The breaches at Catalent, the Wegovy pen filler, were found by inspectors from the U.S. Food and Drug Administration who visited the plant in Brussels in October 2021 and August 2022 to check on ...

Catalent's Brussels plant repeatedly breached U.S. sterile-safety rules in 2021 and 2022 and staff failed to perform required quality checks, Reuters reported last year citing regulatory documents.

Catalent’s Belgium manufacturing operations were slapped with a second Form 483 by the FDA ... In the wake of an FDA inspection conducted between August 10 and August 18 at the Brussels ...

Catalent, one of the top ... had coincided with higher-than-expected costs and production challenges at its facilities in Indiana and in Brussels. ...

Joe Ferraro joined Catalent in 2023, just before a blizzard of challenges hit. Courtesy photo Joe Ferraro doesn’t believe in micromanaging. Instead, he empowers his team, trusting them to rise ...

The first facility is Catalent's factory in Brussels. Reuters reported this week that the second facility is Thermo Fisher's TMO.N factory in Greenville, North Carolina.

Problems at Catalent’s Brussels plant were previously pegged as part of the reason behind a supply squeeze on Novo Nordisk’s Wegovy in 2022.

In April, Catalent reported productivity challenges and higher-than-expected costs at its drug product and drug substance manufacturing facilities in Bloomington, Indiana, and Brussels, Belgium.

Catalent faced criticism for failing to investigate unexplained discrepancies in ... FDA inspectors visited the Brussels-based plant in October 2021 and August 2022 to assess its ...

BRUSSELS (Reuters) -Novo Holdings on Friday gained unconditional EU antitrust approval for its $16.5 bln acquisition of U.S. contract drug maker Catalent after EU regulators said they did not see ...

Novo Nordisk plans to buy from the holding company three sites — Brussels; Anagni, Italy; ... Catalent shares in January spiked on news of the planned acquisition to near $60.

Novo Holdings to purchase drug manufacturer Catalent for $16.5 billion, a deal that could expand Wegovy ... Novo will pick up sites that focus on filling drugs in Italy, Brussels, and ...