UGC CARE norms ugc approved journal norms IJRTI Research Journal

WhatsApp
Click Here

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)

Call For Paper

For Authors

Forms / Download

Published Issue Details

Editorial Board

Other IMP Links

Facts & Figure

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

Indexing Partner

Licence

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
Published Paper Details
Paper Title: Drug Master File: an Overview
Authors Name: Mundada Atish S. , Shaikh Ahtesham M. , Basarkar Ganesh D.
Download E-Certificate: Download
Author Reg. ID:
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
Downloads: 000202333
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
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
Share Article:

Click Here to Download This Article

Article Preview
Click Here to Download This Article

Major Indexing from www.ijrti.org
Google Scholar ResearcherID Thomson Reuters Mendeley : reference manager Academia.edu
arXiv.org : cornell university library Research Gate CiteSeerX DOAJ : Directory of Open Access Journals
DRJI Index Copernicus International Scribd DocStoc

ISSN Details

ISSN: 2456-3315
Impact Factor: 8.14 and ISSN APPROVED
Journal Starting Year (ESTD) : 2016

DOI (A digital object identifier)


Providing A digital object identifier by DOI.ONE
How to Get DOI?

Conference

Open Access License Policy

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

Creative Commons License This material is Open Knowledge This material is Open Data This material is Open Content

Important Details

Social Media

Join RMS/Earn 300

IJRTI

Indexing Partner