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How To Use DMF Content To Support Your Application To The FDA
By S. D. Devendra Raj, Ph.D., Freyr
A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA at the discretion of the DMF holder to assist its customers. A DMF is used to provide confidential detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing one or more active pharmaceutical ingredients (APIs) and/or human drugs in the absence of relevant information about the drug substance, drug product, and/or container closure. A DMF is not an alternate regulatory submission for an IND, an (NDA, an ANDA, another DMF, an export application, or amendments and supplements to any of the mentioned, but can be used to support these applications. ....

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