The share price of drug major Lupin fell more than 4 percent after the company received a warning letter from the US health regulator for its Somerset, New Jersey facility.
The US FDA had inspected the Lupin Somerset site from September 10, 2020 to November 5, 2020.
The company does not believe that the warning letter will disrupt supplies or impact the existing revenues from operations of the facility. However, the company cannot apply for any new ANDA from the facility.
“We are committed to addressing the concerns raised by the US FDA and will work with the FDA and the New Jersey District to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and are committed to be compliant with Good Manufacturing Practice standards across all our facilities,” Lupin said in an exchange filing.
Somerset plant was under USFDA observation since 2019 and is likely to remain under observation for at least next 3-6 months, said Yash Gupta, Equity Research Associate, Angel Broking.
At 1:16 pm, the stock was trading 2.75 percent lower at Rs 1,196.45 apiece on the BSE.