Aurobindo Pharma shares plunged as much as 8 percent on Friday after the US Food and Drug Administration classified the inspections at the drugmaker’s API intermediates facilities as Official Action Indicated (OAI).
NSE
OAI means regulatory and/or administrative actions will be recommended in future.
FDA can assign a facility with the most serious food safety or regulatory infractions an official action indicated (OAI) classification, which warrants agency action to ensure the violation is fixed.
In its press release, the company said that it has received letters from the US FDA classifying the inspections concluded at their API (Active Pharmaceutical Ingredient) facilities of Unit I and XI and intermediates facility of unit IX in February 2019 as OAI.
“The company has already submitted its initial response to US FDA, and is sending further updates on the committed corrective actions,” it said in the press statement.
Aurobindo Pharma said that it is confident that the OAI classifications will not have any impact on the supplies or the revenue from its API facilities.
At 11:11 AM, the share price was trading lower by 6.75 percent to Rs 677.0 per share on the National Stock Exchange.
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