Lupin receives approval from U.S. FDA for Rivaroxaban for Oral Suspension

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban for Oral Suspension, 1 mg/mL which is bioequivalent to Xarelto® for Oral Suspension, 1 mg/mL of Janssen Pharmaceuticals, Inc. The product will be manufactured at Lupin's Chhatrapati Sambhajinagar facility in India.

Rivaroxaban for Oral Suspension is indicated for:

- Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.

- Treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.

Rivaroxaban for Oral Suspension, 1 mg/mL (RLD Xarelto®) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT July 2025).

Shares of Lupin Limited was last trading in BSE at Rs. 1910.15 as compared to the previous close of Rs. 1931.15. The total number of shares traded during the day was 7288 in over 1205 trades.

The stock hit an intraday high of Rs. 1957.00 and intraday low of 1901.45. The net turnover during the day was Rs. 14060917.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals USFDA Approval Rivaroxaban OralSuspension