Abstract

DMF FILING IN UNITED STATES, EUROPE AND JAPAN

*Akhilesh. P, T. M. Pramod Kumar

ABSTRACT

Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively. The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. A drug master file comprises two parts: the Applicant’s Part (USA: Open Part), which contains all the information that the licence-holder needs to assess the quality and submit a licence or amendment application; and the Restricted Part (USA: Closed Part), which contains confidential information about the manufacturing procedure that only needs to be disclosed to the authorities.

Keywords: Active Pharmaceutical Ingredient, European Drug Master File, US-Drug Master file