Nifedipine tablets(IR/ER)

Form: Tablet(IR & ER)

Strength: 10 mg, 20 mg, 30 mg, 60 mg, 90 mg (IR and ER forms)

Reference Brands: Procardia(US);

Category: Heart Disorder

Nifedipine tablets, marketed as Procardia and generic formulations, are approved in the US by the FDA and in the EU via EMA for hypertension and angina. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The US reviews detailed clinical trial and manufacturing data for timely approval, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and global availability, helping healthcare providers effectively manage cardiovascular conditions worldwide.