Shares of Aurobindo Pharma Ltd came under pressure on Monday after the US Food and Drug Administration (USFDA) classified Eugia Pharma Specialities' Unit III manufacturing facility in Telangana as "Official Action Indicated" (OAI). The stock fell 5.42% to ₹1,393 on the NSE, making it one of the worst performers in both the Nifty Pharma index and the BSE Mid-Cap index.

Eugia Pharma Specialities, a wholly owned subsidiary of Aurobindo Pharma, received the classification following a USFDA inspection conducted between January 27 and February 6, 2026. The inspection concluded with 11 observations, and the company was informed of the OAI status on June 12, 2026.

An OAI classification indicates that the USFDA has identified significant compliance issues that may warrant regulatory or administrative action. While the facility is permitted to continue manufacturing and supplying products that have already received regulatory approval, it will not be eligible to obtain approvals for new drug applications until the identified concerns are adequately addressed.

The regulatory action weighed on investor sentiment, even though Aurobindo Pharma stated that the classification is not expected to have any impact on its existing operations or financial performance.

The development also affected the broader pharmaceutical sector, with the Nifty Pharma index declining 0.61% during an otherwise positive market session, making it the only major sectoral index trading in negative territory.

The decline comes shortly after Aurobindo Pharma announced its entry into the biologics contract manufacturing segment through the launch of TheraNym, a dedicated biologics contract manufacturing organization. However, market attention remained focused on the USFDA's regulatory observations and the timeline for corrective actions at the Eugia facility.