Captopril Tablet

Form: Tablets

Strength: 25 mg, 50 mg, 100 mg

Reference Brands: Capoten(US)

Category: Hypertension

Captopril tablets, marketed as Capoten, are approved in the US by the FDA and in the EU via EMA for hypertension and heart failure. 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 information, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional requirements supports timely approval, safe use, and global availability of captopril tablets, assisting healthcare providers in managing cardiovascular conditions worldwide efficiently and effectively.