Gastro-Resistant Omeprazole

Omeprazole, a proton pump inhibitor (PPI), is widely prescribed for the treatment of acid-related gastrointestinal conditions. It is primarily used for managing gastroesophageal reflux disease (GERD), peptic ulcers, erosive esophagitis, and Zollinger-Ellison syndrome. To maintain its efficacy, Omeprazole is formulated as gastro-resistant tablets or capsules to prevent degradation by stomach acid and ensure optimal absorption in the intestine.

At BluepillExpress, we specialize in the third-party manufacturing of Gastro-Resistant Omeprazole, offering premium-quality, WHO-GMP certified products tailored for diverse markets. With scalable manufacturing capacity, robust quality systems, and global regulatory support, we provide our clients with competitive advantages in supply reliability, compliance, and cost-efficiency.

About BluepillExpress

BluepillExpress is a leading pharmaceutical manufacturing and exporting company with a strong presence across Asia, Africa, CIS, Latin America, and the Middle East. Our facilities are certified under WHO-GMP, ISO 9001:2015, GLP, and other relevant international standards.

Our third-party manufacturing solutions include:

• Custom formulation and dosage development
• Full-service production and quality assurance
• Private label branding and packaging
• Regulatory documentation and dossier preparation
• Global supply and logistics support

We serve a wide range of clients, including generic companies, healthcare institutions, distributors, public health programs, and OTC brands.

Product Overview: Gastro-Resistant Omeprazole

Omeprazole is a benzimidazole derivative that selectively inhibits the hydrogen-potassium ATPase enzyme system (proton pump) in the gastric parietal cells, thereby suppressing gastric acid secretion at its source. It is highly effective in both short-term symptomatic relief and long-term maintenance therapy.

However, due to its acid-labile nature, Omeprazole is formulated in a gastro-resistant form that ensures stability in acidic conditions and targeted release in the intestines. This formulation enhances bioavailability and therapeutic effectiveness.

Key Therapeutic Indications

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease (gastric and duodenal ulcers)
• Erosive esophagitis
• Zollinger-Ellison syndrome (gastrin-secreting tumors)
• Helicobacter pylori eradication regimens (in combination with antibiotics)
• Dyspepsia and chronic gastritis (off-label use)

Omeprazole is recommended for use in both adult and pediatric patients, based on dosage and formulation type.

Mechanism of Action

Omeprazole irreversibly binds to the H+/K+ ATPase enzyme system (proton pump) on the surface of gastric parietal cells. This inhibition prevents the final step in gastric acid production, leading to a profound and prolonged reduction in stomach acidity.

Unlike antacids and H2 blockers, PPIs like Omeprazole act at the molecular level and are considered the most effective agents for acid suppression. Their once-daily dosing and long-lasting action make them ideal for chronic acid-related disorders.

Available Dosage Forms

At BluepillExpress, we offer a wide range of Gastro-Resistant Omeprazole formulations, designed for global distribution and compliance with pharmacopeial standards (IP, BP, USP, Ph. Eur.).

1. Gastro-Resistant Omeprazole Capsules

• 10 mg, 20 mg, 40 mg
• Hard gelatin capsules with enteric-coated granules
• Superior acid-resistance and dissolution profiles
• Blister or bulk packaging options

2. Gastro-Resistant Omeprazole Tablets (on request)

• 20 mg and 40 mg
• Enteric-coated core tablets for optimal absorption
• Suitable for patients with capsule intolerance

3. Omeprazole + Antibiotic Combinations (custom orders)

• Omeprazole + Clarithromycin + Amoxicillin (H. pylori therapy)
• Available as co-packs or strip combinations
• Standard triple therapy regimens for export markets

All products are manufactured using high-purity APIs and excipients, ensuring batch-to-batch consistency, bioequivalence, and patient tolerability.

Packaging Options

We provide custom packaging solutions for Gastro-Resistant Omeprazole that ensure stability, regulatory compliance, and strong visual branding.

Capsule Packaging:

• Blister packs (PVC/Alu or Alu-Alu)
• Strip packs (paper/aluminum foil)
• Mono cartons with multilingual instructions
• Bulk packs for institutional supply

Custom Branding Options:

• Country-specific regulatory labeling
• Custom logo printing and color coding
• Multilingual inserts and warnings
• Barcode and serialization (as required)

Our packaging is designed to protect from moisture, light, and mechanical damage, extending product shelf life and supporting secure logistics.

Manufacturing Infrastructure

BluepillExpress operates a WHO-GMP compliant manufacturing facility with advanced infrastructure for oral solid dosage forms. Our production process for Omeprazole includes:

• High-shear granulation for core preparation
• Fluid bed drying and coating for enteric protection
• Encapsulation in hard gelatin shells (for capsules)
• Tablet compression and enteric film coating
• Automated blister packing lines
• Dust-free cleanrooms with HEPA filtration

Our facility features HVAC-controlled environments, validated equipment, and automated batch tracking systems, ensuring precision and reliability throughout the production cycle.

Quality Assurance and Quality Control

We follow a robust Quality Management System (QMS) to ensure that every batch of Gastro-Resistant Omeprazole meets global standards of safety, efficacy, and stability.

In-House QA/QC Capabilities:

• Analytical testing of APIs and excipients
• In-process controls (granule size, compression force, coating thickness)
• Dissolution and disintegration studies
• Microbiological testing
• Stability testing under ICH guidelines (Zones I–IVb)
• Final product release with full documentation

Each batch is released only after passing rigorous tests aligned with USP, BP, and Ph. Eur. standards. Certificate of Analysis (CoA), Certificate of Compliance (CoC), and full batch records are provided.

Regulatory Documentation Support

BluepillExpress provides complete regulatory documentation required for global product registration and import clearance. This includes:

• Certificate of Pharmaceutical Product (CoPP)
• WHO-GMP and ISO certifications
• Certificate of Analysis (CoA)
• Free Sale Certificate
• Batch Manufacturing Records (BMRs)
• Stability data and shelf-life reports
• Common Technical Document (CTD/eCTD) dossiers
• Material Safety Data Sheet (MSDS)

Our team also supports clients in regulatory submissions for private label registration, government tenders, and public health procurement.

Export and Global Supply Chain Services

BluepillExpress has a dedicated export division with extensive experience in delivering pharmaceuticals worldwide. We support clients with:

• Multilingual labeling and packaging customization
• Air and sea freight logistics
• Incoterms (FOB, CIF, DDP) flexibility
• Complete export documentation and customs clearance
• Temperature-controlled shipping (if needed)
• Post-shipment tracking and support

We currently supply Gastro-Resistant Omeprazole to clients in:

• Africa: Nigeria, Kenya, Ethiopia, South Africa
• Middle East: UAE, Iraq, Saudi Arabia, Yemen
• Asia: Sri Lanka, Bangladesh, Vietnam, Myanmar
• CIS: Kazakhstan, Uzbekistan, Georgia
• Latin America: Peru, Bolivia, Dominican Republic

Target Clients and Applications

Our third-party manufacturing services for Gastro-Resistant Omeprazole are suitable for:

• Generic pharmaceutical companies
• OTC brands in acid-relief and digestive health segments
• Hospital and institutional procurement programs
• Government tender participants and NGOs
• Online pharmacies and telemedicine brands
• Distributors seeking private label formulations

We offer flexible minimum order quantities (MOQs) to accommodate both startup brands and high-volume bulk buyers.

Why Choose BluepillExpress?

1. WHO-GMP Certified Facilities
   Internationally recognized manufacturing standards ensure quality and compliance.
2. Comprehensive Regulatory Support
   Full documentation and CTD dossiers to facilitate registration in global markets.
3. Custom Formulations and Packaging
   Tailored solutions for private labels, OTC brands, and institutional supply.
4. Batch-to-Batch Consistency and Proven Quality
   Rigorous testing ensures every batch meets the highest quality benchmarks.
5. Flexible MOQs and Competitive Pricing
   Scalable manufacturing solutions to match market demand and budget constraints.
6. Global Export Expertise
   Seamless logistics and documentation for more than 25 export destinations.

Conclusion

Gastro-Resistant Omeprazole remains one of the most prescribed medications for the management of acid-related gastrointestinal disorders. Its inclusion in essential medicine lists and clinical guidelines underscores its importance in both acute and chronic care settings.

With BluepillExpress as your third-party manufacturing partner, you gain access to world-class production facilities, regulatory expertise, and a proven global supply chain. Whether you are launching a new brand, fulfilling a public health order, or expanding your gastrointestinal portfolio, we are ready to support your success with precision, quality, and reliability.