1. Meaning of a Drug Master File DMF stands for Drug Master File which is a voluntarily submission at the holder’s discretion to help the customers. 2. Drug Master Files’ Regulatory Basis It is not a necessity by law to submit DMF, on the other hand, it is submitted at the holder discretion. Upon ...

There are four types of DMF. They are referred to by their numbers in Roman numerals: Type-II: DMF is for companies who supply drug substances, drug products, intermediates & material used in their manufacture. Type-III: DMF is for companies who supply packaging (container closure system) for human ...