Friday, September 22, 2023

Novo's semaglutide API plant in North Carolina had a 483 in May 2022

Via Reuters, this bit of news: 

LONDON, Sept 21 (Reuters) - U.S. drug regulators issued a report detailing quality control lapses at Novo Nordisk's (NOVOb.CO) main factory in North America as early as May last year, according to the report obtained by Reuters via a Freedom of Information Act request.

The inspection by the U.S. Food and Drug Administration (FDA) was at Novo's facility in Clayton, North Carolina, which the company says produces the active pharmaceutical ingredient (API), semaglutide.

The site makes oral semaglutide for Novo's diabetes drug Rybelsus, a spokesperson told Bloomberg on Thursday. A spokesperson declined to comment when asked by Reuters to confirm this.

Semaglutide is also used in Novo's hugely popular weight-loss drug Wegovy and type 2 diabetes drug Ozempic, which are injections.

There is no evidence that compliance failures flagged in the report known as a Form 483 resulted in harm to users of Wegovy and Ozempic. A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable".

The issues were with the factory's control systems to prevent microbial contamination, the same as those raised in the more recent inspection this July, which was first reported by financial news agency MarketWire and pushed Novo's shares down 3%.

Novo declined to comment on the May 2022 report, which was first reported by Reuters, but repeated its statement on Monday in response to the FDA's report from its July inspection that the Clayton site was "running and producing for the market".

As regular readers know, I am very interested in understanding the supply chain of semaglutide. What is really remarkable to me is that there have been almost immediate shortages from launch. Some of this is clearly demand -  I have long suspected that Novo, being Europeans, did not accurately anticipate either 1) off-label use of Wegovy/Ozempic for weight loss 2) the demand for this in the United States or both. 

I also imagine that a lot of this is about available manufacturing capacity, either for sterile injectables or for API. It seems to me pretty clear that part of the supply problem has been about sterile injectable manufacturing capacity available to Novo. That there may have also been a crimp in API supply in May 2022 might add another piece of the puzzle as well. 

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