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2 publications

  • Published Subscription

    An Overview of GMP Requirements for Generics in Brazil and Russia

    By Achin jain, Jayant Kumar, M. P. Venkatesh

    Abstract: Implementation of good manufacturing practice (GMP) is an intelligent investment in building the good quality generics. It is the matter of fact that key GMP requirements for both generics and innovator drugs almost covers all aspects of production, from the starting materials, premises, equipment and training and personal hygiene to personnel. This work helps in bringing the awareness about the key GMP requirements for manufacturing of generics in Brazil and …

    Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 2, 2016 · pp. 7–14 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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