A Review On Drug Master File
Year: 2024
Type: article
Abstract: Master file on drugs A "DMF" is a document that includes details about the procedures, facilities, or materials used in the manufacturing, processing, packing, and storage of one or more human pharmaceuticals. A DMF contains information about the chemistry, manufacturing, and control of a drug component. A DMF is filed when two or more companies work together to develop or produce a medicinal product. Businesses can protect their partner's intellectual property by completing a DMF and following the regulatory requirements for processing information disclosure. Details about a drug formulation's chemistry, stability, purity, manufacture, packaging, impurity profile, and cGMP status are available in the DMF.Without researchers, no single chemical entity would be marketed; in particular, medical researchers and specialists worked tirelessly to ensure that they would receive regulatory authority clearance; DMFs, which have two parts and five types as discussed in this review article, must be submitted to the Food and Drug Administration.
Author: Mange Ram*, Vipin Kukkar
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6911966198
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