Trenches- I am not saying stating the manufacturer on NDA is or is not required. I do not know. I am just saying that instead of speculating and debating it, ask IPCI what they feel is required for the NDA and how they plan to handle it. Then let us know what they say in regards to this. I fully expect they understand this requirement and will handle it appropriately. But am curious to hear what they say.
In regards to a partner, I feel IPCI has been very clear that they will not partner Rexista until at least after the NDA submission.
It is required to have the manufacturer of the drug in the NDA filing, which also includes a run of the drug in question to test as part of the review process. An inspection of the manufacturing facility is part of the approval process.
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