Shown: posts 1 to 3 of 3. This is the beginning of the thread.
Posted by garylee on April 2, 2003, at 19:41:07
Hi
To some this post may sound a tad strange...
I'd like to ask if anyone has had any experience with getting API's made up?
I am in the process of trying to resurrect a discontinued med. I have " specials " companies willing to make the finished dose (caps or tabs) but they are having trouble finding the raw material (API).
I have been do the searching myself. Most companies can make to R & D standard only, but I am told there are some that will make an API for human consumption.
Back to the question tho... Can any one help?!
Cheers
Gary
Posted by djmmm on April 2, 2003, at 21:04:42
In reply to Active Pharmacuetical Ingredient - manufacturers, posted by garylee on April 2, 2003, at 19:41:07
what chemical(s) are you looking for?..
First look here for info: http://www.fda.gov/ora/inspect_ref/igs/bulk.html#Status%20of%20Bulk
http://www.fda.gov/cder/regulatory/default.htm
Then, keep this in mind: http://www.rhodium.ws/chemistry/watched.html
some companies:
http://www.voigtglobal.com/pharmaceutical_chemicals.htmhttp://www.exporters.com.sg/chemicals/pharmaceutical_chemicals/
http://www.biopharmalink.com/companies/2365.htm
http://www.biopharmalink.com/companies/2354.htm
http://www.biopharmalink.com/companies/2196.htm
http://www.chemindustry.com/chem2ask.asp?id=0,11&n=26751&d=lc
Posted by garylee on April 3, 2003, at 17:04:54
In reply to Re: Active Pharmacuetical Ingredient - manufacturers, posted by djmmm on April 2, 2003, at 21:04:42
Hi Dj
Thanks for the links.
The API I'm after is Amineptine. I checked the FDA regs that you sent and didn't see it anywhere.
I have been in contact with a few wholesalers around the world, but their 'minimum quantities' are far too much, we're talking Kilo's and the rest...
It may be better to go down the synthesis route. I've contacted a numerous companies, as well as the links you sent me, so I'll have to see what they come up with.
Cheers
Gary
This is the end of the thread.
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