Lupin shares fall 2.5% after USFDA says Goa facility may be subject to regulatory action

New Delhi: Shares of Lupin fell 2.5 percent 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 2.49 percent to close at Rs 743.95 on the BSE. During the day, it dropped 5.43 percent to Rs 721.50.

On the National Stock Exchange (NSE), shares fell 2.38 percent to close at Rs 745.10 apiece.

In terms of traded volume, 2.56 lakh shares were traded on the BSE and over 32 lakh shares on the NSE during the day.

 Lupin shares fall 2.5% after USFDA says Goa facility may be subject to regulatory action

Representational image. Reuters

The drug maker 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 and 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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Updated Date: May 27, 2019 16:54:26 IST