Paediatric Co-Trimoxazole

Paediatric Co-Trimoxazole, a fixed-dose combination of Sulfamethoxazole and Trimethoprim, remains a cornerstone in the treatment and prevention of various bacterial infections in children. Recognized by the World Health Organization (WHO) as an essential medicine, Co-Trimoxazole is used globally for the treatment of respiratory, gastrointestinal, and urinary infections, as well as for prophylaxis in immunocompromised children.

As a globally certified pharmaceutical manufacturer and exporter, BluepillExpress offers high-quality, stable, and pediatric-friendly formulations of Co-Trimoxazole for third-party manufacturing. Our products are manufactured in state-of-the-art WHO-GMP facilities with a strict focus on safety, palatability, quality, and international compliance. We cater to pharmaceutical brands, hospitals, NGOs, public health organizations, and tender-based procurement entities worldwide.

Product Overview

Product Name: Paediatric Co-Trimoxazole
Form: Oral Suspension (Syrup)
Dosage Strengths Available:

• Co-Trimoxazole 200 mg + 40 mg per 5 mL (Sulfamethoxazole + Trimethoprim)
• Co-Trimoxazole 100 mg + 20 mg per 5 mL (for infants or lower-dose treatments)

Route of Administration: Oral
Packaging Options:

• 60 mL / 100 mL / 200 mL amber or PET bottles with child-resistant cap
• Each bottle packed with a dosing cup or spoon in a mono-carton
• Flavor: Banana, Raspberry, or Orange (customizable)

Pharmacological Class

Paediatric Co-Trimoxazole belongs to the class of antibacterial sulfonamides and contains two active components:

• Sulfamethoxazole, which inhibits bacterial synthesis of dihydrofolic acid
• Trimethoprim, which inhibits bacterial production of tetrahydrofolic acid
  Together, they act synergistically to inhibit successive steps in folate metabolism, effectively killing a wide range of susceptible bacteria.

Mechanism of Action

Co-Trimoxazole works by sequentially inhibiting two bacterial enzymes involved in the synthesis of folic acid:

1. Sulfamethoxazole inhibits dihydropteroate synthase
2. Trimethoprim inhibits dihydrofolate reductase

This dual inhibition leads to a bactericidal effect, making the combination more effective than either component used alone. It demonstrates broad activity against many gram-positive and gram-negative bacteria.

Indications in Pediatric Use

Co-Trimoxazole is indicated in children for the treatment and prophylaxis of the following conditions:

• Acute otitis media
• Pharyngitis and tonsillitis
• Bronchitis and pneumonia (including Pneumocystis jirovecii pneumonia)
• Urinary tract infections (UTIs)
• Gastrointestinal infections such as traveler’s diarrhea
• Skin and soft tissue infections
• Prophylaxis in HIV-infected or immunocompromised children

Its affordability and efficacy make it a preferred option in low-resource settings and public health programs globally.

Why Choose BluepillExpress for Co-Trimoxazole Paediatric Manufacturing?

1. WHO-GMP Certified Pediatric Manufacturing Facilities

Our manufacturing units meet global standards for pediatric pharmaceutical production. All products are developed and manufactured in dedicated WHO-GMP, ISO 9001:2015, and FSSAI-compliant facilities.

Key infrastructure advantages:

• Dedicated production areas for pediatric liquids
• HEPA-filtered clean rooms and microbiologically controlled zones
• Dust-free, contamination-controlled bottling and labeling systems
• Fully automated syrup filling and sealing lines

2. Palatable and Child-Friendly Formulations

We prioritize taste, color, and stability in all pediatric formulations. Our Co-Trimoxazole syrup is:

• Pleasant-tasting to improve compliance
• Available in sugar-free or low-sugar variants
• Free from harsh preservatives (optional)
• pH-adjusted for stability and safe gastrointestinal absorption
• Designed to maintain flavor and consistency throughout the shelf life

Quality Control and Quality Assurance

Each batch of Paediatric Co-Trimoxazole undergoes extensive in-process and final testing to ensure product integrity and safety.

Tests conducted include:

• Assay of both active ingredients (Sulfamethoxazole and Trimethoprim)
• Uniformity of content and homogeneity
• Viscosity and pH
• Microbiological safety (Total viable count, absence of pathogens)
• Preservative efficacy testing
• Organoleptic properties (taste, appearance, and smell)
• Stability testing under ICH guidelines (accelerated and long-term)

All finished products are packaged and released only after passing through multiple layers of quality assurance protocols.

Documentation and Regulatory Support

BluepillExpress provides full regulatory support for domestic registrations and international exports. Our comprehensive documentation includes:

• Certificate of Analysis (CoA)
• Batch Manufacturing Records (BMR)
• Certificate of Origin
• Stability Data (as per ICH)
• GMP Certificate
• Free Sale Certificate
• Method of Analysis (MoA)
• Material Safety Data Sheet (MSDS)
• Dossier in CTD or ACTD format (on request)

We support product registration in Africa, Latin America, Southeast Asia, CIS, and Middle East countries, and are well-versed with local authority requirements.

Packaging and Branding Customization

We offer full private labeling and custom packaging services for our third-party clients, including:

• Custom artwork with your brand name and logo
• Language-specific labeling for target markets
• Batch coding and serialization support
• Multiple volume options (60 mL, 100 mL, 200 mL)
• Optional inclusion of dosing devices (dropper, spoon, measuring cap)
• Tamper-evident seals and child-resistant caps

Global Supply and Export Capabilities

BluepillExpress is a trusted exporter of pediatric antibiotics and supplies both public and private sectors globally. Our international logistics and documentation support includes:

• Custom clearance coordination
• Shipment via air or sea with temperature monitoring
• Cold chain support (if required)
• Export documentation: Invoice, Packing List, CoO, and test reports
• Third-party inspection by SGS, Bureau Veritas, or Intertek (on request)

We are experienced in working with ministries of health, WHO programs, NGOs, and pharmaceutical tender procurement.

Third-Party Manufacturing Process at BluepillExpress

Our third-party manufacturing model is structured, scalable, and transparent. Here’s how the process flows:

1. Product Finalization
   • Choose strength, dosage form, flavor, volume, packaging, and labeling requirements
2. Quotation and Agreement
   • Commercial terms, batch size, MOQ, timelines, and confidentiality agreements
3. Product Development (Optional)
   • If new customization is required, we prepare formulation trials or sample batches
4. Production and QA/QC
   • Manufacturing under GMP guidelines with real-time and end-point quality checks
5. Labeling and Packaging
   • Custom artwork printing, final packing, batch coding, and carton assembly
6. Dispatch and Documentation
   • Shipment, export paperwork, and regulatory assistance

Lead Time: Typically 30 to 40 working days from artwork approval and payment milestone.

Target Clients and Market Application

Our Paediatric Co-Trimoxazole products are widely used by:

• Government procurement programs (public hospitals, primary health centers)
• NGOs and global healthcare initiatives
• Retail pharmaceutical companies launching pediatric lines
• Distributors targeting pediatricians and child specialists
• Exporters requiring GMP-certified pediatric antibiotics for tenders

With its wide clinical application and inclusion in WHO’s essential medicine list, Paediatric Co-Trimoxazole maintains steady and growing demand worldwide.

Key Benefits of Working with BluepillExpress

• WHO-GMP compliant manufacturing for pediatric formulations
• Custom formulation and packaging for global adaptability
• Support for private labeling and public tender compliance
• Stringent QA/QC with validated analytical methods
• Complete technical documentation for registration and export
• Export experience in over 35 countries
• Affordable pricing without compromising quality
• Scalable production for both pilot and large commercial batches

Conclusion

Paediatric Co-Trimoxazole continues to play a vital role in managing childhood infections, particularly in resource-limited and high-burden regions. At BluepillExpress, we bring together scientific expertise, regulatory insight, and world-class infrastructure to offer reliable third-party manufacturing solutions tailored to your brand’s pediatric antibiotic needs.

Whether you’re targeting domestic markets or planning to launch in international territories, we are equipped to support you with a safe, effective, and customizable Co-Trimoxazole formulation.