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Glenmark Pharma bags USFDA nod for Topiramate Extended-Release Capsules

Ruchika SharmaWritten by Ruchika Sharma Published On 2021-02-04T12:21:46+05:30  |  Updated On 4 Feb 2021 6:52 AM GMT
Glenmark Pharma bags USFDA nod for Topiramate Extended-Release Capsules
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Mumbai: Drug major, Glenmark Pharmaceuticals Limited, has recently announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.The product is a generic version of Qudexy XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, of...

Mumbai: Drug major, Glenmark Pharmaceuticals Limited, has recently announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.

The product is a generic version of Qudexy XR 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 December 2020, the Qudexy XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg 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," Glenmark said in a filing.

Read also: Glenmark gets USFDA nod for amphetamine sulfate tablets to treat ADHD

Glenmark Pharmaceuticals Ltd. (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.

Read also: Glenmark gets CDSCO panel conditional nod to Minocycline Hydrochloride Topical Gel





glenmark pharmaglenmark pharma newsusfdatopiramate extended-release capsulesqudexy xr capsules
Ruchika Sharma
Ruchika Sharma

    M.Com

    Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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