Is there a quality problem with generics in the US? There doesn't seem to one in Europe (or at least Sweden). I assume you also have regulations and testing protocols etc?
It's extremely hard to enforce GMP and QA/QC from across the world and there's a strong incentive to cheat and lie when it comes to these costly procedures. Whether it'll be any better in a US manufacturing facility is of course up for debate.
> Because the FDA requires very specific GMP requirements that differ from those of the EU and other countries, drugs approved or synthesized without US FDA certification cannot be legally sold in the U.S.
Sounds a bit like trade protectionism - but I assume that goes both ways between e.g. EU and US.
