Elite Pharmaceuticals Inc (ELTP)

[Winechemist]

Thanks for the extra information, Cake Eater. Yes for a normal API you are correct, DMFs can be approved from different companies all over the world, FDA will not give you approval unless you use a US source. This is a CII, has to be manufactured in the US, no options around the CFRs. Keep in mind I am the DEA controlled substance manager for my company ;)