U.S. FDA issues warning letter to Aurobindo Pharma’s subsidiary Eugia Pharma
A formulation manufacturing unit of subsidiary Eugia Pharma Specialities near Hyderabad had earlier received four observations and an Official Action Indicated (OAI) status from the regulator
The U.S. Food and Drug Administration (U.S. FDA) issued a warning letter to Aurobindo Pharma's subsidiary, Eugia Pharma Specialities, located near Hyderabad. This action came after the regulator issued four observations in February and designated the facility under Official Action Indicated (OAI) status in May. Subsequently, the unit received the warning letter on August 14, 2026, as reported by Aurobindo Pharma.
The parent company's shares on the BSE were down 1.25% at ₹1,636.20 each, recovering from a sharper decline at market opening. Aurobindo Pharma stated that it does not anticipate any impact on existing supplies to U.S. markets. The facility in question, Unit I of Eugia Pharma Specialities, contributes approximately 2% to the company's overall group revenue.
For the quarter ending June of the current fiscal year, the parent company reported ₹9,150 crore in revenue from operations, while for FY26, it logged ₹33,653 crore. Aurobindo Pharma remains committed to working closely with the U.S. FDA and enhancing its compliance on an ongoing basis.
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