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Tag Archives: Biological License Application

Comparison Study for Drug Master file Procedure in USA & Canada with Regard to Regulatory Technicalities

Rajkiran Kolakota1 & N. Sireesha2* 1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP. A  B  S  T  R A C T Drug Master File (DMF) is a document containing complete information on drugs and its related compounds i.e, Active Pharmaceutical Ingredient (API) or finished drug dosage form such as drug product’s chemistry, manufacture, ... Read More »

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