Ramipril Capsules/Tablets

Form: Capsules/Tablets

Strength: 1.25 mg, 2.5 mg, 5 mg, 10 mg, and 20 mg

Reference Brands: Altace(US)

Category: Heart Disorder

Ramipril capsules and tablets, marketed as Altace in the US and as generic Ramipril across the EU, are approved for hypertension, heart failure, and cardiovascular risk reduction. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality data, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance supports timely approval, safe use, and worldwide availability of ramipril, enabling effective blood pressure and cardiovascular management globally.