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-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.

 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.