Lupin Faces USFDA Compliance Action, Expands US Diabetes Portfolio

announced that the USFDA has classified its inspection of the Pithampur Unit 2 facility as Official Action Indicated (OAI) following an inspection conducted from July 8–17, 2025, which resulted in four observations under Form 483. The company stated it is working closely with the regulator to address the concerns and remains committed to maintaining compliance with global CGMP standards. In a separate update, Lupin launched Liraglutide injection (18 mg/3 mL) in the US market, a bioequivalent version of Victoza® by Novo Nordisk, which records annual sales of around $350 million. The product, used to improve blood sugar control in adults and children aged 10 years and above with type 2 diabetes, reinforces Lupin’s strategic focus on expanding its presence in the global diabetes care segment. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.