Lupin and Natco Receive Approval from U.S. FDA for Eribulin Mesylate Injection

Mumbai, India and Naples, Florida - Global pharmaceutical company Lupin Limited and its alliance partner Natco Pharma Limited have received approval from the United States Food and Drug Administration (U.S. FDA) for 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 bioequivalent to the reference listed drug (RLD) Halaven® Injection, developed by Eisai, Inc. The injection is indicated for the treatment of adults with metastatic breast cancer who have undergone at least two previous chemotherapeutic regimens for metastatic disease, as well as for patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

Estimated annual sales for Eribulin Mesylate Injection (RLD Halaven®) in the U.S. reached USD 43.7 million as of April 2026, according to IQVIA.

Lupin Limited, headquartered in Mumbai, distributes its products in over 100 markets worldwide. The company specializes in various pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. With a robust presence in both India and the U.S., Lupin operates 15 manufacturing sites and seven research centers globally, employing over 24,000 professionals.