Product/Composition:- | Aliskiren tablets |
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Strength:- | 150 mg, 300 mg |
Form:- | Tablets |
Reference Brands:- | Tekturna(US & EU) |
MOQ | As per the manufacturer batch size |
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Aliskiren is a direct renin inhibitor that reduces the production of angiotensin I, lowering blood pressure. It decreases cardiovascular risk, improves hypertension control, and helps prevent stroke and heart failure. Benefits include blood pressure reduction, improved cardiovascular health, and enhanced long-term disease management with minimal side effects.
Aliskiren tablets, marketed as Tekturna, are approved in the US by the FDA and in the EU via EMA for hypertension management. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and safety data, while the EMA ensures regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and worldwide availability of aliskiren tablets, helping improve blood pressure control and reduce cardiovascular risks globally.