Sun Pharmaceutical Industries Limited has received a warning letter from USFDA for the Halol facility. The warning letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. USFDA shall make public the contents of the warning letter in due course.

This is in continuation to communications dated May 10, 2022, August 13, 2022 and December 8, 2022 regarding the USFDA inspection at the company’s Halol (Gujarat, India) facility from April 26 to May 9, 2022.warning letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. USFDA shall make public the contents of the warning letter in due course

As per the communication dated December 08, 2022, the Halol facility was placed under Import Alert by USFDA.