Lupin receives approval from U.S. FDA for Rufinamide Tablets USP

Global pharma major Lupin Limited (Lupin) today announced that it 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 USD 164 million in the U.S. (IQVIA MAT June 2022).

Shares of Lupin Limited was last trading in BSE at Rs. 687.55 as compared to the previous close of Rs. 684.10. The total number of shares traded during the day was 31401 in over 2236 trades.

The stock hit an intraday high of Rs. 692.00 and intraday low of 679.55. The net turnover during the day was Rs. 21562789.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 USFDA ANDAApproval RufinamideTablets EisaiInc Banzel GenericEquivalent