USFDA action on Eugia unit II puts Aurobindo Pharma shares in focus

Shares of Aurobindo Pharma Ltd. will be in focus on Wednesday, March 18, after the company said that the US Food and Drug Administration (USFDA) has classified its Eugia Pharma Unit II as "Official Action Indicated" (OAI).

The inspection at Unit II was conducted between November 3 and November 14, during which the regulator issued nine observations.

The company, however, said it does not foresee any material impact on its business from this development.

This comes amid recent regulatory scrutiny across its facilities.

The USFDA had also inspected the company's Unit III, a formulation manufacturing facility, between January 27 and February 6, 2026, where 11 observations were issued.

Earlier, the same unit had been classified under OAI status in May 2024 and subsequently received a warning letter in August 2024.

Aurobindo Pharma's December quarter performance remained strong. The company reported earnings that were largely ahead of estimates, while margins were in line with expectations.

Growth during the quarter was driven by robust performance in the European market, where revenue increased 27% year-on-year. The anti-retroviral segment also posted healthy growth of 22.5% year-on-year.

The United States business exceeded analyst expectations, while research and development expenditure stood at 4.7% of sales, amounting to ₹409 crore.

Shares of Aurobindo Pharma Ltd. settled 0.80% higher at ₹1,289.80 on Tuesday. The stock has gained 11% over the past one month.