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by go1979 3926 days ago
I'm surprised about the drug trial bit. I thought generics didn't need to have new trials .. they just need to have the exact same formulation. The oddness is that they need to "reverse engineer" the formulation themselves. The pill's color, shape and markings couldn't be copied though.

Can anyone knowledgeable on this critique what I wrote? I got my info during a tour of a generic drug manufacturer's plant a looooong time ago.

1 comments

I believe the generic maker must show bioequivalency to make sure the thing they are making works the same as the thing the other manufacturer was making. There's probably numerous ways that making a complicated medicine can be screwed up.