Glenmark Pharmaceuticals receives ANDA approval for Topiramate extended-release capsules

25 milligram, 50 milligram, 100 milligram, 150 milligram, and 200 milligram capsules approved

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Glenmark
Photo: Candace Mathers on Unsplash

Glenmark Pharmaceuticals (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate extended-release capsules, 25 milligram, 50 milligram, 100 milligram, 150 milligram, and 200 milligram, the generic version of Qudexy1 XR Capsules, 25 milligram, 50 milligram, 100 milligram, 150 milligram, and 200 milligram, of Upsher-Smith Laboratories, LLC.

According to IQVIATM sales data for the 12 month period ending December 2020, the Qudexy XR Capsules, 25 milligram, 50 milligram, 100 milligram, 150 milligram, and 200 milligram market achieved annual sales of approximately $120.8 million.

Glenmark’s current portfolio consists of 169 products authorized for distribution in the U.S. marketplace and 43 ANDA’s pending approval with the U.S. 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.

*IQVIATM National Sales Perspectives: Retail & Non-Retail, December 2020

Glenmark Pharmaceuticals (GPL) is a global research-led pharmaceutical company with presence across generics, specialty, and OTC business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology, and oncology. It is ranked among the top 80 pharma and biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). The company has been listed in the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world’s most respected and widely accepted sustainability benchmarks globally with only the top-ranked companies in terms of corporate sustainability within each industry are featured in the index.

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