Wednesday, May 17, 2023

Who is making "generic" semaglutide, part 2

I know I've covered this before, but it continues to bother me - who is making "generic" semaglutide? (via the New York Times): 
...Because the F.D.A.’s drug shortage website lists as Ozempic as “currently in shortage,” compounding pharmacies are allowed to buy semaglutide from pharmaceutical ingredient manufacturers and compound it into an injectable medication they dispense. They also often mix it with B vitamins or a metabolic compound called L-carnitine, which limited research has shown may contribute to weight loss. Some compounding pharmacies are distributing a different active ingredient altogether: semaglutide sodium, the salt form of semaglutide.

In recent weeks, regulators have raised concerns about semaglutide sodium, which is sometimes sold as a research chemical. Semaglutide sodium does not appear to meet standards for compounding in federal law, in part because the substance is not part of any F.D.A.-approved medication — and officials have expressed alarm at how widespread it is.

I don't wish to cover the questions that I've already asked, but I'll note some other questions that I have about this situation: 

  • Are we basically in a world where US consumers are ordering API from Chinese manufacturers directly?  
  • Why isn't the FDA stopping these shipments from coming in? 
  • Semaglutide doesn't appear to be a particularly easy peptide to make, but I suppose that these sorts of efforts are run by solid-phase synthesizers? Is it the fact that the dosages are relatively low that allow Chinese peptide manufacturers to participate in this? 
I'm genuinely surprised that people are willing to entrust their lives to a supply chain that is completely opaque and untraceable, but it is around weight loss, and so folks are pretty motivated to get themselves access to Ozempic, whether it's through their physicians or not. 

2 comments:

  1. I have a standing script for semaglutide for a legit reason and I've not seen shortages, thankfully. But as I understand it, people in Hollywood are "abusing" it for weight loss purposes and they're paying full retail cash prices. There is a lot of unsubstantiated claims that Novo and Lilly are aware of this and are diverting more supplies there for higher prices. I feel bad for the regular working people who have found this drug to help them and more or less need the drug to help them with either diabetes and/or weight loss and are unable to find it.

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