Novo’s primary Ozempic plant cited for high quality lapses by FDA

The plant in Kalundborg, Denmark lacked data supposed to point out that water utilized in drug manufacturing was adequately managed for sure microorganisms, in line with 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 problem this 12 months.

Novo has been racing to spice up provides of its medication for weight problems and diabetes after initially underestimating demand whereas overcoming points at a contract producer. The Kalundborg web site, the place a fireplace was additionally reported earlier this 12 months, performs a key position in Novo’s long-term plan to fulfill demand. It’s one among two locations on the earth 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 medication are driving Novo’s development, insulin has been the corporate’s core product for a century. Folks with kind 1 diabetes rely upon injected insulin to control 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, extra data in fourth.)