A Drug Master File (DMF) is a confidential and detailed document submitted to the US FDA by a drug manufacturer. It contains comprehensive information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMF submission is not required by FDA regulation. DMF is solely submitted at the discretion of the DMF holder. A MDF is not approved or disapproved. Technical contents of a DMF may be reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application. DMF allows FDA to review this information to ensure the quality and safety of the drug products without disclosing proprietary information to the drug product’s sponsor.
The submission of a DMF can be made by:
- API manufacturers
- Excipient manufacturers:
- Container Closure System manufacturers
- Drug Product manufacturers
Types of DMF:
- Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (discontinued since September 2010).
- Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product.
- Type III: Packaging Material.
- Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation.
- Type V: FDA Accepted Reference Information
Non-US DMF applicants are required to appoint a US Agent in their DMF for FDA communication purpose.
Liberty Management Group Ltd. can help you DMF submissions & US Agent service.
Namrata
Regulatory Consultant