Lupin, Natco Pharma gets USFDA approval for breast cancer injection; here's how the stocks are faring

Pharma major Lupin, along with its alliance partner Natco Pharma, on Wednesday, June 3, received the United States Food and Drug Administration (US FDA) approval for Eribulin Mesylate injection.

The injection is indicated for the treatment of adults with metastatic breast cancer who have previously received at least two chemotherapy regimens for metastatic disease. It is also approved for patients with liposarcoma that cannot be removed by surgery or that has spread, who have already been treated with a chemotherapy that includes anthracycline.

Eribulin mesylate injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials, with estimated annual US sales of $43.7 million, is bioequivalent to the reference listed drug Halaven Injection by Eisai, Inc.

“Global pharma major Lupin Limited (Lupin) and its alliance partner Natco Pharma Limited (Natco) today announced the 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", the company said in a regulatory filing.

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai with products distributed in over 100 markets. The company specialises in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

Lupin & Natco Pharma Q4 results

Lupin had reported a strong performance in Q4 FY26, with consolidated net profit rising 89% year-on-year (YoY) to ₹1,460 crore from ₹773 crore in the same quarter last year. Revenue from operations grew 32% to ₹7,475 crore compared to ₹5,667 crore, reflecting robust business momentum during the quarter.

The drugmaker’s EBITDA surged 88% YoY to ₹2,486 crore from ₹1,321 crore, while EBITDA margin expanded significantly to 33.3% from 23.3% a year ago.

Natco Pharma had posted a 34% fall in consolidated net profit to ₹268 crore for Q4 FY26, compared with ₹406.6 crore in the same period last year.

Its revenue from operations declined 39.5% to ₹739 crore in the March quarter against ₹1,221 crore a year ago. Earnings before interest, tax, depreciation and amortisation (EBITDA) slipped sharply by 77% to ₹127.5 crore from ₹548 crore. The EBITDA margin contracted to 17.2% from 45% in the year.

Share price trends

Shares of both Lupin and Natco Pharma were trading lower on Wednesday. At 11:45 AM, Lupin shares were trading flat down at ₹2,249.10 on NSE, while Natco Pharma stock was trading at ₹917.30 apiece, declining 2.34%.

Since the beginning of the year, Lupin's shares have jumped 7%, and its market capitalisation stands at ₹1.03 lakh crore.

Natco Pharma, with a market capitalisation of ₹16,359.90 crore, has gained 3% so far since the beginning of 2026.