Lupin share price fell 1 percent in the opening trade on October 6 following the company received four observations to its Pithampur unit from USFDA.
At 09:25 hrs Lupin was quoting at Rs 1,952.35, down Rs 19.65, or 1.00 percent, on the BSE.
The USFDA issued a Form-483 with four observations to company's Pithampur Unit-2 manufacturing facility, on completion of inspection between from July 8 to July 17, 2025.
The inspection classified as Official Action Indicated (OAI).
The company is working with the USFDA to satisfactorily resolve the compliance issues and is committed to be compliant with CGMP standards at all its manufacturing facilities.
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In another development, the company announced the launching of Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen, in the United States, which is bioequivalent to Victoza Injection of Novo Nordisk Inc," company said in its press release.
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.
“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.
On October 1 the company launched Rivaroxaban for Oral Suspension, 1 mg/mL, in the United States for i) treatment of venous thromboembolism (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 and ii) treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.
On September 30, the company received approval from the USFDA for its Abbreviated New Drug Application for Rivaroxaban for Oral Suspension, 1 mg/mL which is bioequivalent to Xarelto for Oral Suspension, 1 mg/mL of Janssen Pharmaceuticals, Inc. The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India.
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