Complex Generic Drug Product


According to the FDA 2016 generic drug user free amendment, a complex generic drug is a product that that has, complex active ingredients e.g. (peptides polymeric compounds, complex mixtures of active pharmaceutical ingredient, naturally sourced ingredients) or a complex formulation such as (liposomes, colloids). drugs with the complex route of administration tropical drugs such as dermatological drugs, pomological drugs which are basically formulate as suspensions or emulsions, and complex dosage form (e.g. long acting injectables, metered-dose inhalers, transdermal) drug device combinations and drugs whose complexity concerning approval pathway.


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