Novo Nordisk A/S was cited for high quality lapses at a drug manufacturing plant in Denmark that makes the hit medicines Ozempic and Wegovy.
The plant in Kalundborg, Denmark lacked data meant to indicate that water utilized in drug manufacturing was adequately managed for sure microorganisms, in response to a US Meals and Drug Administration inspection report from March. The manufacturing course of was getting used on the plant to make a once-weekly type of insulin, a Novo spokesperson mentioned.
The FDA earlier questioned the method when it denied approval of the product, the spokesperson mentioned. The corporate stays in touch with the FDA and doesn’t anticipate to resolve the difficulty this yr.
Novo has been racing to spice up provides of its medicine for weight problems and diabetes after initially underestimating demand whereas overcoming points at a contract producer. The Kalundborg web site, the place a hearth was additionally reported earlier this yr, performs a key position in Novo’s long-term plan to fulfill demand. It’s one in every of two locations on the planet the place Novo makes semaglutide, the energetic ingredient within the two blockbusters.
Novo’s different web site that makes semaglutide is in North Carolina. That plant was cited by the FDA final September for failing to correctly examine bacterial contamination.
Whereas new weight problems medicine are driving Novo’s progress, insulin has been the corporate’s core product for a century. Individuals with sort 1 diabetes rely upon injected insulin to manage blood sugar as a result of they don’t produce sufficient of the hormone naturally.
Novo’s American depositary receipts have been little modified on the shut of buying and selling in New York.
(Updates with firm remark in second paragraph, further data in fourth.)
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