COVID-19: Pfizer to manufacture Gilead’s remdesivir (Contract Manufacturing)

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Aug 07, 2020

Pfizer announced a multi-year agreement with Gilead Sciences to manufacture and supply Gilead’s investigational antiviral, remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19.

“Together, we are more powerful than alone,” said Pfizer CEO Albert Bourla in a press release.

Gilead is aiming to make enough of the drug by the end of the year to treat more than 2 million COVID-19 patients and anticipates being able to make “several million more” in 2021. But hospitals and politicians have said it is difficult to gain access to the drug.

Pfizer will provide contract manufacturing services through its McPherson, Kansas, plant — the same plant that has been at the center of FDA warnings in the past. FDA investigators conducted an inspection of the human sterile drug manufacturing site in the summer of 2018, with the agency later posting a Form 483. That came a year after the plant — originally a Hospira plant —drew an FDA warning specifying significant violations of good manufacturing practices, such as an inadequate investigation into the detected presence of cardboard in vial samples.


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