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You're massively misunderstanding that Reddit post, and it doesn't help that the 'HenryMedsInfo' account is misconstruing how the pharma manufacturing supply ch
by sithadmin 2y ago
You're massively misunderstanding that Reddit post, and it doesn't help that the 'HenryMedsInfo' account is misconstruing how the pharma manufacturing supply chain works.
For one, the FDA does not 'license' any manufacturer, period. They do enforce safety and quality standards, but this is not controlled through some sort of a general license, and operates on a per-facility basis.
DMF listing (which isn't a 'license') does not necessarily have any relation to whether that manufacturer is supplying a brand name provider.
The 'license' that account is posting about a complete fiction. There is not a license granted here in any government context, nor a license between NN and the manufacturers the post discusses.
> The compounders are legally selling the real thing directly to customers.
This is debatable. They are not selling 'OEM' NN product to consumers.
Also - stop talking about 'feedstock'. It's weird. It's not standard industry lingo and obscures whatever the hell it is you're talking about (precursors? lyophilized product? something else?)
- andrewla 2y agoI'll stop saying feedstock -- I thought I saw that in the astralcodexten article but I am mistaken. When I say "the real thing" I mean that they are selling semaglutide, which they are obtaining somehow. The reddit post was the closest thing I've seen to an answer to the question "where are they getting it". So if they are not getting it from producers under license from NN, where are they getting it? Why isn't the legality of that path under active legal attack? There must be some fig leaf at least that they can use to say how they got the substance when the patent is still in force, otherwise judges would immediately shut them down with an injunction.
- sithadmin 2y ago>When I say "the real thing" I mean that they are selling semaglutide, which they are obtaining somehow >So if they are not getting it from producers under license from NN, where are they getting it? They're obtaining it from pharma labs with the right equipment and talent to produce it. The synthesis process is well understood, it's not like it's a Novo Nordisk secret. > Why isn't the legality of that path under active legal attack? It is.
- cthalupa 2y agoMy understanding is that a significant number of them are getting them from Chinese manufacturers (that are also selling them to other Chinese companies, that then sell them to individuals, more resellers, or compounding pharmacies) I've got a high enough risk tolerance that I've got lyophilized tirzepatide on the way from a Chinese seller. Even if I send one of the vials off to be tested, it will still be cheaper than I can get it from a compounding pharmacy in the US.
- trogdor 2y agoFor at least some compounding pharmacies, their source for semaglutide is crushed Rybelsus pills. See, for example: https://a4pc.org/2024-04/mass-confusion/ https://a4pc.org/2024-04/mass-confusion/ https://subsema.com/wp-content/uploads/2024/05/White-Paper-Semaglutide-Crushing-of-RYBELSUS%C2%AE-Tablets.pdf https://subsema.com/wp-content/uploads/2024/05/White-Paper-S... https://mynextgenrx.com/wp-content/uploads/2024/03/Compounded-Semaglutide-Sublingual-Script-Sheet.pdf https://mynextgenrx.com/wp-content/uploads/2024/03/Compounde...