Sun Pharma Halol facility gets 8 USFDA observations post GMP inspection

The U.S Food and Drug Administration (USFDA) conducted a Good Manufacturing Practices (GMP) inspection of the company's Halol facility (Gujarat, India) from 03-13 December 2019.

New Delhi: Drug giant, Sun Pharmaceutical Industries Ltd.(Sun Pharma) recently informed the bourses that the company has received Form 483 with 8 observations for its Halol facility (Gujarat, India) from the US Health regulator.

"The U.S Food and Drug Administration (USFDA) conducted a Good Manufacturing Practices (GMP) inspection of the 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, " Sun Pharma said in a filing.

Also Read: Sun Pharma arm-SPARC updates on Paclitaxel Injection Concentrate for Suspension litigation

The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days, it added.

"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," further added.

Also Read: Sun Pharma updates on Ranbaxy Generic Drug Application Antitrust Litigation in the US