>>1) Has the FDA inspected the facilities and production lines you will use for the manufacture of your enoxaparin, and if so, did those facilities pass said inspections?
2) Has the FDA inspected the facilities used to manufacture your
source material (i.e. those of your suppliers of porcine intestinal
mucosa and heparin), and if so, did those facilities pass said
inspection? <<
"I can confirm that both facilities have been inspected. Momenta supporters must be getting nervous. --from Teva"
I didn't actually ask about commercial facilities (pre commercial facilities have to be inspected, at least with NDAs; I am not sure how that works with ANDAs), but I would think it was strongly implied. Like I said, I tried not to leave much wiggle room, but I do not know how exactly Ms. Chen put these questions to her Teva contact.
Regards, RockRat
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