Catalent received an FDA write-up for its syringe filling facility in Belgium, BioProcess International reports, adding that it is "allegedly" the culprit behind supply challenges for Novo Nordisk’s obesity med Wegovy.
An FDA inspection of the CDMO's filling site in Brussels yielded a Form 483, the publication said, calling it a "recent" inspection.
Neither Catalent nor Novo Nordisk immediately responded to Fierce Pharma’s request for comment.
“We are treating the FDA’s 483 observations at the Brussels, Belgium, site very seriously and are working closely with them to resolve these, and with customers to minimize any potential disruptions this may cause to their supply chains,” a Catalent spokesperson told BioProcess Insider.
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While the publication reports that Catalent could not confirm Novo Nordisk is a customer at the Brussels site, the news outlet referenced a note from Jefferies analyst David Windley naming the Brussels site as the primary fill-finish supplier for Novo’s Wegovy. In the note, Windley blamed the 483 for Wegovy’s recent supply hurdles.
Toward the end of December, Novo Nordisk said a contract manufacturer in charge of syringe filling for Wegovy pens in the U.S. had temporarily paused deliveries following problems with good manufacturing practices. The Danish drugmaker said at the time that because of the manufacturing issue, it didn’t expect to be able to meet demand for the drug in the U.S. during the first half of 2022.
Novo did not clarify the nature of the manufacturing issue nor did it identify its manufacturing partner by name.
On its website, Catalent says its Brussels facility stands at 265,287 square feet, about the size of four and a half football fields. It boasts one of the largest syringe-filling capacities in Europe at more than 175 million units per year, the CDMO says.
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2022-01-07 21:20:00Z
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