Aurobindo Pharma’s subsidiary, Eugia Pharma Specialities Limited, has had its Unit-II classified as ‘Official Action Indicated’ (OAI) by the United States Food and Drug Administration (US FDA). This follows an inspection conducted from 3rd to 14th November 2025.
The inspection at the facility located in RIICO Industrial Area, Phase–III, Bhiwadi, Rajasthan, resulted in the issuance of a ‘Form 483’ with nine observations. The OAI classification indicates that the US FDA has identified significant issues that may warrant regulatory action.
Despite the classification, Aurobindo Pharma has stated that it does not anticipate any immediate impact on its business operations. The company reiterated its commitment to maintaining high-quality manufacturing standards across its global facilities.
Aurobindo Pharma has assured stakeholders that it will keep stock exchanges informed of any further developments regarding this matter.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).