Glenmark Pharma receives tentative ANDA approval for Regadenoson Injection

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® Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.

According to IQVIA™ 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 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.

Shares of Glenmark Pharmaceuticals Limited was last trading in BSE at Rs. 516.00 as compared to the previous close of Rs. 521.55. The total number of shares traded during the day was 54663 in over 2338 trades.

The stock hit an intraday high of Rs. 528.05 and intraday low of 514.00. The net turnover during the day was Rs. 28362634.00.

Source : Equity Bulls

Keywords

GlenmarkPharmaceuticals INE935A01035 TentativeApproval USFDA RegadenosonInjection