Lupin gets USFDA approval for Rufinamide Tablets USP

18 Aug 2022 , 02:31 PM

Global pharma major Lupin Limited on Thursday has announced that it has received United States Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA), Rufinamide Tablets USP, 100 mg, 200 mg, and 400 mg, to market a generic equivalent of Banzel Tablets, 100 mg, 200 mg, and 400 mg, of Eisai Inc. 

In addition to this, the product will be manufactured at Lupin’s facility located in Goa, India.

According to the IQVIA MAT June 2022, Rufinamide Tablets (RLD Banzel) had estimated annual sales of USD 164 million in the U.S.

At around 2:31 PM, Lupin Ltd was trading at Rs688.75 per share up by Rs1.2 or 0.17% from its previous closing of Rs687.55 per share on the BSE.