Glenmark Receives ANDA Approval For Indomethacin Extended-Release Capsules

Glenmark  Pharmaceuticals  Inc.,  USA  (Glenmark)  has  been  granted final  approval  by  the United  States  Food  &  Drug  Administration  (U.S.  FDA)  for  Indomethacin  Extended‐Release Capsules  USP,  75  mg,  the  generic  version  of  Indocin  SR  Extended‐Release  Capsules, 75 mg of Iroko Pharmaceuticals LLC. 

According  to  IMS  Health  sales  data  for  the  12  month  period  ending  April  2017,  the Indocin®  SR  Extended‐Release Capsules, 75 mg market1 achieved annual sales of approximately $6.3 million.  

Glenmark’s  current  portfolio  consists  of  118  products  authorized  for  distribution  in  the  U.S. marketplace and 67 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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