Sun Pharmaceutical Industries Ltd.

United States Food and Drug Administration (USFDA) has conducted Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries’ Halol facility in Gujarat from December 03 to 13, 2019. At the conclusion of the inspection, the agency issued a Form 483, with eight observations. 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. The company remains committed to working closely with the USFDA and continues to enhance its GMP compliance on an ongoing basis.

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