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.