A confidential submission to FDA containing information about facilities, processes, or articles used in the manufacture of drugs — commonly used by API and component suppliers to support customers’ applications without disclosing trade secrets.
A DMF lets a supplier — of an active ingredient, excipient, or packaging component — give the FDA the detailed manufacturing information a drug application needs, without revealing that trade-secret detail to the customer filing the application. The applicant references the DMF by number and includes a Letter of Authorization; the FDA reviews the DMF only in support of an application that relies on it.
A DMF is not “approved” on its own — it is reviewed when a referencing application (an NDA, ANDA, or IND) is filed. Type II API DMFs additionally carry a GDUFA fee and undergo a completeness assessment before they can be referenced by an ANDA.
- —Type II — Drug substance (API), drug intermediates, and materials used in their preparation.
- —Type III — Packaging materials.
- —Type IV — Excipients, colorants, flavors, and other additives.
- —Type V — FDA-accepted reference information not covered by the other types.
- —(Type I, for a manufacturing site/facility, was discontinued by the FDA in 2000.)
US: 21 CFR 314.420 (Drug Master Files); GDUFA fee and completeness assessment for Type II API DMFs referenced by ANDAs.
Frequently asked questions
What does DMF stand for?
DMF stands for Drug Master File.
What is DMF?
A confidential submission to FDA containing information about facilities, processes, or articles used in the manufacture of drugs — commonly used by API and component suppliers to support customers’ applications without disclosing trade secrets.
Which regulations cover DMF?
US: 21 CFR 314.420 (Drug Master Files); GDUFA fee and completeness assessment for Type II API DMFs referenced by ANDAs.
SPEQ decodes published regulatory concepts in plain language. Definitions are a practitioner reference, not legal or regulatory advice.
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