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Regulatory Requirements for Registration of Generic Drug Product in BrazilBy Pallavi Bengre, Mudit Dixit, Rohit Dixit
Abstract: Drug Product Registration is a procedure of expertise of the pharmaceutical products quality, efficacy and safety by Regulatory Authority. This present study focuses mainly on the marketing regulatory requirements for filing a generic product, the regulations that are applicable for the Pharmaceutical drug products. The emergence of various formats has enabled the manufacturers of the drug product, to easily gain access into various markets and thus, able to place their …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 2, Issue 2, 2015 · pp. 38–45 Read article →