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Glenmark receives ANDA approval for adapalene and benzoyl peroxide gel

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MUMBAI, India —  Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for adapalene and benzoyl peroxide gel, 0.1% 2.5%, the generic version of Epiduo Gel, 0.1% 2.5%, of Galderma Laboratories.

According to IQVIA sales data for the 12 month period ending September 2019, the Epiduo Gel,  0.1%|2.5% market2 achieved annual sales of approximately $33.7 million.

Glenmark’s  current  portfolio  consists  of  163  products  authorized  for  distribution  in  the  U.S.  marketplace  and  45  ANDA’s  pending  approval  with  the  U.S.  FDA.  In  addition  to  these  internal  filings,  Glenmark  continues  to  identify  and  explore  external  development  partnerships  to  supplement and accelerate the growth of its existing pipeline and portfolio.


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