Glenmark Pharmaceuticals receives ANDA approval for Topiramate Capsules USP, 15 mg and 25 mg

Glenmark Pharmaceuticals Ltd. (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate Capsules USP, 15 mg and 25 mg. Glenmark's Topiramate Capsules USP, 15 mg and 25 mg has been determined by the FDA to be bioequivalent and therapeutically equivalent to Topamax® Capsules, 15 mg and 25 mg of Janssen Pharmaceuticals, Inc., and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIAâ„¢ sales data for the 12-month period ending May 2024, the Topamax® Capsules, 15mg and 25 mg market achieved annual sales of approximately $21.9 million*.

Glenmark's current portfolio consists of 198 products authorized for distribution in the U.S. marketplace and 50 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.

Shares of Glenmark Pharmaceuticals Limited was last trading in BSE at Rs. 1410.50 as compared to the previous close of Rs. 1407.75. The total number of shares traded during the day was 9293 in over 954 trades.

The stock hit an intraday high of Rs. 1426.70 and intraday low of 1405.80. The net turnover during the day was Rs. 13129693.00.

Source : Equity Bulls

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GlenmarkPharmaceuticals INE935A01035 USFDA ANDA Approval TopiramateCapsules