Glenmark Receives FDA Approval for Esomeprazole Magnesium Delayed-Release Capsules USP

Glenmark Receives FDA Approval for Esomeprazole Magnesium Delayed-Release Capsules USP

By, Admin 13 June 2024

Glenmark receives US FDA approval for esomeprazole magnesium delayed-release capsules USP, 20 mg

Overview

Glenmark Specialty SA (Glenmark) has received final approval by the United States Food & Drug Administration (FDA) for esomeprazole magnesium delayed-release capsules USP, 20 mg (OTC), determined by the FDA to be bioequivalent to Nexium 24 HR delayed-release capsules, 20 mg (OTC), of Haleon US Holdings LLC.

Esomeprazole Magnesium

Esomeprazole magnesium delayed-release capsules USP, 20 mg (OTC), will be distributed in the US by Glenmark Therapeutics Inc., USA.

Annual Sales

According to Nielsen syndicated data for the latest 52 weeks period ending May 18, 2024, the Nexium 24 HR delayed-release capsules, 20 mg (OTC) market achieved annual sales of approximately $259.2 million.

Glenmark’s Current Portfolio

  • Glenmark’s current portfolio consists of 197 products authorized for distribution in the US marketplace and 50 ANDA’s pending approval with the US 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.

Glenmark Pharmaceuticals Ltd.

  • Glenmark Pharmaceuticals Ltd. is a research-led, global pharmaceutical company, having a presence across branded, generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. 
  • The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries.

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