drugset / Press release

Glenmark Pharmaceuticals receives ANDA approval for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules,1 mg/20 mcg

2022-07-29 · Glenmark Pharmaceuticals Ltd. India · original glenmarkpharma.com ↗

Press Release For Immediate Distribution Glenmark Pharmaceuticals receives ANDA approval for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg Mumbai, India; July 29 2022: Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg, the generic version of Taytulla®1 Capsules, of Allergan Pharmaceuticals International Limited. According to IQVIA TM sales data for the 12 month period ending May 2022, the Taytulla® Capsules market 2 achieved annual sales of approximately $85.9 million*. Glenmark’s current portfolio consists of 177 products authorized for distribution in the U.S. marketplace and 47 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. ------End------ About Glenmark Pharmaceuticals Ltd. Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries. Glenmark is ranked among the world’s top 100 biopharmaceutical companies (Top 100 Companies Ranked by Pharmaceutical Sales, 2020, by In Vivo/Scrip 100) and among the world’s top 50 companies in the off-patent sector (Top 50 Generics and Biosimilars Companies ranked by Sales, 2020, by Generics Bulletin/In Vivo). The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world’s most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year. For more information, visit www.glenmarkpharma.com. Follow us on Social Media: LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma) For more information, please contact Udaykumar Murthy DGM, Corporate Communications +91 9960377617 | [email protected] References: 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, May 2022

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