6 publications
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Regulatory Requirement for Supergenerics in Saudi Arabia, Brazil and MalaysiaBy Achin jain, Dixit M, Samaga V, Bairy BG, Dixit R, Venkatesh MP
Abstract: Supergeneric is the general form of nomenclature for value-added generics globally, which is coined suitably in different regulatory authorities. The supergeneric form of the medicinal product is one that considers changes, which may not be limited to, form of active substance, therapeutic indications, strength, pharmaceutical form or route of administration. They rely partly of results of preclinical tests and clinical trials of an innovator product and also on new data …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 3, Issue 1, 2016 · pp. 38–45 Read article →
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An Overview of GMP Requirements for Generics in Brazil and RussiaBy 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 →
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An Overview of GMP Requirements for Drug Product in ChinaBy Achin jain, Jayant Kumar, M.P. Venkatesh
Abstract: Good manufacturing practice (GMP) is a tool which facilitates the innovation and continual improvement throughout the lifecycle of products and strengthens the link between pharmaceutical development and manufacturing activities. It also helps in increasing the process efficiency and product quality by adopting the current, risk-based manufacturing approach and in turn optimizes manufacturing process and improves quality of the end product which improves the health of the individual patient and the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 2, 2016 · pp. 1–6 Read article →
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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 →
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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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Post Approval Life Cycle Management of Variations for Generic Drugs in BrazilBy Achin jain, Neenu Ganesh
Abstract: Changes or variations in respect of any information concerning the registered or approved drug products, including information on the formulation of the registered/listed goods or other aspects of their manufacture, and the labeling of the goods, shall forthwith be notified to the agency and the change or variation shall not be implemented until approved by the agency. Changes occurs to have business continuity, if any quality problem arises, to maintain …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 3, 2017 · pp. 37–42 Read article →