Quality Control Issues at Novo Nordisk's Clayton Plant - Key Site for Weight-Loss, Diabetes Drug Production

The FDA has reportedly issued a report detailing quality control lapses at Novo Nordisk A/S's NVO Clayton, North Carolina plant.

Clayton is a major site for the company's production of its active pharmaceutical ingredients, including semaglutide, which is used in its hugely popular weight-loss drug Wegovy and type 2 diabetes drug Ozempic.

Also Read: Novo Nordisk's Famed Drug Ozempic Could Be Contender For Medicare Negotiations.

Citing Novo Nordisk's emailed statement, Reuters reported that the site was "running and producing for the market."

With this update, Novo Nordisk has hired U.S. private contract manufacturer PCI Pharma Services to handle the assembly and packaging of Wegovy as it races to boost output of the weight-loss drug to meet demand.

PCI, which has 15 facilities in North America, Europe, and Australia, is putting together the self-injection pens used to administer Wegovy, Reuters reported, citing the confidential source. The source did not say when Novo signed up PCI.

Novo Nordisk has faced challenges in meeting the demand for the drug in the five markets where it is available, necessitating substantial investments in production expansion, including the construction of new facilities and the engagement of additional contract manufacturers to produce the pens.

There are reports that scientists are now exploring the potential of popular obesity drugs to address conditions like dementia and alcohol addiction, following recent trials that demonstrated the drugs' effectiveness in treating severe health issues.

Price Action: NVO shares are down 3.26% at $184.22 on the last check Monday.