Definition
Drug Master File (DMF) is a confidential submission to FDA containing detailed information about facilities, processes, or articles used in drug manufacturing. DMFs allow manufacturers to protect proprietary information while supporting drug applications.
How Drug Master Files Work
DMF holders submit detailed manufacturing information to FDA but keep it confidential. Drug applicants reference the DMF through a Letter of Authorization, allowing FDA to review the information.
DMF Types
| Type | Content |
|---|---|
| Type I | Manufacturing site, facilities, personnel (rarely used) |
| Type II | Drug substance (API), drug intermediate, material |
| Type III | Packaging material |
| Type IV | Excipient, colorant, flavor, essence |
| Type V | FDA-accepted reference information |
DMF Review Process
- Holder Submits: DMF filed with FDA
- Authorization: Holder issues LOA to applicant
- Reference: Applicant cites DMF in NDA/ANDA
- FDA Review: Agency reviews DMF during application review
- Deficiencies: Any issues communicated to both parties
Why BD Teams Track Drug Master Files
For business development professionals, DMFs affect supply chain strategy:
- Deal Implication: Active DMFs enable multiple product opportunities
- Due Diligence Focus: Verify DMF status and review history with FDA
- Opportunity Signal: Companies with established DMFs offer faster development paths