Review on Drug Master File (DMF)

Drug master file (DMF) is a submission to Food and Drug and Administration (FDA) and is a kind of confidential document which contains detailed information about the facilities, processes, manufacturing, processing, packaging, and storing of human drug products. In DMF the details mentioned may be used to support an (IND) Investigational New Drug Application,( NDA) New Drug Application, (ANDA) Abbreviated New Drug Application.