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Sun’s Key Halol Plant Flunks FDA Inspection Again

 
• By Penelope MacRae

The US FDA has flagged more issues at Indian firm Sun Pharma’s largest manufacturing plant in Halol but analysts are hoping the infractions are minor and that the Indian facility will get the regulatory green light soon, ending a blacklist on the factory supplying new products to the US.

production line

After more than three years of remediation efforts, Sun Pharmaceutical Industries Ltd., India’s largest drug maker by sales, was hoping that the US Food and Drug Administration’s most recent inspection of its biggest plant, Halol, would lead to an all-clear for the facility.

Sun has spent millions of dollars, hired costly consultants and invested in new systems to upgrade Halol, located in western...

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