Drug Master File and types of DMF
Description
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 manufactured 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.
