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CDER has restricted specifics of API suppliers for items that don't need an authorized application from FDA to generally be promoted, for instance compounded and OTC monograph drugs. API suppliers for these kinds of merchandise may well not sign up their facility with FDA If they're sending substance into a drug item producer outside The usa to cre
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For instance, Even though the CPG will not specially mention concurrent validation for an API To put it briefly provide, the Company would think about the usage of concurrent validation when it's important to address a true shorter-offer problem, and In the event the concurrent validation review conforms to the problems discovered during the CPG (s