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Drug Master File

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USFDA DMF (Drug Master Files) are submissions made to USFDA for human drug products which provide confidential and detailed information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing.

The DMF are required to be submitted in eCTD formats with exception of type III DMF. The DMF are not required by the regulation. DMFs are neither approved nor rejected. 

Your Drug Master File’s technical sections will be reviewed by USFDA with reference to the drug applications (IND/NDA/ANDA etc.). 

DMF shall be formed based on the regulation 21 CFR 314.420. 

Database for List of DMFs

Below link can be looked into for the various list of DMF received by FDA. This database is updated on quarterly basis. 

You will be able to review the details as per below table – 

DMF#STATUS TYPE SUBMIT DATE HOLDERSUBJECT
0IIIDD/MM/YYYYABC XYD CO.#DRUGNAME#

https://www.fda.gov/drugs/drug-master-files-dmfs/list-drug-master-files-dmfs

Types of DMF

DMF TypeInformation Included
Type IIDrug substances and intermediates, the materials involved in their manufacturing or Drug Product
Type IIIPackaging material
Type IVExcipients, Colorants, Flavors, Essence, or Material Used in Their Preparation
Type VReference information accepted by the FDA

Drug Master File Content

US FDA accepts DMF in Electronic format. The e-submissions will have a pre-assigned number. The pre-assigned number can be requested via email.
Restricted part (Closed Part) or also called as Confidential Part

  1. Manufacturer
  2. Manufacturing facility and GMP
  3. Description of the manufacturing process and process controls
  4. Control of materials
  5. US Agent appointment and authorization
  6. Owner/operator

Multiple resources can be used for the DMF submissions

  1. To request for a pre-assigned application number –https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/requesting-pre-assigned-application-number
  2. For standard format for electronic regulatory submission (Electronic Common Technical Document – eCTD) –https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd
  3. Central Submission point for e-submissions –https://www.fda.gov/industry/electronic-submissions-gateway
  4. To provide regulatory e-submissions (Rev 6 of CHPPA & related submissions) –https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications
  5. List of CTD section headings & hierarchy –https://www.fda.gov/media/76444/download
  6. Information about binders for submissions –https://www.fda.gov/drugs/drug-master-files-dmfs/fda-ind-nda-anda-or-drug-master-file-binders
  7. FDA Form 3938 (e-form for DMF submissions) –https://www.fda.gov/media/151559/download
  8. Guidance for creation of SD file –https://www.fda.gov/media/151718/download

Restricted part (Closed Part) or also called as Confidential Part

  • Manufacturer
  • Manufacturing facility and GMP
  • Description of the manufacturing process and process controls
  • Control of materials
  • US Agent appointment and authorization
  • Owner/operator contact information

Applicant’s part (Open Part) or also called a Non-confidential part

  • General information
  • Specification
  • Control of critical steps and intermediates
  • Process validation and/or evaluation
  • Manufacturing process development
  • Material Characterization
  • Quality Control
  • Reference standards or materials
  • Container closure system
  • Stability
  • Shelf-life

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