Lupin receives tentative approval from U.S. FDA for Siponimod Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Siponimod Tablets, 0.25 mg, 1 mg and 2 mg. This product would be manufactured at Lupin's Pithampur facility in India.

Siponimod Tablets, 0.25 mg, 1 mg and 2 mg are bioequivalent to Mayzent® Tablets, 0.25 mg, 1 mg and 2 mg of Novartis Pharmaceuticals Corporation, and indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.

Siponimod Tablets (RLD Mayzent®) had estimated annual sales of USD 195 million in the U.S. (IQVIA MAT October 2025).

Shares of Lupin Limited was last trading in BSE at Rs. 2097.65 as compared to the previous close of Rs. 2091.95. The total number of shares traded during the day was 16290 in over 1379 trades.

The stock hit an intraday high of Rs. 2104.80 and intraday low of 2083.90. The net turnover during the day was Rs. 34179180.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals TentativeApproval USFDA SiponimodTablets