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Samsa

08/26/16 6:49 AM

#17172 RE: InTheTrenches #17169

Trenches....I think you may be onto something. I read the same requirement. they need to state the manufacturing facility. Pretty tough to do without a partner. unless, I missed something in the import laws which allows a company to "transfer" goods between partners and therefore they aren't importing an actual final class 2 drug, that they would manufacture at their facility and then be able to transfer the pills to a partner who would package and get ready for shipment. the legal question is when is a drug a drug that is now subject to import laws? they will need to show where the manufacturing is taking place for the application as far as I read as well, which means they need to have a partnership in place prior to filing. the old classic question, which comes first? actually I would take a partnership deal being disclosed prior to the filing. that would make a real nice one two punch.