Aurobindo Pharma: USFDA designates 3 facilities as 'Official Action Indicated'

Aurobindo Pharma is confident these OAI classifications would not have an impact on the disruption of supplies or revenue from operations of these facilities, it added.

New Delhi: The US Food and Drug Administration (USFDA) has classified Aurobindo Pharma's three facilities as Official Action Indicated (OAI).

Aurobindo Pharma, in a filing in the BSE, said they have received letters from the FDA, classifying the inspections at its API (Active Pharmaceutical Ingredient) facilities of Unit I and XI and intermediates facility of unit IX in February 2019 as Official Action Indicated (OAI).

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According to the FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory administrative sanctions by the FDA are indicated" during inspections.

OAI means 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 USFDA. The Company is sending further updates on the committed corrective actions," the drug maker said.

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Aurobindo Pharma is confident these OAI classifications would not have an impact on the disruption of supplies or revenue from operations of these facilities, it added.

The company is headquartered at HITEC City in Hyderabad. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients.

The company’s area of activity includes six major therapeutic/product areas: antibiotics, anti-retroviral, cardiovascular products, central nervous system products, gastroenterological, and anti-allergic. The company markets these products in over 125 countries. Its marketing partners include AstraZeneca and Pfizer.

The company's shares fell 6 per cent to Rs 682 on the BSE on Friday after the drug firm announced that the American drug regulator classified the inspection of the company’s API intermediates facilities of Unit I, IX and XI as Official Action Indicated (OAI), reports Business Standard.

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