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 action comes after the regulator issued four observations in February and later designated the facility as "Official Action Indicated" (OAI) in May. Following the OAI, Eugia Pharma Specialities received a warning letter from the U.S. FDA.
Aurobindo Pharma confirmed that the incident does not anticipate any impact on existing supplies to the U.S. markets, as Unit I of Eugia Pharma Specialities contributes around 2% to the company's overall group revenue. For the quarter ended in June of the current fiscal year, Aurobindo Pharma reported ₹9,150 crore in revenue from operations, while for the fiscal year 2026, it logged ₹33,653 crore in revenue from operations.
The company remains committed to maintaining compliance with U.S. FDA regulations and is working closely with the regulator.
Written by urgent.news from The Hindu - Sci-Tech's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
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