Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries has received Warning Letter from United States Food and Drug Administration (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.

Earlier, the USFDA had placed the company’s Halol facility under 'import alert'. The USFDA had conducted a GMP inspection of the company’s Halol facility (Gujarat, India) from April 26 to May 9, 2022.

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