FDA flags Aurobindo Pharma’s Eugia unit after inspection; issues 9 observations
Published on 17/03/2026 05:53 PM
FDA flags Aurobindo Pharma’s Eugia unit after inspection; issues 9 observationsAurobindo Pharma announced that the US FDA classified its subsidiary Eugia Pharma's unit-II in Bhiwadi as 'Official Action Indicated' after inspection. No business impact is expected. Shares of the company closed 0.80% up at ₹1,289.80 ahead of the announcement on Tuesday, March 17.By Gareema Bangad March 17, 2026, 5:53:48 PM IST (Updated)2 Min ReadAurobindo Pharma Ltd on Tuesday, March 17, said the US Food and Drug Administration (FDA) has classified one of its subsidiary units as ‘Official Action Indicated’ (OAI) following an inspection.
In an exchange filing, the company said the FDA inspected during November 3-14, 2025, unit-II of Eugia Pharma Specialities Ltd, a wholly-owned subsidiary, located in Bhiwadi, Rajasthan.
At the end of the inspection, the regulator had issued a Form 483 with nine observations.
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The company said the FDA has now determined the inspection classification status of the facility as OAI, which indicates that regulatory action may be warranted based on the inspection findings.
Aurobindo Pharma added that, at present, it does not foresee any impact on its business due to the classification.
The company said it remains committed to maintaining high-quality manufacturing standards across its global facilities and will update exchanges on any further developments.
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For the December quarter, Aurobindo Pharma reported a 7.5% year-on-year increase in its net profit to ₹909.8 crore from ₹846 crore, inclusive of a one-time cost of ₹65 crore due to a change in the labour code.
Revenue for the quarter rose 8.4% YoY to ₹8,646 crore from ₹7,979 crore in Q3FY25. EBITDA was 12.4% up at ₹1,773.6 crore from ₹1,577.5 crore a year ago. EBITDA margin expanded to 20.5% from 19.8% in the same quarter last year.
Shares of the company closed 0.80% up at ₹1,289.80 ahead of the announcement on Tuesday, March 17. The stock has gained 8.69% in the last month.Continue Reading(Edited by : Shoma Bhattacharjee)First Published: Mar 17, 2026 5:46 PM ISTTagsAurobindo Pharmashare market todayUS Food and Drug Administration USFDA