IndiaMart
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Gastrointestinal (GI) disorders have become increasingly prevalent worldwide due to sedentary lifestyles, dietary habits, stress, and widespread use of non-steroidal anti-inflammatory drugs (NSAIDs). Conditions such as gastroesophageal reflux disease (GERD), erosive esophagitis, and peptic ulcers require long-term management strategies, primarily with proton pump inhibitors (PPIs). Among these, Pantoprazole Sodium Sesquihydrate has emerged as a well-tolerated, highly effective PPI that offers robust acid suppression with a favorable safety profile.
At BluepillExpress, we specialize in the third-party manufacturing of Pantoprazole Sodium Sesquihydrate, offering high-quality, cost-effective pharmaceutical solutions to domestic and international markets. With WHO-GMP certified facilities and a proven track record in global pharmaceutical supply, we support pharmaceutical distributors, hospitals, and government procurement programs with scalable and customizable Pantoprazole formulations.
About BluepillExpress
BluepillExpress is a prominent Indian pharmaceutical manufacturer and exporter offering contract and third-party manufacturing services for a wide range of active pharmaceutical ingredients (APIs) and finished dosage forms. Our commitment to quality, compliance, and affordability has positioned us as a reliable manufacturing partner for businesses operating across Asia, Africa, the Middle East, CIS, and Latin America.
Key Strengths:
- WHO-GMP and ISO 9001:2015 certified manufacturing infrastructure
- CTD and ACTD dossier support for international registrations
- Customized branding and packaging solutions
- Regulatory documentation assistance for importers and health ministries
- End-to-end third-party manufacturing and logistics support
Our Pantoprazole production is conducted under stringent quality standards and can be tailored to match market-specific requirements and treatment guidelines.
Product Overview: Pantoprazole Sodium Sesquihydrate
Pantoprazole Sodium Sesquihydrate is a proton pump inhibitor used for the management of acid-related gastrointestinal disorders. It works by irreversibly binding to and inhibiting the H+/K+ ATPase enzyme system at the secretory surface of gastric parietal cells, thereby suppressing gastric acid secretion.
Pharmacological Class: Proton Pump Inhibitor (PPI)
Molecular Formula: C16H14F2N3NaO4S·1.5H2O
Mechanism of Action: Inhibits the final step in acid production by blocking proton pumps in the gastric lining
Bioavailability: Approximately 77% (oral administration)
Therapeutic Indications
Pantoprazole is indicated for the treatment and prevention of:
- Gastroesophageal reflux disease (GERD)
- Erosive esophagitis associated with acid reflux
- Zollinger-Ellison syndrome and other pathologic hypersecretory conditions
- Duodenal and gastric ulcers
- NSAID-induced ulcer prophylaxis
- Helicobacter pylori eradication (as part of combination therapy)
It is effective for both short-term symptom relief and long-term maintenance therapy, making it a preferred PPI in both outpatient and hospital settings.
Available Formulations and Dosages
BluepillExpress manufactures Pantoprazole Sodium Sesquihydrate in multiple dosage forms to meet diverse clinical and regional market needs:
- Pantoprazole Sodium 20 mg Gastro-resistant Tablets
- Pantoprazole Sodium 40 mg Gastro-resistant Tablets
- Pantoprazole Sodium 40 mg Powder for Injection (Lyophilized or Dry Powder)
- Pantoprazole Sodium 40 mg Capsules (available on request)
Our gastro-resistant (enteric-coated) tablets are designed to prevent drug degradation in the stomach and ensure release in the intestine for maximum absorption and efficacy.
Key Advantages of Pantoprazole
- Rapid and sustained acid suppression with once-daily dosing
- Favorable safety profile, suitable for long-term use
- Minimal drug-drug interactions compared to other PPIs
- Stable pharmacokinetics, not affected significantly by food intake
- Well-tolerated in elderly and renal-compromised patients
- Essential medicine as listed by WHO for gastrointestinal treatment programs
Manufacturing Capabilities at BluepillExpress
Our state-of-the-art manufacturing units are equipped with specialized infrastructure for acid-sensitive drug production such as Pantoprazole:
Facility Highlights:
- Fully automated granulation, compression, and coating lines
- Dedicated enteric-coating zones for gastro-resistant formulations
- Advanced lyophilization units for injectable production
- Environmental controls including humidity and temperature regulation
- Segregated areas for oral solids, injectables, and sterile processes
- Compliance with international standards (WHO-GMP, PIC/S)
Our flexible production systems allow us to cater to large-scale procurement contracts, private-label brands, and government tenders.
Quality Control & Assurance
Quality is at the core of every operation at BluepillExpress. We implement rigorous QA/QC systems throughout the production cycle.
Quality Control Measures:
- Analytical testing of all incoming raw materials (API & excipients)
- In-process checks including weight variation, hardness, and friability
- Final product testing for assay, dissolution, disintegration, and microbial limits
- Compatibility and impurity profiling
- Accelerated and long-term stability studies as per ICH guidelines
- Finished product specifications based on IP/BP/USP standards
All manufacturing is supported by Batch Manufacturing Records (BMRs), CoA, Validation Protocols, and MSDS.
Shelf Life and Storage
- Shelf Life: Typically 24 to 36 months
- Storage Conditions: Store in a cool, dry place below 25–30°C; protect from moisture and light
- Packaging: Blister packs (Alu-Alu, Alu-PVC) or bottles with desiccants to enhance shelf life in tropical climates
Special packaging options for government health agencies and international donors are available upon request.
Packaging and Labeling Options
We provide fully customizable packaging formats tailored to regional and institutional requirements:
Packaging Formats:
- Blister packs: 10×10, 10×15, 1×7 (for weekly use)
- Alu-Alu or Alu-PVC packaging for enhanced protection
- Vials and ampoules for injectables with Flip-Off seals
- HDPE Bottles for bulk hospital supplies
Labeling Services:
- Private-label branding
- Multilingual inserts and outer cartons
- Barcoding, serialization, and QR codes for track and trace
- Regulatory-compliant designs for FDA, EMA, NAFDAC, PPB, and other global authorities
Regulatory & Documentation Support
BluepillExpress supports clients with complete documentation packages required for international registrations and tenders.
Available Documents:
- WHO-GMP Certificate
- Certificate of Pharmaceutical Product (COPP)
- Free Sale Certificate
- Certificate of Analysis (CoA)
- CTD/ACTD Dossiers – Modules 1 to 5
- Stability Reports and Validation Data
- Product Information Leaflets and Label Templates
- MSDS and Technical Data Sheets
We also provide country-specific dossier customizations, registration support, and post-approval variation handling.
Private Labeling and Custom Manufacturing
Our private-label services allow partners to launch Pantoprazole under their own brand identity:
- Trademark support and exclusivity agreements (volume-dependent)
- Custom tablet engraving or color coding
- Branding assistance for retail, hospital, and pharmacy supply
- Flexible batch sizes and formulation changes (e.g., sugar-free syrups or dispersible tablets on request)
We also offer Pantoprazole + Domperidone combinations for clients seeking GI motility-focused therapies.
Export & Logistics Support
BluepillExpress ensures smooth international shipping and documentation handling for all Pantoprazole formulations:
- Ocean, air, and courier shipping options
- Temperature and humidity-controlled packaging (where required)
- Pre-shipment inspections (SGS, Intertek, Bureau Veritas)
- Consolidated multi-product shipments
- Documentation: Packing List, Invoice, Bill of Lading, Certificate of Origin, Phytosanitary Certificates (if applicable)
We deliver to government agencies, NGOs, pharmacy chains, and institutional buyers worldwide.
Ideal Client Segments
Our third-party manufacturing services for Pantoprazole are suitable for:
- Pharmaceutical distributors and importers
- Hospital procurement divisions
- Private-label OTC and prescription brands
- Government tender participants
- NGOs and international development programs
- E-pharmacies and telehealth companies
Why Choose BluepillExpress for Pantoprazole Manufacturing?
- WHO-GMP certified facilities with international regulatory experience
- High-quality gastro-resistant and injectable Pantoprazole
- Full support for dossier preparation and global registrations
- Customizable packaging and branding solutions
- Proven export logistics across 30+ countries
- Strong QA/QC systems with transparent documentation
- Competitive pricing with flexible batch size production
Conclusion
As gastrointestinal disorders continue to rise globally, Pantoprazole Sodium Sesquihydrate remains a frontline therapeutic agent for acid-related conditions. At BluepillExpress, we offer comprehensive third-party manufacturing services for Pantoprazole, helping partners deliver world-class quality and affordability across international healthcare systems.
With our end-to-end solutions, regulatory expertise, and scalable manufacturing capacity, we are your trusted ally in expanding your gastrointestinal product line for both prescription and institutional markets.
