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International Journal for Research Trends and Innovation
International Peer Reviewed & Refereed Journals, Open Access Journal
ISSN Approved Journal No: 2456-3315 | Impact factor: 8.14 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.14 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
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Issue: January 2023
Volume 8 | Issue 1
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Impact Factor : 8.14
Issue per Year : 12
Volume Published : 8
Issue Published : 80
Article Submitted : 5819
Article Published : 3222
Total Authors : 8187
Total Reviewer : 541
Total Countries : 71
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Paper Title: | Drug Master File: an Overview |
Authors Name: | Mundada Atish S. , Shaikh Ahtesham M. , Basarkar Ganesh D. |
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IJRTI_184624
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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 |
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Published Paper ID: IJRTI2211050
Registration ID:184624
Published In: Volume 7 Issue 11, November-2022
DOI (Digital Object Identifier):
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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