Aurobindo Pharma unit gets USFDA ‘OAI’ status after inspection

New Delhi, March 17 (IANS) Aurobindo Pharma on Tuesday said that the US Food and Drug Administration (USFDA) has classified one of its subsidiary units as “Official Action Indicated” (OAI) following an inspection conducted last year.

In a regulatory filing, the company said that the USFDA inspected Unit-II of Eugia Pharma Specialities Limited, its wholly-owned subsidiary, located in Bhiwadi, Rajasthan, between November 3 and 14, 2025.

At the end of the inspection, the regulator had issued a Form 483 with nine observations.

“At the end of the inspection, a ‘Form 483’ was issued with nine observations,” Aurobindo Pharma said in its exchange filing.

“Subsequently, US FDA has now determined the inspection classification status of this unit as ‘Official Action Indicated’ (OAI),” it added.

The OAI classification means that the regulator believes certain issues found during the inspection may require regulatory action.

However, the company clarified that it does not expect any immediate impact on its business operations due to this development.

“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 stated.

Aurobindo Pharma said it remains committed to maintaining high standards of manufacturing quality across all its facilities and will inform exchanges about any further updates.

Despite the regulatory development, the company’s financial performance has remained strong.

For the December quarter, Aurobindo Pharma reported a 7.5 per cent year-on-year increase in net profit to Rs 909.8 crore, compared to Rs 846 crore in the same period last year.

The profit figure includes a one-time cost of Rs 65 crore due to changes in the labour code.

Revenue during the quarter rose 8.4 per cent year-on-year to Rs 8,646 crore from Rs 7,979 crore a year ago.

The company’s EBITDA also increased by 12.4 per cent to Rs 1,773.6 crore, while EBITDA margin improved to 20.5 per cent from 19.8 per cent in the corresponding quarter last year.

Shares of Aurobindo Pharma closed 0.80 per cent higher at Rs 1,289.80 on Tuesday, ahead of the announcement.

--IANS

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