lyophilization in the USA: Made in the USA?

[gershon]

Hi there! its been a while since I posted. I've just been busy with work etc but the forum and peptides are one of my passions.

While many obtain research materials from China, I have seen some US vendors mention that they lyophilize/formulate in the USA. Would any contract drug manufacturing organizations (CDMOs) even touch this? I asked a colleague who does drug formulations as a living and he didn't want to go near it stating that the FDA and other regulators are cracking down on this.

Do compounding pharmacies lyophilize? I dont think so. When i had an RX for compounded GLP-1 it came in solution already.

So, how/where is this being done? I don't want to cause a ruckus, I'm quite interested. Apparently there are facilities that will take the chinese raw materials/API and lyo it for US vendors. I understand there are places in Florida and California that do this.

Feel free to DM me if you have any thoughts or insights.

 

[keangkong]

No place that has a license to actually produce drugs would likely touch this. That leaves places that are not licensed. Also, I'm not saying that no one lypholizes research stuff in the US, but I will say that just because a place claims that they lypholize in the US would not mean that the person is telling the truth. There is a huge (and in my belief unwarranted) desire that people have to obtain their drugs from the "manufacturers."

 

[Calm Logic]

The compounding pharmacies get their freeze-dried powder from FDA-registered facilities (or are supposed to anyway). With tirz, for example, such FDA-registered facilities are located in both the US and China (and maybe other countries too). But it is mostly a joke to be FDA-registered, at least in another country where inspections are extremely unlikely.

 

[gershon]

No place that has a license to actually produce drugs would likely touch this. That leaves places that are not licensed. Also, I'm not saying that no one lypholizes research stuff in the US, but I will say that just because a place claims that they lypholize in the US would not mean that the person is telling the truth. There is a huge (and in my belief unwarranted) desire that people have to obtain their drugs from the "manufacturers."

this is what I am gathering as well. AND....even if they do lyo in the US, no one seems to want to say where they are doing it which makes me suspicious as well.