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” (OAI) following an inspection conducted late last year.
In a regulatory filing, the company said the USFDA inspected Unit-II of Eugia Pharma Specialities Ltd., its wholly owned subsidiary, located in Bhiwadi, Rajasthan, from Nov. 3 to Nov. 14, 2025.
At the conclusion of the inspection, the regulator issued a Form 483 with nine observations.
“At the end of the inspection, a ‘Form 483’ was issued with nine observations,” the company said. “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 believes the observations may warrant regulatory action.
Aurobindo Pharma said it does not expect any immediate impact on its business operations as a result of the classification.
“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.
The drugmaker added that it will continue to update stock exchanges on any further developments and reiterated its commitment to maintaining high manufacturing quality standards.
Despite the regulatory development, the company reported solid financial performance in the most recent quarter.
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 a year earlier. The profit included a one-time expense of Rs 65 crore related to changes in labor regulations.
Revenue for the quarter rose 8.4 percent year-over-year to Rs 8,646 crore, up from Rs 7,979 crore, while EBITDA increased 12.4 percent to Rs 1,773.6 crore. EBITDA margin improved to 20.5 percent from 19.8 percent in the corresponding quarter last year.
Shares of Aurobindo Pharma closed 0.80 percent higher at Rs 1,289.80 on Tuesday, ahead of the announcement. (Source: IANS)
