Sun Pharma says it sought re-inspection of its Halol facility, awaiting US FDA response
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Sun Pharma, India’s largest drug maker on Friday said it has completed remediation exercise at its Halol plant in Gujarat and made a request to the US FDA for re-inspection.
“The remedial steps to address these observations are now complete and we are now awaiting a re-inspection by the US FDA,” said Dilip Shanghvi, Managing Director of Sun Pharma in the company’s earnings call.
“Till we have a successful outcome from the re-inspection we will not get any approvals from this facility,” Shanghvi added.
Shanghvi said the drug maker is giving top priority to bring back Halol unit under compliance.
The US FDA re-inspected the Halol facility from November 17, 2016, through December 1, 2016, and issued nine Form 483 observations.
Halol is an important plant for the company and contributed 10-15 percent to its US sales before the factory received a warning letter from the US FDA for violation of manufacturing norms in December 2015.