Sun Pharmaceuticals Industries announced that USFDA conducted a Good Manufacturing Practices (GMP) inspection of company's Halol facility (Gujarat, India) from 03-13 December 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 US FDA within 15 business days. The company is committed to addressing these observations promptly. The Company remains committed to working closely with the US FDA and continues to enhance its GMP compliance on an ongoing basis.
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