Dexrabeprazole

Dexrabeprazole, the S-enantiomer of Rabeprazole, is a potent proton pump inhibitor (PPI) used for the treatment of acid-related gastrointestinal disorders. As an advanced molecule with improved pharmacodynamic and pharmacokinetic properties, Dexrabeprazole is widely prescribed for conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, erosive esophagitis, Zollinger-Ellison syndrome, and NSAID-induced gastric injury.

Dexrabeprazole offers enhanced acid suppression, improved bioavailability, and better therapeutic response compared to the racemic mixture of Rabeprazole. Its increasing demand in international markets makes it a high-value addition to any pharmaceutical portfolio focused on gastroenterology.

At BluepillExpress, we specialize in WHO-GMP-certified third-party manufacturing of Dexrabeprazole tablets, providing high-quality, affordable, and export-ready formulations for global pharmaceutical brands, hospitals, and NGOs.

About BluepillExpress

BluepillExpress is a leading Indian pharmaceutical manufacturer and global exporter, offering end-to-end third-party manufacturing services in compliance with WHO-GMP, ISO 9001:2015, and international pharmacopoeial standards (IP, BP, USP). We serve pharmaceutical distributors, hospitals, and government agencies across Africa, Asia, Latin America, the Middle East, and CIS countries.

Our services include:

• Contract manufacturing of branded and generic formulations
• Private label development with full branding and packaging
• Regulatory documentation for global product registration
• CTD/ACTD dossier support
• Export compliance and logistics coordination

With modern facilities, a robust QA/QC infrastructure, and a commitment to quality, we are proud to manufacture specialty molecules like Dexrabeprazole for global markets.

Pharmacological Overview

• Generic Name: Dexrabeprazole Sodium
• Pharmacological Class: Proton Pump Inhibitor (PPI)
• Therapeutic Category: Anti-ulcer, Gastroprotective agent
• Mechanism: Inhibition of H⁺/K⁺ ATPase pump in gastric parietal cells
• Dosage Form: Delayed-release tablet
• Route of Administration: Oral

Mechanism of Action

Dexrabeprazole is the active S-enantiomer of Rabeprazole, which selectively inhibits the H⁺/K⁺ ATPase enzyme—the final step in the acid secretion process in gastric parietal cells. This irreversible inhibition leads to:

• Long-lasting reduction in gastric acid production
• Faster onset of action than other PPIs
• Improved healing of gastric and esophageal lesions
• Symptom relief in acid-peptic disorders

Due to its stereoselective activity, Dexrabeprazole exhibits higher potency and lower dose requirements, enhancing patient compliance.

Clinical Indications

Dexrabeprazole is indicated for the treatment of:

• Gastroesophageal Reflux Disease (GERD)
• Peptic Ulcers (gastric and duodenal)
• Erosive Esophagitis
• Zollinger-Ellison Syndrome
• Helicobacter pylori eradication therapy (in combination)
• NSAID-induced gastritis or ulcer prevention
• Functional dyspepsia with acid-related symptoms

It is typically prescribed once daily and is best administered 30–60 minutes before a meal for optimal acid suppression.

Dexrabeprazole Dosage Forms Manufactured by BluepillExpress

We manufacture Dexrabeprazole in delayed-release tablet form, using enteric coating technology to ensure acid resistance and targeted intestinal absorption.

Available Strengths:

• Dexrabeprazole 10 mg Delayed-Release Tablets
• Dexrabeprazole 20 mg Delayed-Release Tablets

Formulation Features:

• Enteric-coated core tablet (protects from gastric degradation)
• Uniform granule size for consistent drug release
• Stability-enhancing excipients
• Blister or bottle packaging
• Shelf life: 24 to 36 months depending on market

Customized strengths or fixed-dose combinations (e.g., with Domperidone or Levosulpiride) are available upon request, based on regulatory compliance.

Manufacturing Capabilities

Our advanced pharmaceutical manufacturing unit is certified for WHO-GMP, ISO, and Schedule M, allowing us to handle high-volume and specialty manufacturing requirements for Dexrabeprazole.

Key Capabilities:

• Fully automated tablet compression and coating lines
• Air-controlled cleanrooms and humidity-controlled processing areas
• High-precision enteric coating machinery
• In-house quality control and testing laboratories
• High-speed blister and strip packing machines
• Capability to scale batches from pilot to commercial volumes

We ensure that every batch is manufactured with standardized process validation, ensuring uniformity, bioavailability, and long-term stability.

Quality Control and Quality Assurance

At BluepillExpress, quality assurance is integrated into every stage of the manufacturing lifecycle. Our laboratories are equipped with HPLC, UV, dissolution testers, disintegration testers, and stability chambers, ensuring compliance with IP/BP/USP standards.

Our QC Testing Includes:

• API assay and purity tests
• Tablet weight variation and hardness tests
• Disintegration and dissolution time verification
• Moisture content and microbial load testing
• Enteric coating integrity checks
• Accelerated and long-term stability studies

Each batch is accompanied by:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Stability data reports
• Raw material and finished product specifications

All documentation is audit-ready and accepted by regulatory authorities worldwide.

Packaging & Labeling Solutions

BluepillExpress provides complete custom packaging and private-labeling services, tailored to your market and regulatory needs.

Packaging Options:

• Alu-Alu blisters for improved moisture protection
• PVC-Alu blisters for standard retail packaging
• HDPE bottles for institutional supply
• Cartons with multilingual labeling and barcoding
• Patient Information Leaflets (PIL) included

We support custom branding with your logo, artwork, and design, helping you create a unique identity in your target market.

Regulatory and Documentation Support

We provide complete regulatory documentation and technical dossiers to help you register and launch Dexrabeprazole in your country.

Available Documents:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Analysis (COA)
• Certificate of Origin
• Product Specification Sheet & MSDS
• Free Sale Certificate
• Stability data (real-time and accelerated)
• Dossier in CTD or ACTD format

We also assist with:

• Product registration filing
• Labeling compliance checks
• Legalization through Chamber of Commerce or embassy
• Batch documentation for tenders and institutional supply

Our regulatory team is experienced with filings for Africa (NAFDAC, PPB, FMHACA), Asia (DRAP, BFAD), Middle East, and CIS countries.

Private Label and Third-Party Manufacturing Process

BluepillExpress offers an end-to-end solution for third-party manufacturing under your brand.

How the Process Works:

1. Product Inquiry – Share your required strength, formulation, and market
2. Quotation & Terms – Receive competitive pricing and manufacturing timelines
3. Sampling – Get a pilot batch for testing or registration
4. Artwork Design – We assist with custom packaging and branding
5. Commercial Manufacturing – Production begins after your approval
6. Quality Checks & Packing – Batches are packed under your brand name
7. Dispatch & Documentation – Global shipping with complete regulatory papers

We support low MOQs for startups and bulk production for established brands or institutions.

Export Markets and Supply Reach

BluepillExpress exports Dexrabeprazole to over 50 countries, supporting partners in:

• Africa: Kenya, Nigeria, Ethiopia, Sudan, Tanzania, Ghana
• Asia: Myanmar, Cambodia, Nepal, Bangladesh, Philippines
• Middle East: Iraq, Yemen, Jordan, UAE
• CIS Countries: Kazakhstan, Uzbekistan, Kyrgyzstan
• Latin America & Caribbean: Dominican Republic, Haiti, Peru, Bolivia

We supply:

• Pharmaceutical wholesalers and distributors
• Government and institutional health tenders
• NGO and humanitarian health programs
• Private-label marketers in e-commerce and retail chains

Sustainability and Ethical Manufacturing

BluepillExpress is deeply committed to sustainability, ethics, and social responsibility:

• Eco-friendly operations with water and waste treatment
• Recyclable packaging materials
• No use of child labor or discriminatory employment practices
• Fair-trade procurement of raw materials
• Social impact through medical access partnerships

Our operations align with the United Nations Sustainable Development Goals (SDGs) for healthcare and industry responsibility.

Why Partner with BluepillExpress for Dexrabeprazole Manufacturing?

• WHO-GMP certified, globally trusted manufacturing
• Expertise in gastroenterology and delayed-release formulations
• End-to-end third-party and private-label services
• CTD dossier support for regulatory filings
• High-quality enteric-coated tablets
• Multilingual packaging and export logistics
• Ethical, sustainable, and cost-effective production

Whether you are launching a new Dexrabeprazole brand or expanding your existing product line, BluepillExpress is your reliable manufacturing partner.

Conclusion

Dexrabeprazole is an advanced, enantiomerically pure PPI that offers superior acid suppression, faster symptom relief, and enhanced healing rates for acid-related gastrointestinal disorders. With growing demand for high-quality PPIs in international markets, Dexrabeprazole represents a valuable opportunity for brands focused on gastroenterology.

BluepillExpress provides world-class third-party manufacturing services to bring Dexrabeprazole tablets to global markets with quality, compliance, and trust. From formulation and manufacturing to packaging and registration support, we manage every step of the journey with professionalism and integrity.