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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

Aurobindo Pharma
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Aurobindo Pharma

BS Reporter Hyderabad
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

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First Published: Jan 30 2020 | 4:30 PM IST

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