Glenmark Pharmaceuticals receives ANDA approval for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe

MUMBAI, India, May 24, 2021 /PRNewswire/ — Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the generic version of Firazyr®1 Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies, Inc. This marks Glenmark’s first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.

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According to IQVIA sales data for the 12 month period ending March 2021, the Firazyr® Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe market2 achieved annual sales of approximately $223.4 million*.

Glenmark’s current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 44 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. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). The company has been listed in the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world’s most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index.

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1 All brand names and trademarks are the property of their respective owners.

2 Market includes brand and all available therapeutic equivalents

  • IQVIA National Sales Perspectives: Retail & Non-Retail, March 2021


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