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International Journal of Drug Regulatory Affairs
Year : 2020, Volume : 8, Issue : 2
First page : ( 7) Last page : ( 14)
Print ISSN : 2321-2162. Online ISSN : 2321-6794.
Article DOI : 10.22270/ijdra.v8i2.385

DMF filing procedure in US, Europe and Canada: A review

Chakraborty Krishnasis*

Department of Quality Assurance, Al-Ameen College of Pharmacy, Opp. Lalbagh Main Gate, Hosur Road, Bangalore, Karnataka, India - 560027

*Corresponding author Tel.: +91-9632703191, E-mail address: krishnasis07p@gmail.com (Krishnasis Chakraborty)

Online published on 24 May, 2021.

Abstract

DMF widely known as Drug Master File, is a kind of confidential document which covers all comprehensive, accurate and precise information about Active Pharmaceutical Ingredient (API) or Finished Product Dosage Form (FP). The Drug master file consist of two parts, one the applicant’s part which covers all the information that the license holder needs to review about quality of drug product & other one is the restricted part which covers all the confidential information about the manufacturing process that can only be presented in front of health authorities. A DMF can be used by holder who establishes the file or by one or more parties in support of their files or applications. The present study is to brief an overview of DMF filing in different countries which are USA, Europe and Canada. In USA, Canada the drug master file is known as DMF and in EUROPE, known as ASMF (Active Substance Master File).

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Keywords

Drug master file (DMF), ASMF, Master file (MF), API, IND, NDA, ANDA, FDA, Ectd, LOA.

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