FDA Drug Master Files (DMF)

FDA Drug Master Files (DMF)

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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.


  1. Allow parties to reference material without disclosing DMF contents to those parties.
  2. Are not required by statute or regulation.
  3. 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).


If you would like “FDA Registration Assistance” to create and submit a Drug Master File (DMF) on your companies behalf please CONTACT US. 

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