Wegovy, Ozempic, Shots Manufactured at Facility With Cleanliness Issue

A plant in Belgium that helps manufacture injection pens for popular weight loss drugs Ozempic and Wegovy is plagued by sterilization issues, according to a new report.

Novo Nordisk, the Danish manufacturer of the drugs, partners with pharmaceutical technology company Catalent to fill syringes with the drug. These devices are used weekly by patients – often via self-administration – to inject the drug into their arm, leg or stomach.

During required inspections, Food and Drug Administration (FDA) officials found issues with the air filtration in Catalent’s plant in Brussels. Failures in air filtration “compromised” the sterility of devices made on site. A copy of the report was obtained by Reuters.

Regulators first noted these failures during an inspection in October 2021. One filtration system had repeatedly failed from 2017 to 2021, FDA inspectors wrote. Another check in August 2022 found employees were failing to properly inspect equipment at risk of contamination.

"Standard operating procedures are not followed or are deficient," the FDA report read.

Microbes, small organisms that can sometimes be deadly bacteria, thrive in warm and moist environments. These bacteria can be deadly if injected into the body, potentially causing serious and sometimes fatal infections.

The FDA regularly inspects plants that manufacture drugs the agency has approved. It did not order the plant closed because they did not constitute the issues as a public health emergency. There are no reported cases of injury caused by these sterilization issues.

Neither Catalent, which is headquartered in New Jersey, nor Novo Nordisk immediately replied to a request for comment from The Messenger.

Novo has previously pointed to issues at this Catalent plant as part of the reason the drug faced supply issues in 2022. Catalent shut down the Brussels facility two times between the FDA inspections, Reuters reports. However, the Danish firm has continued to back Catalent as a reliable partner.

However, this isn’t the first time Catalent has faced  similar issues. Inspections by FDA officials in 2018 and 2019 found “objectionable conditions” in three U.S. based plants operated by the company.

Wegovy and Ozempic are some of the most in-demand drugs in the world at the moment. They fueled a 26% growth in revenue for Novo in 2022 compared to the year earlier – the firm raked in $25.6 billion last year.

The pair of sister drugs – which both use the active ingredient semaglutide – have run into a few roadblocks, however. Novo faced supply issues that made the drugs largely unavailable for new patients in 2022. 

While Novo quelled some manufacturing issues at the start of 2023, it has since once again had to limit the number of starter doses available to make sure it had the manufacturing capacity to continue supplying existing users.

Recent research has also found that users of the drug will often regain lost weight after they stop taking the drugs – which many do within the first year. The drugs have also been linked in some cases to a  phenomenon known as stomach paralysis and they are currently being investigated by the EU and the UK for potentially causing suicidal thoughts in some patients.

The American pharmaceutical giant Eli Lilly is also vying for Wegovy’s place in the market, with its blockbuster diabetes drug Mounjaro nearing FDA approval as a weight loss medication.