Sun Pharmaceuticals has received a warning letter from the United States Food and Drug Administration for its Dadra facility.
“The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations,” Sun told the BSE, adding that the contents of the letter would be made public by the USFDA in due course. “This intimation is further to our communication dated April 11, 2024, about the Dadra facility receiving OAI (Official Action Indicated) status by the USFDA,” Sun added.
Sun shares were down 1.90 per cent at ₹1,475.50 on the BSE on Thursday (12.27 pm).
In April, Sun had said its Dadra facility had undergone an inspection from the USFDA from December 4, 2023 to December 15, 2023. The US regulator had subsequently determined the inspection classification as an OAI status, it had then said, adding “We will work with the regulator to achieve fully compliant status”.