Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg
Mumbai, India; December 19, 2022 – Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg, the generic version of Cardene®1 Capsules, 20 mg and 30 mg, of Chiesi USA, Inc. Glenmark’s Nicardipine Hydrochloride Capsules, 20 mg and 30 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
According to IQVIATM sales data for the 12-month period ending October 2022, the Cardene® Capsules, 20 mg and 30 mg market2 achieved annual sales of approximately $10.9 million*.
Glenmark’s current portfolio consists of 178 products authorized for distribution in the U.S. marketplace and 46 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.
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, LinkedIn (Glenmark Pharmaceuticals), Instagram (glenmark_pharma).
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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, October 2022