Aurobindo Pharma Shares Drop 9.5% After US FDA Inspection

19 Feb 2025 , 12:17 PM

Hyderabad-based Aurobindo Pharma Ltd announced on February 18 that the US FDA has completed its pre-approval inspection (PAI) at Eugia Steriles Private Ltd, a wholly owned step-down subsidiary, located in Parawada Mandal, Andhra Pradesh. The inspection was conducted between February 10 and February 18.

The shares of the company fallen 9.5% to ₹1053 per share from the previous close on Feb 19 post USFDA completed  inspection of its subsidiary.

In a regulatory filing, the company stated that the inspection resulted in five procedural observations, which it plans to address within the required timeframe. Aurobindo Pharma also assured that it would keep the stock exchanges informed of any further updates related to the inspection.

“The United States Food and Drug Administration (US FDA) conducted a PAI at Eugia Steriles Private Limited (a 100% subsidiary of Eugia Pharma Specialities Limited and a step-down subsidiary of the Company), situated at Parawada Mandal, Anakapalli District, Andhra Pradesh, from February 10, 2025 to February 18, 2025,” Aurobindo Pharma said in a regulatory filing.

It stated, “The inspection concluded with 5 observations. The observations are procedural in nature and will be responded to within the stipulated time. We will keep the stock exchanges informed if there is any further information relating to the above in the future.”