Mumbai, Naples, September 17, 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 Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg. Lenalidomide Capsules are bioequivalent to Revlimid® Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, of Bristol-Myers Squibb Company. This product will be manufactured at Lupin’s Pithampur facility in India.

Lenalidomide Capsules are indicated for the treatment of adult patients with:

• Multiple myeloma (MM), in combination with dexamethasone
• MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT)
• Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.

Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg (RLD Revlimid®) had estimated annual sales of USD 7,511 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
Revlimid® is the registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company.