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Any change to a manufacturing process, raw material supplier, critical piece of equipment, or analytical method for a product authorized in the EU must flow through the change control system and, depending on its regulatory impact classification, through a variation application

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Both medications are available only as brand-name drugs, with no generics currently available

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In Phase 2 detoxification, various enzymes act directly on the toxic substances partially degraded and processed in Phase 1, such as heavy metals and organo-toxins, by binding them with protective compounds, thereby either inactivating the toxins