Aurobindo Pharma's Eugia Unit-III Receives OAI Status from USFDA
Hyderabad: Aurobindo Pharma Limited has informed stock exchanges that the United States Food and Drug Administration (USFDA) has classified its wholly owned subsidiary, Eugia Pharma Specialities Limited's Unit-III manufacturing facility at Pashamylaram, Telangana, as Official Action Indicated (OAI).
The formulation manufacturing facility was inspected by the USFDA from January 27 to February 6, 2026, during which the regulator issued 11 observations. Following its review, the USFDA has now categorized the inspection outcome as OAI.
An OAI classification indicates that the regulatory agency has identified significant objectionable conditions that may warrant further administrative or regulatory action. However, Aurobindo Pharma stated that the classification currently has no impact on the company’s financials or operations.
The company reaffirmed its commitment to maintaining the highest quality manufacturing standards across its global facilities and said it would keep stock exchanges informed of any further developments related to the matter.
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