Synopsis :
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan®1 Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.
According to IQVIATM sales data for the 12 month period ending November 2021, the Lexiscan® Injection, 0.4 mg/5 mL (0.08 mg/mL) market2 achieved annual sales of approximately $659.9 million.*
Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe
Glenmark’s current portfolio consists of 172 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.
About Glenmark Pharmaceuticals Limited (Mumbai, India)
Glenmark Pharmaceuticals Limited (Glenmark) is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 80 countries. Glenmark’s key therapeutic areas of focus are respiratory, dermatology and oncology. It ranks among the world’s top 50 Generics and Biosimilar companies (Top 50 Company Rankings, 2020, from Informa’s Generics Bulletin). The company has been listed on the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the fourth 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 being featured in the index.