Lupin Limited (LUPIN) and its alliance partner Natco Pharma Limited announced that the U.S FDA has approved Natco's Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials.Eribulin Mesylate Injection is the bioequivalent to the reference listed drug Halaven Injection from Eisai, Inc. It is indicated for the treatment of adults with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease, and for adults with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
According to IQVIA data (MAT April 2026), Halaven had estimated annual U.S. sales of $43.7 million. The approval of Lupin and Natco's product provide a generic alternative, expanding treatment access for patients while supporting affordability in oncology care.
Lupin, headquartered in Mumbai, India, is a pharmaceutical company with operations across more than 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Natco Pharma, based in Hyderabad, India, is known for its focus on niche pharmaceutical products and partnerships that enhance global reach.
This FDA approval underscores both companies' commitment to advancing oncology therapies and improving patient outcomes through accessible, high-quality medicines.
LUPIN has traded between INR 1,836.80 and INR 2494.00 over the past year. The stock is currently trading at INR 2,247, down 0.11%.
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