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) has issued a warning letter to Aurobindo Pharma's subsidiary, Eugia Pharma Specialities, located near Hyderabad. This decision followed four observations made by the regulator during an inspection in February and an Official Action Indicated (OAI) status in May. Subsequently, the unit received the warning letter on August 14, 2026, as reported by Aurobindo Pharma.
Despite the news, the parent company's shares were experiencing a slight decline on the BSE, recovering from a sharper drop at the market opening. Aurobindo Pharma clarified in a filing that they do not anticipate any impact on their existing supplies to the U.S. markets. The specific facility, Unit I of Eugia Pharma Specialities, contributes around 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 fiscal year 2026, the figure was ₹33,653 crore. Aurobindo Pharma remains committed to collaborating closely with the U.S. FDA and continuously working to enhance compliance.
Written by urgent.news from The Hindu's reporting — not their text. Machine-written — it may contain errors, so check the original before relying on it.
