Aurobindo Pharma has announced that Unit I of its wholly owned subsidiary, Eugia Pharma Specialities has received a Warning Letter from the US Food and Drug Administration (FDA) following the facility’s earlier designation as Official Action Indicated (OAI).

The development was disclosed by Aurobindo Pharma in a regulatory filing dated August 14, 2026, submitted to the National Stock Exchange (NSE) of India and Bombay Stock Exchange (BSE) under Regulation 30 of the Securities and Exchange Board of India (SEBI) Listing Obligations and Disclosure Requirements Regulations, 2015.

Unit I of Eugia Pharma Specialities is a formulation manufacturing facility and had previously received OAI status from the US FDA, as communicated by Aurobindo Pharma on May 24, 2026. The latest disclosure confirms that the Warning Letter has subsequently been issued to the facility.

Aurobindo Pharma stated that there is no impact on the company’s existing supplies to the US market following the Warning Letter. The company also disclosed that Unit I of Eugia Pharma Specialities contributes approximately 2 percent of Aurobindo Pharma’s overall group revenue.

The company said it remains committed to working closely with the US FDA and continuing to strengthen compliance at the facility on an ongoing basis.

Aurobindo Pharma added that it will keep the stock exchanges informed about further developments.