FDA concerns at contractor Catalent site spurred on shortages of Novo Nordisk's semaglutide — report
Just before the start of the new year, Novo Nordisk revealed its supply of obesity med Wegovy was low and that it would not be able to meet demand in the US until the second half of 2022.
Thanks to a Form 483 from the FDA, we now know that issues at Catalent’s flagship syringe filling site in Brussels, Belgium, was the reason for the delay, BioProcess International reported.
The site is 265,000 square feet and has been handed 12 483s in nine FDA visits, a source told BioProcess, though it is believed that this is the first that has halted production.
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