Aurobindo Pharma shares tanked nearly 7% in early trade on Friday after the US Food and Drug Administration (USFDA) classified its inspection of the company’s API intermediates facilities of Unit I, IX and XI as Official Action Indicated (OAI).
OAI means a USFDA inspection revealed significant objectionable conditions or practices and action must be taken to address the issues. It also indicates that approvals of pending applications or supplements from the site maybe withheld.
“The company has received letters from the USFDA classifying the inspections concluded at our API (active pharmaceutical ingredients) facilities of Unit I and XI and intermediates facility of unit IX in February 2019 as Official Action Indicated.” the regulatory fiing said.
The company has already submitted its initial response to USFDA, Aurobindo Pharma said in the release.
The company is sending further updates on the committed corrective actions.
Aurobindo Pharma added it is confident that these OAI classifications will not have an impact on disruption of supplies or the revenue from operations of these facilities.
Shares of Aurobindo Pharma were trading at Rs 678.35, down 6.6%, at 10:47am on BSE.
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