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Indoco FDA Warning Letter Will Take 12 Months To Resolve

 
• By Penelope MacRae

India’s Indoco Remedies has received a new warning letter from the US Food and Drug Administration over its Goa manufacturing site. The company says it will take a year to fix the problems and the warning letter will delay approval of four ANDAs from the plant.

Goa
Indoco Has Been Warned Over Its Goa Plant • Source: Shutterstock

Indoco has been hit by another US Food and Drug Administration warning letter, marking the latest in a string of regulatory setbacks for the troubled generic drug-maker.

The FDA letter was issued for Indoco’s oral-dosage plant in the western state of Goa. Indoco said “corrective action” was already under way at Plant I at its Verma industrial site in Goa when it got the FDA letter as the facility was slapped with a good manufacturing practice non-compliance notice by the UK’s Medicines and Healthcare Products Regulatory Agency back in March 2018

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