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Re: InTheTrenches post# 16874

Wednesday, 08/03/2016 9:37:09 PM

Wednesday, August 03, 2016 9:37:09 PM

Post# of 38634
Trenches & Amigo....Yes I knew that Rexista can not be imported and therefore needs to be manufactured in the states. the ramp of the manufacturing of the current facility is no doubt for their ANDA line. that being said, it makes me wonder if you were correct that they need to include projected manufacturing in the NDA. that would mean they need to partner prior to filing so they could add that information. so my guess is that is not needed however I cant say I ever read that requirement one way or another.