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There's also the matter that in the US, if they change *anything* about the process of producing a drug - put it in a yellow-tinted capsule rather than a clear one, for example - they have to go through another round of expensive testing.

They need to go through stability testing, which is a long process. More time than cost. To the FDA, the drug product is not just the active ingredient, but the entire pill, label, and the bottle it comes in.

Even if the same yellow-tinted capsule is already in use for several other medicines. Several other countries are much more sensible about allowing drug-makers to switch among inert fillers, inert packaging, etc. without retesting.

No, other countries are pretty strict here to, but most will approve if FDA or EMA approval has been obtained. A validated process is important for a great many drugs.

Ralph
Helical Investor & drug developer.
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