Verapamil tablets IR & ER

Form: Tablets(IR & ER)

Strength: IR: 0 mg, 120 mg, 180 mg, 240 mg; ER: 180 mg and 240 mg

Reference Brands: Isoptin, Calan(US)

Category: Heart Disorder

Verapamil IR and ER tablets, marketed as Isoptin, Calan, and Verapamil HCl, are approved in the US by the FDA and in the EU via EMA for hypertension, angina, and arrhythmias. 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 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 regulatory compliance supports timely approval, safe use, and global availability, facilitating effective cardiovascular treatment worldwide.