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  1. Forms & Submission Requirements

Drug Master Files (DMFs)

Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs:

  • Allow parties to reference material without disclosing DMF contents to those parties.
  • Are not required by statute or regulation.
  • Are neither approved nor disapproved. Instead, FDA reviews the technical contents of DMFs in connection with the review of applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs).

The draft guidance for industry Drug Master Files details information about preparing and submitting DMFs and to learn about FDA’s DMF review process. When final, this guidance will represent FDA’s current thinking on DMFs.

Additional resource for industry provide more details about the different types of DMFs, submission requirements, and helpful templates. Additionally, a list of Drug Master Files (DMFs) received by the FDA and other resources are provided for a well-rounded understanding of the DMF process. A frequently asked questions (FAQs) section regarding DMFs is coming soon.

Latest News

Visit GDUFA III Drug Master File (DMF) Review Enhancements for more information on the GDUFA III enhancements for Type II API DMFs.

Review the draft guidance for Industry: Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. This guidance clarifies how the FDA implements a program improvement agreed upon during the Generic Drug User Fee Amendments (GDUFA) reauthorization. It applies to holders of certain drug master files referenced in abbreviated new drug applications.

The SBIA DMF Workshop, GDUFA III Enhancements and Structured Data Submissions, addressed upcoming changes to Drug Master File (DMF) submissions. It focused on how GDUFA III simplifies the process with earlier reviews and separate amendment assessments, highlighting benefits for the industry. The agency's efforts to modernize Chemistry, Manufacturing, and Controls (CMC) submissions using KASA, SD files, and GSRS for a more efficient drug approval process were also presented.

View Workshop Recording

Contact Information

Send all DMF-related submission questions to dmfquestion@fda.hhs.gov; include the DMF number, if applicable.

A Physical Media Submission is only accepted if submission is over 10GB: Submit physical submissions to:

Central Document Room
5901-B Ammendale Road
Drug Master File Staff
Beltsville, MD 20705-1266
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G112
Silver Spring, MD 20993-0002

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