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Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules USP,

 

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Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules USP

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. 

Glenmark Specialty SA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), determined by the FDA to be bioequivalent1 to Nexium® 24 HR Delayed-Release Capsules, 20 mg (OTC), of Haleon U.S. Holdings LLC. Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics Inc., USA.

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) market3 achieved annual sales of approximately USD 259.2 million.