The Quality Unit is also responsible of the issuing and updating of Drug Master Files (DMF) and Certificates of Suitability (CoS) of our different APIs as well as management with the relevant Health Authorities.
More than 38 different DMF have been registered in more than 20 countries around the world.
14 US DMF presented and reviewed by the FDA for the US market.
The European Directorate for the Quality on Medicines (EDQM) has granted CoS for 11 of our products and 4 additional dossiers are under assessment.
