Labela Regsources Blog

What is a Pharmaceutical Drug Master File? A  drug master file  is a document that’s curated and prepared by the pharmaceutical manufacturer. This confidential file is then submitted to the regulatory agency. What is an API (Active Pharmaceutical Ingredient) Drug Master File? The pharmaceutical drug manufacturers usually prepare a single  drug masterfile,  where information about the API used in pharma drug is usually included. Though sometimes, they have to create a separate  API DMF ,  which is exclusively about the USP and composition of the API used by the pharmaceutical drug manufacturers.    What does a  Drug Master File  contain? A drug master file is usually prepared after the completion of the manufacturing process of a pharmaceutical drug. It includes factual and confidential details of the facilities of the manufacturing plant, info on the manufacturing process, active pharmaceutical ingredients a...