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 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
Frequently Asked Questions
Related Products
Pancreatin Tablets
Strength:
10,000, 25,000, 40,000, 50,000, 80,000 USP units.
Form: Tablets
Reference Brands: Creon(US)
View Details
Ursodeoxycholic Acid Capsule
Strength:
150 mg, 300 mg
Form: Capsules
Reference Brands: Actigall(US), rsofalk, Ursocaps, Ursode(EU)
View DetailsQuick Response Guaranteed | Verified Suppliers
