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Glenmark receives tentative ANDA approval for Olmesartan Medoxomil Tablets


Mumbai, June 24, 2016: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative 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 of Daiichi Sankyo, Inc. WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue olmesartan medoxomil as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Glenmark will market this product upon receiving final approval of its Olmesartan Medoxomil Tablets, 5 mg, 20 mg and 40 mg ANDA. According to IMS Health sales data for the 12 month period ending April 2016, the Benicar® Tablet market1 achieved annual sales of approximately $1.05 billion*. Glenmark’s current portfolio consists of 114 products authorized for distribution in the U.S. marketplace and 62 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. Press Release For Immediate Release Glenmark Pharmaceuticals receives tentative ANDA approval for Olmesartan Medoxomil Tablets, 5 mg, 20 mg and 40 mg Mumbai, June 24, 2016: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative 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 of Daiichi Sankyo, Inc. WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue olmesartan medoxomil as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Glenmark will market this product upon receiving final approval of its Olmesartan Medoxomil Tablets, 5 mg, 20 mg and 40 mg ANDA. According to IMS Health sales data for the 12 month period ending April 2016, the Benicar® Tablet market1 achieved annual sales of approximately $1.05 billion*. Glenmark’s current portfolio consists of 114 products authorized for distribution in the U.S. marketplace and 62 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 organization headquartered at Mumbai, India. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2016). 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 the branded generics markets across emerging economies including India. GPL along with its subsidiary has 17 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India. For further information, please contact: Ramkumar Uppara/Shibani Shah Glenmark, Mumbai, India Tel: [+91 22] 4018 9984/9348 Email: corpcomm@glenmarkpharma.com About Glenmark Pharmaceuticals Ltd.: Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2016). 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 the branded generics markets across emerging economies including India. GPL along with its subsidiary has 17 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India. For further information, please contact: Ramkumar Uppara/Shibani Shah Glenmark, Mumbai, India Tel: [+91 22] 4018 9984/9348 Email: corpcomm@glenmarkpharma.com