Aurobindo's oral solid formulations unit under USFDA scrutiny

The company in a filing on Thursday said the OAI classification will not have any material impact on the existing revenues or the supplies to its US business at this juncture

The US Food and Drug Administration (US FDA) has escalated the audit observations issued for Unit 7 of Aurobindo Pharma Limited in October, 2019 to the Official Action Indicated (OAI) level in a latest communication to the company.

The latest classification of the audit evaluation indicates the regulatory and/or administrative actions will be recommended against the unit by the US drug regulator based on the objectionable conditions found during the inspection,

Aurobindo's Unit 7 oral solids formulations manufacturing facility located at Polepally in Telangana was issued Form 483 with 7 observations after a CGMP (current good manufacturing practices) inspection was conducted from