Product/Composition:- | Amiloride tablets |
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Strength:- | 5 mg |
Form:- | Tablets |
Reference Brands:- | Midamor(US) |
MOQ | As per the manufacturer batch size |
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Amiloride is a potassium-sparing diuretic that blocks sodium channels in the distal nephron, reducing sodium reabsorption and potassium excretion. It effectively treats hypertension, edema, and heart failure. Benefits include potassium conservation, blood pressure reduction, decreased fluid retention, and improved cardiac function in heart failure patients.
Amiloride tablets, marketed as Midamor, are approved in the US by the FDA and in the EU via EMA for managing hypertension, edema, and heart failure. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and manufacturing information, while the EMA ensures regional safety and quality compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and global availability of amiloride tablets, helping optimize treatment outcomes for potassium-sparing diuretic therapy worldwide.