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The pharmaceutical industry is one of the most regulated industries and no drug would be marketed unless teams of medical researchers and other specialists tirelessly work toprove the safety and efficacy of the product so that it gets approved by regulatory authorities. When two or more companies collaborate to develop or manufacture a drug product, a drug master file (DMF) is created. A DMF is a confidential, detailed document containing accurate and complete information about a drug product's chemistry, manufacture, control, container closure system, excipient, packaging material, and cGMP status submitted by Active Pharmaceutical Ingredient (API) manufacturers to the US Food and Drug Administration (USFDA). The DMF filing enables a company to protect its intellectual property from its partner while meeting regulatory requirements for processing detail disclosure. Although DMF filing is not required by law or regulation, it helps in rapid processing of INDA, NDA, ANDA or export application. This review article provides in depth information about the contents and submission guidelines for DMF to USFDA.
Keywords:
Drug Master File (DMF), US Food and Drug Administration (USFDA), INDA, NDA, ANDA, Active Pharmaceutical Ingredient (API) manufacturers
Cite Article:
"Drug Master File: an Overview", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.7, Issue 11, page no.348 - 352, November-2022, Available :http://www.ijrti.org/papers/IJRTI2211050.pdf
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ISSN:
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
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