Lupin gets warning letter from USFDA for its Somerset facility in US

Lupin gets warning letter from USFDA for its Somerset facility in US
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On Sunday, drug firm Lupin said it has received a warning letter from The United States Food and Drugs Administration for the company’s Somerset facility. 

 

The United States Food and Drugs Administration (USFDA) had inspected the company’s Somerset facility, New Jersey, from September 10, 2020, to November 5, 2020, Lupin said in a regulatory filing.

 

“The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility,” it added.

 

“We are committed to addressing the concerns raised by the USFDA and will work with the FDA and the New Jersey District to resolve these issues at the earliest,” the company added.

 

Shares of Lupin Limited were trading more than 3% lower at ₹1,191.9 per share on the BSE in Monday’s early deals.

 

Lupin is under USFDA scanner over compliance issues. The Indore Unit-2 (makes oral solid and ophthalmic formulations), Goa (oral solids), and Mandideep Unit-1 (cephalosporins) are also under warning letters.