June 20,2024
New Delhi: Sun Pharmaceutical Industries Ltd on Wednesday said it has received a warning letter from the US health regulator for its Dadra facility over violation of manufacturing norms. The warning letter by the US Food and Drug Administration (USFDA) summarises violations with respect to Current Good Manufacturing Practice (cGMP) regulations, Sun Pharma said in a regulatory filing.
The contents of the warning letter shall be made public by the USFDA in due course, it added.
This intimation is further to our communication dated April 11, 2024, about Dadra facility receiving OAI status by the USFDA.
On April 11, Sun Pharma had informed stock exchanges that its Dadra facility had received Official Action Indicated (OAI) status from the USFDA.
It followed an inspection at the company’s Dadra facility from December 4 to December 15, 2023.
Source: Pharma