Aurobindo Pharma’s Eugia Steriles Facility Completes US FDA Pre-Approval Inspection with Five Observations
Aurobindo Pharma Limited announced that its step-down subsidiary, Eugia Steriles Private Limited, has successfully completed a Pre-Approval Inspection (PAI) by the US Food and Drug Administration (US FDA) at its manufacturing facility in Anakapalli District, Andhra Pradesh.
According to the company’s regulatory filing with BSE and NSE, the inspection was conducted between February 10 and February 18, 2025, and concluded with five observations. Aurobindo Pharma clarified that these observations are procedural in nature and will be addressed within the stipulated timeline.
The facility, a 100% subsidiary of Eugia Pharma Specialities Limited, plays a key role in Aurobindo Pharma’s global supply chain, particularly in the sterile injectables and complex generics segment.
Aurobindo Pharma assured investors and stakeholders that it will respond to the US FDA within the required timeframe and will keep the exchanges informed regarding any further updates.
Shares of Aurobindo Pharma will be closely watched as the market assesses the impact of these observations on the company’s US business.
