Product/Composition:- | Losartan tablet |
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Strength:- | 25 mg, 50 mg, 100 mg |
Form:- | Tablet |
Reference Brands:- | Cozaar(US & EU) |
MOQ | As per the manufacturer batch size |
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Losartan is an angiotensin receptor blocker (ARB) that prevents angiotensin II from binding to its receptors, causing vasodilation. It lowers blood pressure, reduces the risk of stroke, and protects kidney function in diabetics. Benefits include effective hypertension control, improved cardiovascular health, and decreased heart failure progression.
Losartan tablets, marketed as Cozaar, are approved in the US by the FDA and in the EU via EMA for treating hypertension, protecting kidney function, and reducing cardiovascular events. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial data and manufacturing processes, while the EMA ensures compliance with regional safety and quality regulations. For guidance on dossier preparation, regulatory pathways, and market strategies, visit PharmaTradz. Ensuring regulatory adherence supports timely approval, safe use, and global availability of losartan tablets, helping improve cardiovascular health outcomes worldwide.