Mumbai, Naples, July 24, 2025: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications 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 kit¹, is bioequivalent to Glucagon for Injection, 1 mg/vial of Eli Lilly and Company. It is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus and as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. 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.”

About Lupin
Lupin Limited is a global pharmaceutical leader 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. Trusted by healthcare professionals and consumers globally, the company enjoys 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, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com  or follow us on LinkedIn https://www.linkedin.com/company/lupin

For further information or queries please contact –

Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com

*Safe Harbor Statement
Victoza® is a registered trademark of Novo Nordisk A/S.

¹ We note that the RLD upon which you have based this ANDA, Eli Lilly’s Glucagon for Injection, 1 mg/vial, is no longer being marketed in the United States and is currently listed in the discontinued section of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). The Agency has determined that Eli Lilly’s Glucagon for Injection, 1 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. FDA published this determination in the Federal Register (89 FR 64928; August 8, 2024). This determination allows the Agency to approve ANDAs for the discontinued drug product.