Aurobindo Pharma has announced that its wholly owned subsidiary, Eugia Pharma Specialities, has received a warning letter from the US Food and Drug Administration (US FDA) concerning Unit-I, its formulation manufacturing facility in Telangana.

The company said the regulatory development will not affect existing supplies to the US market. Unit-I currently contributes approximately 2 percent of Aurobindo Pharma’s overall group revenue.

The development follows the US FDA’s decision in May 2026 to classify the formulation manufacturing facility under Official Action Indicated (OAI) status.

Aurobindo Pharma said it remains committed to working closely with the US FDA and continues to strengthen compliance measures at its manufacturing facilities. The company added that it is undertaking ongoing efforts to enhance its regulatory and quality systems.