Aurobindo Pharma Subsidiary Receives FDA Warning for Telangana Unit

Aurobindo Pharma Ltd's subsidiary, Eugia Pharma Specialities Ltd, has received a warning letter from the USFDA for its Telangana manufacturing unit. This follows the unit's earlier classification as 'Official Action Indicated' (OAI) by the US regulator after an inspection. Currently, there is no impact on the existing US supplies.

Aurobindo Pharma Ltd announced on Friday that its subsidiary, Eugia Pharma Specialities Ltd, received a warning letter from the United States Food and Drug Administration (USFDA) for its Telangana-based formulations manufacturing unit.

Back in May, the unit was classified as 'Official Action Indicated' (OAI) by the USFDA after an inspection conducted between January 22 and February 2, 2024. This classification suggests the possibility of withheld approvals for any pending product applications or supplements from the facility until compliance issues are resolved.

Despite the warning, Aurobindo Pharma assures there is no current impact on the supply to US markets, and the company is committed to working closely with the USFDA to enhance compliance continually.

(With inputs from agencies.)