Drugmaker Lupin on June 13 said it had received a warning letter from the USFDA for the company’s Somerset facility in New Jersey.
The USFDA had inspected the Lupin Somerset site from September 10, 2020 to November 5, 2020, and issued 13 observations. Somerset site had received warning letter in 2019 after a 2018 inspection of the same plant.
USFDA issues warning letter if it finds any deficiencies of good manufacturing practices (GMP). The warning letter restricts new approvals filed from that site.
Lupin said in a statement to stock exchanges that it believed the letter won’t have any impact on supplies or existing revenues.
"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," Lupin said.
Lupin has earlier said the facility contributes less than 5 percent of its global revenues. Somerset facility manufactures oral formulations, derma and controlled substances.
"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.
The company said it will uphold quality and compliance issues with utmostimportance and is committed to be "compliant with Good Manufacturing Practice standards across all our facilities."
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 (cephlosporins) are also under warning letter.