Lupin Launches Generic Liraglutide Injection in US Market Despite FDA Manufacturing Compliance Issues
核心洞察
Lupin announced the launch of its generic Liraglutide Injection in the United States, bioequivalent to Novo Nordisk's Victoza for type 2 diabetes treatment.
The FDA issued four observations to Lupin's Pithampur Unit-2 manufacturing facility following an inspection, classifying it as Official Action Indicated (OAI).
The company also received FDA approval for Rivaroxaban oral suspension for pediatric patients with venous thromboembolism (搜索) and congenital heart disease (搜索).
Lupin Limited has launched its generic version of Liraglutide Injection in the United States market, marking a significant expansion of the company's complex injectable portfolio despite concurrent regulatory challenges at one of its manufacturing facilities.
Generic Diabetes Treatment Launch
The Indian pharmaceutical company announced the availability of Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen, which is bioequivalent to Novo Nordisk's Victoza Injection. The medication 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 (搜索).
"We are pleased to launch Liraglutide Injection in the US. This marks a significant milestone in enhancing our portfolio of complex injectables and highlights our continued commitment to making essential therapies more accessible for patients," said Spiro Gavaris, President – U.S. Generics, Lupin.
FDA Manufacturing Compliance Issues
Concurrent with the product launch announcement, Lupin disclosed that the FDA issued a Form-483 with four observations to the company's Pithampur Unit-2 manufacturing facility following an inspection conducted from July 8 to July 17, 2025. The inspection was classified as Official Action Indicated (OAI), indicating significant regulatory concerns.
The company stated it is working with the FDA to satisfactorily resolve the compliance issues and remains committed to maintaining compliance with current Good Manufacturing Practice (cGMP) standards at all its manufacturing facilities.
Additional Product Approvals
Lupin also received FDA approval for Rivaroxaban for Oral Suspension, 1 mg/mL, which launched on October 1. The product, bioequivalent to Janssen Pharmaceuticals (搜索)' Xarelto for Oral Suspension, is indicated for treatment of venous thromboembolism (搜索) (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.
The suspension is also approved for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease (搜索) after the Fontan procedure. The product will be manufactured at Lupin's Chhatrapati Sambhajinagar facility in India.
Market Impact
Following the FDA compliance disclosure, Lupin's share price fell 1 percent in opening trade on October 6, with shares trading at Rs 1,952.35, down Rs 19.65 on the BSE at 09:25 hours.