FDA finds quality issues at Novo’s primary Ozempic facility

Novo Nordisk A/S was recently found to have quality lapses at a drug production plant in Denmark that manufactures the popular medicines Ozempic and Wegovy.

The plant, located in Kalundborg, Denmark, was found to lack information demonstrating that the water used in drug production was adequately controlled for certain microorganisms, as per a report from a US Food and Drug Administration inspection in March. The manufacturing process at the plant was being utilized to produce a once-weekly form of insulin, as stated by a Novo spokesperson.

The FDA had raised concerns about the process when it rejected the product’s approval, the spokesperson added. Novo is currently in communication with the FDA and does not anticipate resolving the issue within this year.

Novo has been working to increase the supply of its drugs for obesity and diabetes after initially underestimating demand and facing challenges at a contract manufacturer. The Kalundborg site, which also experienced a fire earlier this year, is crucial to Novo’s long-term strategy to meet demand. It is one of only two locations worldwide where Novo manufactures semaglutide, the active ingredient in the two blockbuster drugs.

The other site producing semaglutide for Novo is located in North Carolina. This plant was cited by the FDA in September of last year for failing to properly investigate bacterial contamination.

While new obesity drugs are propelling Novo’s growth, insulin has been the company’s flagship product for a century. Individuals with type 1 diabetes rely on injected insulin to regulate blood sugar levels due to insufficient natural hormone production.

Novo’s American depositary receipts saw minimal change at the end of trading in New York.

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(Updates with company comment in second paragraph, additional information in fourth.)

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