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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 ....

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


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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. ....

United States , Upsher Smith Laboratories , Glenmark Pharmaceuticals Limited , United States Food Drug Administration , United States Food , Drug Administration , Topiramate Extended Release Capsules , ஒன்றுபட்டது மாநிலங்களில் , க்ளேண்மர்க் மருந்துகள் வரையறுக்கப்பட்டவை , ஒன்றுபட்டது மாநிலங்களில் உணவு ,

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 acc ....

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