Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries has received warning letter from US Food and Drug Administration (USFDA) for its Dadra facility. The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. The contents of the Warning Letter shall be made public by the USFDA in due course. 

In April 2024, USFDA has issued Official Action Indicated (OAI) status to Dadra facility. USFDA had conducted an inspection at Company’s Dadra facility from December 4, 2023 to December 15, 2023.

Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.