
f.
T-Mab (Trastuzumab) 440mg Vial of M/s Macter International, Karachi
Sr.
No
1
2
Documents
and
data
required as per 246th
meeting
Legalized GMP certificate of
biological drug as an
evidence
that
the
manufacturer
is
an
authorized manufacturer of
that particular biological
drug in its country of origin.
Structural
similarity
of
subject
biological
drug
product (concentrate/ ready
to fill bulk for further
processing) with reference
biological
product
(innovator)
Documents and data submitted by Remarks
M/s Macter International Karachi
Legalized GMP Certificate No.
CN20110019 dated 09-10-2011
valid
until
08-10-2016
M/s
Shanghai
CP
Guojian
Pharmaceutical co., Ltd. China
The application of the
firm is consider in
257th meeting of RB
wherein
it
was
deferred
for
evaluation by the
division.
Charactrization of Primanry and
secondary structure of anti-HER2
rh.MAb and its comparability
analysis with innovator Herceptin
by M/s Shanghai CP Guojian
Pharmaceutical co., Ltd. China
following methods:
 The pimary structure of antiHER2 rhMAb. Similarity in
secondary sturucture by circular
dichroism (CD) and Spectra.
Minutes for 260th Meeting Registration Board
420








3
Manufacturer to manufacture
the
finished
biological
product for trial studies
4
Bio-comparability
studies
including identity testing to
parent
molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing
data,
gel
electrophoresis,
WesternBlot and other analytical
techniques) and stability
studies of finished biological
product
Similarity in IEF profile.
Similarity in molecular weight
by reducing SDS-PAGE.
MALDI-TOF Mass spectrum
performed the test results
demonstrate that the main
components
of
basically
identical, and the molecular
weight of relative to each other.
Peptide Mapping by RP-HPLC
which demosntrates that our
products are homogeneioujs and
stable.
N-Glycosylation Analtysis.
Similarity
in
Biological
Activities and Immunological
Properties
Biological Charatarization was
done
by
biocactivity
determination
and
affinity
comparison
by
immumofluorescence method.
Inpurities by SEC-HPLC, SDSPAGE
Biocomparability of finished drug
the firm has submitted following
data are as under:
Comparative Analysis of Locally
Manufactured Drug Product of TMab 15mg WITH Reference
Medicinal Product Harceptin,
Materials, Indentificatin (BySDSPAGE), Purity (By SDS-PAGE),
Reiative Potency (By ELISA),
General Safety Tests (By Bacterial
Endotoxin Test) (By Sterility Test)
(By Abnormal Toxicity Test) (By
Abnormal Toxicity Test).
Stability Studies of Locally
Manufactured Drug Product of TMab 15mg with Reference
Minutes for 260th Meeting Registration Board
421
Medicinal Product Harceptin.
Real Time stability studies,
Accelerated stability studies
5
Others
Animal Toxicology study The firm
submitted data are as under:
1. Pharmacology
(Primary pharmacology, Secondary
Pharmacology,
Safety
Pharmacology, Pharmacodynamic
drug interactions).
2. Pharmacokinatics
(Absorption,
distribution,
Metabolism,
Excretion,
Pharmacokinetics Drug Interaction)
3. Single-Dose Toxicity
(Acute Single-Dose toxicity for
intravenous injection anti-HER2 rh
MAB of CPGJ into mice)
4. Repeat-Dose toxicity
(Repeat-Dose
toxicity
for
intravenous injection anti-HER2 rh
MAB of CPGJ into rhesus)
5. Genotoxicity
(Genotoxicity of –HER2 rh MAB of
CPGJ)
6. Hepolytic Study
(Hemolytic Study of –HER2 rh
MAB of CPGJ)
The submitted data needs to be evaluated in the light of 246th meeting of RB by panel of experts
for geniuness and accuracy.
g.
Sr.
No
1
Macgrastim (Filgrastim (rhGCSF) 300mcg/ 1.2 ml) vial.
Documents
and
data
required as per 246th
meeting
Legalized GMP certificate of
biological drug as an
evidence
that
the
manufacturer
is
an
Documents and data submitted by Remarks
M/s Macter International Karachi
Legalized CoPP No: CN20130269
dated 30.09.2013 valid upto
29.09.2018 of M/s Hangzhou
Jiuyuan Gene Engeineering Co.,
Minutes for 260th Meeting Registration Board
422
authorized manufacturer of Ltd, China indication that the
that particular biological manufacturer has approval to
drug in its country of origin. manufacture the rhGCSF injection
2
Structural
similarity
of
subject
biological
drug
product (concentrate/ ready
to fill bulk for further
processing) with reference
biological
product
(innovator)
3
Manufacturer to manufacture
the
finished
biological
product for trial studies
Bio-comparability
studies
including identity testing to
parent
molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing
data,
gel
electrophoresis,
WesternBlot and other analytical
techniques) and stability
studies of finished biological
4
Physicichemical and biosililarity
analysis of rhGSCF with Filgratim
produced by Kirin Brewery Co.,
Japan:
rhGSCF
Formula/
chemical
structure.
 Molecular weight:
SDS reducing Page
HPLC
 Purity:
Gel electrophoresis
Isoelecric focusing
RP HPLC
SEC HPLC
Capillary electrophoresis
 Assay for chemical structure:
Sequencung of rDNA
UV spectrum
Composition of amino acids
Pepetide mapping
N- terminal sequencing
 Immunology:
Identification by wetstern
blot
ELISA
 Bilogical activity.
Comparative Analysis of Locally
Manufactured
Product
Macgrastim Liquid Solution for
Injection (300 mcg/ 1.2 ml ) VS
Neupogen (Innovator):
Minutes for 260th Meeting Registration Board




Immunoidentification by
western blot
Purity by SDS Page
Purity by gel filteration
Potency
protein
by
Bradford assay
423
product
5
Others

Bilogical activity by cell
proliferation assay
 General safety tests : BET
and sterlity
Certificate of analysis of bulk
material to be supplied is sunmitted.
Stability data of finished product
(accelerated and real time is
provided)
Clincal data submitted.
The submitted data needs to be evaluated in the light of 246th meeting of RB by panel of experts
for geniuness and accuracy.
Local manfacturing of (biological drugs) M/s Sami Pharmaceuticals (Pvt) Limited, Karachi.
h.
Sr.
No
1
2
PEGINTOR-2a Recombinant Human Peginterfereon Alfa-2a, (180mcg) 0.5ml
filled syringe of M/s SAMI Pharmaceutical s(Pvt Limited Karachi.
Documents
and
data
required as per 246th
meeting
Legalized GMP certificate of
biological drug as an
evidence
that
the
manufacturer
is
an
authorized manufacturer of
that particular biological
drug in its country of origin.
Structural
similarity
of
subject
biological
drug
product (concentrate/ ready
to fill bulk for further
processing) with reference
biological
product
(innovator)
Documents and data submitted by
M/s SAMI Pharmaceutical s(Pvt
Limited Karachi
Legalized GMP Certificate No.
20132014-001810-14 dated 30-12015 of M/s LABORATORIO
PABLO
CASSARA
S.R.L
Republica Argentina.
Pre-
Remarks
Firm will import the
bulk interferon alfa 2a
and pegylation will be
done
at
manufacturing facilty
of M/s Sami Pharma
Karachi
Following details are provided for
the bulk concentrate against the
standard
by
the
M/s
LABORATORIO
PABLO
CASSARA
S.R.L
Republica
Argentina.
 Appearance
 PH
 Identification:
a. Assay: Protein content,
biological activity
b. Isoelectic focusing
c. Test for impurities fo
molecular
masses
differing from that of
interferon alfa 2 (SDS
Page
reducing
Minutes for 260th Meeting Registration Board
424
condition)
d. Peptide mapping
e. impurities fo molecular
masses differing from
that of interferon alfa 2
(SDS Page reducing
and
non
reducing
condition)
f. related proteins by
HPLC
g. BET
3
Manufacturer to manufacture
the
finished
biological
product for trial studies
Bio-comparability
studies
including identity testing to
parent
molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing
data,
gel
electrophoresis,
WesternBlot and other analytical
techniques) and stability
studies of finished biological
product
Others
4
5
Accelerated stability data 6 months
of 3 batches submitted and
biocomparibility
studies
witb
pepgasys are provided with
fillowing parameters:
 Appearance
 Identification by SDS Page
 Proetein content by optical
density
 Impurities
 BET
 Sterility
Clinical data provided.
Product specific inspectin for the facility is required. The submitted data needs to be evaluated in
the light of 246th meeting of RB by panel of experts for geniuness and accuracy.
Local Manfacturing of (Biological Drugs) M/S BF Biosciences, Lahore
i.
S.No.
1.
Noxane (Prefilled syringe) (Enoxaprin sodium 20mg/0.2ml,
60mg/0.6ml and 80mg/0.8ml) of M/S BF biosciences, Lahre
Documents
and
data
required as per 246th
meeting
Legalized GMP certificate
of biological drug as an
evidence
that
the
manufacturer
is
an
authorized manufacturer of
that particular biological
40mg/0.4ml,
Documents and data submitted
Remarks
Firm has submitted the Copy of
GMP Certificate No. SD 20140225
vlidupto
26-5-2019
of
M/s
Dongying Tiandong Phamraceutical
Co., Ltd No. 1236, Noner Road,
dongying
City
China,
for
The
Director
Technical has inform
that the bulk will be
imported from the
Uroguay. The API in
the said bulk will be
Minutes for 260th Meeting Registration Board
425
drug in its country of origin.
2.
3.
4.
Enoxaparin Sodium
used
Legalized COPP No. 156026 dated manufacturer
09-4-2014 for Noxprin Sodium China.
manufacurerd by Laboratorios
Clausen S.a.- Bulevar Artigas 3896
– Montevideo, Uruguay.
Eludication of structure Following
details are provided by M/s
Dongying Tiandong Phamraceutical
Co., Ltd China.
from
at
Structural
similarity
of
subject
biological
drug
product (concentrate/ ready
to fill bulk for further
processing) with reference
biological
product 
(innovator)
Absorption Spectrophotometry
, The infrared spectra of sample
is consitent with that of the
CRS
 Absorption Spectrophotometry,
UV spectra is consitent with
that of the CRS
 NMR Spectrophotometry ( 1H
–NMR spectrum and 13CNMR cpectrum of thesample is
consistent with those of the
CRS
 Imputities
(Potential
Imopurities
Originating from the route of
synthesis), (Potential Impurities
Orininating from the raw
material s and from the
impurities in the raw materials),
(Protein
and
nucleotide),
Dermatan
sulfate) (Heavy
metals) (Bacterial endotoxins),
(Limit of Impurities and
Analytical Methods applied by
the
API’s
manufacturer),
Protein and nucleotide heavy
metals
and
bacterial
endotoxins),
Dermatan
sulphate),
(The
Potential
Toxicity
of
Impurities),
(Residual solvents)
Manufacturer
to Not provided
manufacture the finished
biological product for trial
Minutes for 260th Meeting Registration Board
426
studies
Bio-comparability
studies Not provided
including identity testing to
parent molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing
data,
gel
electrophoresis,
WesternBlot and other analytical
techniques) and stability
studies of finished biological
product
Others
5.
6.
Product specific inspectin for the facility is required. The submitted data needs to be evaluated in
the light of 246th meeting of RB by panel of experts for geniuness and accuracy.
j.
Eritrogen (Erythropoetin) 2000IU, 4000IU and 10000IU PreFilled Syringe of M/S BF
Biosciences, Lahre
S.No.
1.
2.
Documents
and
data
required as per 246th
meeting
Legalized GMP certificate
of biological drug as an
evidence
that
the
manufacturer
is
an
authorized manufacturer of
that particular biological
drug in its country of origin.
Documents and data submitted
Structural
similarity
of
subject
biological
drug
product (concentrate/ ready
to fill bulk for further
processing) with reference
Under Eludication of structure of
API, comparative analysis with
EPO Standard BPR is provided by
M/s ZELLTEK S.A, Argentine
Republic.
Remarks
Firm has submitted the Legialized
GMP certificate No. 20132021-000
033-15 dated 08-6-2015 of M/s
ZELLTEK S.A, Ruta Nacional No
168 S/N, Pasaje “EI Pozo’, Parque
Tecologico Litoral , of the Province
of Santa Fe, of the Argentine
Republic.
Minutes for 260th Meeting Registration Board
427
biological
(innovator)
product











3.
4.
5.
Glycoform analysis
Primary Structure
Secondary Structure
Tertiary structure
Disulfide bridges
N-terminal sequence
Sialic Acid Content
Native N-glycans profile
Neutra N-glycans profile
O-glyscosilatin site occupation
Content of dimmers and
related substances of high
molecular weight
 Invivo biological activity.
Manufacturer
to Not provided
manufacture the finished
biological product for trial
studies
Bio-comparability
studies Not provided
including identity testing to
parent molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing
data,
gel
electrophoresis,
WesternBlot and other analytical
techniques) and stability
studies of finished biological
product
Others
Product specific inspectin for the facility is required. The submitted data needs to be evaluated in
the light of 246th meeting of RB by panel of experts for geniuness and accuracy.
Decision:
Regiatration Board deliberated and deferred these applications that manufacturing
and quality control of biological products require specialized facilities and approval
from the Licensing Division, DRAP. The Baord dicussed that theses manufacturing
units have already been granted registrations of various biological products for local
manufacturing (mostly therapeutic proteins). As theses firms have applied for
registration for local manufacturing of various biological products including rDNA
products, Theraputic protein, Monocronial antibodies, Vaccines (Live, Attentuated,
Minutes for 260th Meeting Registration Board
428
rDNA vaccines, so the Board decided to have opinion of licensing division DRAP
regarding approved manufacturing facilities (categories of biological products) of
these firms and status of already registerd biological drugs from these firms.
Case No.05:
As per decision of 258th meeting of RB. All the cases of import of Heparin are placed
below for a joint collective decision as per recommendation of WHO.
Deferred case of M/s Ghazali Brothers Karachi in 258th meeting of Registration Board
a.
Following product of M/s Ghazali brothers Karachi are deferred by the Registration
Board 254th meeting for completion of applications, remaining fee, CoPP status, information regarding
availability in country of origin and deliberations regarding requirement for bio-similarity of products.
Sr.
No
Name
of Brand Name & Type
of
Importer
& Composition
Form
Manufacturer
Dy No &
Date
of
application
Document
details
(CoPP)
Remarks
Me
too
status/New
molecule
Fee
submitted
1.
Ghazali Brothers,
Karachi.
KotraPharma(M)
SdnBhd,
Jalan
TTC 12
ChengIndustrial
Estate,Melaka,
Malaysia.
VAXCELL
Heparin
Sodium Injection
5000 IU/ml
Each 5ml
contains:Heparin
Sodium…..25000I
U
Anticoagulant
Shelf
years
life:
Pack
size/
Demanded
Price
Form-5A
Legalized
CoPPCertific
Dy No. 43 ate No. 0346/
dated 03-03- 2015 dated
2011
10-03-2015
15000/- dated Me too
03-03-2011
3500/- dated
09-10-2012
50000/- dated
16-06-2015
Product
is
available
in
country of origin
and full fee as
required
is
submitted. Firm
has submitted the
clinical
data/
biosimilarity data
three
Minutes for 260th Meeting Registration Board
Rs.540/ 5ml
429
Decision:
Registration board deliberated that WHO exempts Heparins and Enoxaprin from
the condition of biosimilarity. Keeping in view this position, the Board approved the
above products for registration as per Import Policy for Finished Drugs.
b.
Deferred case of M/s Shamco Traders (Pvt) Limited, Lahore in 258th meeting of
Registration Board.
Company Name
and Name of
Manufacturer
M/s Shamco
Traders (Pvt)
Limited, Lahore
S.#.
13.
License Holder:
PolifarmaIlacSanayi
VeTicaretAS
TozkoparanMah.
HaldunTaner&SkAl
parsalanMerkezi
Istanbul
Brand Name
and
Composition
POLIPARIN
25000 IU/ 5ml
IV/ SC
Injectable vial
Date of
application/Fe
e status
Form-5A
Each 5ml vial
contains:
Heparin
sodium……250
00IU
Rs 100000
dated 12-10-15
Dy No. 1241
dated 12-10-15
625/ vial
Document
ary details
Remarks
CoPP No
2014/ 335
dated 2207-2014
Copy of
GMP dated
15-08-2013
valid up to
12-2015
Manufacturer:
MefarIlac San AS
RamazanogluMah.
Ensar Cad. No: 20
34906
KurtkoyPendik
Istanbul.
Decision:
Registration board deliberated that WHO exempts Heparins and Enoxaprin from
the condition of biosimilarity. Keeping in view this position, the Board approved the
above products for registration as per Import Policy for Finished Drugs.
c. Registration of Import Product Namely Medirin Heparin Sodium 5000IU/ml &
25000IU/ml M/s Medi Mark Pharmaceutical Lahore and Hepacin Injection 25000
iu/5ml, Bajwal Sons, Lahore
M/s Medi Mark Lahore had applied for registration of Medirin Injection (Heparin) 25000
IU/5ML and Medirin Injection (Heparin) 5000IU/ml and M/s Bajwa sons, Lahore had applied for
registration of Hepacin Injection 25000 iu/5ml. Both companies have same manufacturer abroad. The
case is being placed 254th meeting before the Registration Board. The decision of 254th Registration
Board meeting as follows:
Minutes for 260th Meeting Registration Board
430
“Registration Board deferred the case. M/s Medi Mark and Bajwa sons has same source. Firm will be
advised to provide latest Whole Sale Agency Certificate from manufacturer. Complete information for
CoPP is also required”.
Later on the M/s Medi Mark has provided copy of sole agency agreement with its Chinese
manufacturer. The document is not on the company letter head nor has been notarized. The Medi Mark
provided also copy of CoPP. The case was placed on agenda of 256th meeting of Registration Board.
Documentary details as below:
S.#.
Company Name and Name of Product
Name
of / Composition
Manufacturer
1.
Medi Mark Pharma, MEDIRIN INJECTION Date
of Me too
Lahore.
5000IU/ML
Application
23-05-2013
Furen Pharmaceutical Composition
Group Co., Ltd,
Fee deposited
Address: 1
(Heparin
Sodium Rs.100000/Xuan Wu Economic Injection 5000 IU/ml )
Developing
-area,
Balance fee
Luyi Country, Henan Anti Coagulant
Nil
China.
Address 2:
No.1 Tongyuan road,
Industrial centralized
area, LuYi County,
Henan
Province
China
2.
Medi Mark Pharma, MEDIRIN INJECTION
Lahore.
25000 IU/5ML
Furen Pharmaceutical
Group Co., Ltd,
Address: 1
Xuan Wu Economic
Developing
-area,
Luyi Country, Henan
China.
Composition
(Heparin
25000IU/5ml)
Anti Coagulant
Minutes for 260th Meeting Registration Board
Date
of Remarks
application / Fee
status
Date
Application
23-05-2013
of Me too
Sodium Fee deposited
Rs.100000/Balance fee
Nil
431
Address 2:
No.1 Tongyuan road,
Industrial centralized
area, LuYi County,
Henan
Province
China
Registration Board decided as follows:
“Registration board considered above applications of Medi Mark Pharma, Lahore and
advised to provide legalized CoPPs and notarized sole agency agreement.”
M/s Medi Mark has now provided the legalized CoPP (original) and notarized sole agency
agreement as per directions of the Registration Board.
Decision:
Registration Board considered the request of M/s Medi Mark Lahore and referred the
applications for expert opinion of the following:
i.
ii.
iii.
Brig. (R) Muzamil Hussain Najmi, Member Registration Board.
Brig. Abid Azhar, AFIP, Rawalpindi.
Dr. Masud-ur-Rehman, DDG DRAP, Islamabad.
“M/s Medi Mark is advised to provide the notarized sole agency agreement from country of
origin. As two manufacturing sites are mentioned on CoPP submitted by M/s Medi Mark
Lahore, therefore clarification will be obtained from firm about manufacturing site. The
application of M/s Bajwa Sons Lahore will be considered after aforementioned
clarification”.
M/s Medi Mark has submitted Legalized and Notarized Sole Agency Agreement and Notarized
cancellation letter from Furen Pharmaceutical Group Co., Ltd. China as per directions of the Registration
Board in 257th meeting mentioned above.
Decision:
Registration Board deliberated that WHO exempts Heparins and Enoxaprin from
the condition of biosimilarity. Keeping in view this position, the Board approved the
above products for registration as per Import Policy for Finished Drugs.
Minutes for 260th Meeting Registration Board
432
d.
Grant of Registration Human Imported product Enclex 40 (Enoxaparin Sodium Injection
IP 40MG/0.4ml) M/s AJ Mirza Pharma (Pvt) Ltd, Karachi.
M/s AJ Mirza Pharma (Pvt) Ltd Karachi has applied for grant of registration
HumanImported product Enclex 40 (Enoxaparin Sodium Injection IP 40MG/0.4ml). Product details is as
1.
M/s AJ Mirza Enclex 40
Form 5-A
Pharma (Pvt)
(Enoxaparin
Ltd, Karachi
sodium Injection
Dy. No. 29 R&I
IP 40mg/0.4ml
DRAP dated 10Cipla Ltd 289, Each
prefilled 10-2014
Bellasis Road, syringe contains:
Mumbai
Enoxaparin
Central,
Fee
deposited:
Mumbai
400 Sodium
Rs.
100000/IP…….40mg.
008 India
dated 10-10-2014
Equivalent to 4000
IU
anti-Xa
activity.
Packs: 0.4ml PFS
Water for Injection
Ip…….q.s.
Pharmacological
group:
Antithrombotic
agent,
low
molecular weight
Heparin.
Legalized COPP
No.
831/MFG/WHOGMP/DFDA/201
2/1742 valid up
to
14-6-2014
from India
Valid and
legalized
COPP/ FSC
along with
GMP
Certificate
need to be
submitted as
per above
of
Product License decision
th
255
meeting.
No. 704 dated
08-4-2005
Condition of
inspection
abroad as per
DML
No. import policy.
831/MFG/CERT/
DFDA/12/5863
dated 06-2-2012
Route
of
Adminstration:
Intara Venous &
Sub cutaneous
under:
Minutes for 260th Meeting Registration Board
433
2.
M/s AJ Mirza Enclex 60
Form 5-A
Pharma (Pvt)
(Enoxaparin
Ltd, Karachi
sodium Injection
Dy. No. 28 R&I
IP 60mg/0.6ml
DRAP dated 10Cipla Ltd 289, Each
prefilled 10-2014
Bellasis Road, syringe contains:
Mumbai
Enoxaparin
Central,
Fee
deposited:
Mumbai
400 Sodium
Rs.
100000/IP…….60mg.
008 India
dated
10-10Equivalent to 6000 2014.
IU
anti-Xa
activity.
Water for Injection Packs: 0.6ml PFS
Ip…….q.s.
Pharmacological
group:
Antithrombotic
agent,
low
molecular weight
Heparin.
Legalized COPP
No.
831/MFG/WHO
GMP/DFDA/201
2/1734 valid up
to
14-6-2014
from India
Valid and
legalized
COPP/ FSC
along with
GMP
Certificate
need to be
submitted as
per above
of
Product License decision
th
255
meeting.
No. 704 dated
08-4-2005
Condition of
DML
No. inspection
831/MFG/CERT/ abroad as per
import policy.
DFDA/12/5863
dated 06-2-2012
Route
of
Adminstration:
Intara Venous &
Sub cutaneous.
Decision:
Registration Board deliberated that WHO exempts Heparins and Enoxaprin from
the condition of biosimilarity. Keeping in view this position, the Board approved the
above products for registration as per Import Policy for Finished Drugs.
e. Grant of Registration Human Imported product Heparodic 5000 (Heparin sodium)
M/s AA Pharma, Karachi.
M/s AA Pharma, Karachi has applied for grant of registration Human Imported product
Heparodic 5000 (Heparin sodium) Product details is as under:
Minutes for 260th Meeting Registration Board
434
S.
No
Name of Importer
& Manufacturer
Brand Name &
Composition
1
M/s AA Pharma,
Karachi
HEPARODIC 5000
(Heparin sodium
5000U/ml
IV, Deep SC
Injection
IV infusion
Each 1ml ampule
(injectable
solution) contains:
Heparin sodium
USP……5000IU
Benzyl alcohol
B.P……9.45 MG
Sodium chloride
B.P…….. 9 mg
Water for injection
USP……..q.s
Caspian tamin
PhamaceuticalCo.
First Entrance, Rasht
Industrial Zone, P.O.
Box: 43375-1116,
Rasht-Iran
Decision:
Dy No & Date of
application/ Fee
status/ Pack size/
demanded Price
Form 5-A
Dy No. 958 R& I
DRAP dated 17-32014
Fee deposited: Rs.
50000/- dated 0711-2012 + Rs.
50000/- dated 3112-2014
Document
details (CoPP)
Remarks
Me too status
Legalized
Me too
COPP available
from Islamic
Republic of
Iran
Product
License No.
IRC
1228049750
dated 04-72011
Balance fee: Nil
Legalized Free
Sale Certificate
available from
the country of
origin
Registration Board deliberated that WHO exempts Heparins and Enoxaprin from
the condition of biosimilarity. Keeping in view this position, the Board approved the
above products for registration as per Import Policy for Finished Drugs.
f. Cases of Imported Human Biological Drugs ENOXAPRIN M/s Allmed
Laboratories, Karachi
S.No.
Name of
Importer &
Manufacturer
Brand Name &
Composition
Dy No & Document
Date
of details
application/ (CoPP)/
International
Fee Status/
Pack
size/ availability/
Me too status
Price
Decision in
257th RB
Meeting
1.
M/s Allmed
Laboratories, A21/3 KDA
Scheme No. 1
Ext Karachi
Pakistan
ENOXA 2000 IU
anti Xa 20mg
Solution Injectable 2
Syringes / 0.2 ml
Dy No. 1140 Market
R&I
dated authorization
23-5-2014
no. 9233494
until valid 0515000 dated 2017
02-1-2012
Sole agency
85000/- dated agreement
11-10-2012
dated 23-112015
Deferred for
expert opinion
of following:
a. Dr. Abid
Azhar,
A.Q.Khan
Institute of
Biotechnol
ogy,
University
of Karachi.
Les
Laboratories
One prefilled
syringe of 0.2 ml
contains:
Enoxaparin Sodium
Minutes for 260th Meeting Registration Board
435
2.
Medis Route De
Nabeul Km
78000 Nabeul
Tunise
……20mg
M/s Allmed
Laboratories, A21/3 KDA
Scheme No. 1
Ext Karachi
Pakistan
ENOXA 4000 IU
anti Xa 40mg
Solution Injectable 2
Syringes / 0.4 ml
Les
Laboratories
Medis Route De
Nabeul Km
78000 Nabeul
Tunise
3.
M/s Allmed
Laboratories, A21/3 KDA
Scheme No. 1
Ext Karachi
Pakistan
Les
Laboratories
Medis Route De
Nabeul Km
78000 Nabeul
Tunise
Antithrombotic
One prefilled
syringe of 0.4 ml
contains:
Enoxaparin Sodium
……40mg
Antithrombotic
ENOXA 6000 IU
anti Xa 60mg
Solution Injectable 2
Syringes / 0.6 ml
One prefilled
syringe of 0.6 ml
contains:
Enoxaparin Sodium
……60mg
Antithrombotic
Minutes for 260th Meeting Registration Board
As per PRC/
Pack of 2’s Clexane
syringes
prefilled
syringes
(MHRA)
b. Dr.
Zeeshan
Danish,
University
of the
Punjab.
c. Prof. Dr
Clexane PFS
Ghias Butt,
PIMS
of
Sanofi
Islamabad.
Karachi
Dy No. nil Market
R&I
dated authorization
26/5/2014
no. 9233494
until valid 0515000 dated 2017
02-1-2012
Sole agency
85000/- dated agreement
11-10-2012
dated 23-112015
As per PRC/
Pack of 2’s Clexane
syringes
prefilled
syringes
(MHRA)
Deferred for
expert opinion
of following:
a. Dr. Abid
Azhar,
A.Q.Khan
Institute of
Biotechnol
ogy,
University
of Karachi.
b. Dr.
Zeeshan
Danish,
University
of the
Punjab.
Clexane PFS c. Prof. Dr
of
Sanofi
Ghias Butt,
PIMS
Karachi
Islamabad.
Dy No. 1139 Market
R&I
dated authorization
23/5/2014
no. 9233494
until valid 0515000 dated 2017
02-1-2012
Sole agency
85000/- dated agreement
11-10-2012
dated 23-112015
As per PRC/
Pack of 2’s Clexane
syringes
prefilled
syringes
(MHRA)
Deferred for
expert opinion
of following:
a. Dr. Abid
Azhar,
A.Q.Khan
Institute of
Biotechnol
ogy,
University
of Karachi.
b. Dr.
Zeeshan
Danish,
University
of the
Punjab.
436
Clexane PFS c. Prof. Dr
Ghias Butt,
of
Sanofi
PIMS
Karachi
Islamabad.
4.
M/s Allmed
Laboratories, A21/3 KDA
Scheme No. 1
Ext Karachi
Pakistan
Les
Laboratories
Medis Route De
Nabeul Km
78000 Nabeul
Tunise
ENOXA 8000 IU
anti Xa 80mg
Solution Injectable 2
Syringes / 0.8 ml
One prefilled
syringe of 0.8 ml
contains:
Enoxaparin Sodium
……80mg
Antithrombotic
Dy No. 1141 Market
R&I
dated authorization
23/5/2014
no. 9233494
until valid 0515000 dated 2017
22-11-2011
Sole agency
85000 dated agreement
11-11-2011
dated 23-112015
As per PRC/
Pack of 2’s Clexane
syringes
prefilled
syringes
(MHRA)
Deferred for
expert opinion
of following:
a. Dr. Abid
Azhar,
A.Q.Khan
Institute of
Biotechnol
ogy,
University
of Karachi.
b. Dr.
Zeeshan
Danish,
University
of the
Punjab.
Clexane PFS c. Prof. Dr
of
Sanofi
Ghias Butt,
PIMS
Karachi
Islamabad.
The expert opinion of above products have no been received yet.
Decision:
Registration Board deliberated that WHO exempts Heparins and Enoxaprin from
the condition of biosimilarity. Keeping in view this position, the Board approved the
above products for registration as per Import Policy for Finished Drugs.
g:
Cases of Imported Human Biological Drugs Heparin sodium 25000IU M/s Genome
Phamra, Rawalpindi
S.No.
1.
Name of
Importer &
Manufacturer
Brand Name &
Composition
Genome
Phamra,
Rawalpindi
NEFRIN
Injection
Belmedpreparat
Each 5 ml
contains:
Heparin sodium
Minutes for 260th Meeting Registration Board
Dy No & Date Document
of application/ details
(CoPP)/
Fee Status/
Pack
size/ International
availability/
Price
Me too status
Form 5-A
Dy No. 119
R&I DRAP
dated 11-12016
Legalized valid
COPP is required
As the firm has
submitted copy of
COPP issued on
dated 07-8-2014.
437
y RUE
Republic of
Belarus
25000IU
Pharmacological
group: Anti
cogualant
Shelf life :
03years
Decision:
Fee deposited
Rs.100000/dated 30-122015
Price: Not
provided.
Copy of sole agency
agreement is
submitted.
Orignal legalized
documents are
required.
Registration Board approved NEFRIN Injection as per Import Policy for Finished
Drugs. The firm will provide the original legalized CoPP and sole agency agreement
and Chairman RB will allow further processing of the case as per Import Policy for
Finished Drugs.
Deferred/ Miscellenous Cases
Case No.06:
Following product of M/s BroMed animal Health, Lahore are deferred in the 258th meetin
of RB due to non submission of original legalized GMP Certrificate. The firm has now provided the
legalized GMP certificate. The case is placed before the board for consideration please.
Sr.
No
1.
Name
of Brand Name & Type of Form
Document
Importer
& Composition
details
Manufacturer
Dy No & Date of (CoPP)
application
Me
too
Fee submitted
status/New
molecule
Pack
size/
Demanded Price
BroMed animal
TRIDy No. 2841
Product Reg
Health, Lahore
APHTHOVAC
(R&I) DRAP
No 614
dated 21-12-2015
Dated
Inactivated Foot
19/02/2014
Middle East for
& mouth TriFee deposited:
Legalized
Vaccines (ME
vlent Vaccine
Rs.100000/- dated Free sale
VAC)
Strain A Iran05,
18-12-2015.
dated 17-09Industrial area 2
O Pan Asia 2,
2015
Piece 22-24,
Asia 2, Asia 1
20/50/100/300 ml
New Salhia, el
Shamir
vial
Sharkia Head
Each ldose (2ml)
Office : 20
contains:
Jospeh teto el
nozha el gededa, Inactivated FMD
Minutes for 260th Meeting Registration Board
Remarks
Decision
The Firm has
submitted GMP
certificate
legalized
through
Embassy
of
Pakistan
Approved As
Per
Valid
Legalized
COPP
And
Import Policy
For
Finished
Drugs
Condition of
inspection
abroad as per
import policy.
438
Cairo, Egypt.
Virus Serotype A
Iran 05……≥ 108
TCID50 per dose.
(4 ug of viral
protein / Dose
which is
equivalent to 6
PD50/ dose).
Inactivated FMD
Virus Serotype O
Panasia 2……≥
108 TCID50 per
dose. (4 ug of
viral protein /
Dose which is
equivalent to 6
PD50/ dose).
Inactivated FMD
Virus Serotype
Asia 1
Shamir…..……≥
108 TCID50 per
dose. (4 ug of
viral protein /
Dose which is
equivalent to 6
PD50/ dose).
Montanide Isa
50…….1ml
Inactivant
BEI……….3mM
Bulk
saline…………..
Q.S. to2ml
Total ……….2
ml
Protection of
cattle dairy sheep
goat from FMD
Shelf life: 24
months
Route : SC
Minutes for 260th Meeting Registration Board
439
2.
BroMed animal
Health, Lahore
Middle East for
Vaccines (ME
VAC)
Industrial area 2
Piece 22-24,
New Salhia, el
Sharkia Head
Office : 20
Jospeh teto el
nozha el gededa,
Cairo, Egypt.
ME FLUVAC
H9+ND 0.3%
Inactivated
Bivalent Virus
Vaccine against
Avian influenza
H9N2 and
Newcastle
disease.
Composition:
Inactivated
Avian Influenza
A /Chicken
/Egypt/114940v/
NLQP /2011
(H9N2)……≥108
EID50/dose
before
inactivation.
Dy No. 2842
(R&I) DRAP
dated 21-12-2015
Fee deposited ;
Rs.100000/- dated
16-12-2015 vide
challan no.
0131605
300 ml vial
Product Reg
No 653
Legalized
Free sale
dated 17-092015
The Firm has
submitted GMP
certificate
legalized
through
Embassy of
Pakistan
Approved As
Per
Valid
Legalized
COPP
And
Import Policy
For
Finished
Drugs
Condition of
inspection
abroad as per
import policy.
Inactivated
Newcastle
Disease
NDV/Chicken/E
gypt/11478AF/2
011
(ND)……≥108EI
D50/dose before
inactivation.
Mantonied Isa
71VG…021 ml
BNE
……..0.0005 G
Bulk saline ……
Q.S.to 0.3ml
Total ….. 0.3ml
Protection
against AI, and
ND
Shelf life 24
months
Route: IM/SC
Minutes for 260th Meeting Registration Board
440
3.
BroMed animal
Health, Lahore
Middle East for
Veterinary
Vaccines (ME
VAC)
Egypt.
MEVAC IB+ND
Inactivated
trivalent Virus
Vaccine of
Infectious
Bronchitis
Disease.
Each (0.5ml) ml
contains:
Dy.No. 2844
(R&I) DRAP
dated 21-12-2015
Fee deposited;
Rs.100000/- dated
16-12-2015 vide
challan
no.0131609.
500 & 300 ml vial
Inactivated Virus
Vaccine of
Infectious
Bronchitis
Disease of IB
Classical
(Eg/11539F)&
IB Variant type 2
(Eg/1212B)……
≥107EID50/dose
at release.
Product Reg
No 630
Legalized
Original free
sale certificate
dated 20-062015
The Firm has
submitted GMP
certificate
legalized
through
embassy of
Pakistan.
Approved As
Per
Valid
Legalized
COPP
And
Import Policy
For
Finished
Drugs
Condition of
inspection
abroad as per
import policy.
Inactivated
Newcastle
Disease
NDV/Chicken/E
gypt/11478AF/2
011
(ND)……≥108EI
D50/dose at
release
(>128PD50).
Mantonied Isa
70V……0.35 ml
Formaldehyde
solution
…..0.0045ml
Bulk saline ……
Q.S.to 0.5ml
Total …. 0.5ml
Minutes for 260th Meeting Registration Board
441
Immunization
against IB and
ND
4.
BroMed animal
Health, Lahore
Middle East for
Vaccines (ME
VAC)
Industrial area 2
Piece 22-24,
New Salhia, el
Sharkia Head
Office : 20
Jospeh teto el
nozha el gededa,
Cairo, Egypt.
Shelf life: 24
months
Route : IM/ SC
ME FLUVAC
H9 0.3%
(Inactivated virus
Vaccine against
Avian influenza
H9N2)
Each (0.3ml)
dose contains:
Inactivated
Avian Influenza
A /Chicken
/Egypt/114940v/
NLQP
/2011(H9N2)…
…≥108EID50/do
se before
inactivation.
Dy No. 2845
(R&I) DRAP
dated 21-12-2015
Fee deposited: Rs.
100000/- dated 1612-2015. vide
challan no.
0131604.
Legalized
Original free
sale certificate
dated 20-062015
The Firm has
submitted GMP
certificate
legalized
through
Embassy of
Pakistan
Approved As
Per
Valid
Legalized
COPP
And
Import Policy
For
Finished
Drugs
Condition of
inspection
abroad as per
import policy.
Packs: 300 ml vial
Protection
against influenza
5.
BroMed animal
Health, Lahore
Middle East for
Vaccines (ME
VAC)
Industrial area 2
Piece 22-24,
New Salhia, el
Sharkia Head
Shelf life: 24
months
Route : IM/ SC
ME VAC ND
Broiler
Inactivated Virus
Vaccine against
Newcastle
disease
Dy No. 2843
(R&I) DRAP
dated 21-12-15
Each 0.3 ml dose
contains:
Fee deposited: Rs.
100000/- dated 1612-2015 vide
challan no.
0131607.
Inactivated
300 ml vial
Minutes for 260th Meeting Registration Board
Legalized
Original free
sale certificate
dated 20-062015
Product reg
no 651 dt
8/5/2014
The Firm has
submitted GMP
certificate
legalized
through
Embassy of
Pakistan
Approved As
Per
Valid
Legalized
COPP
And
Import Policy
For
Finished
Drugs
Condition of
inspection
abroad as per
442
Office : 20
Jospeh teto el
nozha el gededa,
Cairo, Egypt.
Newcastle
Disease
NDV/Chicken/E
gypt/11478AF/2
011
(ND)……≥108EI
D50/dose before
inactivation.
import policy.
Protection
against ND
Shelf life: 24
months
Route : IM/ SC
Case No.07:
Cases of Imported Products of Veterinary Biological Drugs M/s SNAM
Pharma, Lahore
M/s Snam Pharma, Lahore applied the new registration of following Veterinary Biological
Products. The Registration Board considers the request in 256th Registration Board meeting. The decision
of 256th RB meeting is below:
Decision of 256thRB: Approved as per import Policy for Finished Drugs.
The firm is provided registration certificates of three (03) Eastern Europe Countries as per Import
Policy. Product details as under:
Sr #.
1.
Name of
Indenter/
Manufactur
er
Manufacturer
Name of Drug
(s)/ Composition
& Therapeutic
Group
Date of
applica
tion /
Fee
status
Document
ary Details
Remarks
M/s SNAM
Pharma
61-G
Defense
Housing
Authority ,
Lahore
BIOVETA,
a. s.
Komenskeho
212, 683 23
Ivanovice na
Hane, Czech
Republic,
Biofel PCH
emulsion for
injection for cats
Date of
applicat
ion
25-112014
CoPP No.
047/2014
dated 01-42014
Me too
Prod
License No.
97/004/06C dated 0106-2006
Market
authorization No.
130217dated 2211-2013.
Active Substance
Virus
panleucopeniae
contagiosae felis
inactivatum,
Minutes for 260th Meeting Registration Board
Fee
deposite
d
1. Marketing
Country: Romania
443
satrain FPV-Bio
7
Calicivirus felis
inactivatum,
strain FCV F 9Bio 8
Herpesvirus felis
inactivatum,
strain FHV-1-Bio
9
2.
M/s SNAM
Pharma 61G Defense
Housing
Authority ,
Lahore
BIOVETA,
a. s.
Komenskeho
212, 683 23
Ivanovice na
Hane,
Czech Republic,
Biocan Puppy
lyophilisate for
the preparation of
injection
suspension with
diluent
Composition- 1
ml (1 dose):
a) Component D
(freeze-dried)
Virus febris
contagiosae canis
min. 10 4.2
TCID50 – MAX.
10 5,0 TCID50
b) Component P
(fluid)
Parvovirus
enteritidis canis
inact. Min. 1024
HAU- max. 4096
HAU
Minutes for 260th Meeting Registration Board
Rs.1000
00/vide
Challan
No
022788
0 dated
27-112014
Balance
fee
Nil
Date of
applicat
ion
25-112014
Fee
deposite
d
Rs.1000
00/vide
Challan
No
022787
9 dated
27-112014
Balance
fee
Nil
Free Sale
Certificate
No.
048/2014
dated 01-42014
GMP
Certificate
No.
178/2012/C
GMP dated
03-9-2012
CoPP No.
057/2014
dated 01-42014
Prod
License No.
97/011/04C dated 0402-2004
Free Sale
Certificate
No.
058/2014
dated 01-42014
GMP
Certificate
No.
178/2012/C
GMP dated
03-9-2012
2. Marketing
Country: Republic
of Poland
Authorization No.
2398/14 dated 1812-2014
3. Marketing
Country: Hungary
Marketing
Authorization
No.3612/1/14
NEBIH ATI
(1dose) dated 112-2014
Me too
1. Marketing
Country: Romania
Market
authorization No.
120087 dated 213-2012.
2. Marketing
Country: Slovak
Republic
Market
authorization No.
97/115/99-S dated
12-12-2012
3. Marketing
Country: Republic
of Bulgaria
Marketing
Authorization of
Veterinary
product No,
444
0022-1461 dated
14-7-2015
3.
M/s SNAM
Pharma 61G Defense
Housing
Authority ,
Lahore
BIOVETA,
a. s.
Komenskeho
212, 683 23
Ivanovice na
Hane,
Czech Republic,
Biocan DHPPi+L
lyophilisate for
the preparation of
injection
suspension with
diluent
Composition- 1
ml:
Freeze-dried
Component
Virus febris
contagiosae canis
min. 10 3.0
TCID50 – max. 10
4.5
TCID50
Virus
laryngotracheitidi
s contagiosae
canis min. 10 3.5
TCID50 – max. 10
4.5
TCID50
Parvovirus
enteritidis canis
min. 10 4.5
TCID50 – max. 10
5.5
TCID50
Date of
applicat
ion
25-112014
Fee
deposite
d
Rs.1000
00/vide
Challan
No
022787
8 dated
27-112014
Balance
fee
Nil
CoPP No.
209/2014
dated 03-72014
Prod
License No.
97/046/02C dated 0606-2002
Free Sale
Certificate
No.
210/2014
dated 03-72014
GMP
Certificate
No.
178/2012/C
GMP dated
03-9-2012
Me too
1. Marketing
Country: Hellenic
Republic (Greece)
Marketing
authorization No.
81940 dated 22-92014.
2. Marketing
Country: Republic
of Poland
Authorization No.
2010/10 dated 2110-2010
3. Marketing
Country: Hungary
Marketing
Authorization
No, 250/1/09
MgSzH ATI
(1dose) dated 214-2015
Virus
parainfluensis
canis min. 10 3.0
TCID50 – max. 10
4.2
TCID50
b) Liquid
component
Leptospira
icterohaemorrhag
Minutes for 260th Meeting Registration Board
445
iae inact.
Min.titre 32
defined by
MAT*)
Leptospira
canicola inact.
Min.titre 32
defined by
MAT*)
Leptospira
grippotyphosa
inact. Min.titre
32 defined by
MAT*)
*) geometrical
mean of titres of
specific
antibodies
defined by
microagglutinatio
n test
3.
Two Veterinary Biological Products namely Biocan Puppy (lyophilisate for the preparation of
injection) and Biocan DHPPi+L (lyophilisate for the preparation of injection ) of M/s Snam Phamra,
Lahore deferred in 256th Registration Board meeting for expert opinion of confirmation of need vis-à-vis
compatibility with local immunogenic requirement safety profile product.
Pannel of experts are as under:
a.
Dr. Qurban Ali Animal Husbandary Commissioner, Ministry of National Food Security,
Islamabad.
b.
Prof. Dr. Khushi Muhammad, UVAS, Lahore
c.
Prof.Akram Munir, Ripha University, Lahore
1. The opinion of Prof. Dr. Khushi Muhamad against Biocan DHPPi and Biocan Puppy Vaccine
are as under:
Comments: Based on the “quality control data, results of the experimental trails and composition of the
Vaccines”, it can be stated that vaccines against the said canine disease in Pakistan seem to be safe and
effective.
It is therefore recommended that the said vaccines may be registered in Pakistan in the best interest of
canine lovers.
Minutes for 260th Meeting Registration Board
446
2.
The opinion of Prof. Dr. Muhamad Akram Muneer, Riphah International University,
Lahore against Biocan DHPPi and Biocan Puppy lyophilisate
Vaccine are as under:
Comments against Biocan Puppy lyophilisate:The technical data provided in the dossier supports the
efficacy of this vaccine product against CD Aand CPV. In view of supporting documents I recommend
that the registration of this vaccine may be considered by the Registration Board.
Comments against Biocan DHPPi+L lyophilisate: The technical data support the efficacy of this
multivalent vaccine against canine distemper (CDV), infectious canine hepatitis (CAV-1), infectious
laryngotracheitis (CAV-2), parvovirus infection (CPV), parainfluenza (CPIV-2) vivid and leptospirosis in
dogs. I recommend consideration of this multivalent preparation by the registration board.
3.
The Opinion of Dr. Qurban Ali, DG, NVL, Islamabad
lyophilisate and Biocan DHPPi+L lyophilisate are as under:
against Biocan Puppy
Biocan Puppy lyophilized is a two component vaccine for active immunization of dogs against canise
distemper and parvovirus. The subject vaccine is a veterinary requirement especially for the pet dogs in
the country. The dossier has merits of clear description of technical contents. The product is registered in
the country of origin, multiple European and developed and developing countries. The product is
recommended.
Biocan DHPPi+L is a multicomponent veterinary caccine containing veterinary vaccine containing
freeze dried and liquid components having biological entities. The vaccine is required for pet dogs for
immunization against multiple diseases for the age of eight weks and above. The technical application has
scientific contents with clear description of technical details. The product is registered in country of
origin, multiple developed and developing countries. The product is recommended.
Decision:
Registration Board approved avove Product as per Import Policy for Finished
Drugs. The firm shall provide legalized and Notarized COPP from three regulatory
bodies of Eastern European countries, where the drug is registered for purpose of
the waiver of inspection aborad as required as per Import Policy for Finished
Drugs.
Case No.08:
Deferred cases Registration of Products of M/s Mustafa Brothers, Faisalabad
Following veterinary vaccine products of M/s Mustafa Brothers Faisalabad are deferred for
submission of valid legalized documents i.e. CoPP or Free sale certificate with GMP, issued by the
regulatory agency of country of origin with certified English translation in 257th meeting of Registration
Board. The firm has submitted the documents. The evaluation is detailed below for consideration of
Registration Baord please.
S.
No
Name of
Importer &
Manufacturer
Brand Name &
Composition
Minutes for 260th Meeting Registration Board
Dy No & Date
of application/
Fee status/
Pack size/
demanded
Document
details (CoPP)
Remarks
Me too status
447
1.
Mustafa
Brothers
Faisalabad.
Manufacturer
Federal
Governmental
Budgetary
Institution
“Federal Centre
for Animal
Health” (FGBI
“ARRIAH”,
Vladimir,
Russia.
2.
Mustafa
Brothers
Faisalabad.
Manufacturer
Federal
Governmental
Budgetary
Institution
“Federal Centre
for Animal
Health” (FGBI
“ARRIAH”,
Vladimir,
Russia.
3.
Mustafa
Brothers
Faisalabad.
Manufacturer
Virus Vaccine
against infectious
bursal disease from
BG strain “ARRIAH
GUMBORO VAC”
Contains:Infectivity of the virus
vaccine shall be at
least 104.5EID50/cm3
One dose of the
vaccine shall contain
103 EId50
(Vaccine).
Pharmacological
group:
Vaccine.
Vaccine against
chicken infectious
bronchitis from strain
“H-120” strain live
dry Contains:One immunizing
vaccine dose contains
not less than 104 EID50
of the chicken
infectious bronchitis
virus (‘H-120” strain,
serotype
Massachusetts).
Price
Dy. No.600
(R&I) dated
12-6-2012
Fee Rs.15000/dated 12-62012 + 85000/dated 01-22016
Balance Fee
Nil
Minutes for 260th Meeting Registration Board
DML No.00-111-001221 dated
11-8-2011
GMP Registration
N 4-4060
enclosed
Firm
has
submitted valid
lealized
documents i.e.
Free
sale
certificate with
GMP issued by
the
regulatory
agency
of
country of origin
with
English
translation
Condition of
inspection
abroad as per
import policy.
Dy No. 599
(R&I) dated
12-6-2012
Fee Rs.
15000/- dated
12-6-2012 +
85000/- dated
01-2-2016
Balance fee
Nil
Product
Registration No.
1023/301283720
Dated 26-7-2011
State Registration
No.
1047796296437
Dated 26-122011
Legalized Free
sale Certificate
Registration N 12347 enclosed
Pharmacological
group:
Vaccine
Associated Vaccine
Against Newcastle
Disease
Infectious Chicken
Bronchitis and egg
State Registration
No.
1047796296437
dated 11-8-2011
GMP Registration
N 4-4060
encosed.
Date of
application
12-Jun-2012
Fee Rs.15000/-
DML No. 00-111-001220 Dated
11-8-2011
enclosed.
.Firm
has
submitted valid
lealized
documents i.e.
Free
sale
certificate with
GMP issued by
the
regulatory
agency
of
country of origin
with
English
translation
Condition of
inspection
abroad as per
import policy.
Firm
has
submitted valid
lealized
documents i.e.
Free
sale
448
Federal
Governmental
Budgetary
Institution
“Federal Centre
for Animal
Health” (FGBI
“ARRIAH”,
Vladimir,
Russia.
4.
Mustafa
Brothers
Faisalabad.
Manufacturer
Federal
Governmental
Budgetary
Institution
“Federal Centre
for Animal
Health” (FGBI
“ARRIAH”,
Vladimir,
Russia.
drop syndrome-76
inactivated emulsion
dated 12-62012+ 85000/dated 01-2Pharmacological
2016
group:
Balance Fee
Vaccine for prevention NIL
of Newcastle Disease
Infectious Chicken
Packing of 400
Bronchitis and egg
doses in a
drop syndrome-76 in
bottle.
breeding and
marketable pultry
farms and farms of
other categories that
have poultry.
Virus vaccine against
Dy No. 596
Bursal disease from
(R&I) dated
Winterfield Disease
12-6-2012
2512 strain
Fee Rs.
One Immunizing dose 15000/- dated
of vaccine shall
12-6-2012
contain:
4,0 lg EID50 of
85000/- dated
attenuated virus of
01-2-2016
infectious bursal
disease of Winter field Balance Fee
strain 2512
Nil
Composition:
Active substances:
Virus of infectious
bursal disease (IBDV)
(strain Winterfield2512), titer of
infectivity at lease 6.0
lg EID50/cm3.
Legalized Free
Sale Certificate
No. N 1-2346
encosed.
GMP Certificate
No. N 4-4060
copy enclosed.
certificate with
GMP issued by
the
regulatory
agency
of
country of origin
with
English
translation
Condition of
inspection
abroad as per
import policy.
Prod Reg No.
1023301283720
Dated 26-7-2011
GMP No. 0011-1001221
26-12-2011
Free Sale
Certificate No. 44078
Firm
has
submitted valid
lealized
documents i.e.
Free
sale
certificate with
GMP issued by
the
regulatory
agency
of
country of origin
with
English
translation
Condition of
inspection
abroad as per
import policy.
Pharmacological
group:
The vaccine is used
for prophylactic
immunization of
Minutes for 260th Meeting Registration Board
449
chickens and chicks
against infectious
bursal disease.
5.
Mustafa
Brothers
Faisalabad.
Manufacturer
Federal
Governmental
Budgetary
Institution
“Federal Centre
for Animal
Health” (FGBI
“ARRIAH”,
Vladimir,
Russia.
Virus Vaccine
against infectious
bursal disease from
BG strain “ARRIAH
GUMBORO VAC”
Contains:Infectivity of the virus
vaccine shall be at
least 104.5EID50/cm3
One dose of the
vaccine shall contain
103 EId50
(Vaccine).
Pharmacological
group:
Vaccine.
Dy. No.600
(R&I) dated
12-6-2012
Fee Rs.15000/dated 12-62012 + 85000/dated 01-22016
Balance Fee
Nil
State Registration
No.
1047796296437
dated 11-8-2011
DML No.00-111-001221 dated
11-8-2011
GMP Registration
N 4-4060
enclosed
Firm
has
submitted valid
lealized
documents i.e.
Free
sale
certificate with
GMP issued by
the
regulatory
agency
of
country of origin
with
English
translation
Condition of
inspection
abroad as per
import policy.
Decision:
Registration Board approved above five products as per Import Policy for Finished
Drugs and valid legalized COPP
Case No.09:
Change in Name of company and address already registered and unregistered
products of M/s Sanofi-Aventis Pakistan Ltd.
M/s Sanofi-Aventis Paksitan has applied for the change in name of company and address
for the following products:
i.
Shanvac B 1ml (Reg.No. 0456371) already registerd product.
ii.
Shanvac B 0.5ml (Approved in 240th RB meeting and under process in Pricing)
iii.
Shanvac B 5ml MD (Approved in 240th RB meeting and under process in
Pricing)
iv.
Shan TT 0.5ml single vial (Approved in 240th meeting of RB and 12th DPC.
v.
Shan TT 0.5ml SD (35x0.5ml) (Approved in 240th meeting of RB and 12th
DPC.
vi.
Shan TT 5ml MD (30x5ml) (Approved in 240th meeting of RB and
12th
DPC.
M/s Sanofi-Aventis Pakistan Ltd has requested that the state of Andhra Pradesh by virtue of the
Andhra Pradesh Reorganization Act 2014 has been split in to two states Andhra Pradesh and Telangtana
fro mid of 2014.
Minutes for 260th Meeting Registration Board
450
As a result of Reorganization Act the manufacturing unit located in erstwhile Andhra Pradesh are
now came into existence in the reorganized Telangana and as per fresh certificate of incorporation
consequent upon conversion from public company to private company issued by ministry of corporate
affairs, w.e.f. 19-11-2014. The change of name and address details are as under:
Old Name of Company and Address
New Name of Company and address
Shantha biotechnics Limited
Shantha biotechnics Private Limited
Survey No. 274, Athvelli village, Medchal
Mandal – 501401, Ranga Reddy district,
Andhra Pradesh, India
Survey No. 274, Athvelli village, Medchal
Mandal – 501401, Ranga Reddy district,
Telangana, India
Firm has submitted fee against each product Rs. 5000/- , Legalized COPP and other legal documents.
Decision:
Keeping in view the approval of change of name and address by the regulatory body
of exporting country (valid legalized CoPP), the Registration Board approved the
change of name and address of manufacturer from Shantha biotechnics Limited
Survey No. 274, Athvelli village, Medchal Mandal – 501401, Ranga Reddy district,
Andhra Pradesh, India to Shantha biotechnics Private Limited Survey No. 274,
Athvelli village, Medchal Mandal – 501401, Ranga Reddy district, Telangana, India.
Case No.10: Deferred Case of 256th RB, Request for additional pack size by M/s. Snam Pharma,
Lahore.
M/s Snam Pharma Lahore may be advised to submit the separate application / dossier
alongwith COPP and case may be taken up in the next Registration Board meeting. However the opinion
of Secretary, Registration Board may also be taken on the instant case for further clarification.
Product Biocan R injection is registered Veterinary Product in multiple dose vial (Reg.No.
057167). The firm requested additional volume/ pack in single dose form as per COPP issued by
regulatory body of Czech Republic. The Registration Board acceded to the request of firm in 256 th RB
meeting. Now the clarification is needed wether the firm shall follows the policy of submitting separate
application dossier along with full fee as per policy adopted on human drugs.
The firm has submitted the balance fee of 95000/- other formalities are complete. Case is submitted
before board please.
Minutes for 260th Meeting Registration Board
451
Decision:
Registration Board deferred the request of additional pack volume 1ml x 20 doses of
Biocan R bearing Registration No. 057167 and advised to submit application on
Form-5A with requisite details.
Case No.11:
Transition of Formulation from Lyophilized To Liquid Form of WinRho SDF
Injection (025216) M/s Eastern Trade and Distribution Co. Pvt Limited Karachi
M/s Eastern Trade and Distribution Co. Pvt Limited Karachi have informed that their
principal M/s Cangene Corporation, Canada is transitioning the formulation of their registered product
WinRho SDF Injection from lyophilized to Liquid formulation. The existing formulation was supplied as
freeze dried powder I vial along with single ampoule of sterile water for injection, while the new
formulation is liquid injection will contain a convenient formulation ready to use 3ml single dose vial of
1500IU (300mcg) of Anti Rho (D) in glass vial
The liquid formulation is approved by Health Canada, detailed below:
Existing
WinRho
SDF
formulation composition
Lyophilized New approved SDF Liquid formulation
Each vial contains:
Human
Anti-D
Immunoglobulin
house)………300 mcg
Each vial contains:
(in Human
Anti-D
Immunoglobulin
house)………300 mcg
Glycine Ph. Eur/ USP……22.5 mg
Saodium chloride Ph. Eur/ USP…..7 mg
Ploysorbate 80 Ph. Eur/ USP…..0.3mg
Water for Injection Ph. Eur/ USP……QS *
(in
Maltose USP………………..0.135g
Ploysorbate 80 Ph. Eur/ USP…..0.39mg
Water for Injection Ph. Eur/ USP……QS *
* Removed by lyophilization.
The firm has submitted the following documents:
a.
b.
c.
d.
e.
5000 fee in respect of above application
Copy of registration letter along with renewal evidence.
USFDA Approval and CoPP issued by Health Canada for liquid formulation.
Specifications of new excipients.
Data of long term (36 months) and accelerated (6months) stability studies.
If approved by the board, we may direct the firm to apply afresh, as it is new dosage design. The case
is submitted for consideration of Board please.
Decision: Registration board did not acceed to the request of the firm for change of
formulation from lyophilized to liquid form of Winrho SDF injection (025216) as
Minutes for 260th Meeting Registration Board
452
present formulation is also approved by regulatory authority of Canada. However
firm was advised to apply fresh application with prescribed fee for new formulation/
dosage design.
Case No:12 Reditux TM Injection applied by M/s Macter International Limited
S.
No
1.
Name of
Importer
&
Manufactu
rer
Brand Name /Drug
composition
Macter
Internationa
l (Pvt)
Limited,
Karachi.
Reditux TM Injection
100mg Each 10ml
vial
contains :Rituximab (r-DNA
origin)….............
100mg
(Antineoplastic
Monoclonal
Antibody).
(For Human Use)
Dr. Reddy’s
Laboratorie
s Ltd.,
Ranga
Reddy
District,
Hyderabad,
India.
Original Notarized
and Legalized GMP
certificate no.
259//M3B/2014
issued by Drug
Control
Administration,
Andhra Pradesh. Date
Of Issue 13/02/2014
and valid up to
18/12/2015. COPP
no. 2821/M3B/2014
for finished drug of
strength 100 mg
issued by Drug
Control
Administration, Govt.
of Andhra Pradesh.
Minutes for 260th Meeting Registration Board
Dy No &
Date of
application/
Fee status/
Pack size/
demanded
Price
Date of
application
2.02.2011
Fee deposided
15000 (02-22011)+
85000 (09-102011)
Total. 100000
Balance fee
Nil
Structural
similarity of
subject
biological
product is
available in
provided
DMF by
manufacturer.
Protein
sequence is
compared
with WHO
sequence.
Document
details
(CoPP)
Decision of RB
Me too status
Remarks
The reference
product is
Ristova by
Roche.
The case was
recommended
in 48th ECBD
+
Biosimilarity
+PICS
Copies of
COPP
provided,
valid up to 1812-2015.
Deferred for expert
opinion of following
a. Brig (Retd),
Muzamil Hasain
Najmi, foundation
Medical College,
Rawalpindi
b. Brig. Amir Ikram,
AFIP, Rawalpindi.
c. Dr. Masud-urRehman DDG,
DRAP, Islamabad.
Bioequivalenc
e and efficacy
Clinical trials
data is
submitted
Safety
Studies
Four years
post marketing
surveillance
data of 818
patients.
Animal
453
Original notarized
and Legalized. Valid
up to 18/12/2015.
toxicity
studies are
available in
provided DMF
by
manufacturer
Indications:
Non Hodgkin
Lymphoma
Antineoplastic
Monoclonal
Antibody
2.
Macter
Internationa
l (Pvt)
Limited,
Karachi.
Dr. Reddy’s
Laboratorie
s Ltd.,
Ranga
Reddy
District,
Hyderabad,
India
Reditux TM Injection
500mg Each 50ml
vial
contains :Rituximab (r-DNA
origin)…...........…
500mg
(Antineoplastic
Monoclonal
Antibody).
(For Human Use)
COPP no.
2381/M3B/2014
issued by Drug
Control
Administration, Govt.
of Andhra Pradesh.
Date Of Issue
22/03/2014. Valid up
to 18/12/2015.
Original notarized
and Legalized
Indications:
Non Hodgkin
Lymphoma
Antineoplastic
Monoclonal
Antibody
Minutes for 260th Meeting Registration Board
Date of
application
02.02.2011
Fee deposited
15000+85000
Balance fee
Nil
Animal
toxicity
studies
are available
in provided
DMF by
manufacturer
The reference
product is
Ristova by
Roche.
The case was
recommended
in 48th ECBD
+
Biosimilarity
+PICS
Copies of
COPP
provided,
valid up to 1812-2015.
Deferred for expert
opinion of following
a. Brig (Retd),
Muzamil Hasain
Najmi, foundation
Medical College,
Rawalpindi
b. Brig. Amir Ikram,
AFIP, Rawalpindi.
c. Dr. Masud-urRehman DDG,
DRAP, Islamabad.
Bioequivalenc
e and efficacy
Clinical trials
data is
submitted
Safety
Studies:
Four years
post marketing
surveillance
data of 818
patients.
454
1.
EXPERT OPINIONS
BY BRIG. (Retd) PROF MUZAMIL HASAN
NAJMI,
ON
PRODUCTS
(BIOLOGICAL) OF M/S MACTER
INTERNATIONAL, KARACHI.
Rituximab is a chimeric monoclonal antibody produced by recombinant DNA technique.
It reacts with the CD20 protein present on the surface of B lymphocytes which are thus
destroyed. Reduction in the number of B lymphocytes results in decreased antibody production
by these cells.
The drug is approved for treatment of certain leukemias and lymphomas including nonHodgkin’s lymphoma. It is also used in some of the autoimmune diseases. It is a disease
modifying drug for rheumatoid arthritis, particularly refractory to other treatments.
The drug can cause several adverse effects which include severe reaction after administration as
infusion, cardiotoxicity, lung toxicity, tumor lysis syndrome and reactivation of viral infections
including hepatitis B. However, keeping in view the nature of diseases in which it is used, the
benefit/risk ratio is favorable.
M/S Macter International, Karachi has applied for registration of the brand of Rituximab
which is of Indian origin. The manufacturer, Dr. Reddy’s Lab has provided details of
manufacturing method and biosimilarity studies of their product, Reditux TM injection 100 and
500 mg. The Company has obtained cGMP compliance certificates from USFDA and MHRA of
UK. Having reviewed the data provided, I am of the opinion that both strengths of Reditux TM
injection may be approved so that a cost-effective alternative brand of this drug may become
available for the patients.
2.
EXPERT OPINION BY DR. MASUD UR REHMAN, DDG, DRAP ON
BIOLOGICAL
PRODUCT OF M/S MACTER INTERNATIONAL, KARACHI
Introduction:
Rituximab a long chain monoclonal antibody is produced by recombinant DNA
technique. Having site of action on CD20 protein present on the surface of B lymphocytes. It
binds there and destroys B Lymphocytes cancerous cell. Reduction in the number of B
lymphocytes results in decreased antibody production by these cells. The drug is approved for
treatment of leukemias, lymphomas including non-Hodgkin’s lymphoma. It is also used in some
of the autoimmune diseases. It is a disease modifying drug for rheumatoid arthritis, particularly
refractory to other treatments.
Evaluation of Dossier:
Product dossier carries scientific data of structural characterization & comparability with
innovator product (Mabthera / Rituxan) in peptide mapping, intact protein mass, UV circular dichorism,
Disulphide bonding pattern by LC-MS. There is comparability / similarity of structure in high order
structure by fluorescence spectroscopy, thermal stability by scanning calorimetric method, glycosialation
analysis by Reagent Array Analysis (RAAM), Charge isomers by IEF, SDS PAGE, SEC HPLC. Potency
Minutes for 260th Meeting Registration Board
455
is determined by CDC & ADCC. Specific binding of FCγR1, FCγRIIa, FCγRIIB, FCγRIIIa and FCγRn
regions by ELISA, SPR & FACS has also been done.
Pharmacokinetic studies:
Pharmacokinetic and extensive animal toxicology studies data is provided. Clinical efficacy trial
on Non Hodgkin Lymphoma (NHL) of stage II, III and IV patients has shown overall response of 93.8%.
Toxicity data is also provided which is in acceptable range. Four years post marketing safety data of 808
patients is also submitted.
Manufacturers Profile:
Manufacturer of Rituximab is Dr. Reddy’s Laboratories, India. Its a GMP certified manufacturer
by many international regulatory agencies such as Brazil, Peru, QP EU, GCC and Iran. The Company has
also obtained cGMP compliance certificates from USFDA and MHRA of UK.
Recommendations:
M/S Macter International, Karachi has applied for registration of the generic brand of Rituximab.
Reditux generic biosimiler injection may be approved so that a cost-effective alternative brand of this
drug may become available for the patients. Based on aforementioned evaluated specifications by M/S
Macter International, Karachi, the product registration is recommended.
3.
Reply of Brig. Amir Ikram, AFIP, Rawalpindi
Thanks for referring the case of Reditux TM Injection 100mg and 500mg strength. Comments are as
below:
1.
Product Safety:
The provided literature shows that the preparation s are safe. Trials have
been conducted in the country f origin with satisfactory outcome. The manufacturer is following GMPs.
2.
Efficacy;
The clinical trials conducted in the contry of origin indicate that the
preparations are efficacious, however further evaliuation if requisite may be done.
3.
The provided material indicates that the preparations are comparable to
published literature for innovator rituximab. The preparations are required and if probably not incorrect
not much of preparations are easily available within the country. Its transportation under requisite
parameters especially temperature has to be guaranteed by the company at all levels.
The three experts have recommended the products for registration. The case is submitted is before the
board for consideration as per import policy.
Decision:
Registration Board considered the expert opinions and approved the registration of
Reditux Injection 500mg manufactured by Dr. Reddy’s Laboratories Ltd., Ranga
Reddy District, Hyderabad, India as per Import Policy for Finished Drugs and valid
legalized CoPP
Minutes for 260th Meeting Registration Board
456
Case No.13:
Hepatitis B Vaccine applied by M/s Macter International Limited.
Following products of M/s Macter International Limited Karachi for local manufacturing were
deferred in the 257th meeting of Registration Board for confirmation of manufacturing facility.
S.#.
Name of
Importer/Man
ufactruer
Brand Name
/Composition
Date of
application/Fee
status/price
Documentary
details
1.
Macter
International
Ltd. 216, SITE,
Karachi,
Pakistan (Local
Manufacturer)
Biovac HB
Out Dy No. 184
dated 10.3.2014
Me too
(Recombinant
Hepatitis B
Vaccine)
20 µg/ml
Bulk material
source:
20000/- dated 218-2013
Price. As per PRC
LG Life
Sciences Korea.
2.
Macter
International
Ltd. 216, SITE,
Karachi,
Pakistan (Local
Manufacturer)
Biovac HB
(Recombinant
Hepatitis B
Vaccine)
10 µg/0.5ml
Dy No.40 DDC
(BD) Dated 17-32014
Fee Rs. 20000/Dated 21-8-2013
a. Firm
has
submitted the
CoPP
FSC
and GMP of
Legalized
bulk material
CoPP No. 2issued from
13-A1-1023
regulatory
Republic of
body
of
Korea
Korea.
b. Under
finished
product
Product
specifications
License No.
firm
has
213 dated 29provided, tests
12-1994
of
Physical
appearance,
aluminum
Legalized Free
content,
sale certificate
Potency
by
No. 2013-A1Elisa,
1022 dated 08identification
5-2013
and purity by
SDS-Page,
endotoxin
bioburden and
Legalized GMP
sterility tests.
Dated 15-32013 enclosed.
Me too
Legalized
CoPP No.
2015-A1-0917
Dated 16-72015
Bulk material
source:
LG Life
Minutes for 260th Meeting Registration Board
Remarks
Product
a. Firm
has
submitted the
CoPP
FSC
and GMP of
bulk material
issued from
regulatory
body
of
Korea.
b. Under
finished
product
457
Sciences Korea.
Price: As per PRC
License No.
213 dated 2912-1994
Legalized GMP
No. 2015-F10102 dated 094-2015
specifications
firm
has
provided, tests
of
Physical
appearance,
aluminum
content,
Potency
by
Elisa,
identification
and purity by
SDS-Page,
endotoxin
bioburden and
sterility tests.
The firm has submitted that:
Macter’s Biotech manufacturing license covers the formulation, filling and packing of
recombinant DNA technology products. Hepatitis B vaccine is also recombinant DNA technology protein
which is relevant to the license. Recombinant human hepatitis B antigen (rHBsAg) is a polypeptide
protein of 226 amino acid with molecular weight of 24 KDa produced by incorporating genes that code
for important antigens (HBV envelope proteins) into common baker’s yeast (Saccharomyces cerevisiae).
This polypeptide is similar in nature to any other biopharmaceutical products like Interferon alpha which
is 19Kda polypeptide.
This vaccine is entirely different to other categories of vaccines which contain live attenuated or
killed pathogenic organisms (fully or partially). Ready to fill bulk vaccine will be imported from LG
South Korea which is WHO qualified manufacturer for this vaccine (WHO letter for qualification is
submitted. Weblink of WHO site of prequalified manufacturers of rHBsAG is given. Formulated bulk
will be imported and Firm will do filling in vials with online sterile filtration. Details of availability of QC
equipments is attached. Firm has submitted quality & stability data of three batches manufactured locally.
ADC signed invoice of import of ready to fill bulk is provided. Firm’s Biotech manufacturing license
covers the formulation, filling and packing of recombinant DNA technology products. Hepatitis B
vaccine is also recombinant DNA technology protein which is relevant to the license.
Sr.
no.
1.
Documents/ data as per Documents / data submitted by Remarks
requirement of DRB 246 Macter
Legalized GMP certificate Legalized GMP certificate by KFDA Notarized and legalized (by
of biological drug as issued on March 15, 2013.
Pakistan embassy Soule, South
evidence that manufacturer
Korea) GMP certificate Issued by
is
an
authorized
Korea
Food
&
Drug
Minutes for 260th Meeting Registration Board
458
manufacturer
of
that
particular biological drug
in its country of origin
2.
3.
Administration
on March 15, 2013 is submitted.
WHO pre-qualification letter
Issued by Coordinator quality,
safety and standard is submitted.
WHO prequalification certificate This product & manufacturer are
and Web link of WHO website included in the list of prequalified
vaccines & manufacturer at WHO
link
link
https://extranet.who.int/gavi/PQ_W web
https://extranet.who.int/gavi/PQ_
eb/ 
for WHO prequalified vaccine Web/.
manufacturers included in GAVI
Notarized and legalized (by
program is provided.
Pakistan embassy Soule, South
Legalized COPP certificate no. 2013- Korea) COPP certificate no. 2013A1-1023 issued on May 08, 2013 is A1-1023 issued on May 08, 2013
provided.
is provided.
Structural similarity of Product characterization is performed Studies are performed by LG life
subject biological drug for comparability with WHO Sciences South Korea
are
product (ready to fill bulk) reference standard of NIBSC Hep B available in
provided CTD
with reference biological antigen & innovators product Engerix dossier.
product (innovator).
B of GSK by SDS PAGE (mol. Wt.),
UV
spectrophotometry
(identification), Circular Dichorism
(secondary
structure),
electron
microscopy (particle morphology),
gradient centrifugation (density),
gradient
Centrifugation
(homogeneity), Tryptic digestion &
SDS Page, N Terminal sequence
(identity), C terminal sequencing
(identity), Amino acid composition,
thin
layer
chromatography
(phospholipid
composition),
Antigenicity by ELISA (efficacy),
Size Exclusion Charmatography and
SDS page for purity,
Bio comparability studies Comparative analysis of locally Comparative studies of local
including identity testing to produced
drug
product
with batches with innovators product
parent molecule, purity Reference medicinal product (Engerix Engerix B of GSK are provided.
testing, in vitro biological B).
activity / potency testing
and toxicity with support Identity: SDS PAGE
of
IEF
data,
gel Purity: SDS PAGE
electrophoresis,
western Potency: ELISA
blot and other analytical General safety tests
methods and stability Bacterial Endotoxin test, Sterility test
studies of finished drug.
and abnormal toxicity test.
Real time stability studies for one
Minutes for 260th Meeting Registration Board
459
4.
year and accelerated stability studies
for 6 months.
Animal toxicity studies and clinical Pharmacokinetics
and
trial studies are submitted
toxicological studies are provided.
Others
Section 5.2 requires that dedicated nd self contained facilities for production of particular drug
shall be provided in addition to general facilities sch as highly sensitizing materials ( pencillins or biologicals
preperation, live microorganisams or cytotoxix substances or radio pharamaceuticals or veterinaray
immunological preparation or sterile products or for that matter such hihky active pharmaceutical products,
antibiotics, hormones, as may be identified by the CLB at any stage in order to minimize the risk of serious
medical hazards due to cross contamination, veterinary products contaioning ingrdients similar to those used for
human health and of the sane quality which can be manufactured in the same premises used for manfacture of
pharamacetical products.
It is also described under the above sub rule in exceptional cases of emergency, the prociple of campaign
working in the same facilities may be allowed provided that the specific precautions are taken nd necessary
validations are made.
It is submitted that a discussion was carried out with Licensing Division to discuss the manufacturing
facility for vaccines and other biological products should be separate or can be manufacutered in the same
biotech facility. The Licensing Divisin has desired to make a comprehensive and well thoughtfull delimitation
of manufacturing process being careied out, so the Biological Division and Licensing Division may come up
with comprehensive proposal in the light of existing legislation and international practices being adopted. It is
proposed that the board may allow adaptation of WHO guideline in this regard. (Annex-I)
The case is submitted before the Board for a discussion/delibration/direction on the subject issue by the
Registration Board.
Decision:
Regiatration Board deliberated and deferred these applications that manufacturing and
quality control of biological products require specialized facilities and approval from the
Licensing Division, DRAP. The Baord dicussed that theses manufacturing units have
already been granted registrations of various biological products for local manufacturing
(mostly therapeutic proteins). As theses firms have applied for registration for local
manufacturing of various biological products including rDNA products, Theraputic
protein, Monocronial antibodies, Vaccines (Live, Attentuated, rDNA vaccines, so the
Board decided to have opinion of licensing division DRAP regarding approved
manufacturing facilities (categories of biological products) of these firms and status of
already registerd biological drugs from these firms.
Minutes for 260th Meeting Registration Board
460
S.No
.
1.
Case No.14:
Cases of Import Veterinary Product Medivac ND G7B Emulsion and Medivac
Coryza T Suspension M/s Hilton Pharma, Karachi.
Name of
Importer &
Manufactur
er
Brand Name &
Composition
Hilton
Pharma (Pvt)
Ltd.
13, Sector 15,
Korangi
Industrial
Area,
Karachi,
Pakistan
Medivac ND G7B
Emulsion
Manufacturer
:
Name:
PT.MEDION
Inactivated vaccine
for poultry
Each dose (0.5ml)
of vaccine contains
inactivated
Newcastle disease
virus MD15 strain
at least 50 PD 50
Dy No & Date
of application
Document
details (CoPP)
Fee submitted
Me too status
Pack size
Dy No. 196
R&I dated 123-2014
100000/- dated
18-9-2013
Pack Size
500 ml
Adress: Ji.
Babakan
ciparay No.
282 Bandung
40223 Indoneshia
Hilton
Pharma (Pvt)
Ltd.
13, Sector 15,
Korangi
Industrial
Product
Registration
Kementan RI No.
D-13034471
VTC
Decision
Firm
has
submitted
Legalized Free
Sale Certificate,
GMP
Certificate,
Letter
of
authorization
and
Product
Stability Data.
Approved
as
per
Import
Policy
for
Finished Drugs
and
valid
legalized CoPP.
Firm
has
submitted
Legalized Free
Sale Certificate,
GMP
Certificate,
Approved
as
per
Import
Policy
for
Finished Drugs
and
valid
legalized CoPP.
Legalized GMP
Certificate No.
086/MFJ/HK.340
/F.5/08/11 Dated
23-8-2011 until
valid 23-8-2016
JI.Raya
Batujajar 29
cimareme,
Kabupaten
BandungIndonesia
2.
Legalized
Certificate of
Free Sale No.
10004/PL500/F/0
2/2016 valid until
January, 2021
Remarks
Medivac Coryza T
Suspension
Strrength /
Formulation
Dy No. 543
R&I dated 046-2014
100000/- dated
04-6-2014
Minutes for 260th Meeting Registration Board
Authorization
Letter No.
RD/IJ/III/2016/C
141 dated30-32016 from
Medion
BandungIndonesia.
Legalized
Certificate of
Free Sale No.
10004/PL500/F/0
2/2016
461
Area,
Karachi,
Pakistan
Manufacturer
:
Name:
PT.MEDION
JI.Raya
Batujajar 29
cimareme,
Kabupaten
BandungIndonesia
Address: Ji.
Babakan
ciparay No.
282 Bandung
40223 Indoneshia
Case No.15:
Each 0.5ml dose
contains:
-Haemophillus
paragallinarum W
strain before
inactivation
≥2x108.0 CFU/ml
-Haemophillus
paragallinarum
Spross strain before
inactivation
≥2x108.0 CFU/ml
-Haemophillus
paragallinarum
Modesto strain
before inactivation
≥2x108.0 CFU/ml
Pack Size
500 ml
Inactivated
Suspension
Vaccine
against
infectious
coryza
Product
Registration
Kementan RI No.
D-14022729
VTC.1
Letter
of
authorization
and
Product
Stability Data.
Legalized GMP
Certificate No.
086/MFJ/HK.340
/F.5/08/11 Dated
23-8-2011 until
valid 23-8-2016
Authorization
Letter No.
RD/IJ/III/2016/C
141 dated30-32016 from
Medion
BandungIndonesia.
Deferred Cases of 257th Meetong of Registration Board of M/s Amson
Vaccines Pharma (Pvt) Ltd Rawalpindi (WHO Prequalified)
S.No
Name of
Importer/Man
ufacturer
Brand Name /
Composition
Date of
Dicision of 257RB
application/fe Meeting
e status/
Price/pacsk
Documents
submitted by M/s
Amson Vaccine
Phamra, Islamabad
1.
M/s Amson
Vaccines &
Pharma (Pvt)
Ltd. Rawalpindi
Pakistan
ComBE Five
(Suspension for
Injection).
Dy No. 1216
R&I DRAP
dated 25-22016
Legalized COPP No. Registration Board
COPP/RLA/DI/MDL/ approved
the
HYD/2016 valid upto product as per
03-9-2017
import
policy,
Import policy order
Legalized GMP
(Ministry
of
Certificate No.
Dis.No.
Commerce) and as
10694/E(V)/TS/2015 per valid legalized
dated 04/9/2015 valid CoPP.
for two years from the
Manufacturer
Diphtheria,
Tetanus,
Pertussis
(Whole cell),
Hepatitis B
(rDNA) and
Fee Rs.
100000/dated 25-22016
Minutes for 260th Meeting Registration Board
Deferred for
submission of
following documents
:
a. Sole agency
agreement.
b. Valid legalized
CoPP.
Decision
462
M/s. Biiological
E Limited
18 / 1 7 3,
Azamabad,
Hyderabad,
India-500 020.
Haemophilus
Type b
Conjugate
Vaccine
(Adsorbed)
date of issue
Pack size:
1ml – Two
dose
Legalized Sole
Agency Agreement
dated 6thApril, 2016
submitted.
Each dose of
0.5 ml contains:
Diphtheria
Toxoid : 25 Lf
(≥30IU)
WHO
prequalification
status shall be
verified at the time
of issuance of
registration letter.
Shelf life: 24
months, when
stored at 28oC.
Tetanus toxooid
: 5.5 Lf
(≥60IU).
B. Pertussis :
161 IOU Lf (≥
4 IU)
r-HBs Ag :
12.5 µg.
Purified
capsular
polysaccharide
of Hib
covalently : 11
µg.
Linked to 20 to
36.7 µg of
tetanus toxoid.
A1+++ (as
AIPO4) : ≤1.25
mg
Preservative:
Thiomersal BP
: 0.01% w/v
Pharmacologica
l group:
Vaccine
2.
M/s Amson
Vaccines &
Pharma (Pvt)
Ltd. Rawalpindi
ComBE Five
(Suspension for
Injection).
Dy No. 708
R&I DRAP
dated 03-22016.
Diphtheria,
Minutes for 260th Meeting Registration Board
Deferred for
submission of
following
documents:
Legalized COPP No. Registration Board
DI/BPN/Sec(Mfg)/CO approved
the
PP /18.03.16-02 valid product as per
up to 25-7-2016
import
policy,
463
Pakistan
Manufacturer
M/s. Biiological
E Limited
18 / 1 7 3,
Azamabad,
Hyderabad,
India-500 020.
Tetanus,
Pertussis
(Whole cell),
Hepatitis B
(rDNA) and
Haemophilus
Type b
Conjugate
Vaccine
(Adsorbed)
Each dose of
0.5 ml contains:
Diphtheria
Toxoid : 25 Lf
(≥30IU)
Fee Rs.
100000/dated 03-22016
Shelf life: 24
months when
stored at 28oC.
Pack Size: 2.5
ml Five dose)
a. Sole agency
agreement.
b. Valid legalized
CoPP.
Submitted
Legalized GMP
Certificate No. Dis
No. 1610/M3B/2014
dated 26-7-2014 valid
for two years from the
date of issue.
Submitted
Import policy order
(Ministry
of
Commerce) and as
per valid legalized
CoPP.
WHO
prequalification
status shall be
verified at the time
of issuance of
registration letter.
Legalized Sole
Agency Agreement
dated 7th April, 2016
submitted.
Tetanus toxooid
: 5.5 Lf
(≥60IU).
B. Pertussis :
161 IOU Lf (≥
4 IU)
r-HBs Ag :
12.5 µg.
Purified
capsular
polysaccharide
of Hib
covalently : 11
µg.
Linked to 20 to
36.7 µg of
tetanus toxoid.
A1+++ (as
AIPO4) : ≤1.25
mg
Preservative:
Thiomersal BP
: 0.01% w/v
Pharmacologica
l group:
Vaccine
Minutes for 260th Meeting Registration Board
464
3.
M/s Amson
Vaccines &
Pharma (Pvt)
Ltd. Rawalpindi
Pakistan
Manufacturer
M/s. Biiological
E Limited
18 / 1 7 3,
Azamabad,
Hyderabad,
India-500 020.
ComBE Five
(Suspension for
Injection).
Diphtheria,
Tetanus,
Pertussis
(Whole cell),
Hepatitis B
(rDNA) and
Haemophilus
Type b
Conjugate
Vaccine
(Adsorbed)
Each dose of
0.5 ml contains:
Dy No. 163
R&I DRAP
dated 10-32016
Fee Rs.
100000/dated 10-32016
Pack size:
5ml – Ten
dose
Diphtheria
Toxoid : 25 Lf
(≥30IU)
Shelf life: 24
months, when
stored at 2Tetanus toxooid 8oC.
: 5.5 Lf
(≥60IU).
Deferred for
submission of
following
documents:
a. Sole agency
agreement.
b. Valid legalized
CoPP.
Legalized COPP No. Registration Board
COPP/RLA/DI/MDL/ approved
the
HYD/2016 valid upto product as per
03-9-2017 submitted
import
policy,
Import policy order
(Ministry
of
Legalized Sole
Commerce) and as
Agency Agreement
per valid legalized
dated 6th April , 2016
CoPP.
submitted
WHO
prequalification
Legalized GMP
status shall be
Certificate No. Dis
verified at the time
No.
10694/E(V)/TS/2015 of issuance of
dated 04-9-2015 valid registration letter.
for two years from the
date of issue.
submitted
B. Pertussis :
161 IOU Lf (≥
4 IU)
r-HBs Ag :
12.5 µg.
Purified
capsular
polysaccharide
of Hib
covalently : 11
µg.
Linked to 20 to
36.7 µg of
tetanus toxoid.
A1+++ (as
AIPO4) : ≤1.25
mg
Preservative:
Thiomersal BP
: 0.01% w/v
Minutes for 260th Meeting Registration Board
465
Pharmacologica
l group:
Vaccine
4.
Amson
Vaccines &
Pharma (Pvt)
Ltd. Rawalpindi
Pakistan
BEtt
(Adsorbed
Tetanus
Vaccine
[Tetanus
Toxoid
Vaccine]
Manufacturer
M/s Biological
E Limited
18/1&3,
Azamabad,
Hyderabad –
INDIA, 500 020
Dy No. 707
(R&I) DRAP
Dated 03-22016
Fee Rs.
100000/-
Each 0.5 mL of
Dated 03-2vaccine
2016
contains:
Tetanus
Toxoid……..≥4
0 IU
Deferred for
submission of
following
documents:
a. Sole agency
agreement.
b. Legalized valid
CoPP or Free
Sale Certficate
and GMP
certificate.
Ten dose vial
of 5ml
Adsorbed on
Aluminium
Phosphate
(AIPO4)…….
≥1.5 mg
Legalized COPP no.
COPP
/RLA/DI/MDL/HYD/
2016 valid upto 2010-2016 from Govt of
Telangana submitted.
Registration Board
approved
the
product as per
import
policy,
Import policy order
(Ministry
of
Commerce) and as
per valid legalized
Legalized GMP
Certificate NO. L.Dis CoPP.
No.
8010/AB/(M3)/TS/20 WHO
14 dated 21-10-2014 prequalification
valid for two years the status shall be
date of issuance
verified at the time
of issuance of
registration letter.
Legalized Sole
Agency Agreement
dated 07-4-2016
submitted
Preservative:
Thiomersal
BP…….0.01%
w/v
Pharmacolgical
group:
Vaccine
Indications:
For active
immunization
against tetanus
in adults,
children and
infants.
5.
Amson
Vaccines &
Pharma (Pvt)
Ltd. Rawalpindi
Pakistan
BEtt
(Adsorbed
Tetanus
Vaccine
[Tetanus
Dy No.
1215(R&I)
DRAP Dated
25-2-2016
Minutes for 260th Meeting Registration Board
Deferred for
submission of
following
documents:
a. Sole agency
Legalized COPP No. Registration Board
COPP/RLA/DI/MDL/ approved
the
HYD/2016 valid upto product as per
20-1—2016 submitted
import
policy,
Import policy order
466
Toxoid
Vaccine]
Fee Rs.
100000/-
Manufacturer
M/s Biological
E Limited
18/1&3,
Azamabad,
Hyderabad –
INDIA, 500 020
Each 0.5 mL of Dated 27-01vaccine
2016
contains:
Tetanus
Toxoid……..≥4
0 IU
Single dose
vial of 0.5ml
Adsorbed on
Aluminium
Phosphate
(AIPO4)…….
≥1.5 mg
agreement.
b. Legalized valid
CoPP or Free
Sale Certficate a
and GMP
certificate.
Legalized Sole
Agency Agreement
dated 7th April, 2016
submitted.
(Ministry
of
Commerce) and as
per valid legalized
CoPP.
WHO
prequalification
Legalized GMP
Certificate No. Di.
status shall be
No,
verified at the time
8010/AB/(M3)/TS/20 of issuance of
14 dated 21-10-2014
registration letter.
valid for two years
from the date of issue.
Submitted
Preservative:
Thiomersal
BP…….0.01%
w/v
Pharmacolgical
group:
Vaccine
Indications:
For active
immunization
against tetanus
in adults,
children and
infants.
Case No. 16.
Deferred case of 256 Meeting of Registration Board for expert opinion
M/s Marush (Pvt) Limited, Lahore
M/s Marush (Pvt) Limited, Lahore has applied for the registration of following biological products
which were considered in the 256th meeting of Registration board. The board deferred the request of
the firm for expert opinion.
Minutes for 260th Meeting Registration Board
467
Name of Manufacturer
Name of product & composition
Vaxxinova GmbH AntonFlettner-Str. 6 27472
Cuxhaven, Germany
Distributed by: CEVA SANTE
ANIMALE 10 avenue de la
Ballastiere Libourne, 33500
France
Laboratories Hipra S.A.Avda.
La Selva Amer (Girona) Spain.
Cevac new Flu H9 K
Each dose contains:Atleast 109.0 EID50 of inactivated Newcastle disease Virus (strain
LaSota) and atleast 108.0 EID50 Avian Influenza Virus (strain
H9N2), suspended in the amnio-allantoic fluid from embryonated
SPF hen’s eggs.
-do-.
Hipraviar B1/H120
1 dose contains:
Live Newcastle disease (ND) Virus, strain B1………….105.5
EID50
Live infectious bronchitis (IB) Virus, strain
H120…………..………….103 EID50
Hipraviar SHS
Each dose contains:
Live Turkey Rhinotracheitis Virus, strain 1062---------≥102.4
TCID50
Excipiants q.s……….0.03 ml
The Reply of experts is as under:
Reply of Dr. Iftikhar Hussain
Based on the data provided in the respective dossiers, the products seem to contain the
required antigenic masses of the respective viral strain present in the product for effective amount of
antibody productions, the above mentioned products may be considered for registration.
Reply of Dr. Muhamad Khalil
In the light of current local epidemiology Newcastle (ND), infectious bronchitis (IB) are
the mostprevalent diseases in local commercial layer, broiler & breeder farms, whereaa swollen head
syndrome (SHS) is common disease problem of commercial layer & breeding flocks. All types of
chickens in Paksitan are being vaccinated regularly against these diseases through similar combinations as
of the subject vaccines. It is also cited in the literature that similar vaccines are also carried out in Pakistan
and world wide where commercial poultry is grown.
Keeping in view the local epidemiology, data presented and review of the literature. I feel
the subject veterinary biologics are suitable for prevention of above cited diseases.
Therefore, I recommend to register these vaccines in Pakistan.
Reply of Dr. Masood Rabbani, UVAS, Lahore is still awaited
The case is submitted before the board for consideration please.
Decision:
Registration Board considered the expert opinions and approved the registration of
Cevac new Flu H9 K, Hipraviar SHS, Hipraviar B1/H120 vaccine
Minutes for 260th Meeting Registration Board
468
Case No.17.
Deferred Cases of 257th Me too of Registration Board of Sanofi-Aventis Pakistan
Limited, Karachi
Name of
Importer/
Manufactu
rer
Brand Name / Date of
Composition
application/fee
status/ Price/pacsk
Dicision of
257RB Meeting
SanofiAventis
Pakistan
Limited,
Karachi
THYROGEN
Deferred
submission
following:
Product
License
holder (also
packager,
labeler &
batch
release):
Genzyme
Corporatio
n, 11Forbes
Road,
Northborou
gh, MA
USA
(Thyrotropin
alfa,
thyrotropin
alfa for
injection)
Application submit
(R&I) Section dated
for The firm has
of submitted
Legalized
09-6-2014
Fee Rs. 100000/Dated 09-6-2014
Each vial
contain 1.1mg
thyrotropin
alfa (Each 1
ml contains
0.9 mg/ml of
thyrotropin
alfa when
reconstituted
with 1.2 ml
water for
injection)
Documents
submitted by
Sanofi-Aventis
Pakistan Limited,
Karachi
To be submitted at
time of price fixation/
box of 2vials.
a. Legalized
CoPP/ GMP
& Free Sale
Certifcate.
b. Orignal sole
agency
agreement.
c. Stability data
of
finished
product.
COPP No. 040013-2014-02-PK
Dated 29/4/2014
Decision
The Product is
USFDA approved,
so
Registration
Board
approved
the registration of
product as per
import policy and
valid
legalized
CoPP.
Product License
Holder No. 20-898
dated 30-11-1998
GMP Certificate
No. UK GMP
24655 Insp GMP
22907/37128-0005
[H] dated 31-122012.
Manufactur
er:
Hospira
Inc. 1776
North
Centennial
Drive
McPherson,
KS
67460USA
Pharmacologic
al group:
The stability data
has also been
submitted.
Pituitary and
Hypothalamic
Hormones and
Analogues,
Shelf life:
three years.
Minutes for 260th Meeting Registration Board
469
Case No.18: Deferred Cases of M/s Acumen Pharmaceuticals Rawalpindi in the 258 th meeting of
Registration Board
Following product of M/s Acumen Pharmaceuticals Rawalpindi, are deferred in the 258 th
meeting of registration board for submission of valid legalized CoPP from country of origin and if not
available in the country of origin, then valid reason thereof.
Sr. No
1.
Name of
Importer &
Manufacturer
Acumen
Pharmaceutical
s,
Rawalpindi
BBT Biotech
GmbH Arnold
Sommerfeldrin
g
28
52499Baeswile
r
Germany.
2.
Brand Name
&
Composition
DICLAIR
HP-HCG
For Injection
Each vial
contains:
Human
Chorionic
Gonadotopin
………….50
00IU
Type of Form
Dy No & Date
of application/
Fee status/
Pack size/
demanded
Price
Dy No. 258
dated 13-1-15
Rs. 100000/dated 13-12015
Price 1500/vial
Treatment of
an ovulatory
infertility
Acumen
Pharmaceutical
s,
Rawalpindi
Shelf life 36
months
DICLAIR
HP-FSH
Each vial
contains:
BBT Biotech
GmbHArnoldS
ommerfeldring
Folical
stimulating
Hormone
Document
details
(CoPP)
Dy No. 260
dated 13-12015
Rs. 100000/dated 131-15
Minutes for 260th Meeting Registration Board
Decision of
258th RB
Legalized
CoPP of
Belgium
submitted
Product is
not
available
in the
country of
origin .(
declared
for
export).
Molecule
is me too.
Deferred
for
submission
of
valid legalized
CoPP
from
country of origin
and
if
not
available in the
country
of
origin, then valid
reason thereof.
Legalized
CoPP of
Belgium
submitted
Product is
not
available
in the
Deferred
for
submission
of
valid legalized
CoPP
from
country of origin
and
if
not
available in the
country
of
International
Avalaibality
Me too
status
Legalized
/original
COPP NO
109-07-14
dated 19-72014 of
Federal
Agency 97
Medicine and
health
Belgium.
Me too
Form 5A
Remarks
COPP No.
209-07-14
dated 19-72014 (Copy
submitted)
Federal
Agency 97
Medicine and
470
28
52499Baeswile
r
Germany.
3.
Acumen
Pharmaceutical
s,
Rawalpindi
BBT Biotech
GmbHArnoldS
ommerfeldring
28
52499Baeswile
r
Germany.
75IU
Induction of
ovulation
Shelf life: 36
months
DICLAIR
HP-HMG
Each vial
contains:
Folical
stimulating
Hormone
75IU
health
Beljium.
Price 1500/vial
Dy No. 259
dated 13-1-15
Rs. 100000/dated 131-15
Price 1500/vial
Luteinizing
hormone
75IU
Shelf life: 36
months
Legalized
/original
COPP NO
1023-12-14
dated 23-122014 of
Federal
Agency 97
Medicine and
health
Beljium
country of
origin.
(declared
for
export).
Molecule
is me too.
Legalized
CoPP of
Belgium
submitted
Product is
not
available
in the
country of
origin .(
declared
for
export).
Molecule
is me too.
origin, then valid
reason thereof.
Deferred
for
submission
of
valid legalized
CoPP
from
country of origin
and
if
not
available in the
country
of
origin, then valid
reason thereof.
The firm has submitted a letter from BBT Bio Tech GmbH Germany that the above products are
not marketed in European markets yet, as there was no economical interest for that.
All registration s made in our home market, are only of interest in case the product can have a
status of reimbursement. The social security of western European countries were not reimbursing the
human gonadotrophin until recently.
As European authorities do change the rules of re-imbursment, giving our products
(gonadotrophin) an economical reason to be registered, we can inform that we are now starting MRP
registration process. This process will take some time as we will then cover all countries of the ECC.
Therefore we can conclude that BBT-Biotech GmbH is starting now registration procedures for,
consecutively, HMG, HCG and FSH, throughpartners and /or in direct form.
Our manufacturing sites/facilities are fully GMP/WHO approved. All necessary authorizations are
available including the CPP format declaring that sales on export are allowed by our Ministry of Health.
Decision:
Registraion Board considered the request of the firm. The reason submitted by the firm
for non registration of products in country of origin was from the manufacturer and not
from the regulatory body. The board is of the view that the reason is not sufficient for
granting registration. The board deferred the products till registration in the country of
origin as per policy
Minutes for 260th Meeting Registration Board
471
Case No. 19
Sr.
No
Name of
Importer &
Manufacturer
Deferred case of 258th Meeting of RB M/s LDS (Pvt) Ltd Rawalpindi.
Brand Name &
Composition
Type of Form
Dy No & Date of
application/
Document
details (CoPP)/
International
Avalaibality/ Me
too status
Decision
of Decision
th
258 Meeting
of
RB
/
Remarks
Fee status/
Pack size/
demanded Price
1.
M/s LDS (Pvt)
Ltd
Rawalpindi.
M/s BioMed
Pvt Ltd C-96
site No.1
Bulandshar
Road Industrial
Areal
Ghaziabad UP
India.
PEDA TYPH
Vaccine single
dose vial
Each dose vial
0.5ml contains:
5ug of Vi
polysaccharide
of Salmonella
typhi conjugated
to 5ug Tetanus
toxoid protein in
isotonic saline
0.5ml.
Dy No. 502 dated
22-1-15
Rs. 50000/- dated
22-1-2015
Single dose vial
Rs.495/-
Immunization
against
salmonella in
infants of age ≥
6 months
children and
adults
Shelf Life
36months
Minutes for 260th Meeting Registration Board
Legalized COPP
NO.
Drug/837/403
valid upto 23-12016 from India
Defered
in
th
258
RB
meeting
for
confirmation
of formulation
in
reference
drug agencies
and
submission of
valid legalized
CoPP.
Deferred
for
submission of valid
legalized
CoPP/
FSC and GMP,
evidence
of
approval of product
in
reference
agencies and WHO
prequalification
status as per import
policy order for
importibilty
from
The firm has India
submitted only
legalized free
sale certificate.
Confirmation
of
fee
is
required
Approval
product
reference
agencies
required.
of
in
is
472
2.
M/s LDS (Pvt)
Ltd
Rawalpindi.
Bio Typh
Form 5-(A)
(Tphoid vaccine) Date of application
M/s BioMed
Pvt Ltd C-96
site No.1
Bulandshar
Road Industrial
Areal
Ghaziabad UP
India.
Single dose vial
, Multi (5) dose
vial
Each dose of
(0.5 ml)
contains: Vi
polysaccharide
of Salmonella
typhi (strain
ty2)-25mcg
Isotonic saline
I.P. q.s.- 0.5ml
Proposed dosage
a. For adults :
0.5 ml
b. Children by
age group : 0.5
ml (after 2 years
of age)
Legalized COPP
No.
Drug/837/403
dated 23-1-2016
from India.
53 DDC (BD) dated
22-1-16
Fee deposited;
Rs.50000/- dated
20-1-2016
Demande price;
single dose vial
Rs.160/- and Multi
dose vial Rs. 525/-
Product License
No. 05/LVP/Sera
& Vaccines/2004
dated 20-5-2004
Free sale
certificate No.
Drug/837/37
dated 16-1-2015
from the country
of origin
The firm has Deferred
for
submitted only submission
of
legalized free following
sale certificate.
a. Valid legalized
CoPP/ FSC and
GMP,
b. WHO
prequalification
status as per
Confirmation
import
policy
of
fee
is
orders
for
required
importibilty from
India.
c. Clarification
from the firm for
MHRA
selection of pack
approved
size.
Pack size:
1. Single dose vial
2. Multi (5) dose
vial
c. Infants &
special groups :
Not
recommended
Letter of
authorization No.
BM/PK/LDS/BT/
071015 dated 0710-2015 from the
country of origin.
Pharmacological
group: Vaccine
Route of
administration :
Intramuscular or
subcutaneous
Clinical use:
Recommended
for prevention of
typhoid fever.
Minutes for 260th Meeting Registration Board
473
Case No.20
Case of M/s. Graton Pharma, Karachi for registration of Interferon Alfa 2B 3000IU
/Vial (Lipheron from Beijing Shanglu, China) along with diluent.
The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration of
Interferon Alfa 2b 300MIU injections 22.6. 2011. The request consider in 256th Registratin Board meeting
and deferred for expert opinion. The product details is as under;
S.No
Company
Name
Name
of Name
Manufacturer
Products
of Date
application
Fee status
1.
M/s
Graton
Pharma office #
102,
First
Floor,
The
Plaza, Block-9
Clifton,
Karachi.
Beijing
SL Recombinant
Pharmaceutical Human
Co., Ltd.
Interferon alfa 2b
for injection
No.9.
Zhongyuan
Strength:
3M
Road, Badachu IU/vial
High
Tech.
Park,
Shijingshan
District,
Beijing,
P.R.China
Date
application
of Documentary
/ Details
of CoPP
No.
20150204 dated
10-2-2015
Fee Deposited
Prod License No.
S20100501 dated
18-9-2010.
Rs.15000/dated 22-6-2011
+ 35000/- dated
09-10-2012+
GMP Certificate
50000/- dated No.
CN
11-6-2015
20130327
DATED 31-102013
Free
Sale
Certificate
No.
2015-14
dated
02-1-2015
validity 02 years.
The firm has now submitted the legalized CoPP No . 20150204 dated 10-2-2015 Prod License No.
H20100501 dated 18-09-2010. Submitted for consideration of Registration Board please.
Decision:
Registration Board considered the case and referred the above application of the firm for
expert opinion by following experts:
a. Brig (R), Muzamil Hussain Najmi, Member Registration Board.
b. Brig. Amir Ikram, AFIP Rawalpindi.
c. Dr. Masud-ur-Rehman, DDG, DRAP, Islamabad.
Inspection of the manufacturer abroad can be conducted after the expert opinion.
Minutes for 260th Meeting Registration Board
474
Expert Opinions are as under:
1.
EXPERT OPINION
RAWALPINDI
OF
BRIG.
AAMER
IKRAM,
AFIP,
Thanks for referring the case; comments are as below:
1. Product Safety:
The Preparation seems to be safe. The original manufactures is following GMPs. Toxicological
reports after testing are also attached and are satisfactory. Post market surveillance is also satisfactory.
2. Efficiency:
The provided literature shows that the preparation is efficacious. The trials have been conducted
in the country of origin. Further trials may be done here if required.
3.
Themolecular descriptin seems satisfactory. The preparation is required; however its
transportation under requisite parameters especially temperature has to be ensured by the company at all
levels.
2.
EXPERT OPINION OF DR. MASUD UR REHMAN, ADDITIONAL DIRECTOR
(BIOLOGICAL DIVISION) DRAP, FOR (LIPHERON) INTERFERON ALPHA
2B 3000 IU OF M/S GRATON PHARMA, KARACHI, IS AS UNDER:
Introduction:
Human interferon-α 2a or 2b are well-known characterized proteins consisting of 165
amino acids. The non-glycosylated protein has a molecular weight of approx. 19,240 KD. It
contains two disulfide bonds, one between the cysteine residues 1 and 98, and the other between
the cysteine residues 29 and 138. The sequence contains potential O-glycosylation sites. Physicochemical and biological methods are available for characterisation of the proteins. Recombinant
IFN-α 2a or 2b is approved in a wide variety of conditions such as viral hepatitis B & C,
leukaemia, lymphoma, renal cell carcinoma and multiple myeloma. It is used alone or in
combination in oncology indications. Interferon-alpha may have several pharmacodynamic
effects. The sub-types Interferons alpha 2a and 2b have different clinical use. In general,
interferon-α 2a or 2b use in oncology indications has reduced considerably had been superseded
by other more effective specific treatments. Treatment with recombinant interferon alpha 2a or
2b is associated with a variety of adverse reactions such as flu-like illness, fatigue, and myalgia.
A variety of immunemediated disorders such as thyroid disease, rheumatoid arthritis, systemic
lupus erythematosus, neuropathies and vasculitis have been observed with r-IFN-α.
Minutes for 260th Meeting Registration Board
475
Pharmacology of Product:
The product Lipheron is produced by Beijing SL Pharmaceutical Company, it has provided general
pharmacological action studies at (P 50) which are line with documented action of product as mentioned
in intrduction. Interferon induce pleiotropic biologic responses which include antiviral, antiproliferative,
and immunomodulatory effects, regulation of cell surface major histocompatibility antigen (HLA class I
and class II) expression and regulation of cytokine expression. Company has provided antiviral activity
studies done in vivo using chi cell model (P 65).
Pharmacokinetics:
The pharmacokinetic properties of Interferons were evaluated in normal, healthy volunteer
subjects after subcutaneous injection of 1 mcg, 3 mcg, or 9 mcg Interferons. Plasma levels of
interferon after subcutaneous injection administration of any dose were too low to be detected by
either enzyme-linked immunosorbent assay (ELISA) and by inhibition of viral cytopathic effect.
Antiviral Activity in Cell Culture:
The antiviral activity of interferon against HCV or HCV-derived replicons in cell culture has
been studied and were upto mark.
In vitro studies:
In order to compare any alterations in reactivity between the similar and the reference
medicinal products, data from a number of comparative bioassays (e.g. receptor-binding studies,
antiviral effects in cell culture, antiproliferative effects on human tumour cell lines), is provided.
Standardised assays are used to measure activity and potency (p 65).
In vivo studies:
To support the comparability exercise for the sought clinical indications, the
pharmacodynamic activity of the similar biological medicinal and the reference medicinal
products quantitatively compared is provided:
An appropriate pharmacodynamic animal model (e.g. evaluating effects on
pharmacodynamic markers of serum 2´,5´-oligoadenylate synthetase activity) are provided.
Pharmacodynamic measurements are performed as part of repeat-dose toxicity studies. &
provided (P 64). Toxicological studies data from toxicity study in a relevant species is provided.
The study is performed in accordance with the requirements of the “Guideline on similar
biological medicinal products containing biotechnology-derived proteins as active substance. A
guidance for assessing systemic exposure in toxicological studies is provided. (P 62- 67)
Minutes for 260th Meeting Registration Board
476
•
•
Data on local tolerance is also provided in accordance with the guidance on non
clinical local tolerance testing of medicinal products.
Safety pharmacology, reproduction toxicology, mutagenicity and carcinogenicity
studies are also provided.
Clinical Studies:
Company provided phase II clinical trial to evaluate safety & tolerability in HCV patients
(page 41) conclusion was that it is well tolerated. Company has provided phase II clinical trial to
determine maximum tolerated dose in renal cell cancer patients (P 23). Company has provided
phase III clinical trial in patients suffering from HBV, results and are in line with innovators (P
1-22). Company provided Phase IV clinical trial in patients suffering from HCV results are in
line with innovators (P 33). Company provided post marketing surveillance data which is in line
with published results of innovator on (P 44).
Pharmacovigilance plan:
Company has provided a risk management programme / pharmacovigilance plan in
accordance with current WHO legislation and pharmacovigilance guidelines. Attention has been
paid to immunogenicity and potentially rare and/or delayed serious adverse events, especially in
patients undergoing chronic administration. Company also provided product recall system 7478).
1) Safety of Lipheron;
Company has provided following studies. Single dose toxicity data on mice. Repeat dose
toxicity data on rats. Repeat dose toxicity data on Dogs. Genotoxicity & mutagenicity
studies. Phase II human studies. Phase II human studies to determine maximum tolerated
dose.
2) Efficacy of Lipheron;
Company has provided following studies. Post marketing surveillance studies. Phase III
trail. Multi-center study to determine efficacy. Phase IV study to demonstrate efficacy &
safety, Phase II human studies. Phase II human studies to determine maximum tolerated
dose
Structural Comparative Studies with Innovator:
The company has done purity studies by Chromatogram of purity by HPLC. UV
Spectrum of Stack Spectra Image report. QC reort showing molecular weight, bands and
standered lines. Isoelectric focusing spectrum, Peptide mapping and host cell DNA test has been
done.
Minutes for 260th Meeting Registration Board
477
Administrative documents’ showing legalized GMP, evidence that manufacturer is
authorized manufacturer in country of origin. The provided credentials show that Graton Pharma
is their authorized agent. Provision of bio-comparability studies including identity testing to
parent molecule, purity testing, in vitro biological activity, clinical studies, stability studies of
product, and certificate of analysis of finished product.
After detailed evaluation it is found that product is safe & have efficacy in different
indications of (Recombinant Human Interferon Alpha 2 b) and shall be cost effective to poor
patients. Moreover result of Structure Comparison Studies is similar with Innovator Intron A.
The authenticity of data / documents / adapted protocols cannot be verified here. At the
time of inspection of the firm, the authenticity of all provided documents, their systems /
protocols of manufacturing / quality control / abnormal toxicity etc need to be evaluated on spot
through vigilant inspection. The CoPP and GMP certificates legalized and notarized however
confirm the availability of product in country of origin. Lipheron (interferon alpha 2 b 3000 IU)
is hereby recommended for consideration of registration based on provided documents.
3.
THIR EXPERT OPINION OF BRIG (R), MUZAMIL HUSSAIN NAJMI,
MEMBER REGISTRATION BOARD, DRAP, IS STILL AWAITED.
Decision:
Registration Board considered the expert opinions. The third expert Brig. Muzamil
Hssain Najmi, whose reply was still awaited, also agreed to recommendations of
other two experts. Based of the recommendations of all three experts, Registration
Board approved the registration of Lipheron Injection (Recombinant Human
Interferon alfa 2b for injection 3M IU vial) manufactured by M/s . Beijing SL
Pharmaceutical Co., Ltd. No.9. Zhongyuan Road, Badachu High Tech. Park,
Shijingshan District, Beijing, P.R.China as per import policy and valid legalized
CoPP. The firm shall also submit separate Form 5A, fee and CoPP for registration
of diluent.
Case No.21
DEFERRED CASE IN 257TH MEETING OF RB (DENGVAXIA, POWDER AND
SOLVENT FOR SUSPENSION FOR INJECTION (DENGUE TETRAVALENT
VACCINE (LIVE, ATTENUATED). M/S SANOFI-AVENTIS PAKISTAN
LIMITED, KARACHI
S.
No
.
Name of
Importer/Manfa
cturer
Brand
Name/Composi
tion
Dateof
application/Fee
status/
Packs/Price
Documentary
details
Decision of 257th
RB Meeting
1.
Sanofi-Aventis
Pakistan Limited,
Karachi
DENGVAXIA,
powder and
solvent for
suspension for
Dy No. 940 (R&I)
dated 16-2-2016
COPP NO.
2016010813450
4 Dated 25-12016 FDA
Republic of
Deferred for
evaluation of
clinical data by
following experts:
Minutes for 260th Meeting Registration Board
478
Injection
Manufacturer
Sanofi Pasteur
Parc Industrial
Incarville, 27100
Val de Reuil
France.
Final release site:
Sanofi Pasteur
NVL 31-33 quai
Armand Barbes
69250 Neuvillesur-Saone
France.
(Dengue
tetravalent
vaccine (live,
attenuated).
MRP 9500/- per
dose
One dose (0.5
ml) contains:
CYD dengue
virus
serotype1,2,3,4
………….each
4.5-6.0 log10
CCID50/dose
Pharmacologica
l group:
ATC code:
J07BX
J
(ANTINEFECT
IVES FOR
SYSTEMIC
USE) 07
(VACCINES) B
(VIRAL
VACCINES) X
(OTHER viral
vaccines)
2.
Sanofi-Aventis
Pakistan Limited,
Karachi
Manufacturer:
Fee Rs. 200000/dated 15-2-2016
for powder and
solvent
DENGVAXIAT
M MD, powder
and solvent for
suspension for
Injection
(Dengue
tetravalent
vaccine (live,
Pack size:
1. Powder (1 dose)
in vial + 0.5 ml of
solvent in prefilled syringe with
2 separate needles
(pack size of 1).
Philippines.
a. Maj. Gen.
Muhammad
Aslam, Member
Registration
Product License
Board.
b. Dr. Huma,
No. BR-1128
PMRC,
Dated 22-12Islamabad.
2015
c. Represenrative
of malaria
control, WHO
Pakistan,
GMP Certificate
Islamabad.
No.
HPF/FR/222/20
15 Dated 05-102015
France
2. Powder (1 dose)
in vial + 0.5 ml of
solvent in prefilled syringe with
2 separate needles
(pack size of 10).
Dy No. 941 (R&I)
dated 16-2-2016
Fee Rs. 200000/dated 15-2-2016
for powder and
solvent
Minutes for 260th Meeting Registration Board
COPP NO.
Deferred for
2016010813450 evaluation of
1 Dated 25-1clinical data by
2016 FDA
following experts:
Republic of
a. Maj. Gen.
Philippines.
Muhammad
Aslam, Member
Registration
Board.
479
Sanofi Pasteur
NVL 31-33 quai
Armand Barbes
69250 Neuvillesur-Saone
France.
attenuated).
MRP 9500/- per
dose Pack size:
One dose (0.5
ml) contains:
CYD dengue
virus
serotype1,2,3,4
………….each
4.5-6.0 log10
CCID50/dose
1. Powder (5
doses) in vial +
2.5 ml of solvent
in vial (pack size
of 5).
Product License b. Dr. Huma,
PMRC,
No. BR-1129
Islamabad.
Dated 22-12c. Represenrative
2015
of malaria
control, WHO
Pakistan,
Islamabad.
GMP Certificate
No.
HPF/FR/222/20
15 Dated 05-102015
NVL SITE,
France.
Pharmacologica
l group:
ATC code:
J07BX
J
(ANTINEFECT
IVES FOR
SYSTEMIC
USE) 07
(VACCINES) B
(VIRAL
VACCINES) X
(OTHER viral
vaccines)
1.
EXPERT OPINION OF DR. HUMA QURESHI, EXECUTIVE DIRECTOR,
PMRC, ISLAMABAD IS AS UNDER:
The 1st dengue vaccine is produced by Sanofi and is licensed and being used in Mexico. It is also
available on WHO website. Its phase 3 tgrials have been published in New England Journal of Medicine.
The vaccine is given in 3 doses at 0,6,12 month’s interval and has shown excellent protection in
various dengue serotypes. For serotype 4, protection was seen in 77% for serotype 3 it was 71%, for type
2 it was 43% and for type 1 it was 54%.
Pakistan has been facing outbreaks of dengue infection since many years and each outbreak
causes large morbidity, additional hospitalization cost and some ortality. Panic during outbreak causes
huge out of pocket spending for undergoing various tests and treatments.
Minutes for 260th Meeting Registration Board
480
Evidence shows tht exposure to dengue and its recovery does not protect the individual from
second exposure, in fact 2nd exposure makes the patient more vulnerable to complications like bleeding,
shock and death.
A national study done all over Pakistan by Pakistan Medical Research Council in 2013, showed
that 32% population who had no history of suffering from dengue fever had actually suffered from
dengue fever, as seen by the presence of IgG antibodies in their blood. It can be stipulated from this study
that a large population of Pakistan is vulnerable to dengue complications in every new outbreak.
It is therefore strongly recommended that dengue vaccine may be registered in Pakistanfor
future ude and protection of the population.
2.
EXPERT OPINION OF SYED KHALID SAEED BUKHARI, COUNTRY
ADVISOR MEDICINE & HEALTH PRODUCTS, REPRESENTATIVE OF WHO
PAKISTAN IS AS UNDER:
As you are aware that Dengue is a major health burden all across the world, which can
affect anyone regardless of age, sex, underlying health, or socioeconomic status.
Pakistan is now considered Endemic for Dengue, and in order to limit Dengue, and
integrated approach is optimal for prevention and contro of Dengue. Vector-control efforts prove
to be unsustainable in preventing dengue disease; this gives rise to a need for the inclusion of a
safe and effective dengue vaccine in Countries endemic with Dengue disease.
During the Q & A session with WHO in 2014, WHO commente4d that a safe, effective
and affordable dengue vaccine would repreent amajor advance for the control of the disease and
could be an important tool for reaching the WHO goal of reducing Dengue morbidity by at least
25% and mortality by at least 50% by 2020.
In March 2016, WHO Strategic Advisory Group of Experts on Immunization (SAGE)
issued recommendations on Dengue vaccine that supports the use of the vaccine in endemic
countries. The SAGE recommendations provide important validation of the efficacy, sfety,
quality and potential public health value of the existing Dengue vaccine.
Based on the SAGE recommendations and the WHO initiative to control Dengue, it is
theefore essential that Dengue vaccine is introduced in Pakista in ordr tolimit the burden of
Dengue outbrteaks in the country.
The pricing of the Dengue vaccine should be as per the DRAP regulatory rules.
Minutes for 260th Meeting Registration Board
481
3.
THIRD EXPERT OPINION OF MAJ. GEN. MUHAMMAD ASLAM, MEMBER
REGISTRATION BOARD, DRAP, IS STILL AWAITED.
Recommendations of WHO Strategic Advisory Group of experts (SAGE):
The World Health Organization (WHO) Strategic Advisory Group of Experts
(SAGE) on Immunization today issued recommendations on the use of the first licensed
dengue vaccine. SAGE recommends countries consider introduction of CYDTDV, also
known as Dengvaxia®, only in geographic settings (national or subnational) where
dengue is highly prevalent. SAGE recommends that vaccination should be considered as
an integrated strategy together with a communication strategy, well-executed and
sustained vector control, the best evidence-based clinical care for all patients with
dengue, and robust dengue surveillance.
Dengue, also known as “breakbone fever,” is the most common mosquito-borne
viral disease. Dengue causes about 390 million infections each year, putting at risk nearly
half of the world’s population. To date, no specific treatment for dengue exists.
Dengue vaccines have been under development since the 1940s. In late 2015 and
early 2016, the first dengue vaccine—Dengvaxia®, developed by Sanofi Pasteur—was
approved by Mexico, the Philippines, Brazil, El Salvador and Paraguay for use in
individuals 9-45 years old (9-60 years old in Paraguay) living in dengue-endemic areas.
The world’s first public dengue immunization program started this month in the
Philippines. Several other vaccine candidates are currently in clinical development, two
of which are in advanced stages.
The new recommendations resulted from the SAGE meeting held this week in
Geneva. SAGE consists of independent experts who advise the WHO on optimal use of
vaccines through an evidence-based review process. The age to target for vaccination to
maximize the reduction of dengue cases is projected to vary by transmission setting, but
it will likely fall between 9 and 14 years of age. Dengvaxia® is not recommended for use
in children under 9 years of age, consistent with the vaccine’s current labelling. These
and other SAGE recommendations can be found here.
As SAGE emphasized, introduction requires careful assessment by each country.
Such assessments should consider local priorities; national and subnational dengue
epidemiology; predicted impact and cost-effectiveness with country-specific
hospitalizations rates and costs; and affordability and budget impact.
If dengue vaccines are introduced, support for pharmacoviligance and postintroduction studies will be essential to monitor and evaluate countries’ experiences.
Strategic communication will be critical for effective introduction and to inform partners
and stakeholders about lessons learned on the use of Dengvaxia®. DVI will continue
working to generate and disseminate evidence-based information that supports countries’
decisions on dengue vaccine introduction, as well as to raise the visibility of the
challenges and opportunities ahead in dengue prevention and control.
Decision:
Registration Board considerd the expert opinions and basesd on their
recommendations and recommendations of WHO Strategic Advisory Group
of experts (SAGE) on 15th April 2016 approved the grant of registration of
Minutes for 260th Meeting Registration Board
482
DENGVAXIA, powder and solvent for suspension for Injection (Dengue
tetravalent vaccine (live, attenuated) manufactured by Sanofi Pasteur Parc
Industrial Incarville, 27100 Val de Reuil France and final release by M/s
Sanofi Pasteur NVL 31-33 quai Armand Barbes 69250 Neuville-sur-Saone
France, as per import policy. The firm shall provide the valid legalized CoPP
issued by the regulatory body of France. The Chairman Registration Board
shll allow the issuance of registration letter, if CoPP provided earlier than
the next meeting of Regiration Board.
Case No.22:
MEASLES VACCINE BY NIH, ISLAMABAD
It is submitted that NIH, Islamabad has applied for registration of Measles Virus Vaccine live
attenuated (dried Injectable (Measles virus)
The Registratin Board Approved the request of Measles Virus Vaccine Live attenuated (dried
Injectable (Measles virus) in 256th Meeting of Registration Board. The Registration Board decided as
follows:
Decision of 256th RB:
“Keeping in view the above mentioned discussion, Registratin board
approved the request of NIH, Islamabad for bulk import of measles vaccine concentrate from M/s Beijing
Minhai biotechnology co-operative Ltd, No.1, S1 Miao road, bio-engineering & Pharmacetical Industrial
park, Daxing district, Beijing, China and its local packing and labeling at NIH licensed facility for
manufacturing of measle vaccine for supply to EPI. The NIH shall arranghe the test/ analysis of first
batch from manufacturer at China and submit the reports to DRAP.”
Registratin Board also deliberated about the capacity of NIH for its installed facility where the
NIH was once manufacturingits own vaccine from the measles virus seed. NIH representatives were also
called to explain to the Registratin Board the circumstances under which the previous manufacturing
could not be carried out. The NIH is of view that the seed culture is got out of stock and no one has
showed its interest to supply the seed culture to NIH. The only way is import the bulkconcentrate from
china its local repacking at NIH facility. NIH claimed that all the manufacturing of measles vaccine shall
be for supply to EPI and its lot relaease will be through NCLB. The responsibility of quality, efficacy, and
safety shall be of NIH. EPI shall report AEFI of the said vaccine.
It is to mention that FSC & GMP provided by the NIH of aforementioned manufacturer
fromwhere they import bulk concentrate of measles vaccine, is of Combined Measles and Rubella
Vaccine, Live Injection, However, the product applied for registration is Measles Virus Vaccine live
attenuated (dried) Injectable. Since the submitted legalized documents are not align with information
contained on Form-5 for issuance of market authjorization (Registration Certificate) as approved by the
Registration board., Therefore the NIH was advised to submit clarification for measles bulk concentrate
manufacturing authorization of the manufacturer abroad approved by SFDA.
In reply the NIH has submitted statement leter issued by M/s Minhai biotechnology co. Ltd China:-
Minutes for 260th Meeting Registration Board
483
“ we hereby certify that we are allowed to produce andexport vaccines mentined in the drug
Manufacturing License, containing DTap-Hib vaccine, Live Attenuated combined vaccine of Measles and
rubella,dtap vaccine, Hib conjugate vaccine,freeze-dried conjugate vaccine, 23-valent Pneumococcal
Polysaccharide Vaccine, freeze-dried rabies vaccine for human use, small volume injectin and freezedried powder.
According to Chinese GMP regulation, there is no speprate license for the production of
concentrate and bulk of vaccine, only the drug Manufactguring License of finsished product is available,
which is also the license for all intermediate products.”
Decision: Registration Board deliberated on all the aspects of contentiotion of the Biological
Division in lieu of previous decision of Registration Board. Technical Personels of NIH
also assued that also neccessay precautions shall be adopted to import only measle
vaccine concentrate, as SFDA has granted approval to M/s Beijing Minhai biotechnology
co-operative Ltd, No.1, S1 Miao road, bio-engineering & Pharmacetical Industrial park,
Daxing district, Beijing, China for manufacturing of Rubella and measle vaccine. The
Board finally reconfirmed its previous decision taken in 256th meeting and further
advised to take extra caution by NIH to confirm the import of only measles virus
concentrate and to avoid its mixing of rubella concentrate. The NIH shall also give
undertaking in this regard.
Minutes for 260th Meeting Registration Board
484
Item No.IV: Quality Assurance & Lab Testing Division.
Case No.01: Manufacture & Sale of Sub-Standard Drug-Metrozole Suspension Batch No.
09121508 By M/S Marvi Pharmaceuticals, Karachi. F. No. 3-01/2016-QC
The sample of Metrozole Suspension Batch No. 09121508 manufactured by
M/S Marvi Pharmaceuticals, Karachi drawn by FID Karachi from manufacturing premises on
21st December 2015 for test analysis. The sample was sent to the CDL Karachi, however the
sample was declared Substandard vide test report No.R.KQ.415/2015 dated 13th January 2016.
The result of CDL on the basis of which sample under reference has been declared sub-standard
is under:pH. Determined:- 4.0
Limits:-
5.6 to 6.5 Does not comply BP 2014
The sample is of “Sub-Standard” quality under the Drug Act 1976.
On the explanation letter to the firm by the FID Karachi the firm challenged the CDL
Test report in Appellate Laboratory NIH Islamabad under Section 22(5) of the Drugs Act 1976.
Result of Appellate Laboratory
pH:-
Determined: 4.2
Limit:-5.0-6.5 Does not comply
Assay:
Stated
Found
Metronidazole as
Metronidazole benzoate
200mg/5ml
170.92mg/5ml
Does not comply with BP-2013
Limit
95.105%
Percentage
85.46%
U/s 42 of the Drugs Act 1976, rules framed there under and The DRAP Act 2012 show
cause notices was issued to the firm and accused persons, offering opportunity of personal
hearing before the Drug Registration Board.
They have been called for personal hearing.
Decision:
Mr. Pahlwan Tanvir, Plant Manager of the firm was appeared before the
Registration Board on29-06-2016 and pleaded their case. He stated before
the Board that there is some mistake in calculation in the report of Appellate
Laboratory, which if corrected their sample would be passed in assay. The
Honorable members of the Board after going through the said report found
that there seems some mistake which may be typographical but needs to be
clarified from the Appellate Laboratory (NIH ,Islamabad). The Board after
Minutes for 260th Meeting Registration Board
485
detailed discussion, deliberation, considering the facts and legal provision
decided to defer the case to get the clarification from the Appellate
Laboratory NIH Islamabad regarding the result of assay as percentage of
contents was written as 190.31 while found 170.92 in 5ml.
Case No.02: Manufacture and Sale of Substandard “Regnum Syrup” Batch No. 7297 By
M/s Novamed (Pvt) Ltd Lahore for M/s ICI Pakistan Limited , Karachi
The FID Karachi visited at the premises of M/s ICI Pakistan Limited 5-West Wharf Road,
Karachi on 19-03-2015. The FID took the sample of Regnum Syrup Batch No. 7297
Manufactured by M/s Novamed pharmaceuticals (Pvt) Ltd 28-Km Ferozpur Road Lahore, for the
test analysis and sent the above said sample to, CDL’s Karachi. However the FGA, declared the
sample as substandard quality vide its test report No.KQ.107/2015 dated 11th June 2015
Assay for
Vitamin B2
Limits
Nicotinamide
Limits
Vitamin C
Limits
Determined
stated
amount/10ml:
amount/10ml:
Percentage:
1.482mg
1.2mg
90.0% to 150.0% complies
11.721 mg
10.0mg
90.0% to 150.0% complies
17.61mg
50.0mg
90.0% to 200.0% Does not comply
123.5%
117.21%
35.22%
On explanation letter issued by the FID, the firm challenged the CDL report and requested for
Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also
declared the sample as Substandard vide their test report 025-MNHRS/2015 dated 22nd October
2015.
Assay:Percentage
Vitamin B1
Vitamin A
Vitamin C
Nicotinamide
Stated
Found
Limit
1.5mg/10ml
1.80mg/10ml
90-200%
0.90mg/10ml
1.34mg/10ml
90-200%
50mg/10ml
26.317mg/10ml 90-200%
10mg/10ml
13.123mg/10ml 90-150%
Does not comply with manufacturers specification.
Minutes for 260th Meeting Registration Board
120.04%
148.94%
52.635%
131.23%
486
U/s 42 of the Drugs Act 1976, rules framed there under and The DRAP Act 2012 show cause
notices was issued to the firm and accused persons, offering opportunity of personal hearing
before the Drug Registration Board.
They have been called for personal hearing.
Decision:
Mr. Muhammad Shahid Khan, Production Manager of the firm and Mr.
Muhammad Jhangir, Quality Control Manger of the firm was appeared
before the Registration Board on 29-06-2016 and pleaded their case. The
representative of the firm stated that Regnum Syrup contains multiple
ingredients in the formulation. As the product is in-house the testing method
is also in –house. For the analysis of vitamin “C” they use iodometry titration
and use of startch indicator by using preservative which is very critical to
visualize the end point of the result. The firm representatives stated that as
the formulation is liquid Glucose base which is very thick containing caramel
colour, so it is very hard to watch the end point. So they developed and
validated in- house method for the estimation of vitamin C. They stated that
the Government Lab may have used the Redox titration for the analysis of
vitamin C. The Board after detailed discussion, deliberation, considering the
facts and legal provision decided to conduct the Product specific inspection of
firm for complete investigation of case and confirming aforementioned
statement of firm by performing complete analysis of Regnum Syrup before
them.
i. Chairman Quality Control DRAP, Islamabad,
ii. DTL Lahore.
iii. Area FID
Panel will submit its report in 30 days time for consideration by Registration Board.
Case No.03:
Test Reports declared by Federal Government Analyst that the fate of sample may kindly be
decided under the guidance of Division of PE&R.
The Division of Quality Assurance DRAP Islamabad is receiving many reports from FGA, CDL
Karachi like some of the following cases
Federal Government Analyst does not declare the sample of such ingredients which are used in
both allopathic or non allopathic (or food supplement) allopathic drugs.
S.No.
1.
Name of Product
and manufacturer
Osteo Calcium +
Calcium
Plus
Tablets
manufactured by
Zonex
Pharma
Test Report and
dated
R. LHR.222/2016
dated 12th May
2016
Minutes for 260th Meeting Registration Board
Identification
1)
Calcium
identified
2.)
Vitamin D
not identified
Remarks of the
CDL
1)
The label
claims Nutritional
Supplement
2) Vitamin D was
487
(Pvt) Ltd Lahore
not identified as
suspected by the
Federal Inspector
of
Drugs
concerned.
However Calcium
was
found
340.68mg/tab
3.)
The RDA
(adults)
for
Calcium range is
1000-1200mg/day
hence the assay
result of Calcium
is below the limits
of the respective
RDA
4.) Since Calcium
is used in food
supplements as per
Pharmacopoeia
and also by the
allopathic
manufacturers as a
registered product
therefore the fate
of sample may
kindly be decided
under the guidance
of Directorate of
Registration
DRAP Islamabad
2.
Nucal
600mg
Tablets
manufactured by
M/s
Pak
Nutraceuticals
Karachi
R.KQ.61/2016
dated 27th April
2016
1)
Calcium
identified
The label claims
Natural Product
2.)
Vitamin D
not identified
2)
Assay result
reveals that the
sample
contains
calcium
400mg/tablet
3) Since Calcium
is used in food
supplements as per
pharmacopoeia
and also by the
allopathic
manufacturers as a
registered product
therefore the fate
of sample may
Minutes for 260th Meeting Registration Board
488
3.
Juvederm Tablet
manufactured by
R.IP.86/2015
Alphatacopheral
Vitamin
E
identified
Ascorbic Acid not
identified
kindly be decided
under the guidance
of Directorate of
Registration
DRAP
The label claims
Natural product
2.)
Since
Alphatocopheral
Vitamin E is used
in
food
supplements as per
Pharmacopoeia
and also by the
allopathic
manufacturer as a
registered product
therefore the fate
of sample may be
decided under the
guidance
of
Directorate
of
Registration
DRAP Islamabad
Decision: Registration Board deliberated that Division of Health & OTC, DRAP is functional
and after the promulgation of DRAP Act 2012 Natural, Nutritional, Herbal and Homeo products
etc come in the domain of aforementioned Division. Products referred by Government Analyst
are not registered by Registration Board, hence such references will be sent to Health and OTC
Division for deciding the matter
Case No.04: Manufacture & Sale of Sub-Standard Drug- Regogent Eye/Ear Drops Batch
.No. E-058 Mfd. by M/s Amros Pharmaceutical Karachi. (F. No. 03-39/2014QC)
Background of the case
The Assistant Drugs Controller (ADC), Karachi, Ms Ume Laila vide her letter date 1507-2014 intimated that she took the sample of the drug under reference from the export
consignment for Nigeria on 20-01-2014. It was further submitted that the drug sample has been
declared as of substandard quality by FGA, Central Drug Laboratory (CDL), Karachi vide its test
report No.EXP.19/2014, dated 14th July 2014. Salient features of the CDL test report are
reproduced as under
Assay for Gentamycin:
Determined amount %w/v:
0.2535%
Calculated amount %w/v:
0.3%
Minutes for 260th Meeting Registration Board
489
Percentage:
84.5%
Limits:
90.0% to 135.0% Does not comply.
Remarks:-
The sample is of “Substandard” quality under the Drugs Act, 1976.
As per examination of documents submitted, it was evident that the drug sample under
reference was drawn by the ADC on 20-01-2014. However the CDL test report reflected that the
sample was received in the Lab on 12-06-2014 meaning thereby the sample was sent to the Lab
almost after four months and 21 days after its seizure for test/analysis. As per record of this
office, it was also apprised that Board Portion of sample has not been received in the QC
Section.
The ADC concerned was asked for explaining the reasons for not sending the sample to
the CDL Karachi and disposing off the Board’s portion with in 07 days vide letter dated 16-092014.
In response, the ADC informed that the sample was delivered to the CDL on 20-01-2014
and acknowledgment receipt of CDL was furnished in this regard. The Director CDL also
confirmed vide reply dated 23-10-2014 that the sample was sent to the Lab by ADC Karachi
with Form-4 on 20-01-2014. However the stance of ADC regarding sending Board’s portion was
not correct as neither the Board’s portions of the samples nor Memorandum bearing No.UL-0103/2014-ADC(K) Export dated 20-01-2014 was not received in the Directorate of QA since
January 2014 to 31-10-2014. As per communication made by the ADC, it is very clear that the
mandatory provision of Section 19(3) of the Drugs Act 1976, and rules framed there under was
not followed. So the ADC was asked again as why the Board’s portion was not forwarded as per
above stated mandatory provision of the law
The ADC in response to this office letter dated 17-10-2014 sent retaining sample of the
drug under reference and stated that beside all misunderstanding and minor error of lower staff, I
am again sending the retaining sample of aforesaid batch which was available in her custody.
The view point of the ADC Karachi regarding sending Boards portion is not correct as no sample
as per memorandum bearing No. UL 01-03/2014-ADC (K)-Export date 20-01-2014 has been
received in Directorate of QA/LT Islamabad. The retaining sample sent by the ADC afterwards
and received by QC Section on 31-10-2014 is without memorandum and can not be entertained
as the same has not been forwarded with in mandatory 07 days time period as prescribed under
Section 19(3)(ii) of Drugs Act 1976.
The Director CDL was asked to comment on the delayed analysis of the sample of the
drug under reference sent/delivered to the Lab on 20-01-2014 as same should have been
analysed/reported within 60 days of the receipt of sample as required under Section 22(2) of
Drugs Act 1976. No extension in the testing period was sought from the competent authority as
per record of Directorate of QA/LT. The test report of the samples was issued on 14-07-2014 i.e.
Minutes for 260th Meeting Registration Board
490
05 months and 25 days after the receipt of sample by the Lab. It has also been stated that samples
from export consignment are liable to be charged for testing fee by CDL for test analysis. It was
also submitted that the date of receipt of testing fee is considered as the date of receipt of sample
as per policy framed after repeated observations by audit and public accounts committee of
National Assembly on outstanding testing fee. In the instant case the relevant voucher of testing
fee for the sample was submitted to CDL on 12-06-2014 therefore the same was mentioned as
the date of receipt of sample. It has been further stated that CDL tested and reported the drugs
sample under reference with in only one weak after receiving the sample with complete legal
formalities.
The Director CDL Karachi has not adhered to the above stated mandatory provision of Section
22(2) of Drugs Act 1976.
In the instant case the Board portion has not been received as required under Section
19(3) (ii) of the Drugs Act 1976 and the CDL test report has been issued after the laps of
mandatory time period. In view of above, it was therefore, proposed to place the case before the
Registration Board for consideration, direction and decision as the firm has challenged the CDL
test report under Section 22(4) of the Drugs Act 1976. The Board may also inquire further from
Director CDL Karachi and ADC Karachi on the issue.
The worthy Chairman Registration Board directed to bring the case before the Board for
discussion.
The case was placed before Drug Registration Board in its 248th meeting held on 19th
March 2015 but due to paucity of time the Board deferred the case till next meeting of the
Registration Board. The case was again submitted to the Board in its 249th meeting held on 1905-2015 for consideration and further directions in the matter.
Decision of 249th meeting:
Due to paucity of time the Board deferred the case till next meeting of the Registration Board
Decision:
Registration Board deliberated the matter and advised QA&LT Division to
investigate the case and take appropriate action and inform Registration
Board
accordingly.
Minutes for 260th Meeting Registration Board
491
Item no.V:
Additional cases.
Case No.01: Writ Petition No.758/2015 and 4174/2015, Islamabad High Court.
Registration Board in 259th meeting deliberated decision of Islamabad High Court,
Islamabad in Writ Petition No.758/2015 and 4174/2015. Members were of the view that matter is
required to be discussed in detail with representative of M/o Law and Justice (Member
Registration Board) for opinion regarding registration of drug. Accordingly, decision in subject
petitions was deliberated in presence of representative of M/o Law and Justice. Registration
Board) was of the view that both petitions No. 758/2015 and 4174/2015 filed by the petitioner
M/s Everest Pharmaceuticals, Islamabad were disposed of by Islamabad High Court, Islamabad
vide a single order. The petitioner sought relief on the following five points: i.
ii.
iii.
iv.
v.
Declare that the drug Everlong is validly registered.
The withdrawal of the registration of tablet Everlong may be declared as illegal and
without lawful authority.
That the inspection of the premises, sealing of the tablet section of the premises/factory
be declared as without lawful authority and of no legal effect.
That registration of FIR No. 12/2015 be declared as without lawful authority and of no
legal effect.
The Federal Investigation Agency be directed not to harass the petitioner or its staff.
Vide para 10 of the order, the Islamabad High Court has quashed the F.I.R’s, whereas
regards the withdrawal of registration, the Islamabad High Court has declared this writ petition
as infructuous on the ground that the matter of illegal withdrawal of registration is pending
before Lahore High Court vide writ petition No. 3200/2015.
In other words, the Islamabad High Court has granted relief to the petitioner on clauses
(iv) & (v) of the prayer and has left the decision on clauses (i), (ii) & (iii) upon Lahore High
Court.
The Registration Board in 260th meeting has decided to convey the relevant
quarters of DRAP to vigorously persue the case in Lahore High Court.
Minutes for 260th Meeting Registration Board
492
Case No.02: Deferred Case in 258th RB Meeting ZINNIA F (Levonorgestrel and Ethinylestradiol
Tables with Ferrous Fumarate Tablets) of M/s Hakimsons (Impex) Private Limited, Karachi
Sr.
No
Name of
Importer &
Manufacturer
Brand Name &
Composition
Type of Form
Dy No & Date
of application
Fee submitted
1.
M/s
Hakimsons ZINNIA F
(Impex)
Private (Levonorgestrel
Limited, Karachi
and
Ethinylestradiol
Tables
with
M/s Famy Care Ferrous
Limited Plot No. Fumarate
1606-1609,
Tablets)
G.I.D.C
SARIGAM
Strength
of
396155,
Dist. active
VALSAD,
ingredient:
GUJRAT, INDIA. Label Claim:
Each
Sugar
coated
white
tablet contains:
Levonorgestrel
Ph.
Eur……..150m
cg
Ethinylestradiol
Ph. Eur……..30
mcg
Ferrous
Fumarate
Tablets
Each
Sugar
coated Brown
tablet contains:
Ferrous
fumarate
Minutes for 260th Meeting Registration Board
Pack size/
Demanded
Price
Dy No. 1114
(R&I)
DRAP
(TF) dated 29-92014
Document
details (CoPP)
Me too
status/New
molecule
Legalized
CoPP dated 2305-2014
Legalized GMP
Certificate No.
Fee deposited: 1403070 dated
Rs.
100000/- 05-3-2014
dated 04-9-2014
vide challan no. Free
Sale
0017217.
Certificate No.
ACV/Certi/
For
UNFPA/ Famy
Care/
USAID
2592/14 dated
not for market. 21-4-2014
Combi pack of
21 tablets of
Levonorgestrel
&
ethinylestradiol
& 7 tablets of
ferrous fumarate
Decision in 258th
meeting
Deferred for expert
opinion
by
following
experts
and valid legalized
CoPP:
a. Brig ® Muzamil
Hussain
Najmi
Member
Registration Board
b. Brig.Amir Ikram,
AFIP, Rawalpindi.
c. Dr, Masud-urRehman,
DDG,
DRAP
493
BP………75
mcg
(Equivalent to
Ferrous
iron…24.375m
g)
Pharmacologica
l group:
Hormonal
Contraceptives.
ATC
Classification:
G03AA07.
It is submitted that in the 258th meeting of Registration Board following of the experts of the decided by
the Board.
1. Prof Dr. Sayeda Batool, MCH, PIMS Islamabad.
2. Col.Dr. Abeera Ch. MH, Rawalpindi.
3. Prof Dr. Nasira , PIMS, Islamabad
The above experts were also mentioned in the final draft minutes of 258th RB communicated to Secretary,
Registration Board. However they were in advertently replaced by the experts as mentioned in the last
column of the agenda item and also in the decision of the Board.
Decision:
Registration Board approved following relevant experts :
a. Prof Dr. Sayeda Batool, MCH, PIMS Islamabad.
b. Col.Dr. Abeera Ch. MH, Rawalpindi.
c. Prof Dr. Nasira , PIMS, Islamabad
Registration Board deferred rest of agenda due to paucity of time.
Meeting ended with a vote of thanks to and from the chair.
End of Document
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Minutes for 260th Meeting Registration Board
494