Product/Composition:- | Deferiprone tablets |
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Strength:- | 250 mg, 500 mg |
Form:- | Tablet |
Reference Brands:- | Ferriprox(US) |
MOQ | As per the manufacturer batch size |
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Deferiprone chelates excess iron by binding to free iron in the bloodstream, forming complexes that are excreted in urine. It effectively reduces iron overload in conditions like thalassemia, preventing organ damage. Benefits include oral administration, rapid iron removal, and improved management of iron-related toxicity, enhancing patient health outcomes.
Deferiprone tablets, marketed as Ferriprox, are approved in the EU and US for treating iron overload, particularly in thalassemia patients. Regulatory approval requires a comprehensive dossier including clinical trial data, safety, efficacy, manufacturing standards, and pharmacovigilance plans. In the US, approval is granted by the FDA after rigorous review, while in the EU, EMA guidelines ensure compliance with regional standards. For expert guidance on dossier preparation, regulatory pathways, and successful market entry, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of deferiprone tablets, supporting better patient management worldwide.