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Sun Pharma’s Halol plant in Gujarat has received an import alert from the United States Food and Drug Administration (USFDA).
This would mean that all future shipments of products manufactured at this facility would be refused admission to the US market until the facility complies with cGMP (current good manufacturing practice) standards, Sun Pharma told the Bombay Stock Exchange. However, the USFDA has excluded 14 products from this import alert, subject to certain conditions, it added.
In its previous communications (May 10 and August 13, 2022) Sun had said the US regulator had inspected its Halol facility from April 26 to May 9, 2022.
The USFDA import alert is the second for an Indian drugmaker in less than two months. Drugmaker Glenmark had received an import alert on its Baddi plant, late October. Other pharma companies are also facing warning letters and other regulatory observations from the USFDA, as sector anlaysts point out that this development comes as the regulator resumes its inspections after a lull during the peak of the pandemic.
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Mapping the impact of the import alert, Sun Pharma said that for the year ended March 31, 2022, supplies to the US market from the Halol facility accounted for approximately 3 per cent of its consolidated revenues, including the 14 excluded products. The company said it was undertaking remedial action to set right the issues pointed out by the regulator. In its latest call with analysts, the Sun Pharma management had indicated that resolution of the issues at Halol would take longer than they had expected.
Sun Pharma shares closed on the BSE at ₹980.95, down 3.57 per cent, on Thursday.
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