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Glenmark receives ANDA approval for Clotrimazole and Betamethasone Dipropionate Cream USP, 1%-0.05%


Mumbai, November 9, 2015: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Clotrimazole and Betamethasone Dipropionate Cream USP, 1%|0.05%, the therapeutic equivalent of Lotrisone® Cream USP, 1%|0.05% of Merck, Sharp and Dohme Corporation. According to IMS Health sales data for the 12 month period ending September 2015, the Lotrisone® Cream USP, 1%|0.05% market1 achieved annual sales of approximately $82.4 million*. Glenmark’s current portfolio consists of 103 products authorized for distribution in the U.S. marketplace and 63 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. All brand names and trademarks are the property of their respective owners.   About Glenmark Pharmaceuticals Ltd: Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is ranked among the top 80 Pharma& Biotech companies of the world in terms of revenues. (SCRIP 100 Rankings published in the year 2014). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis etc.] and Pain [neuropathic pain and inflammatory pain]. The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has 14 manufacturing facilities in four countries and has six R&D centers. For further information, please contact: Jason D’Souza / Rajdeep Barooah Tel: [+91 22] 40189919/984 Email: corpcomm@glenmarkpharma.com