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Glenmark receives ANDA approval for HAILEY Fe 1-20

Mumbai, India; November 22, 2017: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for HAILEYTM Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/20 mcg and Ferrous Fumarate Tablets), the generic version of Loestrin®1 Fe 1/20 Tablets, of Allergan Pharmaceuticals International Limited. According to IQVIATM sales data for the 12 month period ending September 2017, the Loestrin® Fe 1/20 Tablets market2 achieved annual sales of approximately $116.8 million*. Glenmark’s current portfolio consists of 129 products authorized for distribution in the U.S. marketplace and 58 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. 1All brand names and trademarks are the property of their respective owners
2Market includes brand and all available therapeutic equivalents *IQVIATM National Sales Perspectives: Retail & Non-Retail, September 2017
About Glenmark Pharmaceuticals Ltd.: Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2017). 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 focused in the areas of oncology, dermatology and respiratory. The company has significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 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