Glenmark receives tentative approval by USFDA for Olmesartan Medoxomil Tablets

24 Jun 2016 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Olmesartan Medoxomil Tablets, 5 mg, 20 mg and 40 mg, the generic version of Benicar Tablets of Daiichi Sankyo, Inc.

Glenmark will market this product upon receiving final approval of its Olmesartan Medoxomil Tablets, 5 mg, 20 mg and 40 mg ANDA. The Benicar Tablet market achieved annual sales of approximately $1.05 billion, according to IMS Health sales data for the 12 month period ending April 2016.

Glenmark’s current portfolio consists of 114 products authorized for distribution in the US marketplace and 62 ANDA’s pending approval with the USFDA. 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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