USFDA classifies inspection of Lupin unit as 'Official Action Indicated'

Topics Lupin | Pharma sector

Lupin Ltd on Monday said the US health regulator has cautioned that its Tarapur manufacturing facility may be subject to regulatory actions.

"The company has received a communication from the US FDA classifying the inspection conducted at its Tarapur manufacturing (API) facility between September 16 to September 20, 2019 as Official Action Indicated (OAI)," Lupin Ltd said in a filing to BSE.

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

The inspection at the Tarapur facility had closed with three observations.

The company, however, said that it does not believe this inspection classification will have an impact on disruption of supplies or the existing revenues from operations of this facility.

"The company is in the process of sending further updates of its corrective actions to the US FDA and is hopeful of a positive outcome," the filing said.

The shares of Lupin were trading at Rs 750.60, down 1.11 per cent on BSE in morning trade.

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