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.

 

[DeafJam]

The raws come from overseas and that is the hard part of the process. Whether they lyophilize and can here is irrelevant. How it test for purity, mass, sterility, and endotoxin and are there consistent third party testing matter much more than “Made in the USA with Chinese raws”

 

[EA1971]

Skye is the only one I know that says they do all the lypholization in the US, so dough comes from CN but baking happens here

 

[gershon]

The raws come from overseas and that is the hard part of the process. Whether they lyophilize and can here is irrelevant. How it test for purity, mass, sterility, and endotoxin and are there consistent third party testing matter much more than “Made in the USA with Chinese raws”

always read the fine print! i had a good conversation with a CDMO in San Diego Friday who told me that they have been approached by many people asking about getting the API and doing the lyo there as an RUO product. They don't do that and were very open about the whole process.

 

[GLP1Pharmacist]

Easier to transport lyophilized api, they maybe buying in 50 gallon drums and repackaging.

 

[dogmom]

They are probably lying. Occam's razor.