Thanks Clyde for getting things clarified on the making side.
The biggest issue will be that for registration of the drug in places like Brazil and Mexico when in a supply arrangement as described, evidence of source from a facility with Good Manufacturing Process (GMP) will be required.How do you get that nailed when you are contracting out to multiple parties and you are not the supplier. Wont SUDA own responsibility for that validation effort?
Supply model, page-7
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