USFDA conducts GMP inspection of Sun Pharma’s Halol facility

14 Jun 2025 Evaluate

US Food and Drug Administration (USFDA) has conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries’ Halol facility (Gujarat, India) from June 2, 2025 to June 13, 2025. At the conclusion of the inspection, the USFDA issued a Form-483, with 8 observations.

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


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