Irbesartan tablets

Form: Tablets

Strength: 75 mg, 150 mg, 300 mg

Reference Brands: Avapro(Us & EU)

Category: Hypertension

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.