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Glenmark Pharma Receives US FDA Approval for Topiramate Capsules USP, 15 mg and 25 mg

18 Jul 2024
Admin
News Article

Glenmark Pharma Receives US FDA Approval for Topiramate Capsules USP, 15 mg and 25 mg

Overview

Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led, global pharmaceutical company, has received final approval by the United States Food & Drug Administration (FDA) for topiramate capsules USP, 15 mg and 25 mg.

Topiramate Capsules & FDA

Glenmark’s topiramate capsules USP, 15 mg and 25 mg has been determined by the US FDA to be bioequivalent and therapeutically equivalent to Topamax capsules, 15 mg and 25 mg of Janssen Pharmaceuticals, Inc., and will be distributed in the US by Glenmark Pharmaceuticals Inc., USA.

Annual sales

According to IQVIA sales data for the 12-month period ending May 2024, the Topamax capsules, 15 mg and 25 mg market achieved annual sales of approximately $21.9 million.

Glenmark’s Portfolio

Glenmark’s current portfolio consists of 198 products authorized for distribution in the US 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.

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.