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Glenmark Pharmaceuticals receives ANDA approval for Olmesartan Medoxomil Tablets, 5 mg, 20 mg and 40 mg


Mumbai, India; May 26, 2017: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Olmesartan Medoxomil Tablets, 5 mg, 20 mg and 40 mg, the generic version of Benicar® Tablets, 5 mg, 20 mg and 40 mg, of Daiichi Sankyo, Inc. Glenmark’s Olmesartan Medoxomil Tablets will be manufactured by Glenmark Pharmaceuticals Limited in its manufacturing facility located in Goa, India.

According to IMS Health sales data for the 12 month period ending March 2017, the Benicar® Tablets, 5 mg, 20 mg and 40 mg market1 achieved annual sales of approximately $950.0 million*.

Glenmark’s current portfolio consists of 115 products authorized for distribution in the U.S. marketplace and approximately 69 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.
1Market includes brand and all available therapeutic equivalents
*IMS Health National Sales Perspectives: Retail & Non-Retail, March 2017

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 80 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of oncology, respiratory disease, and dermatology. Glenmark’s current respiratory pipeline is aimed at addressing the global public health burden of allergic rhinitis, asthma, and COPD, and includes four investigational treatments across the disease spectrum and devices. Headquartered in Mumbai, India, with U.S. headquarters in Mahwah, NJ, Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information visit www.glenmarkpharma.com.

For further information, please contact:
Ramkumar Uppara/ Shibani Shah
Glenmark, Mumbai, India
Tel: [+91 22] 40189984/348
Email: corpcomm@glenmarkpharma.com