Glenmark Receives ANDA Approval For Amlodipine And Olmesartan Medoxomil Tablets


Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S.  FDA) for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5  mg/40 mg, 10 mg/20 mg, and  10 mg/40 mg, the generic version of Azor Tablets, 5 mg/20 mg, 5  mg/40  mg,  10  mg/20  mg,  and  10  mg/40  mg,  of  Daiichi Sankyo, Inc. 

According to IMS Health sales data  for the 12 month period ending May 2017, the Azor Tablets, 5  mg/20  mg,  5  mg/40  mg,  10  mg/20  mg,  and  10  mg/40  mg  market  achieved  annual  sales  of  approximately $211.6 million .  

Glenmark’s  current  portfolio  consists  of  119  products  authorized  for  distribution  in  the  U.S.  marketplace and 66 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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