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USFDA issues 13 observations after inspection of Lupin arm's facility in US

Drug firm Lupin said the US health regulator has issued 13 observations after inspection of its subsidiary's Somerset facility in New Jersey

Lupin | USFDA | Pharma industry

Press Trust of India  |  New Delhi 

Lupin logo on a building

Drug firm on Monday said the US health regulator has issued 13 observations after inspection of its subsidiary's Somerset facility in New Jersey.

In a regulatory filing, said the inspection by US Food and Drug Administration (USFDA) commenced on September 10, 2020, and concluded on November 5, 2020. The duration of the inspection was prolonged due to COVID-related delays and challenges.

The inspection has closed with 13 observations, it said.

"We are confident of addressing these observations and will work closely with the agency to address their concerns," the company said.

said it does not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility.

The facility contributes less than 5 per cent of our global revenues, it added.

Shares of Lupin were trading 0.52 per cent lower at Rs 911.60 apiece on BSE.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Mon, November 09 2020. 12:14 IST