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CGMP Requirements Apply To Remdesivir In COVID-19 Emergency – But Not To Chloroquine Or HCQ

 
• By Bowman Cox

Among the differences between the emergency use authorizations is that manufacturing quality requirements will apply to Gilead’s remdesivir, while chloroquine and hydroxychloroquine received blanket waivers as part of their EUA from the US FDA.

Sterile bottles and ampoules on the dispensing line.Sealed ampoules with medicine.Sterile capsules for injection. Bottles on the bottling line of the pharmaceutical plant.
remdesivir hasn't been approved but will meet cgmp requirements • Source: Shutterstock

Federal quality requirements apply to the remdesivir that Gilead Sciences Inc. produces for emergency use by patients hospitalized with COVID-19 – even though they were waived for emergency-use chloroquine phosphate and hydroxychloroquine sulfate.

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