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FDA Cites Aurobindo Pharma's Eugia Facility with 9 Observations Post-Inspection
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FDA Flags Aurobindo Pharma's Eugia Unit with 9 Observations, OAI Status Issued
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CNBC TV18
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17-03-2026, 17:53
FDA Flags Aurobindo Pharma's Eugia Unit with 9 Observations, OAI Status Issued
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US FDA classified Aurobindo Pharma's Eugia Pharma Specialities Ltd unit-II as 'Official Action Indicated' (OAI).
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The inspection of the Bhiwadi, Rajasthan unit took place from November 3-14, 2025, resulting in nine Form 483 observations.
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OAI status suggests regulatory action may be warranted based on inspection findings.
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Aurobindo Pharma stated it does not foresee any immediate business impact and is committed to high-quality manufacturing standards.
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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.
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