Product/Composition:- | Rabeprazole tablets |
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Strength:- | 20 mg and 40 mg |
Form:- | Tablets |
Reference Brands:- | AcipHex(US & EU) |
MOQ | As per the manufacturer batch size |
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Rabeprazole is a proton pump inhibitor that inhibits gastric acid secretion by irreversibly blocking the H+/K+ ATPase enzyme in stomach lining cells. It effectively treats GERD, ulcers, and Zollinger-Ellison syndrome. Benefits include symptom relief, mucosal healing, reduced acid-related complications, and improved quality of life.
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.