STM Journals Peer-reviewed research from Consortium e-Learning Network

2 publications

  • Published Subscription

    An Overview of GMP Requirements for Drug Product in China

    By 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

  • Published Subscription

    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

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