Glenmark Pharmaceuticals Secures FDA Approval for Topiramate Capsules

On July 17, 2024, Glenmark Pharmaceuticals Ltd announced via a stock exchange filing that it had received final approval from the U.S. FDA for its Topiramate Capsules USP, available in 15 mg and 25 mg doses.

These capsules are equivalent to Topamax® Capsules by Janssen Pharmaceuticals, Inc., and will be sold in the U.S. by Glenmark Pharmaceuticals Inc., USA. In the year ending May 2024, Topamax® Capsules 15 mg and 25 mg had annual sales of about $21.9 million, according to IQVIA™. Glenmark currently has 198 products approved for sale in the U.S. and 50 more awaiting approval. The company also seeks external partnerships to boost its product pipeline and portfolio.

In their recent press release on June 12, 2024, Glenmark Specialty SA announced that the U.S. FDA had approved its Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC). These capsules are equivalent to Nexium® 24 HR Delayed-Release Capsules, 20 mg (OTC) by Haleon U.S. Holdings LLC and will be sold in the U.S. by Glenmark Therapeutics Inc., USA.

Financial Highlights

Results for the January-March quarter of fiscal year 2023-24 (Q4FY24), Glenmark Pharmaceuticals Ltd reported a net loss of ₹1,238.6 crore, up from a net loss of ₹549.4 crore in the same period last year. The company’s revenue for the 4th quarter of FY24 was ₹3,063 crore, compared to ₹3,000.5 crore a year ago.

Operationally, Glenmark’s earnings before interest, taxes, depreciation, and amortisation (EBITDA) for the March quarter increased by 26.7% to ₹504.2 crore, up from ₹398 crore in the same period last year. The EBITDA margin also improved to 16.5% from 13.3% year-over-year.

About Glenmark Pharmaceuticals Ltd

Glenmark Pharmaceuticals Ltd is a global pharmaceutical company known for research and operates in Branded, generic, and OTC markets. It focuses on respiratory, dermatology, and oncology treatments. The company has 11 top-notch manufacturing plants across 4 continents and operates in over 80 countries.

On July 18, 2024, Glenmark Pharmaceuticals Ltd’s share price opened at ₹1,422.00, touching the day’s low of ₹1,413.00 as of 09:52 AM on the NSE.

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