(Reuters) – Indian drugmaker Sun Pharmaceutical Industries said on Tuesday the U.S. Food and Drug Administration had determined that its Halol plant in the western state of Gujarat was not compliant with the regulator’s manufacturing rules. The classification of the plant as “Official Action Indicated” by the FDA follows an inspection from June 2 to […]
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US FDA deems Sun Pharma’s Halol plant not compliant with its manufacturing rules
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(Reuters) – Indian drugmaker Sun Pharmaceutical Industries said on Tuesday the U.S. Food and Drug Administration had determined that its Halol plant in the western state of Gujarat was not compliant with the regulator’s manufacturing rules.
The classification of the plant as “Official Action Indicated” by the FDA follows an inspection from June 2 to June 13 that resulted in eight observations or instances of non-compliance, the company said.
Sun Pharma said the facility is under an import alert, restricting shipments to the United States except for certain products exempted due to drug shortages. The restrictions will remain until the site meets FDA compliance standards.
(Reporting by Nishit Navin; Editing by Anil D’Silva)