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Glenmark Pharma launches Rufinamide Tablets

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Glenmark Pharmaceuticals on Tuesday announced the launch of Rufinamide Tablets USP, 200 mg and 400 mg.

The tablets are a therapeutic equivalent of Banzel Tablets, 200 mg and 400 mg of Eisai Inc. Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA for Rufinamide Tablets USP, 200 mg and 400 mg, with a paragraph IV certification and received final approval on 16 May 2016.

According to IQVIA sales data for the 12-month period ending April 2021, the Banzel Tablets achieved annual sales of approximately $285.3 million.

Commenting on the launch, Sanjeev Krishan, president of Glenmark North America said, We are very pleased to be one of the first generic companies in the US to offer lower cost alternative to Banzel Tablets, 200 mg and 400 mg. The launch is our commitment to provide quality and affordable healthcare to our markets for patients.

 

Glenmark's current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 45 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 were trading 0.74% higher at Rs 597 on BSE.

Glenmark Pharmaceuticals is a global research‐led pharmaceutical company with presence across generics, specialty and OTC business with operations in over 50 countries.

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First Published: Jun 01 2021 | 9:16 AM IST

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