Aurobindo Pharma's Eugia Unit I Receives USFDA Warning Letter After OAI Status
Hyderabad: Unit I of Eugia Pharma Specialities Ltd., a wholly owned subsidiary of Aurobindo Pharma Limited, has received a Warning Letter from the US Food and Drug Administration (USFDA) following the facility being placed under Official Action Indicated (OAI) status by the US regulator.
Aurobindo Pharma disclosed the development to the stock exchanges on August 14, 2026, pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
The development follows Aurobindo Pharma's earlier communication dated May 24, 2026, concerning Unit I of Eugia Pharma Specialities. The facility is a formulation manufacturing unit of Eugia Pharma Specialities Ltd., which is wholly owned by Aurobindo Pharma. According to the company's latest regulatory communication, the facility had earlier received Official Action Indicated (OAI) status from the US FDA, and subsequent to the OAI classification, the unit has now received the Warning Letter.
Aurobindo Pharma clarified that the regulatory development has no impact on the existing supplies to the US markets. The company further stated that Unit I of Eugia Pharma Specialities contributes approximately 2% of the company's overall group revenue.
The company said it remains committed to working closely with the US FDA and continues to take steps to enhance compliance on an ongoing basis.
