Deferasirox Tablets Generics - Manufacturers & Suppliers
Exjade(Dispersible tablets);Jadenu (Film-coated Tablet)s
| Product/Composition:- | Deferasirox tablets |
|---|---|
| Strength:- | 125 mg, 250 mg, and 500 mg |
| Form:- | Tablet |
| Reference Brands:- | Exjade(Dispersible tablets);Jadenu (Film-coated Tablet)s |
| MOQ | As per the manufacturer batch size |
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Deferasirox binds to excess iron in the bloodstream, forming a complex that is excreted primarily via feces. It effectively reduces iron overload in patients with chronic transfusions. Benefits include convenient once-daily oral dosing, improved patient compliance, shortened treatment duration, and prevention of organ damage caused by iron accumulation.
Deferasirox tablets, marketed as Exjade and Jadenu, are approved in the US by the FDA and in the EU via EMA for treating chronic iron overload in transfusion-dependent patients. Regulatory approval requires a comprehensive dossier including clinical data, manufacturing quality, safety, efficacy, and pharmacovigilance plans. In the US, FDA review involves detailed assessment, while EMA approval follows strict regional guidelines, ensuring consistent quality standards. For expert guidance on dossier preparation, regulatory pathways, and successful market access, visit PharmaTradz. Compliance with regional regulations is essential for the safe, effective, and timely approval of deferasirox tablets worldwide, supporting optimal patient management.