Aurobindo Pharma has received letters from the US Food and Drug Administration (USFDA) classifying the inspections concluded at its API facilities of Unit I and XI and intermediates facility of unit IX in February 2019 as Official Action Indicated (OAI).
The company has already submitted its initial response to USFDA. The company is sending further updates on the committed corrective actions. These OAI classifications will not have an impact on disruption of supplies or the revenue from operations of these facilities.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.