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2 publications

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    Supergenerics Regulation in India and US: A Comparative Review

    By 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

  • Published Subscription

    European Regulatory Perspective on Super-Generics: Antacid Orally Disintegrating Tablets (ODT)

    By Achin jain, Mudit Dixit, Vasant Samaga, B. G. Bairy, Rohit Dixit, M. P. Venkatesh

    Abstract: Super-generic is the general form of nomenclature for hybrid medicinal product in European Union (EU). The super-generic form of the medicinal product is one that considers changes in the form of active substance, therapeutic indications, strength, pharmaceutical form or route of administration. They rely partly on results of preclinical tests and clinical trials of an innovator product and also on new data with appropriate bioavailability and bioequivalence studies. Marketing authorization …

    Published in Trends in Drug Delivery · Vol. 3, Issue 1, 2016 · pp. 31–37 Read article

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