Aurobindo Pharma gets OAI status from US FDA for Eugia Pharma?s Bhiwadi Unit

Aurobindo Pharma announced that the United States Food and Drug Administration (US FDA) has concluded an inspection at its subsidiary, Eugia Pharma?s Bhiwadi facility, classifying it as Official Action Indicated (OAI).

According to an exchange filing, the US FDA conducted an inspection at Unit-II of Eugia Pharma Specialities, a wholly owned subsidiary of the company, located in the RIICO Industrial Area, Phase III, Bhiwadi, Rajasthan, between 3 November and 14 November 2025. At the conclusion of the inspection, a Form 483 with nine observations was issued.

The US FDA has now determined the inspection classification status of the unit as official action indicated (OAI).

The company said, 'At this point in time, the company doesn?t foresee any impact on the business.' The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.

Aurobindo Pharma is principally engaged in the manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services.

The company?s consolidated net profit rose 7.6% to Rs 910.29 crore on a 9% increase in net sales to Rs 8,604.51 crore in Q3 FY26 over Q3 FY25.

Shares of Aurobindo Pharma shed 0.54% to Rs 1,280.50 on the BSE.

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