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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