Glenmark Pharmaceuticals receives tentative ANDA approval for Topiramate Extended‐Release Capsules

Deepthi | Myequity news | Date : 24-01-2019 10:04:00 IST

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate Extended‐Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, a generic version of QUDEXY®1 XR Extended‐Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, of Upsher‐ Smith Laboratories, LLC.

According to IQVIATM sales data for the 12 month period ending November 2018, the QUDEXY® XR Extended‐Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg market2 achieved annual sales of approximately $84.0 million*.


About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd. (GPL) is a research‐driven, global, integrated pharmaceutical organization. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2018). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory.


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