Unlocking the benefits of Drug Master File filing in the Indian pharmaceutical industries (Record no. 23002)
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| 000 -LEADER | |
|---|---|
| fixed length control field | a |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250620094437.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 250620b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 26509 |
| Author | Pathak, Rahul |
| 245 ## - TITLE STATEMENT | |
| Title | Unlocking the benefits of Drug Master File filing in the Indian pharmaceutical industries |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.56(5), Sep-Oct |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | New Delhi |
| Name of publisher, distributor, etc. | Wolter Kluwer |
| Year | 2024 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 342-347p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Ensuring the safety and quality of drugs is a crucial component for the development of any pharmaceutical industry. This requires stringent regulation in the process of drug manufacturing and marketing. A Drug Master File (DMF) serves as a comprehensive document containing information about the quality, safety, and manufacturing procedure/facility of a drug or drug substance. Many countries with highly regulated markets use the DMF system extensively to protect their intellectual property rights while providing accurate and detailed information about their products to regulatory bodies. In India, the regulatory body, the Central Drug Standard Control Organization, does not currently mandate the submission of a DMF. However, adopting a DMF system may have immense benefits to regulatory bodies, pharmaceutical industries, as well as to patients. This review aims to provide a comprehensive overview of DMF and highlight the significance of its adoption in India. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4774 |
| Topical term or geographic name entry element | PHARMACOLOGY |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 26510 |
| Co-Author | Singal, Rajat |
| 773 0# - HOST ITEM ENTRY | |
| Title | Indian Journal of Pharmacology |
| Place, publisher, and date of publication | Andheri - Mumbai Wolters Kluwer India Private Limited |
| International Standard Serial Number | 0253-7613 |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://journals.lww.com/iphr/fulltext/2024/09000/unlocking_the_benefits_of_drug_master_file_filing.7.aspx |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | School of Pharmacy | School of Pharmacy | Archieval Section | 20/06/2025 | 2025-0961 | 20/06/2025 | 20/06/2025 | Articles Abstract Database |