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Tuesday, 03/21/2017 11:02:26 AM

Tuesday, March 21, 2017 11:02:26 AM

Post# of 38634
I've read opinions that ipci needs to name an fda approved manufacturing facility in the U.S for their products. From page 40, 3rd paragraph, of the recenly filed 20F:

...."In October 2014, the FDA provided us with written notification that our Toronto, Canada manufacturing facility at 30 Worcester Road had received an “acceptable” classification. Such inspections are carried out on a regular basis by the FDA and an “acceptable” classification is necessary to permit us to be in a position to receive final approvals for ANDAs and NDAs and to permit manufacturing of drug products intended for commercial sales in the United States after any such approvals. Similarly, Health Canada completed an inspection of our 30 Worcester Road facility." ....
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