Filing of DMF in the US, EU, and India, and its comparative review

  • Veera Kota Lakshmi Sravanti student
  • Ruchitha Bandla
  • Ravi Kumar Reddy Juturi


A Drug Master File (DMF) covers all comprehensive, accurate, and precise information about Active Pharmaceutical Ingredient (API) or Finished Product Dosage Form (FP). It is a confidential document that contains complete, factual, and correct information about the active pharmaceutical ingredient and drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP (Current Good Manufacturing Practices) status of any human drug product. When a DMF is filed, it allows a company to safeguard its intellectual property from its partner while complying with regulatory requirements when its process details are disclosed. There is no legalised or regulatory requirement to file a DMF. A DMF comprises of two parts: (a) the Applicant's Part (Open Part), which contains all the information to assess the quality that the license-holder requires and submit a license or amendment application; and (b) the Restricted Part (Closed Part), which contains confidential information about the manufacturing procedure which is only disclosed to the authorities.

A DMF can be used by a holder who establishes the file or by one or more parties to support their files or applications.

The present study is to brief an overview of DMF filing in different countries, which are the USA, Europe, and India. It also gives information on regulatory requirements of Drug Master Files by Food and Drug Administration (USA), European Medicines Agency (Europe), and Central Drug and Standard Control Organization (India) and their comparison.

Keywords: Drug Master File (DMF), ASMF, FDA, CDSCO, LOA, Assessment Process, MAA


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How to Cite
Sravanti, V. K. L., R. Bandla, and R. K. Reddy Juturi. “Filing of DMF in the US, EU, and India, and Its Comparative Review”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 1, Mar. 2021, pp. 22-32, doi:10.22270/ijdra.v9i1.453.

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