Esomeprazole Magnesium

Esomeprazole Magnesium is a proton pump inhibitor (PPI) that reduces the amount of acid produced in the stomach. It is widely prescribed for the treatment of gastroesophageal reflux disease (GERD), erosive esophagitis, Zollinger-Ellison syndrome, and for the prevention and treatment of gastric ulcers, particularly those caused by non-steroidal anti-inflammatory drugs (NSAIDs) and Helicobacter pylori infection.

At BluepillExpress, we are proud to offer third-party manufacturing services for Esomeprazole Magnesium in a variety of dosage forms. With a commitment to quality, compliance, and scalability, our state-of-the-art facilities are fully equipped to meet the needs of our clients in both domestic and international markets. Whether for branded generics, private label launches, or tender supplies, our production model is designed for efficiency, reliability, and global regulatory alignment.

What Is Esomeprazole Magnesium?

Esomeprazole Magnesium is the magnesium salt of the S-isomer of omeprazole. It works by selectively inhibiting the H+/K+ ATPase enzyme system at the surface of the gastric parietal cells, thereby blocking the final step in acid production. Esomeprazole is more stable and provides a longer duration of action compared to earlier-generation PPIs, making it a preferred choice for physicians and patients alike.

Pharmacological Classification:

• Drug Class: Proton Pump Inhibitor (PPI)
• Therapeutic Category: Anti-ulcerative, Acid Reducer
• ATC Code: A02BC05

Therapeutic Indications

Our third-party manufactured Esomeprazole Magnesium products are used to treat a broad spectrum of acid-related gastrointestinal disorders.

Approved Indications:

• Gastroesophageal reflux disease (GERD)
• Erosive esophagitis (healing and maintenance)
• NSAID-induced gastric ulcer prevention and treatment
• Zollinger-Ellison syndrome
• Helicobacter pylori eradication (in combination therapy)
• Chronic heartburn and acid reflux symptoms
• Functional dyspepsia

Its efficacy, safety profile, and convenient once-daily dosing have made Esomeprazole a mainstay in gastroenterology.

Why Choose BluepillExpress for Esomeprazole Manufacturing?

At BluepillExpress, we offer an end-to-end third-party manufacturing solution tailored for partners seeking top-quality Esomeprazole products. From raw material sourcing to packaging and export, our team ensures every stage meets international standards.

Key Advantages:

• WHO-GMP & ISO 9001:2015 certified facility
• Robust process validation and in-process controls
• Compliance with USP, BP, EP, and IP monographs
• High bioavailability and dissolution profiles
• Expertise in gastro-resistant tablet and capsule formulations
• Regulatory documentation for multiple markets
• Flexible production volumes with competitive pricing
• Experienced export division for over 35 countries

Our expertise in acid-labile drug formulation makes us the preferred choice for high-stability PPI manufacturing.

Available Formulations

We manufacture Esomeprazole Magnesium in a variety of pharmaceutical forms, with a focus on maintaining acid resistance, bioequivalence, and patient acceptability.

1. Esomeprazole Magnesium Delayed-Release Tablets

• Strengths: 20 mg, 40 mg
• Tablet Type: Enteric-coated
• Packaging: Alu-Alu or blister packs (10×10, 10×1)
• Labeling: Customizable with multilingual support
• Usage: Once daily before meals

2. Esomeprazole Magnesium Delayed-Release Capsules

• Strengths: 20 mg, 40 mg
• Dosage Form: Hard gelatin capsules with enteric-coated pellets
• Packaging: Blister or HDPE bottles
• Color: Customizable cap/body colors
• Indication: Chronic acid reflux, GERD

3. Esomeprazole Sachets or Granules (on request)

• Pediatric or geriatric use formulations
• Taste-masked granules for oral suspension
• Reconstitution-ready formats for hospital use

All formulations adhere to stringent dissolution and stability profiles, ensuring maximum bioavailability in gastric conditions.

Manufacturing Facility Highlights

BluepillExpress has invested in cutting-edge facilities designed specifically for sensitive and enteric-coated formulations like Esomeprazole.

Infrastructure Includes:

• Fluid bed processors for coating and granulation
• Automatic tablet compression and capsule filling lines
• Controlled environment rooms for hygroscopic materials
• Dehumidification units for product stability
• Coating pan systems with precision spray technology
• In-line quality monitoring and metal detection systems
• HEPA-filtered cleanroom areas (ISO Class 8)
• ERP and barcode-enabled production tracking

Our technology ensures that every dose of Esomeprazole is manufactured with precision, consistency, and therapeutic efficacy.

Quality Assurance and Quality Control (QA/QC)

At BluepillExpress, quality is non-negotiable. Our team of experienced analysts, pharmacists, and microbiologists ensure all products meet global quality standards through continuous monitoring.

Quality Tests Include:

• Assay and identification of Esomeprazole
• Enteric coating integrity and disintegration time
• Dissolution and release kinetics
• Particle size distribution (for pellets and granules)
• pH and moisture analysis
• Microbial load and sterility testing
• Heavy metals and residual solvents
• Stability testing under ICH guidelines

Documentation Provided:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Stability Data (Accelerated and Long-Term)
• Validation reports for process and cleaning
• Packaging specifications and proof copies

Each batch is fully traceable and backed by validated analytical and microbiological data.

Regulatory & Dossier Support

We understand the complexity of international pharmaceutical registration. That’s why we offer comprehensive regulatory assistance tailored to your market.

Our Regulatory Package Includes:

• CTD/ACTD dossier preparation (Modules 1–5)
• WHO-GMP certification
• Certificate of Pharmaceutical Product (CoPP)
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• Site Master File (SMF)
• Bioequivalence and bioavailability support data (upon request)
• Technical data sheet and declaration of conformity

We’ve successfully supported product registrations across Africa, CIS, Latin America, Southeast Asia, and the Middle East.

Packaging & Branding Solutions

We offer full flexibility in packaging and labeling, tailored to meet both regulatory and branding requirements.

Packaging Types:

• Alu-Alu or blister packs with printed foil
• HDPE bottles with induction-sealed caps
• Outer cartons with high-resolution printing
• Leaflets and inserts in multiple languages
• Tamper-evident features and serialization options
• QR codes and barcodes compliant with GS1

We also provide private label and white label services, including:

• Custom design and artwork creation
• Brand registration assistance
• Low MOQ for new brands or startups
• NDA agreements to protect your brand identity

Whether you’re targeting hospitals, retail pharmacies, or government tenders, we can tailor the packaging to match your goals.

Export & Logistics Support

BluepillExpress has a well-established export division, enabling seamless delivery of Esomeprazole formulations worldwide.

Export Support Includes:

• Door-to-door shipment (EXW, FOB, CIF, DDP)
• Air, sea, and multimodal transport options
• Export documentation and pre-shipment inspection
• Temperature-controlled shipping (if required)
• Custom clearance and freight forwarding assistance
• Bulk, trial, and emergency consignment handling

We currently supply to 35+ countries, serving markets across Africa, Asia, the CIS, LATAM, and the Middle East.

Minimum Order Quantities (MOQs)

To meet the needs of businesses of all sizes, we offer flexible MOQ policies:

• Pilot batches for new brand launches or regulatory testing
• Medium-scale batches for regional market rollouts
• Large-scale production for national distribution or tenders
• Annual contract manufacturing with scheduled delivery plans

MOQ depends on formulation type, packaging preferences, and country-specific requirements.

Client Testimonials

“We launched our own line of Esomeprazole tablets with BluepillExpress and were impressed by their technical support and packaging quality.”
— Pharmaceutical Brand Manager, Latin America

“Their regulatory team helped us register Esomeprazole in three African countries without delays. Highly reliable and professional.”
— Regulatory Affairs Head, East Africa

“Excellent formulation stability, precise enteric coating, and top-tier packaging. We are proud to partner with BluepillExpress.”
— Hospital Procurement Officer, Southeast Asia

Conclusion

Esomeprazole Magnesium is a globally recognized treatment for acid-related gastrointestinal conditions. With increasing demand in both prescription and OTC markets, having a trusted manufacturing partner is key to success.

At BluepillExpress, we provide fully integrated third-party manufacturing solutions for Esomeprazole that meet global quality, regulatory, and commercial standards. From formulation development to final export, our commitment is to deliver safe, effective, and compliant pharmaceutical products that help your brand thrive in competitive markets.