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Re: Despicable_Z post# 21861

Thursday, 01/12/2017 1:22:34 PM

Thursday, January 12, 2017 1:22:34 PM

Post# of 38634
This was what I am trying to understand as well. The NDA filing requires them to have a manufacturing site inspected and confirmed it is able to produce the drug to specifications. So if they filed the NDA, certainly they have to have a manufacturer. From their prior press release, it was clearly stated they were evaluating multiple manufacturers. This to me means that they have a partner but not yet finalized and announced.

I just don't know if my understanding of this is correct. If this how it works with the approval process, IPCI already have a partner.
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