NEW DELHI — Aurobindo Pharma said Tuesday that the U.S. Food and Drug Administration has classified one of its subsidiary manufacturing units as “Official Action Indicated” following an inspection conducted late last year.
In a regulatory filing, the company said the FDA inspected Unit-II of Eugia Pharma Specialities Ltd., a wholly owned subsidiary, located in Bhiwadi, Rajasthan, from Nov. 3 to Nov. 14, 2025. At the conclusion of the inspection, the agency issued a Form 483 citing 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).”
An OAI classification indicates that the regulator has identified conditions that may warrant regulatory or enforcement action.
Despite the designation, the company said it does not expect any immediate impact on its business operations.
“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,” the company said.
Aurobindo Pharma added that it remains committed to maintaining high manufacturing quality standards and will provide further updates as needed.
The regulatory development comes as the company continues to report solid financial performance. For the quarter ended December, Aurobindo Pharma posted a 7.5 percent year-over-year increase in net profit to Rs 909.8 crore, compared with Rs 846 crore in the same period last year. The results include a one-time cost of Rs 65 crore related to changes in labor laws.
Revenue for the quarter rose 8.4 percent to Rs 8,646 crore from Rs 7,979 crore a year earlier. EBITDA increased 12.4 percent to Rs 1,773.6 crore, with margins improving to 20.5 percent from 19.8 percent in the prior-year period.
Shares of Aurobindo Pharma closed 0.80 percent higher at Rs 1,289.80 on Tuesday, ahead of the announcement. (Source: IANS)
