Submission & Approval

Drug Master File(DMF)

A confidential document submitted to FDA containing detailed information about manufacturing facilities, processes, or components.

Usage Examples

The API manufacturer maintains a Type II DMF with FDA.
Please provide a Letter of Authorization to reference your DMF.
The DMF review identified several deficiencies requiring amendment.

What is DMF?

A Drug Master File (DMF) is a submission to FDA that provides confidential detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, or storing drugs. DMFs allow holders to reference information without disclosing proprietary data to third parties.

DMF Types include: Type I (no longer used), Type II (Drug Substance, Drug Substance Intermediate, Drug Product), Type III (Packaging Material), Type IV (Excipient, Colorant, Flavor, Essence), and Type V (FDA-Accepted Reference Information).

DMF holders must provide Letters of Authorization to companies wishing to reference their DMF in regulatory submissions.

Regulatory Context

This term appears most often in submission & approval workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 314 420.

FDAICHEMA

When This Matters

The API manufacturer maintains a Type II DMF with FDA.
Please provide a Letter of Authorization to reference your DMF.
The DMF review identified several deficiencies requiring amendment.

Common Mistakes

Treating submission readiness as a formatting-only check without lifecycle validation.
Using outdated guidance references across modules and summaries.
Missing cross-functional review between RA, CMC, and quality before submission.

Related Regulations

21 CFR 314 420

Frequently Asked Questions

Type II DMFs contain information on drug substances, drug substance intermediates, and drug products. This is the most common DMF type, used by API and drug product manufacturers.

No, DMF contents are confidential. Only FDA and authorized applicants (those with your Letter of Authorization) can access the information relevant to their submissions.