1 publication

• Published Subscription 19 Mar 2019

  Regulatory Requirement for Supergenerics in Saudi Arabia, Brazil and Malaysia

  By 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 →