ABSTRACT

DMF is known as the Drug Master File, which includes a proprietary document containing all detailed, reliable and accurate Active Pharmaceutical Ingredient (API) or dosage format information for the finished product. The Drug Master File consists of two parts, one being the part of the applicant and the other being a restricted part. The applicant's part covers all the details needed to be checked by the license holder on the quality of the product, and the restricted part covers all the sensitive production process information that can be submitted to the health authorities. The purpose of this article is to provide an overview of DMF filings and comparison of DMF in various countries, such as the USA and EUROPE. The drug master file is called DMF (Drug Master File) in the USA, but it is known as ASMF (active substance master file) in EUROPE. Keywords: applicant part, API, ASMF, Drug Master File, restricted part
Publication date: 01/11/2021

https://ijbpas.com/pdf/2021/November/MS_IJBPAS_2021_5723.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.11.5723