The site expansion will occur in Bagsværd, Denmark, and sees Novo Nordisk plan to invest DKK 5.4bn (€726m). Novo Nordisk plans to expand its existing site in the location, where the company holds its headquarters.
The investment will create additional capacity in R&D for the manufacture of active pharmaceutical ingredients (APIs), which will be used to provide supply for the company’s global clinical trials. In addition, the expansion will provide capacity for developing future oral and injectable products.
According to the company, the project will be finished in 2024 and is expected to create approximately 160 additional roles.
“This investment in expanding our clinical API capacity in Bagsværd is an important step to ensure the continuous progress of our development pipeline. Increasing our API capacity in R&D will be a key enabler in bringing new innovations to the market, and meet the future demand of our patients,” said Jesper Bøving, SVP, CMC Development, Novo Nordisk.
The extension to its API production capabilities follows on from the company’s recently opened API manufacturing site in Clayton, US, which was the result of an investment of $2bn (€1.93bn). Within its Denmark manufacturing network, Novo Nordisk already produces API at two facilities.
In December 2021, the company announced plans to invest more than DKK 17bn to build three new manufacturing facilities and that it would expand an existing facility in Kalundborg, Denmark. Again, the focus was on the expansion of its capacity for APIs, as well assembly and packaging.
In a third quarter investor call, Karsten Munk Knudsen, CFO of Novo Nordisk, explained that part of the motivation for current manufacturing build-outs has been as a result of constraints seen in the supply of Ozempic (semaglutide).
He stated, “We’re not going into any details about where our constraints are. But again, coming back to that we’re scaling our manufacturing platforms and we’ll be able to cater for the growth trajectory we’re currently on when we look forward.”
The supply constraints also impacted its Wegovy product, which contains the same active ingredient as Ozempic, but in a different concentration.
At the end of last year, the capacity for this product had been limited after a contract manufacturer had temporarily stopped manufacturing and deliveries. The problem occurred due to issues in meeting good manufacturing practice standards. The product has also seen high demand for its indication in weight loss management, with some expectation that it is being prescribed off-label.