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Regulatory Requirement for Supergenerics in Saudi Arabia, Brazil and Malaysia

Jain A, Dixit M, Samaga V, Bairy B G, Dixit R, Venkatesh M P



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 with appropriate bioavailability and bioequivalence studies. Supergenerics have different regulations in different regions of the globe. In this review, an effort has been made to summarize the requirement for supergeneric in Prototype countries of GCC, BRICS and ASEAN.

Keywords: Supergenerics, New Drug, ANVISA, SFDA, BPFK/NPCB

Cite this Article

Achin Jain, Mudit Dixit, Vasant Samaga et al. Regulatory Requirement for Supergenerics in Saudi Arabia, Brazil and Malaysia. Research & Reviews: A Journal of Drug Design & Discovery. 2016; 3(1): 38–45p.


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