Drug Master File- A Review

  • Suraj Kause PG Student
  • Pradnya Raut PG Student


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


Download data is not yet available.


1. Sravanti VKL, Bandla R, Juturi RKR. COVID-19, Filing of DMF in the US, EU, and India, and its comparative review. Int J Drug Reg Affairs [Internet]. 2021 Mar 15 [cited 2023 Jan 15]; 9(1):22-32. Available from:
2. Research C for DE and. Drug Master Files: Guidelines. FDA [Internet]. FDA; 2017 Nov 16 [cited 2023 Jan 15]. Available from:
3. Albert Yehaskel. An Overview of Drug Master Files, Pharmaceutical Regulatory Affairs: Open Access, Jan 18, 2017. Pharm Regul Aff. 2018;7:1.
DOI: 10.4172/2167-7689. 1000198
4. Gupta R. Inside Story for Review of DMF And Dossiers by Regulatory Authorities [Internet]. FDA; 2012 [cited 2023 Jan 16]. Available from:
http://www.perfectdossier.com/pdf/Inside%20Story%20fo r%20Review%20of%20DMF%20&%20Dossiers%20by% 20Regulatory%20Authorities.pdf
5. Anusha S, Mounica N.V.N., Sharmila V, Sravika S, Nagabhushanam M V, Nagarjuna Reddy D. Processing and submission of drug master file. World journal pharmacy and pharmaceutical sciences; 20 Feb 2017.
DOI: 10.20959/wjpps20173-8701
6. Yehaskel A. An Overview of Drug Master Files [Internet]. Pharm Regul Aff Open Access; 2018 [cited 2023 Jan 15]; 07(01). Available from:
7. Guideline for Drug Master Files, Centre for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services. Rockville, Maryland: Office of Drug Evaluation I 20857;1989 Sep.
8. Agarwal P, Badjatya JK. DMF filing in US, Europe and Canada. Int J Drug Reg Affairs [Internet]. 2018 Feb 13 [cited 2023 Jan 15]; 3(4):9-17. Available from:
9. Guidelines for drug master files, United States, Food and Drug Administration, Retrieved 2009-09-19. DMF search engine. FDA: Guideline for drug master file [Internet].FDA; 2017 Nov 11 [cited 2023 Jan 15]. Available from:
10. Peter J. Schmitt. Drug Master Files Global Perspectives [Internet]. slideserve.com; 2011 [cited 2023 Jan 15]. Available from:
11. Shravya K, Swathi P, et al. Regulatory Dossiers of ASEM Countries. International. Journal of pharmaceutical sciences and research [Internet]. 2017 Aug 01 [cited 2023 Jan 15]. Available from:
12. Nizamuddin. What is a Drug Master File (DMF)? [Internet]. Freyr - Global Regulatory Solutions and Services Company; 2019 [cited 2023 Jan 15]. Available from:
13. Kanti SPY, Jain N, Chandra A, Shukla VK. Filing of DMF in US, Canada & Europe. Int J Drug Reg Affairs [Internet]. 2019 Mar 16 [cited 2023 Jan 15];7(1):6-12. Available from:
14. Gurram I, Kavitha MVS, Reddy N, Nagabhushanam MV. Drug Master File Filing in US, Europe, Canada and Australia J Pharm Res. [Internet]. 2017 Feb 16 [cited 2023 Jan 15]. Available from:
http://dx.doi.org/10.18579/jpcrkc%2F2017%2F16%2F2% 2F116432
15. K. Arshad Ahmed Khan. Drug Master File submissions [Internet]. slideshare.net; 2018 Aug 17 [cited 2023 Jan 15]. Available from:
88 Views | 1348 Downloads
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.