Rabeprazole Sodium Tablets 20 mg and 40 mg Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 20 mg and 40 mg
Reference Brands: AcipHex(US & EU)
Category: Gastrointestinal Drugs
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.
Product Description: 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.
Rabeprazole Sodium Tablets — third party manufacturing & bulk supply
Rabeprazole Sodium Tablets 20 mg and 40 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Rabeprazole Sodium Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Rabeprazole Sodium Tablets →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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