What are DMF and their types?

DMF stands for Drug Master File in regulatory submissions of a Drug Substance or Drug Product and all other Drug related packaging and Intermediates, Excipients

It has the complete information about your submission

Drug Master File contains the confidential information about the Material's (Drug Substance or Drug Product or any Intermediate or Packaging Material) CMC that has Chemistry, Manufacturing and controls. that means how your product is Manufacturing and its Specifications.

It is submitted to the Regulatory agencies like FDA as a supporting document during  IND, NDA and ANDA submissions

DMF as it is contains Product and Manufacturing details, It is submitted as a confidential Document which protects the Intellectual Properties of the Submitters  (manufacturers) during IND, NDA and ANDA submissions

DMFs are categorised as Type-I, Type-II, Type-III, Type-IV and Type-V

• Type I has information of Manufacturing site, Personnel, Operating Procedures
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• Type II has information of Drug substance, Drug Product, Intermediates and the Materials used in preparation of Drug product
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• Type-III has Packaging Material Information like Primary and secondary packing, How the Materials and Drug product Packed and the details of chemistry of Packaging Material, like HDPE containers.
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• Type IV has Excipients used in Manufacturing procedure like for a Tablets what and which colorants,  Binders are used and it depends on Formulation like Lyophilised forms, for Injections and Injections and all kinds
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  • Type V has FDA accepted reference information like Biocompatibility and Toxicology information combination product components, any specific procedures