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Glenmark Pharmaceuticals receives ANDA approval for Topiramate Extended-Release Capsules

Glenmark Pharmaceuticals receives ANDA approval for Topiramate Extended-Release Capsules Posted On: 2021-02-02 20:38:31 (Time Zone: Arizona, USA) Glenmark Pharmaceuticals Limited (Glenmark) has received final 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, the generic version of Qudexy® XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, of Upsher-Smith Laboratories, LLC. According to IQVIA™ 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 accel

Glenmark Pharmaceuticals receives ANDA approval for Topiramate Extended-release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg

Glenmark Logo Glenmark Pharmaceuticals receives ANDA approval for Topiramate Extended-release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg ANI | Updated: Feb 03, 2021 12:22 IST Mumbai (Maharashtra) [India], February 3 (ANI/PRNewswire): Glenmark Pharmaceuticals Limited (Glenmark) has received final 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, the generic version of Qudexy®1 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 market2 achieved annual sales of approximately $120.8 million.

Glenmark Pharmaceuticals receives ANDA approval for Amphetamine Sulfate Tablets USP, 5 mg, 10 mg

Glenmark Pharmaceuticals receives ANDA approval for Amphetamine Sulfate Tablets USP, 5 mg, 10 mg ANI | Updated: Jan 29, 2021 11:41 IST Mumbai (Maharashtra) [India], January 29 (ANI/PRNewswire): Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg, the generic version of Evekeo 1 Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC. According to IQVIATM sales data for the 12 month period ending November 2020, the Evekeo Tablets, 5 mg and 10 mg market2 achieved annual sales of approximately USD 21.5 million. Glenmark s current portfolio consists of 168 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

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