Aurobindo Pharma subsidiary Eugia Pharma Specialities’ formulation manufacturing facility near Hyderabad has been classified by the U.S. Food and Drug Administration (U.S. FDA) as “official action indicated” (OAI).One of the three classifications that the regulator assigns to facilities post-inspection is OAI, which means it is recommending regulatory and/or administrative actions.Aurobindo Pharma is expecting no impact on the company’s financials or operations due to the action. The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, it said on Friday (June 12, 2026) in a filing on the U.S. FDA classification.The U.S. FDA had inspected the Unit-III formulation manufacturing facility of Eugia Pharma Specialities in IDA, Pashamylaram, Hyderabad, from January 27 to February 6. The inspection had concluded with 11 observations.“The FDA has now determined that the inspection classification of this facility is official action indicated (OAI),” Aurobindo Pharma said in the filing.Also read: U.S. FDA classifies Aurobindo arm’s formulation unit Official Action IndicatedBesides OAI, the other two classifications the U.S. FDA issues are No Action Indicated (NAI), which conveys that no objectionable conditions or practices were found post-inspection, and Voluntary Action Indicated (VAI), which means that objectionable conditions or practices were found, but the regulator is not prepared to take or recommend any administrative or regulatory action.This is the second plant of the Aurobindo subsidiary to be classified as OAI. The U.S. FDA had also determined Eugia Pharma Specialities’ formulation manufacturing facility in Kolthur village of Ranga Reddy district, near Hyderabad, to be OAI in May. Published - June 13, 2026 11:03 am IST
U.S. FDA classifies Aurobindo Pharma arm Eugia’s formulation plant as OAI
Aurobindo Pharma's Eugia facility in Hyderabad receives U.S. FDA's "official action indicated" classification, signaling regulatory concerns.








