The Moehs’ Quality Unit is responsible for updating the Drug Master Files (DMF) and Certificates of Suitability (CoS) of our different APIs as well as management with the relevant Health Authorities.
More than 70 DMF/CTD with different APIs have been registered in more than 30 countries around the world.
17 US DMF have been presented and reviewed by the FDA for the US market.
The European Directorate for the Quality on Medicines (EDQM) has granted CoS for 18 of our products and 2 additional dossier are under assessment.