Lupin Secures U.S. FDA Nod for Lenalidomide Capsules Across Six Strengths

Mumbai, 17th September 2025: Lupin Limited (NSE: LUPIN, BSE: 500257), one of the leading pharmaceutical companies in the country, announced that it has received an approval from the US FDA for its Abbreviated New Drug Application of Lenalidomide Capsules across six strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg. These capsules are bioequivalent to Revlimid® of Bristol Myers Squibb. The production will be carried out at the company’s Pithampur facility in India.

The product is critical as it helps in treating multiple myeloma and myelodysplastic syndromes. The treatment costs of these two crucial issues are USD 7.51 billion annually, as per IQVIA MAT July 2025 data.

Stock Market Reaction

Following the announcement by the company, the stock traded steadily on the exchanges and closed at ₹2029 (1.11% lower than the previous day’s closing price). The intraday high and low were ₹2057.80 and ₹2015.00. The company’s P/E ratio is 25.33 compared to the industrial average of 35.16. Over 6.72 lakh shares were traded today, and the stock has surged close to 2.80% in the past month.

Strategic Impact

The approval strengthens Lupin’s complex generics pipeline in the U.S., adding scale to its oncology and hematology portfolio. With the large U.S. market opportunity for Lenalidomide, Lupin is expected to see enhanced revenue visibility over the medium term.

REF: https://nsearchives.nseindia.com/corporate/Lupin2_17092025130428_SE_IntimationLetter_with_PressRelease_17092025.pdf

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