Drug master file (DMF) is a submission to Food and Drug and Administration (FDA) and is a kind of confidential document which contains detailed information about the facilities, processes, manufacturing, processing, packaging, and storing of human drug products. In DMF the details mentioned may be used to support an (IND) Investigational New Drug Application,( NDA) New Drug Application, (ANDA) Abbreviated New Drug Application.
DMFs are submitted by the pharmaceutical companies which manufacturers drug Substance, Intermediates which generally contains the chemistry, facilities, process technology for manufacturing processes, quality controls either of drug substance, excipient or packaging material, etc. DMF submission is not essentially required by law or as per the regulation of the FDA and is submitted by the choice of the holder. FDA allows parties to reference the material without disclosing DMF contents to those parties and reviews the technical contents of DMFs in connection with the review of applications that reference them e.g., NDAs, ANDAs, and INDs. This guideline discusses the types of DMF’s and the information required in each type which includes the format of submissions to a DMF, the administrative procedures, and other requirements.
|TYPES||Information provided in the DMF|
|Type I||Manufacturing Site, Facilities, Operating procedures, and personnel|
|Type II||Drug Substance, Drug Substance Intermediate, and Material Used in their Preparation; or Drug Product|
|Type III||Packaging Material|
|Type IV||Excipient, Colorant, Flavor, Essence, or Material used in their Preparation|
|Type V||FDA Accepted Reference Information|
Drug master files (DMF) submission to the Food and Drug and Administration (FDA) and are a kind of confidential document. DMFs contain the complete information on the Drug Substance, Intermediate, chemistry, facilities, process technology for manufacturing processes, quality controls either of drug substance, excipient or packaging material, etc.