Quote:
Originally Posted by jcc911
I would be careful of the origin. I have many years in pharmaceutical and API manufacturing and would also be cautious about drugs manufactured overseas.
It is true they must adhere to all FDA regutions and guideline and manufacture under cGMP standards, but it can take a while for these companies overseas to be audited and when they are, are likely noncompliant.
The CFRs written specific for OTC/drug manufacturing can be difficult for manufacturers in other companies to understand. In speaking with numerous consultants and ex fda personnel, India and china were some of the worst, and Japan on the better end of the spectrum.
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But don't most of the major US pharmaceutical companies have plants worldwide including many in Asia? I think most of the negative reports are BS and just another way of setting fear to the end user. The industry is full of people worse than the 'banksters'. (Edit: Let me add those with the FDA)
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