I knew the answer to my question when I asked it.
You have mistakenly assumed that all those Active Pharmaceutical Ingredients are approved for incorporation into US-marketed medicinal products. They are not.
A current listing of all API's which have been approved for incorporation into US products may be found here: Drug Master Files
I was at one time in my career a Review Chemist who served at FDA. Part of what I did was to review the contents of Drug Master Files which contain all the manufacturing process and stability data necessary to support a drug product applicant's product filing which incorporates the API's.
Drug substances used in products approved for marketing in the US have received thorough assessment of supportive data on file state-side and FDA's inspection teams which visit the facilities during the approval process and regularly afterwards are the best in the world.
As a consultant in my own firm I have audited pharma, biologic, and device firms all over the world. This includes a number of Chinese facilities. One in particular located just outside of Shanghai was one of the best facilities I have seen in my 23 years in business.
One cannot simplistically leap to the assumption that all drug substances made in China are crap. Those incorporated into US-approved medicines must meet high standards of manufacturing, and qualification. FDA generally does a good job of ferreting out the bad actors.
That is not to say that all facilities I have audited pass muster the first time, and I have often been asked on the back side of making observations to help with developing remediation plans to close the the gaps in their quality systems.
Some facilities I've seen can't measure up and I will advise my clients to choose others for their products. Were FDA to visit them, they too would likely reject them, as well.
China has this vision for a "Made in China 2025" where they see themselves as the leaders in significant manufacturing sectors, but, while they may be ones who see themselves that way, they will not be the innovators they will need to be to formally establish themselves credibly that way in the world's eyes.
They can copy a lot of things well, and they can often mass produce, but they are not the innovators driving techno-logic advancements and improvements, and least of all in medical sciences.
They don't have the societal freedom required to do so meaningfully and creatively.
FReegards!
