Drug Master Files (DMFs), Certificates of Suitability (CEPs), and Active Substance Master Files (ASMFs) are confidential dossiers that allow API manufacturers to protect proprietary manufacturing information while enabling downstream finished product manufacturers to reference them in their own regulatory submissions. RBridge Lifesciences supports the full preparation and filing process.
What We Offer
- DMF Preparation and Filing (USFDA)
- CEP / ASMF Preparation and Filing (EDQM / European markets)
- USDMF Preparation and Filing
- Post Approval Changes and Filing
- Annual Reports and DMF Updates
Key Distinctions
- US DMF (Type II) – filed with USFDA to support ANDA/NDA submissions for APIs
- CEP (Certificate of Suitability) – issued by EDQM, demonstrates compliance with European Pharmacopoeia monographs
- ASMF (Active Substance Master File) – used for EU MAA submissions as a confidential API reference
- All three reduce duplication by allowing multiple finished product manufacturers to reference the same API dossier