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Sun Grapples With Impact Of Halol FDA Import Alert

US Supplies From Non-Compliant Plant Account For 3% Of Annual Sales

 
• By Dave Wallace

Sun Pharma’s Halol facility has been placed under an import alert by the FDA following an inspection earlier this year that uncovered GMP deficiencies.

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Sun’s Halol plant is once again under FDA scrutiny • Source: Shutterstock

Sun Pharmaceutical Industries has received a blow from the US Food and Drug Administration after the US agency imposed an import alert on its Halol, Gujarat manufacturing site in India.

Earlier this year, the Halol facility had received 10 “Form 483” observations of deviations from current good manufacturing practice following an FDA inspection which ran from 26 April to 9 May

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