USFDA17 Mar 2026, 04:41 pm
Aurobindo Pharma Subsidiary's Unit Classified as OAI by US FDA
AI Summary
Aurobindo Pharma Ltd. has informed that Unit-II of its wholly owned subsidiary, Eugia Pharma Specialities Limited, has been classified as 'Official Action Indicated' (OAI) by the US FDA. The US FDA inspected the unit located at RIICO Industrial Area, Phase-lll, Bhiwadi, 301 019, Rajasthan, from November 03 to November 14, 2025, and issued a 'Form 483' with 09 observations. Despite this classification, the company currently doesn't foresee any impact on its business. Aurobindo Pharma is committed to maintaining high manufacturing standards across all its facilities worldwide and will keep the stock exchanges informed of any further developments.
Key Highlights
- Aurobindo Pharma subsidiary's Unit-II classified as OAI by US FDA
- US FDA inspection from November 03 to November 14, 2025, resulted in 09 observations
- Company committed to maintaining high manufacturing standards
- No foreseen impact on the business at present
- Company to keep stock exchanges informed of further developments