Aurobindo Pharma’s new injectable facility get 10 observations from US FDA

Aurobindo Pharma announced on Sunday that the United States Food and Drug Administration (US FDA) has completed a Pre-Approval Inspection (PAI) at its new injectable facility in East Windsor, New Jersey. The inspection, conducted from December 11 to December 22, 2023, resulted in 10 observations.

The company reported that the observations are procedural and will be addressed within the stipulated timeframe. The facility, yet to start commercial operations, is operated by Eugia US Manufacturing LLC, a wholly-owned subsidiary of Aurobindo Pharma.

“The observations are procedural and will be responded to within the stipulated time,” the company stated in a regulatory filing.

On the same day, Aurobindo’s shares declined by 2.38 per cent on the Bombay Stock Exchange (BSE), closing at Rs 1,066 per share.

First Published: Dec 24 2023 | 6:26 PM IST