What are the types of DMF? : Pharmaceutical Guidelines

What are the types of DMF?


Drug master files are regulatory submission requirements. 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 drugs & biologics.
Type-IV: DMF is for companies who supply excipients
Type-V: DMF is for companies who supply clinical services, sterile manufacturing etc.
Type-I: Is an obsolete number once used for a category that no longer exists because it was found to easily fit into and overlap with the other four categories.



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