Glenmark receives USFDA approval for generic version of Azor Tablets

07 Jul 2017 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) 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 US marketplace and 66 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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