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International Journal for Research Trends and Innovation
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ISSN Approved Journal No: 2456-3315 | Impact factor: 8.14 | ESTD Year: 2016
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Impact Factor : 8.14

Issue per Year : 12

Volume Published : 8

Issue Published : 80

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Published Paper Details
Paper Title: Drug Master File: an Overview
Authors Name: Mundada Atish S. , Shaikh Ahtesham M. , Basarkar Ganesh D.
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IJRTI_184624
Published Paper Id: IJRTI2211050
Published In: Volume 7 Issue 11, November-2022
DOI:
Abstract: 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
Publication Details: Published Paper ID: IJRTI2211050
Registration ID:184624
Published In: Volume 7 Issue 11, November-2022
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Page No: 348 - 352
Country: Chandwad, Nashik, Maharashtra, India
Research Area: Pharmacy
Publisher : IJ Publication
Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2211050
Published Paper PDF: https://www.ijrti.org/papers/IJRTI2211050
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ISSN: 2456-3315
Impact Factor: 8.14 and ISSN APPROVED
Journal Starting Year (ESTD) : 2016

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