USFDA issues 3 observations for Sun Pharmaceutical’s Halol facility

23 Feb 2018 Evaluate

The United States Food & Drug Administration (USFDA) has issued three observations to Sun Pharmaceutical Industries through form 483 for its Halol facility, Gujarat, India. The USFDA had conducted a Good Manufacturing Practices (GMP) inspection at Halol facility from February 12, 2018 to February 23, 2018.

The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days. The company is committed to addressing these observations promptly.

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

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