Glenmark gets USFDA approval for Rufinamide tablets; up 2%

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26 Aug, 2025 12:21

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Moneycontrol BureauShares of Glenmark Pharma rose 2 percent intraday Thursday as it has received final approval for Rufinamide tablets.Glenmark Pharmaceuticals Inc. USA has been granted final approval by the United States Food and Drug Administration (USFDA) for its Rufinamide tablets USP, 200 mg and 400 mg.Rufinamide tablets is a therapeutic equivalent of Banzel tablets, 200 mg and 400 mg of Eisai, Inc. With this approval the company is eligible for 180 days of shared generic drug exclusivity for Rufinamide tablets USP, 200 mg and 400 mg.According to IMS Health sales data for the 12 months period ending March 2016, the Banzel market achieved annual sales of approximately USD 155.1 million.Glenmark's current portfolio consists of 113 products authorized for distribution in the US marketplace and 63 ANDA's pending approval with the USFDA.The company's March quarter consolidated net profit increased to Rs 143.04 crore compared to net profit of Rs 10.61 crore during the same quarter last fiscal.At 10:02 hrs Glenmark Pharma was quoting at Rs 863.60, up Rs 13.70, or 1.61 percent on the BSE.Posted by Rakesh Patil