Lupin receives approval from U.S. FDA for Lenalidomide Capsules

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg. Lenalidomide Capsules are bioequivalent to Revlimid® Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, of Bristol-Myers Squibb Company. This product will be manufactured at Lupin's Pithampur facility in India.

Lenalidomide Capsules are indicated for the treatment of adult patients with:

- Multiple myeloma (MM), in combination with dexamethasone
- MM, 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.

Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg (RLD Revlimid®) had estimated annual sales of USD 7,511 million in the U.S. (IQVIA MAT July 2025).

Shares of Lupin Limited was last trading in BSE at Rs. 2031.15 as compared to the previous close of Rs. 2051.30. The total number of shares traded during the day was 19407 in over 1926 trades.

The stock hit an intraday high of Rs. 2057.00 and intraday low of 2016.80. The net turnover during the day was Rs. 39542334.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals Approval USFDA LenalidomideCapsules