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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.

As the first of many pharmaceuticals and vaccines that may be cleared for emergency use in the coronavirus pandemic, the approaches taken on

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More from Manufacturing

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

More from Compliance

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.