2 publications
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Published Subscription
Regulatory Concerns in Imports, Exports and Registration of Drugs and Dietary SupplementsBy Jinish Dhar M, S.B. Puranik, Mithun E.G.
Abstract: The main aim of this article was to study the various pharmaceutical products registration processes, regulations and requirements by the Indian Regulatory Authorities. The study emphasizes on the challenges faced by stakeholders entering into the Indian market without difficulty by demonstration of strategy arrived from the established guidelines, regulations and expert opinion. The study was undertaken to identify the challenges in biosimilar developments and dietary supplements and to evaluate the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 1, 2017 · pp. 13–22 Read article →
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Published Subscription
Regulatory Requirements for Registration of Biosimilar Products and Imports in India: A Recent ScenarioBy Jinish Dhar M, S. B. Puranik
Abstract: The main aim of this article is to study the various biosimilar products registration processes, regulations in imports and requirements by the Indian Regulatory Authorities. The study emphasizes on the challenges faced by stakeholders entering into the Indian market without difficulty by demonstration of strategy arrived from the established guidelines, regulations and expert opinion. The study was undertaken to identify the challenges in biosimilar developments and to evaluate the available …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 32–39 Read article →