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FDA 2017 First Generics Approvals Retain India Imprint

 
• By Anju Ghangurde

Indian companies continued to have marked presence in list of first generics approved by US FDA in 2017; clearances include some limited competition drugs and complex products that are vital for Indian firms as they transition their portfolios away from 'plain vanilla' generics.

Approved
INDIAN FIRMS HAVE RECEIVED A SIGNIFICANT SHARE OF FIRST GENERIC APPROVALS FROM THE US FDA.

Indian firms accounted for over a quarter of the “first generics” approved by the US FDA in 2017. The approvals include some limited competition and complex products, reflecting, in part, ongoing efforts of small and big Indian companies that are recalibrating their portfolios towards these underpenetrated and more lucrative segments.

“First generics” represent the first approval by the FDA which permits a manufacturer to market a generic drug in the US – essentially the first generic rival to the reference...

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