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Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. Quality standards in particular help ensure medicines are safe, work as intended, and are available when needed, no matter the company producing them or where they are made.
The organisation stated, PV (pharmacovigilance) events are generally a reflection of the properties of the active drug substance and the drug product, irrespective of where it is manufactured. It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDAs Orange Book database.
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