scorecardresearch
Friday, March 29, 2024
Support Our Journalism
HomeANI Press ReleasesGlenmark Pharmaceuticals receives ANDA approval for Icatibant Injection, 30 mg/3 mL (10...

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

Follow Us :
Text Size:

Glenmark

Mumbai (Maharashtra) [India], May 24 (ANI/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.

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.

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