Esomeprazole + Levosulpiride

Esomeprazole + Levosulpiride is a synergistic combination therapy widely prescribed for the treatment of gastrointestinal disorders such as acid reflux, gastroesophageal reflux disease (GERD), non-ulcer dyspepsia, and functional dyspepsia with motility disorders. While Esomeprazole serves as a proton pump inhibitor (PPI) that suppresses stomach acid, Levosulpiride functions as a prokinetic and antipsychotic agent that enhances gastrointestinal motility and dopamine modulation.

At BluepillExpress, we provide WHO-GMP certified third-party manufacturing for the combination of Esomeprazole and Levosulpiride in various oral dosage forms. With a highly skilled formulation development team, robust infrastructure, and export-grade compliance, we deliver superior-quality products tailored to private labels, pharmaceutical companies, and hospital supply chains worldwide.

What is Esomeprazole + Levosulpiride?

This combination drug comprises two active pharmaceutical ingredients:

• Esomeprazole: The S-isomer of omeprazole, it inhibits gastric H+/K+ ATPase, thereby reducing gastric acid secretion and promoting ulcer healing.
• Levosulpiride: A substituted benzamide derivative that works as a selective dopamine D2 antagonist with prokinetic and antipsychotic activity. It increases gastric emptying and intestinal transit time, easing symptoms of bloating, fullness, and gastric stasis.

Together, the combination treats acid-related and functional gastrointestinal disorders more effectively than monotherapy.

Therapeutic Class: Gastroprokinetic and Acid Suppressant
Mechanism of Action:

• Esomeprazole – Inhibits proton pumps in parietal cells
• Levosulpiride – Enhances acetylcholine release by blocking D2 receptors

Route of Administration: Oral

Therapeutic Indications

The Esomeprazole + Levosulpiride combination is widely recommended in the treatment of the following conditions:

• Gastroesophageal Reflux Disease (GERD)
• Non-ulcer Dyspepsia
• Functional Dyspepsia with Delayed Gastric Emptying
• Chronic Gastritis
• Irritable Bowel Syndrome (IBS)
• Peptic Ulcer Disease (PUD)
• Acid peptic disorders with bloating and indigestion
• Esophagitis and duodenitis
• Motility disorders of the upper gastrointestinal tract

This dual therapy is known to improve gastric transit time, suppress acidity, and relieve symptoms such as nausea, early satiety, and heartburn.

Why Choose BluepillExpress?

At BluepillExpress, we are committed to delivering international-quality gastrointestinal formulations with a focus on therapeutic effectiveness, regulatory compliance, and scalable production.

Our Core Strengths:

• WHO-GMP & ISO 9001:2015 certified manufacturing units
• Dedicated manufacturing lines for gastroenterology products
• Advanced equipment for moisture-sensitive drug handling
• IP/BP/USP/EP compliant formulations
• Customization in strength, packaging, and brand identity
• Full-spectrum third-party and private-label services
• Technical and regulatory support for dossier submissions
• Rapid production timelines with low minimum order quantities

We enable emerging and established pharmaceutical brands to expand their digestive health product portfolios confidently and profitably.

Available Formulations and Dosage Strengths

We manufacture the Esomeprazole + Levosulpiride combination in various strengths and release forms to suit therapeutic needs and international guidelines.

Oral Formulations:

• Levosulpiride 75 mg + Esomeprazole 40 mg SR Capsules
• Levosulpiride 75 mg + Esomeprazole 20 mg SR Capsules
• Levosulpiride 75 mg (SR) + Esomeprazole 40 mg (Enteric Coated) Capsules
• Levosulpiride 25 mg + Esomeprazole 20 mg Tablets (for mild gastric dysfunction)

We offer both capsule-in-capsule and bi-layer tablet options depending on the desired release profile and market preference.

Product Composition

All formulations are developed using high-purity, pharmaceutical-grade ingredients and are tailored to ensure controlled release and optimal absorption.

Example Composition:

Levosulpiride 75 mg (Sustained Release) + Esomeprazole 40 mg (Enteric-Coated) Capsule

• Active Ingredients:
  • Levosulpiride BP/USP 75 mg SR
  • Esomeprazole Magnesium Trihydrate IP/BP/USP equivalent to Esomeprazole 40 mg EC
• Excipients:
  • Microcrystalline cellulose, sodium starch glycolate, magnesium stearate, ethyl cellulose, HPMC, and other polymeric coatings for SR and EC action
• Shell Composition:
  • Hard gelatin capsules (custom color available upon request)

We provide lactose-free, gluten-free, or vegetarian formulations upon request to meet specific market demands.

Manufacturing Process

Our formulations are produced in controlled environments, with humidity and temperature control systems to ensure stability of moisture-sensitive APIs like Esomeprazole.

Key Manufacturing Steps:

1. Granulation of Levosulpiride for sustained release
2. Compression and coating of Esomeprazole granules with enteric polymers
3. Capsule filling or tablet compression and film-coating
4. In-process quality checks (weight, disintegration, friability)
5. Visual inspection, coding, and labeling
6. Final packaging in moisture-resistant blisters or bottles

All equipment is calibrated and validated, and every process is recorded under standard operating procedures to ensure traceability and quality compliance.

Quality Control and Testing

At BluepillExpress, we perform stringent quality assurance protocols to ensure that each batch complies with international pharmaceutical standards.

Testing Parameters:

• Assay of both active ingredients
• Dissolution profile (acid and buffer stages)
• Uniformity of dosage units
• Impurity profiling and residual solvents
• Moisture content and pH
• Stability testing (accelerated and real-time)
• Microbial limit testing
• Disintegration and friability (for tablets)

Each batch is released only after review by QA experts and supported with a Certificate of Analysis (COA).

Packaging and Labeling

We offer custom packaging solutions for diverse retail, hospital, and export markets.

Packaging Options:

• Alu-Alu blister packs (ideal for export and humidity protection)
• PVC-Alu blister packs for cost-effective solutions
• HDPE bottles for tablets
• Monocartons with printed inserts
• Multilingual labeling and serialization support
• QR codes, barcodes, and holograms for brand authentication

We provide OEM/private label packaging, enabling your brand identity to be reflected clearly in every unit.

Regulatory and Documentation Support

We provide complete regulatory documentation support for seamless product registration and market entry in global territories.

Provided Documents:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Analysis (COA)
• Stability Data
• Product Dossier in CTD/ACTD format
• Master Formula Record (MFR)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Safety Data Sheet (SDS)
• Patient Information Leaflet and prescribing info

We assist in regulatory submissions across Africa, Southeast Asia, CIS, Latin America, and Middle Eastern regions.

Export Capability

BluepillExpress exports Esomeprazole + Levosulpiride combinations to multiple countries through established distribution and logistics channels.

Export Markets:

• Africa: Kenya, Ethiopia, Ghana, Nigeria, Tanzania
• Asia-Pacific: Philippines, Vietnam, Sri Lanka, Nepal
• Middle East: Iraq, Jordan, UAE, Saudi Arabia
• CIS Countries: Uzbekistan, Armenia, Georgia
• LATAM & Caribbean: Bolivia, Peru, Dominican Republic
• Island Nations: Maldives, Papua New Guinea

We support air and sea freight, including cold-chain logistics if required, along with all necessary shipping documentation.

Ideal Clients for This Product

Our third-party manufacturing services for Esomeprazole + Levosulpiride are best suited for:

• Gastroenterology-focused pharmaceutical companies
• OTC and prescription brand owners
• Hospital supply networks and institutional distributors
• Government and NGO-based procurement
• E-pharmacies and telemedicine operators
• Generic exporters targeting regulated and semi-regulated markets
• Private label pharmaceutical marketers

Why BluepillExpress?

• WHO-GMP Certified, with a focus on gastroenterological drug manufacturing
• Expertise in moisture-sensitive formulations
• Competitive pricing with consistent quality
• Low MOQ with scalable batch sizes
• Comprehensive regulatory documentation
• Custom packaging and private labeling
• Proven global export logistics and support