Glenmark Pharmaceuticals Ltd. has been granted final approval by the United States Food and Drug Administration (US FDA) for Topiramate Capsules USP, 15 mg and 25 mg.

Glenmark’s Topiramate Capsules USP, 15 mg and 25 mg have been determined by the FDA to be bioequivalent and therapeutically equivalent to Topamax 2 Capsules, 15 mg and 25 mg of Janssen Pharmaceuticals, Inc., and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIATM sales data for the 12 months ending May 2024, the Topamax Capsules, 15 mg and 25 mg market3 achieved annual sales of approximately USD 21.9 million.

Glenmark’s current portfolio consists of 198 products authorized for distribution in the U.S. 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. is a research-led, global pharmaceutical company, with 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.

In Vivo/Scrip 100 positions Glenmark amongst the Top 100 Companies Ranked by R&D and Pharmaceutical Sales, 2022; while Generics Bulletin/In Vivo places it in the Top 50 Generics and Biosimilars Companies Ranked by Sales, 2022. Glenmark’s Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target Initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted more than 3 million lives over the last decade through its CSR interventions.