REGULATORY REQUIREMENTS AND FILING PROCEDURE OF DMF IN INDIA IN COMPARISON WITH BRAZIL
Ashok Kumar P.*, Rakesh S. P., Reshma, Sanjay Kumar D. R., Sanjay S. Shekar and Shilpashree B. R.
The master file is an essential regulatory document that plays a crucial role in the pharmaceutical industry, Ensuring the confidential report of important information related to the manufacturing, quality and safety of drug products DMF plays an important role in the drug approval process such as ANDA (abbreviated new drug applications) and provide a good welfare to both drug manufactures and regulatory agencies, thereby ensuring the successful development and approval drug products.
Keywords: DMF (drug master file), pharmaceutical industry, ANDA (abbreviated new drug applications), regulatory agencies.
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