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  4. Lupin shares drop nearly 6 pc after USFDA observations on Goa plant

Lupin shares drop nearly 6 pc after USFDA observations on Goa plant

Drug maker Lupin on Monday said the US health regulator made two observations after inspection of its Goa plant and cautioned that the facility may be subject to regulatory action and it may withhold approval of pending applications in which this facility is listed.

PTI PTI
New Delhi Published on: May 27, 2019 13:36 IST
Lupin LOGO (Representational Image)
Image Source : TWITTER

Lupin LOGO (Representational Image)

Shares of Lupin dropped nearly 6 per cent on Monday after the US health regulator made two observations following the inspection of its Goa plant and cautioned that the facility may be subject to regulatory action.

The scrip declined 5.43 per cent to Rs 721.50 on the BSE.

On the NSE, shares dropped 5.67 per cent to Rs 720.

Drug maker Lupin on Monday said the US health regulator made two observations after inspection of its Goa plant and cautioned that the facility may be subject to regulatory action and it may withhold approval of pending applications in which this facility is listed.

The company has received a communication from the US Food and Drug Administration (USFDA), classifying the inspection conducted at its Goa facility between January 28 to February 8, 2019, as Official 

Action Indicated (OAI)... The inspection at the Goa facility had closed with two observations, Lupin said in a regulatory filing.

"The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed," the company added.

The Mumbai-based drug maker, however, said it does not believe that the classification would 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 USFDA and is hopeful of a positive outcome, it added. 

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