Rabeprazole Sodium Tablets 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.
Rabeprazole Sodium tablets is available in Tablets
and strengths such as 20 mg and 40 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Rabeprazole Sodium tablets is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Rabeprazole Sodium tablets can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
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.
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