Lupin gets US FDA nod for generic drug Lenalidomide in multiple potencies

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Mumbai-based drugmaker Lupin on Wednesday said that it has received approval from the United States Food and Drug Administration (US FDA) for a generic version of Lenalidomide capsules in multiple strengths—2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.

 

The company said that these capsules are used to treat adult patients with multiple myeloma, a blood cancer that develops in plasma cells in the bone marrow. The treatments include:

 

• Multiple myeloma, in combination with dexamethasone.
• Multiple myeloma, 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.

 

It further added that Lenalidomide capsules are a generic equivalent of Bristol Myers Squibb’s Revlimid, a drug used for similar treatment. Lupin's drug will be manufactured at its Pithampur facility in Madhya Pradesh.

 

The announcement comes a day after Lupin said the US FDA had inspected its Nagpur injectable facility between September 8 and 16, issuing six observations.

 

Earlier this month, the company also secured US FDA approval for its generic risperidone extended-release injectable suspension, used in the treatment and maintenance of schizophrenia and bipolar disorder in adults.

 

Lupin Q1 result

The drugmaker reported a 52 per cent year-on-year (Y-o-Y) rise in consolidated profit after tax (PAT) to ₹1,221 crore for the first quarter of financial year 2025-26 (Q1 FY26), up from ₹805 crore a year earlier, supported by strong sales in the US and India.

 

Total sales for the quarter stood at ₹6,164 crore, including US sales of ₹2,404 crore.

 

Lupin's shares were trading at ₹2,035.4 apiece, down 0.7 per cent, on the BSE at 1.54 pm.