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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< 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 do do do do do do do do do do do 12 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 do 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 Do do Do do Do do Do do Do 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 do Do do Do do Do do Do do Do do Do do Do do Do do Do do Do do Do do Do 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 Do 22 009044 do Do 23 010525 do Do 24 004601 do Do 25 007032 do Do 26 006918 do Do 27 010524 do Do 28 007033 do Do 29 009353 Kotria tablet Each tablet contains Trimethoprim………. 80 mg Sulphamethoxazole……. 400 mg do Do 30 004328 Paracambind tablet Each tablet contains Paracetmol ………..300 mg Aspirin……….. 200 mg do Do 31 010577 Clean Skin Solution Contains Calamine………..15% do Do 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 Do do Do do Do do do 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….inducing5 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….Inducing5 log2 HI units/dose Inactivated Avian Influenza type H7….inducing5 log2 HI units/dose Inactivated Avian Influenza virus H9….inducing5 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…Inducing4.5 log2 HI units Inactivated Avian Inafluenza virus H9…Inducing4.5 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< 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 ************************************************************************* Minutes for 260th Meeting Registration Board 494