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Lupin Secures US FDA Approvals for Key Injectables
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Global pharmaceutical company Lupin Limited announced on July 24, 2025, that it has received approvals from the U.S. Food and Drug Administration (FDA) for two of its Abbreviated New Drug Applications (ANDAs): Liraglutide Injection Single-Patient-Use Prefilled Pens and Glucagon for Injection vials. Both products will be manufactured at Lupin's injectable facility in Nagpur, India.

The Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen, is a bioequivalent version of Novo Nordisk Inc.'s Victoza® Injection. 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. Victoza® had estimated annual U.S. sales of $458 million as of May 2025. The Glucagon for Injection USP, 1 mg/vial, packaged in an emergency kit, is bioequivalent to Eli Lilly and Company's Glucagon for Injection. This product is indicated for the treatment of severe hypoglycemia in pediatric and adult diabetic patients and as a diagnostic aid to temporarily inhibit gastrointestinal tract movement during radiological examinations in adults. Glucagon for Injection USP had estimated annual U.S. sales of $124 million as of May 2025. Dr. Shahin Fesharaki, Chief Scientific Officer at Lupin, expressed satisfaction with these approvals, highlighting them as a significant enhancement to Lupin's portfolio and a reaffirmation of their commitment to expanding access to critical therapies. Lupin, headquartered in Mumbai, India, is a global pharmaceutical leader with a presence in over 100 markets, specializing in a wide range of pharmaceutical products, including complex generics and active pharmaceutical ingredients, and maintains a strong position in key therapy areas in India and the U.S. The company operates 15 manufacturing sites and 7 research centers globally, supported by a workforce of over 24,000 professionals, and is dedicated to improving patient health outcomes through its various subsidiaries.