A Drug Master File (DMF) is a submission made to the Food and Drug Administration (FDA) that is used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs. The submission of a DMF is not required by law, nor is it a FDA regulation. A DMF is submitted by the holder, and is used to support application such as the Investigational New Drug application (IND), New Drug Application (NDA) an Abbreviated New Drug Application (ANDA) or another DMF or export application or for amendments and supplements to any of the above application and submissions.
Information for a drug substance is provided in a Type II Drug Master File. A type II DMF, should in general be limited to a single drug intermediate, drug substance, drug product or type of material used in their preparation.
The information that should be contained in this DMF should summarize all the steps in the manufacturing and control of the drug substance.
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