Lupin Ltd has received tentative approval from the US Food and Drug Administration (USFDA) for its generic formulations of Liraglutide and Glucagon, marking a strategic leap in its diabetes and emergency medicine offerings.
Key Highlights
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- Liraglutide, a GLP-1 receptor agonist, is approved as a generic version of Victoza for type 2 diabetes management. It complements diet and exercise to improve glycemic control.
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- Glucagon is used for treating severe hypoglycemia and as a diagnostic aid in radiologic exams of the gastrointestinal tract.
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- Both drugs will be manufactured at Lupin’s Pithampur facility in India, known for its compliance with global regulatory standards.
Strategic Impact
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- The approvals strengthen Lupin’s US generics pipeline and reinforce its leadership in chronic therapy areas.
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- Liraglutide’s approval helps address the GLP-1 drug shortage in the US, while Glucagon adds to Lupin’s emergency care portfolio.
Sources: Financial Express, JAMA Network, USFDA, Lupin.com.