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Supergenerics Regulation in India and US: A Comparative ReviewBy Achin jain, Mudit Dixit, Vasant Samaga, B.G. Bairy, M.P. Venkatesh
Abstract: ‘Supergenerics’, a new form of generic drugs with improved properties such as safety, efficacy, stability or improved commercial attractiveness such as taste or route of administration. Those drugs are most often based on an incremental re-formulation of a generic API (active pharmaceutical ingredient) or the combination of multiple generic APIs. Process of forming supergeneric molecule need not to be complex all the time. A supergeneric may be as simple as …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 1, 2016 · pp. 30–38 Read article →