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InTheTrenches

08/04/16 9:14 AM

#16883 RE: Samsa #16875

Samsa: IPCI could either sign a contract with a partner that has manufacturing capability OR hire a contract manufacturer.

From my research, it's probable that the name/address of the manufacturer needs to be named in our NDA at the time of submission. I believe the manufacturer has to be named in the 505(b)(1) NDA submission, so more than likely the manufacturer has to be named in our NDA (505(b)(2)) application as well.