Gastro-Resistant Omeprazole

The growing incidence of acid-related gastrointestinal disorders such as peptic ulcers, gastroesophageal reflux disease (GERD), and erosive esophagitis has led to a surge in demand for proton pump inhibitors (PPIs)—with Omeprazole being a widely prescribed and trusted therapeutic option. Its gastro-resistant formulation ensures stability in the acidic environment of the stomach, delivering the drug effectively where it is most needed.

BluepillExpress, a leading third-party pharmaceutical manufacturer, specializes in high-quality gastro-resistant formulations of Omeprazole for domestic and international markets. We manufacture according to WHO-GMP, ISO, and pharmacopeial (IP/BP/USP/EP) standards, offering contract manufacturing solutions that are scalable, compliant, and customized to brand requirements.

Our commitment to precision formulation, regulatory integrity, and quality assurance positions BluepillExpress as a strategic partner in the manufacturing of Omeprazole-based products.

About Gastro-Resistant Omeprazole

Omeprazole is a proton pump inhibitor that works by irreversibly inhibiting the H⁺/K⁺ ATPase enzyme system at the surface of gastric parietal cells. This suppression leads to a significant reduction in gastric acid secretion, providing relief from acid-related disorders and promoting healing of gastric and duodenal ulcers.

As Omeprazole is acid-labile, it is formulated with an enteric coating (gastro-resistant coating) to protect it from degradation in the acidic pH of the stomach, ensuring its release in the more alkaline environment of the small intestine for effective absorption.

Primary Therapeutic Uses:

• Gastroesophageal Reflux Disease (GERD)
• Peptic and Duodenal Ulcers
• Erosive Esophagitis
• Helicobacter pylori eradication (with antibiotics)
• Zollinger-Ellison Syndrome
• NSAID-induced gastric ulcer prevention
• Acid reflux in pediatric and geriatric populations

Why Choose BluepillExpress for Omeprazole Manufacturing?

1. WHO-GMP and ISO Certified Facilities

BluepillExpress operates state-of-the-art facilities with WHO-GMP, ISO 9001:2015, and Schedule M certifications. We ensure:

• Precision in enteric coating processes
• Compliance with international pharmacopeias
• Stringent validation protocols
• Secure and consistent manufacturing environments

2. Multiple Dosage Forms and Strengths

We manufacture a variety of Omeprazole gastro-resistant formulations, including:

• Omeprazole Gastro-Resistant Capsules: 10 mg, 20 mg, 40 mg
• Omeprazole Gastro-Resistant Tablets: 20 mg, 40 mg
• Omeprazole Dry Syrup (Pediatric use): on request
• Omeprazole + Domperidone Combinations: available for markets requiring prokinetic action

All formulations can be customized to meet specific pharmacopeial standards (IP, BP, USP, or EP) depending on your target region.

3. Turnkey Third-Party Manufacturing Support

From product development to logistics, our full-spectrum manufacturing services include:

• Formulation and R&D support
• Stability studies (Zone II & IV)
• Dossier and CTD/eCTD preparation
• Custom packaging and branding
• Regulatory documentation and export compliance
• Batch testing and analytical method validation

We enable fast go-to-market execution with regulatory clarity and technical strength.

Technical Product Specifications

Product Name	Gastro-Resistant Omeprazole
Dosage Forms	Capsules, Tablets, Dry Syrup
Strengths Available	10 mg, 20 mg, 40 mg
Pharmacopoeial Grades	IP / BP / USP / EP
Route of Administration	Oral
Shelf Life	24–36 months
Packaging	Blisters, Bottles, Sachets, Cartons
Storage Conditions	Store in a dry place, below 25°C

Therapeutic Benefits and Applications

1. GERD and Acid Reflux Management

Omeprazole reduces the secretion of gastric acid, making it effective in managing GERD symptoms such as heartburn, regurgitation, and chest discomfort.

2. Peptic and Duodenal Ulcers

By lowering acid levels, Omeprazole helps heal ulcers in the stomach and duodenum, especially when used in conjunction with antibiotics for H. pylori eradication.

3. Erosive Esophagitis

Omeprazole helps reverse damage to the esophagus caused by prolonged exposure to stomach acid.

4. Zollinger-Ellison Syndrome

High-dose formulations are used to control excessive acid production in patients with gastrin-secreting tumors.

5. Pediatric and Geriatric Uses

Specially designed formulations such as dry syrups or lower-strength capsules are useful in populations with difficulty swallowing tablets.

Manufacturing Process Overview

Our Gastro-Resistant Omeprazole is manufactured using a multistep GMP-compliant process designed to ensure precision and therapeutic efficacy.

Process Summary:

1. API and Excipient Dispensing – According to batch record
2. Pelletization (for Capsules) – Neutral core spheres coated with Omeprazole
3. Enteric Coating – Use of methacrylic acid co-polymers to protect from gastric acid
4. Blending and Encapsulation – Filling of coated pellets into hard gelatin capsules
5. Tablet Compression (if applicable) – Followed by enteric coating
6. In-process Testing – Weight variation, dissolution, assay
7. Blister or Bottle Packaging – Using automated packing lines
8. Final Quality Control and Release – As per pharmacopoeial standards

Our facilities are equipped with:

• Fluid bed processors
• Rapid mixer granulators
• Enteric coating pans and systems
• Capsule filling machines
• Stability chambers (Zone I-IV)

Quality Assurance and Analytical Testing

All Omeprazole formulations are tested at our in-house, GLP-compliant analytical labs. Our quality control (QC) and quality assurance (QA) teams ensure adherence to:

• USP, BP, IP, and EP monographs
• ICH guidelines for stability and impurities
• Microbial limit testing
• Dissolution and disintegration profiling
• pH and moisture content control
• Enteric coat integrity and acid resistance testing

Documentation Provided:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MoA)
• Stability data
• Packaging specifications and artwork compliance reports

Packaging and Branding Options

BluepillExpress provides customized packaging solutions to meet client branding, regulatory, and market positioning requirements.

Available Options:

• Alu-Alu or PVC-Alu Blister Packs: 10×10, 10x1x10
• HDPE or PET Bottles: With moisture-absorbing inserts
• Unit Dose Sachets: For single-use powder/syrup formats
• Secondary Packaging: Mono-cartons, multi-language inserts, outer cartons
• Labeling: Serialization, QR codes, barcodes, holograms as per client specs

Our team works with your artwork or can provide graphic design services for branding.

Export and Global Supply Capability

BluepillExpress has a strong presence in the export market, supplying Omeprazole formulations to:

• Africa (Ghana, Kenya, Ethiopia)
• Asia (Sri Lanka, Myanmar, Vietnam)
• Middle East (Iraq, Yemen, UAE)
• Latin America (Peru, Guatemala)
• CIS countries and Southeast Europe

Export Support Services Include:

• Dossier preparation in CTD/eCTD format
• Certificate of Pharmaceutical Product (CoPP)
• Free Sale Certificates (FSC)
• Certificate of Origin (COO)
• Product Registration Assistance
• Logistics and customs documentation

We offer Incoterms including FOB, CIF, CFR, and DDP, depending on client preferences.

Client Segments Served

Our Omeprazole third-party manufacturing is ideal for:

• Branded generic pharmaceutical companies
• Retail pharmacy chains and OTC brands
• Hospital supply companies and tenders
• Online pharmacy platforms
• Gastroenterology-focused brands
• Telemedicine companies and subscription medicine services

We accommodate both low MOQs for emerging markets and bulk production for high-volume clients.

Research and Development Expertise

Our in-house R&D division supports:

• Custom combinations (e.g., Omeprazole + Domperidone)
• Pediatric formulations (dry syrup, mini-tabs)
• Orally disintegrating tablet development
• Advanced enteric coating solutions
• Cost-effective formulation optimization

We also assist clients with pilot batch production, method validation, and product scale-up.

Environmental and Ethical Responsibility

BluepillExpress adheres to strict environmental and ethical manufacturing practices:

• Zero Liquid Discharge (ZLD) facilities
• Safe disposal of chemical waste
• Renewable energy integration (in progress)
• No animal testing
• Ethical sourcing and labor practices

Our operations are aligned with global sustainability and compliance goals.

Confidentiality and Partnership Approach

We value trust and transparency in every third-party engagement:

• Confidentiality agreements and NDAs
• Exclusive manufacturing contracts (on request)
• Intellectual property protection for custom products
• Transparent pricing and flexible contract terms
• Post-manufacturing technical and regulatory support

Whether you’re launching a new product or outsourcing established lines, BluepillExpress is a partner you can rely on.

Conclusion

Gastro-Resistant Omeprazole continues to dominate the treatment of acid-related GI conditions due to its efficacy, safety, and affordability. With growing global demand and regulatory focus on high-quality formulations, having a reliable manufacturing partner is essential.

BluepillExpress delivers end-to-end third-party manufacturing services for Omeprazole, offering compliance, customization, and global reach. Our capabilities in enteric-coated formulations, strong quality systems, and export support make us a trusted name in pharmaceutical contract manufacturing.