Generics Development
The Generics Development sector, as part of the Quality Control Department, is a very important sector of “Profarma”. The scope of work for this sector is the development of innovative generic medications and the assessment of their importance based on pharmaceutical market demand.
The Generics Development team is composed of specialists with different profiles who work on:
- study and development of formulations and production processes for different dosage forms in pilot batches and production scale batches;
- selection of the immediate packaging in contact with the product;
- development and validation of analysis methods;
- establishment of specifications and tests of analysis methods for all ingredients used for the production of finished products;
- In-vitro studies of bioequivalence for different preparations;
- stability planning and periodical testing of generic drugs under normal and accelerated conditions.
The period from 2000 to 2015 is characterized by a great work of this sector in the development and registration of new generic products in all pharmaceutical market in which "Profarma" is present: in Albania and Kosovo. More than 220 new generic products have been registered during this period.
Since 2008, in cooperation with DERMAPHARM Group, "Profarma" as part of the German group, has developed and registered a large number of different dosage form in two Balkan markets, Albania and Kosovo.
