Drug Master File (DMF) Submissions Expertise - Overview
Drug Master File (DMF) includes information about facilities and processes used in the manufacturing, processing, packaging, and storing of one or more human drugs and it is submitted to support generic drug applications and contains complete information of an Active Pharmaceutical Ingredient (API) or finished dosage form. It is referred to as the US-Drug Master File (US-DMF) in the United States and the Active Substance Master File (ASMF) in the EU. API manufacturers can also file Certification of Suitability (CEP) with the European Directorate for the Quality of Medicines and HealthCare (EDQM). Most of the emerging markets, in addition to Australia, Canada, and all the European Union (EU) countries accept CEP instead of ASMF/DMF submissions.
Freyr has well-defined processes for creating, publishing, and dispatching the existing and new ASMF/DMFs in eCTD/NeeS/PDF format, as per the Health Authority requirements, along with providing pre-assigned application numbers for eCTD submissions. Our well-versed Regulatory team keeps track of region-specific DMF submission requirements and assists customers with effective DMF lifecycle management services including, amendments and annual report for quick submission turnaround times.
