Drug Master File (DMF)

A drug master file (DMF) is a master file that provides a full set of data on an API. In some countries, the term may also comprise data on an excipient or a component of a product such as a container Drug Master Files provide a way for companies other than drug product manufacturers, such as chemical manufacturers or contract manufacturing facilities, to submit information to FDA which can then be referenced by a drug manufacturer in an IND or NDA submission. This eliminates the redundancy of the same information being submitted to FDA several times if the chemical manufacturer or contract laboratory works with several different drug product manufacturers. In addition, the confidentiality of the contract facility’s manufacturing processes is maintained by use of a DMF. A sponsor submitting an NDA would incorporate a DMF by reference in the section of the NDA (within the CMC section) where this information would normally appear.


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