USFDA sends warning letter to Lupin for Goa & Pithampur plants
Lupin has received a warning letter from the US Food and Drug Administration for its Goa and Pithampur plants indicating a continued regulatory concerns for the drug maker.
The Lupin stock fell 14.5 per cent in intraday trade to Rs 884 after the company notified the exchange about the warning letter. While the company can continue to supply existing products to the US market, fresh approvals will be delayed.
“We are deeply disappointed to have received this outcome. We uphold quality and compliance issues with utmost seriousness and remain fully committed to be compliant with the current good manufacturing practices quality standards across all our facilities. We plan to address the concerns raised by the USFDA expeditiously and will work with the USFDA to resolve these issues at the earliest,” Lupin informed the exchange.