The air-filtration system on one filling line at a factory in Brussels had failed again and again between 2017 and 2021. Plant staff had repeatedly logged the failures as “minor.” In October 2021, inspectors from the US Food and Drug Administration went through the plant’s operating history and wrote that sterility had been “compromised” in the area where drugs were being made. The plant belonged to Catalent, a contract manufacturer that fills syringes for drug companies.
Reuters, which later obtained the inspection reports, found no evidence that anyone was harmed. But after that visit, Catalent shut the plant down. Among the things it filled were the syringes for Wegovy, Novo Nordisk’s new weight-loss drug.
Wegovy had been approved in the US that June, and at first its problem was a pleasant one. In November, Novo’s chief executive, Lars Fruergaard Jørgensen, said US demand had “significantly exceeded our expectations.” Some patients might have to wait for their prescriptions, the company warned, but supply was gradually going up and it expected to meet demand in early 2022.
On December 17, Novo put out a company announcement. A contract manufacturer filling syringes for Wegovy pens for the US market, it said, had “temporarily stopped deliveries and manufacturing following issues with Good Manufacturing Practices.” Novo did not name the plant. It no longer expected to meet US demand in the first half of 2022, and “few new patients are expected to be able to initiate treatment.” Patients already on the drug would come first.
The announcement did not say Novo was short of semaglutide, the active ingredient. In its annual filing a few weeks later, the company said it expected no raw material shortage to significantly affect supply to any major market. What had stopped was one of the last steps on the line, where the medicine goes into a syringe. Reuters later called the Brussels plant “the factory that fills the self-injection pens” for Wegovy. A Novo spokesperson told it that, given the demand, “it would have been good to have more capacity and thus, more than one facility for supplies.”
Over the next two years, Novo kept having to decide who got the pens. The FDA put Wegovy on its drug shortage list on March 31, 2022. Novo limited launches outside the US, citing the constraints, and kept pushing back the date when supply would catch up. In late December 2022, it said all five dose strengths were available again. Five months later, with demand still ahead of supply, it cut US supply of the three lowest “starter” doses by half, so people already on the drug could keep going. It began gradually raising that supply again in January 2024. A second contract manufacturer had begun producing Wegovy in April 2023.
Then Novo went after the step itself. On February 5, 2024, Novo Holdings, the foundation-owned company that controls Novo Nordisk, agreed to buy Catalent for $16.5 billion. Novo Nordisk would take three Catalent sites that specialize in sterile filling, for $11 billion up front, and expected them to raise its filling capacity gradually from 2026.
The deal closed on December 18, 2024. Two months later, the FDA declared the semaglutide shortage resolved. Of the three filling plants Novo now owned, one was in Anagni, Italy, and one in Bloomington, Indiana. The third was in Brussels.