Drug Master File- A Review

  • Suraj Kause PG Student
  • Pradnya Raut PG Student

Abstract

Drug master file “DMF” is a record that contains information on the practices, infrastructure, or resources utilized in or even during the production, processing, packaging, and storage of one or more human medicines. The chemistry, production and control of a drug component are contained in a DMF. When two or businesses collaborate to develop or produce a drug product, a DMF is submitted. The filing of DMF enables business for safeguard the intellectual property of its partner with adhering to legal specifications for the disclosure of processing information. Chemistry, stability, purity, production, packaging, impurity profile and cGMP status of a drug formulation available as detail in DMF. No single chemical entity will be marketed without researchers, especially medical researchers and specialists who labored for ensuring that they will win regulatory authority clearance; DMF need to submit to the Food and Drug Administration having two parts and five types as discussed in this review article.

Keywords: Drug Master File (DMF), Food and Drug Administration (FDA), Drug Regulatory Affairs, DMF Filing

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References

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How to Cite
Suraj Kause, and P. Raut. “Drug Master File- A Review”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 50-53, doi:10.22270/ijdra.v11i2.592.