Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Company Profile Vifor Pharma The most effective partner for contract development and manufacturing. Contract development and contract manufacturing offer a challenging environment for Vifor’s talented pharmaceutical technologists, and enables the company to use its diversified equipment for the production of medium-sized order volumes. ●● To ensure speedy delivery times and the development of innovative products, Vifor Pharma can rely on the following expertise: A Customised Contract Development Approach ●● ●● ●● Fulfilment of high GMPquality standards (EU and FDA requirement) certification through a corporate quality management system ; QA interaction based on quality agreement A development team, centrally managed from Switzerland, taking advantage of a multicultural background and experience Three manufacturing facilities based in Switzerland and Portugal for oral and topical product ranges Skilled employees, Swiss precision, strong technical capabilities and a high level through commitment of relatively small, yet efficient teams at each individual site, for a great flexibility and a strong, customer service orientated The formulation team ensures the product development at laboratory and pilot scale, based on a DoE approach. They perform industrial scale-up and process validation, including manufacture of clinical material. Efficient containment solutions are proposed, such as preservative-free sprays, biphasic system, blisters with inert gas and aluminium-/aluminium blisters. The analytical team develops, validates and transfers analytical methods and manages ICH stability studies. The development team offers a large spectrum of customised services from preliminary formulation to regulatory submission. The scope of activities is essentially pharmaceutical oral and topical formulations with key strengths in the following areas: ●● ●● Solid dosage forms with sustained release, enhanced control by use of micro-tabs, oneday delivery and gastro-resistance Liquid formulations with attractive flavours, enhanced stability and paediatric formulation Micro-Tablet Regulatory support is offered for the preparation and submission of product registration files. Specific expertise includes development of a complete CTD technical documentation (modules 2.3 and 3). The company shows a large knowledge in regulatory requirements for: drug and product (EU), medical devices, nutraceuticals, cosmetics, and can also provide support for submission and notification to the relevant authorities. Key Niche Applications Images: Vifor Pharma Micro-Tablet 34 This modern technology presents many technical advantages (high flexibility of drug load, immediate or modified release, functional coating) and clinical advantages (gastro-intestinal tolerance) with a comparable level of manufacturing productivity equal to regular tablets. This multi-particulate form also enables a comfortable intake for the patient. Innovations in Pharmaceutical Technology Issue 42 Biphasic System Biphasic System Specific filling equipment fills powder or granulate into cap of bottle containing liquid formulation as a single dose container approach. Consumer friendly designed, this device brings the formulation some of the essential benefits of enhanced stability profile of API and can prevent incompatibility issues between two APIs or components that are physically segregated until the reconstitution of the solution for intake. Dropper Tube This innovative packaging for liquid formulation is designed for precise dose of intake or a replacement for traditional packaging for drops. The solution is filled into tubes equipped with a dropper assembled on a speciallydesigned tube filling equipment, enabling a switch from semisolid to liquid filling. Dropper Tubes ●● ●● ●● ●● Well-Established Liquid and Semi-Solid Forms ●● Solid Dosage Form: a Wide Range of Capabilities ●● Wet and dry granulation is available to prepare final blends from pilot scale to industrial batch size Tablets, micro-tablets are produced on automated presses for regular and matrix tablets. Sustained release profile are obtained by film-coating on various coating pans Last generation fillers enable the filling of capsules with powder or two different components (volumetric dosage, 100 per cent weightcheck). A unique equipment fills caps with a solid component (powder or granulate, pellets, microtablets) before closing the bottles filled with liquid Blistering operations are done on lines equipped with the most recent technologies and enable individual cell identification Pot filling is done for capsules, tablets and soft gel capsules into plastic pots ●● Innovations in Pharmaceutical Technology Issue 42 Solution and suspension having high sugar alcohol content are manufactured in different equipment size and under controlled conditions Filling of solutions, suspensions and emulsions is carried out on flexible lines ●● with full control of the packaging operations (barcode scanners, on-line weighing and optical control) Semi-solid: a wide range of equipment enables the manufacture and package of gel, ointment cream, suppositories, paste and enema with the highest level of control Company History Vifor Pharma is a Switzerland-based pharmaceutical company belonging to the Galenica Group since 1977. Mainly active in formulation development, the production and commercialization of Rx and OTC pharmaceutical products, Vifor Pharma covers the Swiss and a part of the European market. Focused on expanding internationally by establishing new relationships with selected partners, Vifor Pharma accentuates the customized development of new products of the highest pharmaceutical standard. To find out more, please visit the company’s stand at CPhI/ICSE, in Madrid from the 9th to 11th October, Hall 10, Stand 10A02 Or contact: Vifor Ltd Route de Moncor 10, PO Box CH-1752 Villar-sur-Glâne, Switzerland Phone: +41 (0)58 851 6111 Fax: +41 (0)58 851 6050 Web: www.viforpharma.ch Email: [email protected] 35