Instant Report
FDF

Drug master files (DMFs) are submissions to FDA for the purpose of providing confidential, comprehensive details about manufacturing facilities, processes used, or materials and methods applied in the manufacturing, processing, packaging, and storing of pharmaceutical drug products.

  • Drug master files allow parties to reference material without disclosing DMF contents to those parties.
  • As per the law Registration in the Drug Master File is not mandatory.
  • Drug master files (DMFs) 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, and BLAs).

Categories of Drug Master Files (DMFs)

  • Category I: Drug Master Files for Manufacturing Site, Facilities, Operating Procedures, and Personnel
  • Category II: Drug Master Files for Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product
  • Category III: Drug Master Files for Packaging Material
  • Category IV: Drug Master Files for Excipient, Colorant, Flavor, Essence, or Material Used in their Preparation.
  • Category V: Drug Master Files for FDA-Accepted Reference Information

Every Drug Master File must have single category of data and all the supporting statistics.

Chemxpert provides data regarding DMF of various countries as under

  • USDMF: US Drug Master File(DMF)
  • JDMF: Japanese Drug Master File(DMF)
  • KDMF: Korean Drug Master File(DMF)
  • CEP/COS: Certificate of Suitability of European Pharmacopoeia

For Example: Chemxpert has the following information about various specific DMFs for paracetamol.

  • USDMF: US Drug Master File(DMF) –80 US Drug Master Files for Paracetamol are available in Chemxpert
  • JDMF: Japanese Drug Master File(DMF) – 14 Japanese Drug Master Files for Paracetamol are available in Chemxpert
  • KDMF: Korean Drug Master File(DMF) – 69 Korean Drug Master Files for Paracetamol are available in Chemxpert
  • CEP/COS: Certificate of Suitability of European Pharmacopoeia – 18 CEPs for Paracetamol are available in Chemxpert.