US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited's Halol facility (Gujarat, India) from 02 June to 13 June 2025. At the conclusion of the inspection, the US FDA issued a Form-483, with 8 observations. Earlier on 16-Dec-2022 Sun Pharmaceutical Industries Ltd the Company has received 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

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