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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.
Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. To address this challenge and to support the development of generic versions of NBCPs, as well as assist manufacturers in planning of required studies for approval, the U.S.
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