Glossary

Drug Master File (DMF)

February 27, 2012

A document prepared by a pharmaceutical manufacturer and submitted to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF, but it provides the regulator with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Typically, a DMF is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details. The information contained in the DMF may be used to support an IND, NDA, ANDA or Export Application, but is not a substitute for those filings.

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