Glenmark Pharmaceuticals’ subsidiary — Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by United States Food & Drug Administration (USFDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc. Sales data for the 12 month period ending November 2021, the Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL) market achieved annual sales of approximately $659.9 million.
Glenmark’s current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 47 ANDA’s pending approval with the USFDA. 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.