Lupin wins USFDA nods for Liraglutide, Glucagon Injectable Products
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-07-24 05:44 GMT | Update On 2025-07-24 05:44 GMT
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Mumbai: Global pharma major Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) for Liraglutide Injection Single-Patient-Use Prefilled Pens and Glucagon for Injection vials.
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India.
Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen is bioequivalent to Victoza Injection, 18 mg/3 mL (6 mg/mL) of 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 older, with type 2 diabetes mellitus.
Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen (RLD Victoza) had an estimated annual sale of USD 458 million in the U.S. (IQVIA MAT May 2025).
Glucagon for Injection USP, 1 mg/vial, packaged in an emergency kit, is bioequivalent to Glucagon for Injection, 1 mg/vial of
Glucagon for Injection USP, 1 mg/vial, had an estimated annual sale of USD 124 million in the U.S. (IQVIA MAT May 2025).
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.”
Lupin Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
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