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26. September 2017
Updated list of Excipient US Drug Master Files extracted from the FDA list. New files from 2nd quarter 2017 and full list of active excipient DMFs (Type IV). Access to lists
05. January 2017
Background and Current State A Drug Master File (DMF) is a submission of information to the U.S. FDA to permit the Agency to review information on a drug component (e.g., API, excipient and packaging material) in support of a third party’s drug application. DMFs usually cover the Chemistry, Manufacturing and Controls (CMC) and where appropriate, toxicology reports/summaries for a drug substance, excipient or packaging material. The Drug Master File Guidance states “The submission of a DMF...
27. July 2015