Novo Nordisk's Kalundborg plant, crucial for producing Ozempic and Wegovy, faced FDA scrutiny over microbial control, complicating efforts to meet rising drug demand.
The Kalundborg site is vital for Novo's strategy to satisfy demand for semaglutide, exacerbated by an earlier FDA query on production processes.
Despite quality inspections, Novo Nordisk remains in ongoing discussions with the FDA, with the company not anticipating a resolution to its issues this year.
Novo Nordisk’s core insulin product has been essential for diabetes management, but the recent surge in demand for obesity treatments has increased production challenges.
Collection
[
|
...
]