Glenmark Bags US FDA Approval for Esomeprazole Magnesium

Glenmark Specialty SA (Glenmark) has secured final endorsement by the US Food and Drug Administration (FDA) for esomeprazole magnesium delayed-release capsules USP, 20), determined by the FDA to be bioequivalent to Nexium 24 HR deferred discharge capsules, 20 mg (OTC), of Haleon US Holdings LLC.

Glenmark Therapeutics Inc., USA, will distribute Esomeprazole magnesium delayed-release capsules USP, 20 mg (OTC), in the United States. The Nexium 24 HR delayed-release capsules, 20 mg (OTC) market generated approximately $259.2 million in annual sales, according to syndicated Nielsen data for the most recent 52 weeks ending May 18, 2024.

The firm's ongoing portfolio comprises of 197 items approved for distribution in the US commercial center and 50 ANDA's pending endorsement with the US FDA. Notwithstanding these inward filings, Glenmark proceeds to distinguish and investigate outer advancement agreements to enhance and speed up the development of its current pipeline and portfolio.

Glenmark Pharmaceuticals Ltd. is a global pharmaceutical company driven by research that operates in the branded, generic, and over-the-counter (OTC) sectors and focuses on respiratory, dermatology, and oncology therapeutic fields. The organization has 11 elite assembling offices spread across 4 continents, and tasks in more than 80 nations. In the beginning, they sold their products in Africa, India, and Russia. In 1999, they went public in India and used some of the proceeds to build their first research facility.