Lupin has received approval from the United States Food and Drug Administration (FDA) 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. The product will be manufactured at Lupin’s facility in Goa, India. Rufinamide Tablets (RLD Banzel) had estimated annual sales of $164 million in the U.S. (IQVIA MAT June 2022).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
