Forum Discussion
Bumpyroad
Jul 21, 2018Explorer
One problem with this thread is that folks are confusing the product manufacturer and the active pharmaceutical ingredient (API) manufacturer. evidently the manufacturer of the API is the one that changed manufacturing methods/processes and caused this impurity to exist. this would of course be in violation of the New Drug Application requirements.
It is theoretically possible that that supplier in India, and others, actually obtain the API from the chinese firm.
and knowing the manufacturer of the finished drug product gives you no knowledge as to who manufactured the API.
bumpy
It is theoretically possible that that supplier in India, and others, actually obtain the API from the chinese firm.
and knowing the manufacturer of the finished drug product gives you no knowledge as to who manufactured the API.
bumpy
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