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Aurobindo Pharma Unit Gets USFDA 'OAI' Status After Inspection

The US Food and Drug Administration has classified Unit-II of Aurobindo Pharma's subsidiary Eugia Pharma Specialities as "Official Action Indicated" following an inspection in November 2025. The classification indicates the regulator believes issues found may require regulatory action, though the company stated it does not expect any immediate impact on its operations. Despite this development, Aurobindo Pharma reported strong financial results for the December quarter, with net profit rising 7.5% year-on-year. Revenue also increased by 8.4% to Rs 8,646 crore, demonstrating robust business performance.

Key Points: Aurobindo Pharma Unit Gets USFDA OAI Status

  • USFDA classifies unit as OAI
  • Inspection revealed 9 observations
  • Company sees no immediate business impact
  • Q3 net profit rose 7.5% YoY
  • Revenue grew 8.4% to Rs 8,646 crore
2 min read

Aurobindo Pharma unit gets USFDA 'OAI' status after inspection

Aurobindo Pharma's subsidiary receives USFDA OAI classification after inspection with 9 observations. Company reports strong quarterly profit growth.

"At this point in time, the Company doesn't foresee any impact on the business. - Aurobindo Pharma"

New Delhi, March 17

Aurobindo Pharma on Tuesday said that the US Food and Drug Administration has classified one of its subsidiary units as "Official Action Indicated" 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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Reader Comments

P
Priyanka N
The financial results are still strong, which is a good sign. But the market will watch this closely. USFDA compliance is critical for our pharma companies' global reputation. 🤞 Hope they fix the issues before it impacts business.
A
Aman W
As someone from Rajasthan, it's worrying to hear about the Bhiwadi unit. These facilities provide many local jobs. The company must be fully transparent about the corrective actions they are taking. Public trust is important.
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Sarah B
While I respect the company's statement, saying there's "no immediate impact" feels a bit dismissive of the regulatory concern. An OAI classification is a red flag. I'd appreciate more detail on the nature of the observations and the remediation timeline.
K
Karthik V
The stock price held up, which shows investor confidence. But the real test is in the follow-up. Indian pharma has faced these challenges before and come out stronger. Let's hope Aurobindo does the same. Jai Hind!
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Nikhil C
Nine observations is not a small number. The USFDA doesn't give OAI lightly. The company needs to treat this with utmost urgency. Our pharma sector's credibility is built on strict adherence to global standards.

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