The US Food and Drug Administration (USFDA) has classified Aurobindo Pharma’s three facilities under Official Action Indicated.
Aurobindo Pharma, in a filing in the BSE, said they have received letters from the FDA, classifying the inspections in February 2019, at it’s API (Active Pharmaceutical Ingredient) facilities of Unit I and Unit XI and intermediate facility, unit IX, as Official Action Indicated (OAI).
OAI implies that an FDA inspection revealed significant objectionable conditions or practices and action must be taken to address the issues.
“The company has already submitted its initial response to the USFDA. The Company is sending further updates on the committed corrective actions,” the drug maker said.
Aurobindo Pharma is confident these OAI classifications would not disrupt the supplies or revenue from operations of these facilities, it added.
Shares of Aurobindo Pharma Ltd stands at ₹670.25 a piece, down by 7.53 per cent over the previous close in the BSE.