Sun Pharma Research Div Likely for file new drug application with USFDA

Published On 2015-07-31 06:59 GMT   |   Update On 2015-07-31 06:59 GMT
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Sun Pharma Advanced Research Company likely to file new drug application with FDA, confirms Dilip Shanghvi

The research division of Sun Pharmaceuticals, is considering filing of a new drug application. However, no information has been shared on the therapeutic areas on which those three chemical entities are under research

The innovative business set up of Sun Pharma, the Sun Pharma Advanced Research Company (SPARC), may file 3 new drug applications with US Food and Drug Administration in the next two to three years. As confirmed by Dilip Shanghvi, Managing Director to PTI, SPARC is currently working on three new drugs that are currently under clinical trial stage. The company is reported to budget about 6 per cent of its revenues on Research and Development.
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However, Shanghvi did not elaborate on the therapeutic areas on which those three chemical entities are under research.

The company has around 1,800 research scientists working in multiple R&D centres with expertise in developing generics, difficult to make technology intensive products, Active Pharmaceutical Ingredients (APIs), Novel Drug Delivery Systems (NDDS) and New Chemical Entities (NCEs), according to SPARC's website (as confirmed by PTI).
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