Lupin bags USFDA approval for Multiple myeloma treatment
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-09-17 12:49 GMT | Update On 2025-09-17 12:49 GMT
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Mumbai: Global pharma major Lupin Limited has announced that the company 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, 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).
Read also: Lupin wins USFDA nod for Risperidone for extended-release injectable suspension for schizophrenia
Strengthening its oncology portfolio, last year Lupin launched Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials in the United States.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
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