Rabeprazole Sodium tablets

Form: Tablets

Strength: 20 mg and 40 mg

Reference Brands: AcipHex(US & EU)

Category: Gastrointestinal Drugs

Rabeprazole tablets, marketed as AcipHex, are approved in the US by the FDA and in the EU via EMA for GERD, erosive esophagitis, and Zollinger-Ellison syndrome. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews comprehensive clinical trial and quality data to ensure safety and efficacy, 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 regulations supports timely approval, safe use, and worldwide availability, helping manage acid-related disorders effectively across the globe.