Product/Composition:- | Eplerenone tablets |
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Strength:- | 25 mg and 50 mg |
Form:- | Tablet |
Reference Brands:- | Inspra(US & EU) |
MOQ | As per the manufacturer batch size |
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Eplerenone is a selective mineralocorticoid receptor antagonist that blocks aldosterone, reducing sodium retention and counteracting heart remodeling. It effectively lowers blood pressure, decreases hospitalization in heart failure, and improves cardiac function. Benefits include improved survival, reduced fluid retention, and better cardiovascular outcomes.
Eplerenone tablets, marketed as Inspra, are approved in the US by the FDA and in the EU via EMA for managing hypertension and heart failure. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical and quality information, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional compliance supports timely approval, safe use, and global availability of eplerenone tablets, helping improve cardiovascular health worldwide and supporting effective management of hypertension and heart failure.