MARKETS

Lupin Falls 2% After USFDA Issues OAI for Pithampur Unit 2

Lupin
Lupin will receive an upfront licence fee along with royalties on net sales.

Shares of Lupin Ltd fell 2% on 6th October after touching a day’s high of Rs 1,972.90. This occurred as the company announced that the US drug regulator has classified its inspection of the Pithampur Unit 2 manufacturing facility as ‘official action indicated’ (OAI).

The USFDA inspected Lupin’s Pithampur Unit 2 plant between 8th and 17th July, 2025. It later issued a Form 483 with four observations.

In an exchange filing on Saturday, Lupin stated that it is working closely with the US USFDA to resolve the issues. It remains committed to adhering to current good manufacturing practices (CGMP) across all its facilities.

Separately, on 3rd October, Lupin announced the launch of Liraglutide injection in the US. The drug, available in an 18 mg/3 mL prefilled pen, is used with diet and exercise to manage blood sugar in adults and children over 10 years with type 2 diabetes.

The injection is a bioequivalent version of Victoza, manufactured by Novo Nordisk. It generates annual US sales of approximately $350 million.

At 10:50 AM, the shares of Lupin Ltd were trading 1.78% lower at Rs 1,938.50 on NSE.

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