Global pharma giant Lupin has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Liraglutide Injection Single-Patient-Use Prefilled Pens and Glucagon for Injection vials.

Both products will be manufactured at Lupin’s injectable facility in Nagpur.

Dr. Shahin Fesharaki, Chief Scientific Officer, Lupin said, “We are pleased to obtain the USFDA approvals for two of our complex injectable products. This is a meaningful enhancement to our portfolio and reaffirms our commitment to expanding access to critical therapies for our patients.”

Liraglutide Injection, 18 mg/3 mL (6 mg/mL) is the generic version of Victoza by Novo Nordisk Inc. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and above with type 2 diabetes mellitus. The reference drug Victoza recorded annual US sales of approximately USD 458 million.

Glucagon for Injection USP, 1 mg/vial, packaged in an emergency kit, is bioequivalent to Eli Lilly's Glucagon for Injection. It is used for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus and as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. The product had estimated US annual sales of USD 124 million.

Headquartered in Mumbai, Lupin is a global pharmaceutical leader with a presence in over 100 countries through its subsidiaries — Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Lupin specialises in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients (APIs).

The company holds a strong position in the US and Indian markets across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.

The company operates 15 manufacturing sites and seven research centers globally.