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Glenmark Pharmaceuticals Receives FDA Approval for Esomeprazole Magnesium Capsules

20 June 20242 mins read by Angel One
Glenmark Pharma has received US FDA approval for Esomeprazole Magnesium Capsules, equivalent to Nexium®. Glenmark will distribute the capsules in the US.
Glenmark Pharmaceuticals Receives FDA Approval for Esomeprazole Magnesium Capsules
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On June 12, 2024, Glenmark Pharmaceuticals Limited informed in a stock exchange filing that the company got final approval from the United States Food and Drug Administration (US FDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC). The FDA has determined these capsules to be bioequivalent to Nexium® 24 HR Delayed-Release Capsules, 20 mg (OTC), of Haleon U.S. Holdings LLC. Glenmark Therapeutics Inc., USA, will distribute Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), in the United States.

For the latest 52-week period ending May 18, 2024, Nielsen® syndicated data indicates that the Nexium® 24 HR Delayed-Release Capsules, 20 mg (OTC) market generated approximately $259.2 million in annual sales.

Glenmark currently has 197 products approved for distribution in the United States market, along with 50 Abbreviated New Drug Applications (ANDAs) awaiting approval from the United States Food and Drug Administration. Apart from these internal submissions, Glenmark actively seeks external development partnerships to complement and expedite the expansion of its pipeline and product portfolio.

Meanwhile, Glenmark Specialty S.A. (Glenmark), a subsidiary of Glenmark Pharmaceuticals Ltd signed an exclusive marketing and distribution agreement with BeiGene, a global oncology company. The company stated that under this agreement, Glenmark will register and commercialise BeiGene’s oncology medicines, Tislelizumab and Zanubrutinib, in India.

In the fourth quarter of FY 2023-24, Glenmark’s consolidated revenue stood at ₹30,630 million, marking a 2.1% year-on-year increase from ₹30,005 million. For the fiscal year ending March 31, 2024, Glenmark’s consolidated revenue reached ₹1,18,131 million, reflecting a 2% increase compared to the previous corresponding period’s ₹1,15,832 million.

About Glenmark Pharmaceuticals Ltd

Glenmark Pharmaceuticals Ltd is an international pharmaceutical company known for its research-driven approach, offering a range of products in the generics, speciality, and OTC sectors. It operates in more than 80 countries worldwide.

On June 12, 2024, the share price of Glenmark Pharmaceuticals Ltd opened at ₹1,195.00, touching the day’s high at ₹1,204.00, as of 1:32 PM on the NSE.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.

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