what is dmf in pharma

DMF stands for Drug Master File, which is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is a submission made to the appropriate regulatory authority in the intended drug market, such as the Food and Drug Administration (FDA) in the United States. The DMF contains factual and complete information on a drug products chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. The submission of a DMF is not required by law or FDA regulation, but it may be 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 information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.