Glenmark receives USFDA approval for generic version of Azor Tablets

Mumbai, July 14, 2017: Glenmark Pharmaceuticals today said that its US Arm Glenmark Pharmaceuticals 1Inc., USA 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. Azor-amlodipine and olmesartan medoxomil tablets is used in the treatment of high blood pressure. 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 USD211.6 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.