Glenmark Pharmaceuticals launches generic version of Eisais Banzel tablets

On Tuesday, Glenmark Pharmaceuticals Limited announced that it has launched Rufinamide tablets in the strengths of 200 mg & 400 mg, which is a therapeutic equivalent of Banzel tablets, 200 mg and 400 mg of Eisai, Inc.  

The company said in a filing to BSE that it was one of the first abbreviated new drug application (ANDA) applicants to submit a substantially complete ANDA for the drug with a paragraph IV certification. It received the final approval on May 16, 2016.   

According to data from IMS Health (IQVIA), for the 12-month period ending April 2021, Banzel tablets, 200 mg, and 400 mg achieved annual sales of approximately US$ 285.3 million.  

The drug manufacturer now has a portfolio that includes 172 products authorised for distribution in the US marketplace and 45 ANDA’s pending approval with United States Food & Drug Administration (USFDA)   

At 1.48 pm on Tuesday, the stock of Glenmark Pharmaceuticals Limited was trading at Rs 595.35, up by 0.46 per cent or Rs 2.75 per share. The 52-week high and 52-week low of the scrip was recorded at Rs 640.30 and Rs 356.20, respectively.