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Lupin Secures FDA Nod for Liraglutide and Glucagon Injectables

Lupin Strengthens Diabetes Care Portfolio

In a significant stride towards expanding its complex generics portfolio, Lupin Limited, a global pharmaceutical leader based in Mumbai, has received the U.S. Food and Drug Administration (USFDA) approval for two crucial injectable therapies—Liraglutide Injection and Glucagon for Injection.

These approvals mark a strategic win for Lupin as it continues to strengthen its presence in the U.S. diabetes care market, one of the largest globally.

🔬 Liraglutide: A Key Addition in Type 2 Diabetes Therapy

Lupin’s Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen has been deemed bioequivalent to Victoza® by Novo Nordisk Inc., a well-established injectable used as an adjunct to diet and exercise for glycemic control in adults and children aged 10 and older with type 2 diabetes.

With estimated annual U.S. sales of $458 million (IQVIA MAT, May 2025), Victoza®’s generic equivalent opens a pathway for more affordable therapy options in diabetes management.

🚑 Glucagon: A Life-Saving Emergency Medication

Also approved is Lupin’s Glucagon for Injection USP, 1 mg/vial, bioequivalent to Eli Lilly’s Glucagon Emergency Kit. The product is vital in treating severe hypoglycemia in diabetic patients and also serves as a diagnostic aid during gastrointestinal radiologic exams.

This product segment too represents a notable market, with estimated U.S. annual sales of $124 million (IQVIA MAT, May 2025).

🏭 Made in India, Approved Globally

Both injectable products will be manufactured at Lupin’s world-class injectable facility in Nagpur, reflecting India’s growing prowess in complex generics manufacturing.

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

🌍 About Lupin

Lupin operates across 100+ markets, offering a wide portfolio of branded and generic pharmaceuticals, biosimilars, and APIs. With 15 manufacturing sites, 7 research centers, and a team of over 24,000 professionals, the company continues to push boundaries in drug development and patient-centric healthcare innovations.


📢 This milestone underscores Lupin’s strategic focus on building a resilient pipeline of complex generics and biosimilars to address pressing global health needs.

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Biopatrika News Desk
Biopatrika News Deskhttp://www.biopatrika.com
Life science news, jobs, careers, fellowships, admissions, and interviews. BioPatrika covers academia, startups, and industry, bridging the gap between science and society

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