Drug Master File (FDA DMF)
Drug Master File (FDA DMF) is a confidential document submitted voluntarily to the FDA by human drug manufacturers, processors, packagers, and stores. DMF contains information about production facilities, processes, packaging, quality control, and storage products. FDA DMF is generally submitted by manufacturers of Active Pharmaceutical Ingredient (API), Drug Substance, Drug Intermediate Substance, and Drug Packaging Material.
Drug master file usually contains the components/ingredients, chemistry, process technology, quality controls either of drug substance, excipient, or packaging material. Drug Master File has a significant role in finished product drug applicants’ NDAs, ANDAs, and INDs. So, careful preparation of files by an expert is highly essential for successful submission.
Drug Master File Types
Drug Master File TYPE I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable).
Drug Master File TYPE II: Drug products or substances or intermediate and or materials used for drug preparation.
Drug Master File TYPE III: Packaging Material.
Drug Master File TYPE IV: Excipient or Colorant or Flavour/Essence or material used in the Preparation.
Drug Master File TYPE V: FDA Accepted Reference Information.
Regional DMFs:
The DMFs generated for regions (excluding USA and Europe) are covered under Regional DMFs for the following countries: Canada, China, Turkey, Brazil, Korea, South Africa, Australia, Syria, and Saudi Arabia. Regional guidelines of the respective countries must be followed for generation and submission of the Regional Drug Master Files.
