Aurobindo Pharma Ltd. announced that the US Food and Drug Administration has classified its Unit II formulation manufacturing facility, operated by Eugia Pharma Specialities, as ‘Official Action Indicated' following an inspection.
The inspection, which took place from April 25 to May 3, was conducted at the Bhiwadi facility in Rajasthan's Alwar.
The OAI classification signifies that the US FDA has identified issues requiring corrective action before the facility can resume normal operations or obtain new product approvals.
In response, Aurobindo Pharma has pledged to work closely with the FDA to address the concerns raised and to continuously enhance its compliance practices.
Shares of the company fell 1.71% to Rs 1,418.55 apiece on the NSE, compared to a 2.68% decline in the benchmark Nifty.
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