Glenmark Pharmaceuticals launches Rufinamide Tablets

01 Jun 2021 Evaluate

Glenmark Pharmaceuticals has launched Rufinamide Tablets USP, 200 mg and 400 mg, 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 May 16, 2016.

According to IQVIA sales data for the 12 month period ending April 2021, the Banzel Tablets, 200 mg and 400 mg market achieved annual sales of approximately $285.3 million. 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.

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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