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.

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