Rabeprazole Sodium

Rabeprazole Sodium is a proton pump inhibitor (PPI) widely used in the treatment of acid-related gastrointestinal disorders, including gastroesophageal reflux disease (GERD), peptic ulcers, Zollinger-Ellison syndrome, and H. pylori-associated conditions. Due to its potent and long-lasting acid suppression, rapid onset of action, and favorable side-effect profile, Rabeprazole has become a cornerstone in gastroenterology therapeutics.

At BluepillExpress, we specialize in third-party and contract manufacturing of Rabeprazole Sodium formulations for pharmaceutical marketing companies, hospital supply chains, NGOs, and global exporters. With WHO-GMP certified facilities, extensive regulatory support, and tailored packaging solutions, we provide a seamless pathway to bring high-quality gastrointestinal medications to both domestic and international markets.

Product Overview

Generic Name: Rabeprazole Sodium
Therapeutic Class: Proton Pump Inhibitor (PPI)
Pharmacological Action: Gastric acid suppressant via irreversible inhibition of H+/K+-ATPase enzyme in gastric parietal cells

Available Dosage Forms and Strengths

• Enteric-Coated Tablets:
  • Rabeprazole Sodium 10 mg
  • Rabeprazole Sodium 20 mg
• Combination Formulations:
  • Rabeprazole + Domperidone (10/20 mg + 10 mg SR)
  • Rabeprazole + Levosulpiride (10/20 mg + 75 mg SR)
• Capsules: Available upon request (with or without pellets)
• Injection Form (Lyophilized Rabeprazole 20 mg/vial): On demand

Packaging Formats

• Alu-Alu or PVC-Alu blister strips (10×10 tablets)
• HDPE bottles (bulk packaging or hospital supply)
• Mono-cartons with printed or multilingual inserts
• Custom export packaging for regulated and semi-regulated markets

Indications and Uses

Rabeprazole Sodium is indicated for the management of a wide range of acid-peptic disorders, including:

• Gastroesophageal Reflux Disease (GERD)
• Erosive esophagitis
• Peptic Ulcer Disease (gastric and duodenal)
• Zollinger-Ellison Syndrome
• Helicobacter pylori eradication regimens (in combination therapy)
• NSAID-induced ulcer prophylaxis and treatment
• Dyspepsia and acid reflux associated with hyperacidity

Due to its rapid absorption and sustained acid suppression, Rabeprazole offers superior symptom control and mucosal healing compared to older PPIs.

Mechanism of Action

Rabeprazole Sodium acts by irreversibly binding to and inhibiting the H+/K+ ATPase enzyme system, also known as the “proton pump,” in the parietal cells of the stomach lining. This inhibition prevents the final step of gastric acid production, resulting in:

• Reduced gastric acidity
• Alleviation of acid reflux symptoms
• Enhanced healing of peptic ulcers
• Optimal environment for antibiotics to eradicate H. pylori

It has a faster onset of action compared to some other PPIs and maintains therapeutic acid suppression for up to 24 hours.

Pharmacokinetics and Bioavailability

• Absorption: Rapidly absorbed with peak plasma concentrations in 2–4 hours
• Bioavailability: Approx. 52% after a single dose, increases with repeated dosing
• Protein Binding: 96.3%
• Metabolism: Extensively metabolized in the liver via non-CYP450 enzymes
• Half-life: Approximately 1–2 hours
• Excretion: Mainly via urine and feces as metabolites

The enteric-coated formulation ensures Rabeprazole is absorbed in the intestine, bypassing stomach acid degradation.

Why Choose BluepillExpress for Rabeprazole Manufacturing?

1. WHO-GMP Certified Facilities with Modern Equipment

BluepillExpress adheres to the highest international manufacturing standards. Our state-of-the-art production units feature:

• Fluid bed processors and rapid mixing granulators
• Compression machines with auto weight controls
• Enteric coating pans with advanced film coating capabilities
• Cleanroom environments compliant with Class 100,000
• Blister and strip packaging lines with batch coding and serialization

Our facility is designed to manufacture acid-sensitive formulations like Rabeprazole under controlled environmental conditions.

2. Custom Formulation Services

Our in-house R&D team is equipped to offer:

• Enteric-coated tablets in custom shapes and sizes
• Delayed-release and extended-release formulations
• Fixed-dose combinations (FDCs) with antiemetics or prokinetics
• Custom pellet coating and capsule-filled dosage forms
• Modified formulations for enhanced bioavailability or patient compliance

We support formulation trials, bioequivalence studies, and technology transfers based on client needs.

Quality Control and Assurance

BluepillExpress is committed to delivering safe, effective, and consistent pharmaceutical products. Every Rabeprazole batch undergoes comprehensive testing, including:

• Assay and content uniformity
• Enteric coating integrity
• Dissolution profile in acid and buffer media
• Stability under accelerated and long-term conditions
• Microbial limit testing and residual solvents
• Physical parameters (hardness, friability, weight variation)

All processes follow IP, USP, and BP monographs, with full QA review before product release.

Regulatory Documentation and Compliance

We provide full regulatory support to meet global documentation standards for Rabeprazole Sodium, including:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Free Sale Certificate (FSC)
• Stability Data (Zone II, IVa, IVb)
• Product Specifications and Method of Analysis (MoA)
• CTD/ACTD Dossier Formats for regulated markets
• Certificate of Origin (CoO)
• Material Safety Data Sheet (MSDS)
• WHO-GMP and ISO Certifications

Our team has experience with regulatory approvals across Africa, Southeast Asia, CIS, and Latin America.

Private Label and Export Services

BluepillExpress offers full private labeling and white-label manufacturing services for clients worldwide. Our packaging services include:

• Customized foil printing with brand name
• Labeling and cartons in English, French, Spanish, Arabic, or regional languages
• Tamper-proof and serialized packaging
• Eco-friendly options for sustainability-conscious clients
• Institutional packaging for hospital supplies
• QR codes and barcoding as per country-specific guidelines

We assist with visual mock-ups, packaging design, and regulatory artwork review for export readiness.

Export Expertise and Global Delivery

With established supply chains to over 35 countries, BluepillExpress delivers internationally compliant and reliable export services, including:

• Temperature- and humidity-controlled warehousing
• Freight forwarding (air or sea) with bulk or retail packaging
• Coordination with third-party inspections (SGS, Intertek, Bureau Veritas)
• End-to-end documentation for customs and regulatory bodies
• Support for WHO/UN tender submissions and MoH procurement programs

We ensure on-time delivery, global coordination, and high-volume capability for large-scale programs.

Third-Party Manufacturing Process

Our manufacturing model is built for efficiency, transparency, and scalability:

1. Product Finalization
   • Dosage, formulation, and packaging discussions
   • Market-specific regulatory alignment
2. Commercial Agreement & NDA
   • Quotation, confidentiality, and batch size confirmation
3. Product Development
   • R&D support, formulation testing, pilot batch if required
4. Artwork and Branding
   • Label and carton development with client branding
5. Production and Packaging
   • WHO-GMP manufacturing with rigorous in-process checks
6. Quality Assurance and Release
   • Final QC, CoA issuance, and dispatch preparation
7. Dispatch & Export
   • Shipment through certified logistics with complete compliance

Lead Time: 30–40 working days from final artwork and order confirmation

Client Profiles Served

Our Rabeprazole Sodium manufacturing services are tailored for:

• Generic pharmaceutical companies
• Gastroenterology-focused brands
• OTC and prescription product marketers
• Hospitals and government health departments
• Distributors and pharmacy chains
• NGOs and public health suppliers

We support both small MOQs for new market entrants and bulk production for mature markets or tenders.

Why Partner with BluepillExpress?

• WHO-GMP, ISO-certified pharmaceutical manufacturer
• Scalable capacity and diverse dosage forms
• In-house R&D and formulation customization
• Full regulatory support for registration and exports
• Competitive pricing with quality consistency
• Transparent communication and ethical manufacturing practices
• Trusted by clients in 35+ countries and growing

Conclusion

Rabeprazole Sodium continues to be a key therapeutic option in managing acid-related gastrointestinal conditions worldwide. As demand grows for safe, effective, and affordable treatments, pharmaceutical companies, healthcare systems, and global distributors require a trusted and capable manufacturing partner.

BluepillExpress delivers top-tier third-party manufacturing solutions for Rabeprazole that are compliant, scalable, and brand-ready. Whether you’re seeking private-label production, government procurement supply, or market entry with customized formulations, our team is ready to support your journey to success.