Mumbai, Naples, September 30, 2025: 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).

 About Lupin

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com  or follow us on LinkedIn https://www.linkedin.com/company/lupin

For further information or queries please contact –
Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com

*Safe Harbor Statement
Xarelto® is the registered trademark of Bayer Aktiengesellschaft