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Drug master file

Drug Master File (DMF): FDA Guidelines

Published on: February 11, 2024 by Naresh Bhakar
Drug master file

A Drug master file is a submission form, that is required to submit to the Food and Drug Administration (FDA). A US DMF (Drug Master File) is a document that is submitted to regulatory agencies to provide confidential, detailed information about a drug API, drug product, or excipient. It is used to support the approval … Read more

Categories GMP Tags Drug master file, FDA DMF Leave a comment

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