scorecardresearch
Add as a preferred source on Google
Sunday, November 23, 2025
Support Our Journalism
HomeANI Press ReleasesGlenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson Injection, 0.4 mg/5 mL...

Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe

Follow Us :
Text Size:

Glenmark

Mumbai (Maharashtra) [India], January 17 (ANI/PRNewswire): 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’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.

References:

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, November 2021

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. For more information, visit www.glenmarkpharma.com.

For more information, please contact:

Udaykumar Murthy

Deputy General Manager, Corporate Communications

+91-9960377617

corpcomm@glenmarkpharma.com

This story is provided by PRNewswire. ANI will not be responsible in any way for the content of this article. (ANI/PRNewswire)

This story is auto-generated from a syndicated feed. ThePrint holds no responsibility for its content.

Subscribe to our channels on YouTube, Telegram & WhatsApp

Support Our Journalism

India needs fair, non-hyphenated and questioning journalism, packed with on-ground reporting. ThePrint – with exceptional reporters, columnists and editors – is doing just that.

Sustaining this needs support from wonderful readers like you.

Whether you live in India or overseas, you can take a paid subscription by clicking here.

Support Our Journalism

  • Tags

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Most Popular