Lupin Gains USFDA Approval for Cancer Drug Lenalidomide

Lupin has been granted approval by the USFDA to market Lenalidomide Capsules, a cancer treatment drug, in the US. The drug, a bioequivalent to Revlimid by Bristol-Myers Squibb, will be produced at Lupin's Pithampur facility. Lenalidomide addresses cancers like multiple myeloma.


Devdiscourse News Desk | New Delhi | Updated: 17-09-2025 15:49 IST | Created: 17-09-2025 15:49 IST
Lupin Gains USFDA Approval for Cancer Drug Lenalidomide
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In a significant development for pharmaceutical company Lupin, the firm has announced its successful acquisition of approval from the US Food and Drug Administration (USFDA) to commercialize Lenalidomide Capsules in the United States.

The cancer treatment medicine is expected to compete with Bristol-Myers Squibb Company's Revlimid, as Lupin highlights its bioequivalence. Production is set to commence at the company's Pithampur plant.

This move comes as IQVIA data reveals the drug's strong market potential, with annual US sales estimates reaching USD 7,511 million. Meanwhile, Lupin's stock showed a slight decline on the Bombay Stock Exchange (BSE).

(With inputs from agencies.)

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