Aurobindo's Eugia Unit-I Receives OAI Classification After 4 USFDA Observations
New Delhi: Aurobindo Pharma has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has classified Unit-I of Eugia Pharma Specialities Limited, its wholly owned subsidiary, as "Official Action Indicated" (OAI) following an inspection conducted earlier this year.
According to the company’s regulatory filing, the USFDA inspected Unit-I, a formulation manufacturing facility of Eugia Pharma Specialities Limited located at Kolthur Village, Shameerpet Mandal, Ranga Reddy district in Telangana, from February 16 to February 27, 2026.
The inspection had concluded with four observations.The company stated that the USFDA has now determined the inspection classification status of the facility as “Official Action Indicated” (OAI).
An OAI classification is issued by the USFDA when objectionable conditions or regulatory non-compliance observed during an inspection warrant regulatory or administrative action.
According to the annexure attached with the filing, the communication regarding the OAI classification was received from the USFDA on May 23, 2026. Aurobindo Pharma stated that the company remains committed to maintaining the highest quality manufacturing standards across all its facilities globally.
The company also informed that it would keep the stock exchanges updated regarding any further developments related to the matter.
According to the filing, there is no impact on the company’s financials or operations due to the said regulatory action.
