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Lupin gets USFDA approval for lenalidomide capsules

17-Sep-25 14:15 Hrs IST

The capsules will be available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths and are bioequivalent to REVLIMID' capsules of Bristol-Myers Squibb Company. The product will be manufactured at Lupin's Pithampur facility in India.

Lenalidomide capsules are used to treat adult patients with multiple myeloma (in combination with dexamethasone), multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplantation (auto-HSCT), and transfusion-dependent anemia caused by low- or intermediate-1-risk myelodysplastic syndromes (MDS) with a deletion 5q abnormality, with or without additional cytogenetic abnormalities.

The RLD REVLMID' version of lenalidomide had estimated annual U.S. sales of $7,511 million (IQVIA MAT July 2025).

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The company's consolidated net profit jumped 52.13% to Rs 1,219.03 crore on an 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.

Shares of Lupin fell 0.84% to Rs 2,034 on the BSE.

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