Product/Composition:- | Irbesartan tablets |
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Strength:- | 75 mg, 150 mg, 300 mg |
Form:- | Tablets |
Reference Brands:- | Avapro(Us & EU) |
MOQ | As per the manufacturer batch size |
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Irbesartan is an angiotensin II receptor blocker (ARB) that prevents angiotensin II from binding to its receptors, causing vasodilation. It lowers blood pressure, reduces kidney damage in diabetics, and decreases cardiovascular risks. Benefits include improved blood pressure control, renal protection, and reduced risk of strokes and heart attacks.
Irbesartan tablets, marketed as Avapro, are approved in the US by the FDA and in the EU via EMA for hypertension and diabetic nephropathy. Regulatory approval requires a detailed dossier, including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews comprehensive clinical trial and quality information, while the EMA verifies compliance with regional safety, efficacy, and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional compliance supports timely approval, safe medication use, and global availability of irbesartan tablets, helping manage hypertension and protect renal function worldwide effectively.