FDA designates Aurobindo's 3 facilities as 'Official Action Indicated'

Aurobindo Pharma | Photo: Wikipedia

The US Food and Drug Administration 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 it's API (Active Pharmaceutical Ingredient) facilities of Unit I and XI and intermediates facility of unit IX in February 2019 as Official Action Indicated (OAI).

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

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

shares of Aurobindo Pharma Ltd ended at Rs 670.25 apiece, down by 7.53 per cent over the previous close in the BSE.


Dear Reader,


Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel