Aurobindo Pharma’s Subsidiary Receives ‘Official Action Indicated’ Classification from US FDA

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Aurobindo Pharma’s Subsidiary Receives ‘Official Action Indicated’ Classification from US FDA​

Aurobindo Pharma Limited announced on March 17, 2026, that the United States Food and Drug Administration (US FDA) has classified Unit-II of Eugia Pharma Specialities Limited, a wholly owned subsidiary of Aurobindo Pharma, as ‘Official Action Indicated’ (OAI).

Eugia Pharma Specialities Limited’s Unit-II, located in the RIICO Industrial Area, Phase -III, Bhiwadi, Rajasthan, was inspected by the US FDA from November 3 to November 14, 2025. Following the inspection, a ‘Form 483’ was issued, detailing nine observations.

Aurobindo Pharma stated that it currently does not anticipate any impact on business operations as a result of this classification. The company affirmed its commitment to upholding high-quality manufacturing standards across its global facilities.

The company will provide updates to the stock exchanges if further information becomes available.

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