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Winechemist

11/19/24 8:19 AM

#415334 RE: User-827038 #415333

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 ;)
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Zardiw

11/19/24 8:49 AM

#415344 RE: User-827038 #415333

$DDAmanda Chart on $ELTP:

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