Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted to the appropriate regulatory authority in the intended drug market. DMF is a document containing complete information on an Active Pharmaceutical Ingredient (API) / drug substance, intermediate of drug substance, packaging material, excipient or drug product.
The DMF contains complete information on quality aspect such as chemistry, manufacture, purity, impurity profile, packaging, stability etc.
In Europe, it is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) whereas in US, it is United State Drug Master File (US-DMF).
There is no regulatory requirement to file a DMF. DMF is never Approved or Disapproved. A DMF is NOT a substitute for an IND (Investigational new drug), NDA (New Drug Application), ANDA(Abbreviated New Drug Application), or Export Application. Technical contents of a DMF/ASMF are reviewed only in connection with drug product registration application where it is used as raw material, packaging or other relevance.