FDA Flags Aurobindo Pharma's Eugia Unit with 9 Observations, OAI Status Issued

• US FDA classified Aurobindo Pharma's Eugia Pharma Specialities Ltd unit-II as 'Official Action Indicated' (OAI).
• The inspection of the Bhiwadi, Rajasthan unit took place from November 3-14, 2025, resulting in nine Form 483 observations.
• OAI status suggests regulatory action may be warranted based on inspection findings.
• Aurobindo Pharma stated it does not foresee any immediate business impact and is committed to high-quality manufacturing standards.
• The company reported a 7.5% YoY net profit increase to ₹909.8 crore and an 8.4% YoY revenue rise to ₹8,646 crore for the December quarter.