Lupin expands U.S. portfolio with launch of Liraglutide Injection

Lupin has announced the launch of its Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen in the United States.

The product is bioequivalent to Novo Nordisk Inc.s Victoza Injection, 18 mg/3 mL (6 mg/mL), and is indicated as an adjunct to diet and exercise for improving glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.

The reference drug, Victoza, has an estimated annual U.S. market sale of approximately $350 million (IQVIA MAT Aug 2025).

Spiro Gavaris, President U.S. Generics, Lupin, said, We are pleased to launch Liraglutide Injection in the U.S. This marks a significant milestone in enhancing our portfolio of complex injectables and highlights our continued commitment to making essential therapies more accessible for patients.

In an another exchange filing, Lupin disclosed that the U.S. Food and Drug Administration (FDA) conducted an inspection of its Pithampur Unit-2 manufacturing facility from 8 July to 17, July 2025. The inspection concluded with the issuance of a Form-483 citing four observations. Subsequently, the FDA classified the inspection status of the facility as Official Action Indicated (OAI).

The company affirmed it is actively working with the FDA to address the compliance issues and remains committed to meeting current Good Manufacturing Practices (cGMP) standards across all its manufacturing sites.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The company's consolidated net profit jumped 52.13% to Rs 1,219.03 crore on an 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.

The counter declined 0.49% to Rs 1,972 on the BSE.

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