Pharma major Glenmark Pharmaceuticals Limited on Tuesday announced the launch of Rufinamide tablets, 200 mg and 400 mg, a therapeutic equivalent of Banzel tablets, 200 mg and 400 mg of Eisai, Inc.
In a statement issued Glenmark said it was one of the first Abbreviated New Drug Application (ANDA) applicants to submit a substantially complete ANDA for Rufinamide tablets.
Commenting on the launch, Sanjeev Krishan, President, 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.”
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 US marketplace and 45 ANDA’s pending approval with the US Food and Drug Administration (USFDA).