Lupin receives OAI classification from USFDA for Pithampur Unit 2 manufacturing facility

Lupin Ltd. on Saturday, October 4, said the US drug regulator has classified its inspection of the Pithampur Unit 2 manufacturing facility as ‘official action indicated’ (OAI).The US Food and Drug Administration (USFDA) had conducted inspections at the facility from July 8 to July 17, 2025, and closed it by issuing Form 483 with four observations.

Lupin, in an exchange filing on Saturday, said it is working with the US drug regulator to satisfactorily resolve the compliance issues. It said it is committed to be compliant with the current good manufacturing practices (CGMP) standards at all its manufacturing faciltiies.

On another note, Lupin on Friday, October 3, said it has launched Liraglutide injection, which to helps control blood sugar, in the United States.The injection, available in an 18 mg/3 mL single-patient prefilled pen, is used along with diet and exercise to improve blood sugar control in adults and children aged 10 years and above with type 2 diabetes.

The medicine is bioequivalent to Victoza® by Novo Nordisk, which has annual sales of around $350 million in the US.

Lupin shares ended the previous session 0.3% lower at ₹1,975 apiece. The stock has declined 16.5% this year, so far.

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