Lupin receives FDA approval for Rivaroxaban, manufacturing executive retires

Lupin Limited announced on September 30, 2025, that it received U.S. FDA approval for its Abbreviated New Drug Application for Rivaroxaban for Oral Suspension, 1 mg/mL. This product, bioequivalent to Xarelto® for Oral Suspension, 1 mg/mL, will be manufactured at Lupin's facility in Chhatrapati Sambhajinagar, India.

The approved drug is indicated for the treatment of venous thromboembolism (VTE) and reduction of recurrent VTE risk in pediatric patients, as well as thromboprophylaxis in pediatric patients with congenital heart disease after the Fontan procedure. The reference listed drug had estimated annual sales of $11 million in the U.S. (IQVIA MAT July 2025).

Concurrently, Lupin disclosed the retirement of Rajendra Chunodkar, president – manufacturing operations and a member of the senior management. Chunodkar's retirement is effective at the close of business hours on September 30, 2025.

These announcements were made pursuant to Regulation 30 of the SEBI Listing Regulations. The FDA approval represents a strategic product expansion and the retirement marks a change in the company's senior operational leadership.