Industry Outlook Team | Wednesday, 17 September 2025
Lupin, a pharmaceutical company based in Mumbai, announced on Wednesday that the US Food and Drug Administration (US FDA) had approved a generic version of Lenalidomide capsules in many strengths, including 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.
According to the manufacturer, adult patients with multiple myeloma, a blood malignancy that arises in bone marrow plasma cells, are treated with these capsules. The therapy is recommended for the maintenance of multiple myeloma after autologous hematopoietic transplantation (auto-HSCT) and for multiple myeloma in conjunction with dexamethasone.
Transfusion-dependent anemia caused by low or intermediate-1-risk myelodysplastic syndromes (MDS) linked to a deletion 5q anomaly, with or without other cytogenetic abnormalities, is another condition for which it is given.
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It also stated that Lenalidomide capsules are a generic equivalent of Bristol Myers Squibb’s Revlimid, which is used for the same indications. Lupin’s drug will be manufactured at its facility in Pithampur, Madhya Pradesh. The announcement came a day after Lupin said the US FDA had conducted an inspection of its Nagpur injectable plant, from September 8 to September 16, during which it issued six observations.
The company also mentioned that it had received US FDA approval earlier this month for its generic risperidone extended-release injectable suspension - indicated for the next generation- treatments and maintenance of schizophrenia as well as bipolar disorder, in adults.
