Co-Trimoxazole

In the fight against bacterial infections, the need for effective, broad-spectrum antibiotics remains paramount. Co-Trimoxazole, a fixed-dose combination of sulfamethoxazole and trimethoprim, has long been a cornerstone of antimicrobial therapy. Known for its synergistic action and wide application across both gram-positive and gram-negative bacteria, Co-Trimoxazole is frequently prescribed for respiratory, urinary, gastrointestinal, and soft tissue infections.

At BluepillExpress, we specialize in the third-party manufacturing of Co-Trimoxazole, offering high-quality, pharmacopeia-standard formulations that meet global regulatory guidelines. Whether your brand is targeting domestic retail, public health tenders, or international markets, our manufacturing infrastructure and compliance processes ensure safe, effective, and scalable production solutions.

What is Co-Trimoxazole?

Co-Trimoxazole is a combination antibiotic composed of two active pharmaceutical ingredients:

• Sulfamethoxazole: A sulfonamide that inhibits dihydropteroate synthase
• Trimethoprim: A dihydrofolate reductase inhibitor

Together, they inhibit successive steps in bacterial folate synthesis, resulting in a potent synergistic bactericidal effect. Co-Trimoxazole is highly effective against a wide range of infections, especially those resistant to monotherapy antibiotics.

Common therapeutic applications include:

• Respiratory tract infections (bronchitis, pneumonia)
• Urinary tract infections (cystitis, pyelonephritis)
• Gastrointestinal infections (traveler’s diarrhea, cholera, typhoid)
• Otitis media
• Pneumocystis jirovecii pneumonia (PCP)
• Nocardiosis
• Skin and soft tissue infections
• Prophylaxis in HIV/AIDS and immunocompromised patients

Why Partner with BluepillExpress for Co-Trimoxazole Manufacturing?

1. WHO-GMP & ISO Certified Manufacturing Plants
BluepillExpress manufactures Co-Trimoxazole in WHO-GMP, GMP, and ISO 9001:2015 certified facilities. Our infrastructure is designed to support antibiotic production with stringent controls over cross-contamination, hygiene, and sterility.

2. Range of Dosage Forms and Strengths
We offer a comprehensive line of oral Co-Trimoxazole formulations, manufactured to pharmacopoeial standards (IP/BP/USP/EP):

• Co-Trimoxazole Tablets (Adult)
  • 400 mg sulfamethoxazole + 80 mg trimethoprim
  • 800 mg sulfamethoxazole + 160 mg trimethoprim (Double Strength)
• Co-Trimoxazole Oral Suspension (Pediatric)
  • 200 mg/40 mg per 5 ml
  • 100 mg/20 mg per 5 ml
  • Available in 50 ml, 60 ml, 100 ml HDPE bottles

3. Export-Ready and Regulatory-Compliant
Our formulations are manufactured to meet export requirements across Africa, Asia, the Middle East, and Latin America. We support our clients with:

• Product dossiers in CTD/eCTD format
• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Analysis (CoA)
• Free Sale Certificate and GMP approvals
• Zone IV stability data (on request)
• Custom labeling and packaging compliance for destination countries

4. Flexible Private Label and Contract Manufacturing
Whether you require white label production or complete private label services, BluepillExpress offers:

• Branding and packaging design
• Multilingual artwork
• MOA and BMR documentation
• Low and scalable MOQs
• Institutional and retail supply formats

Our client-centric approach ensures confidentiality, transparency, and full control over the final product identity.

Technical Product Specifications

Product Name	Co-Trimoxazole (Sulfamethoxazole + Trimethoprim)
Strengths Available	400+80 mg, 800+160 mg (tablets); 200+40 mg/5 ml (syrup)
Dosage Forms	Tablets, Oral Suspension
Route of Administration	Oral
Pharmacopoeia Compliance	IP / BP / USP / EP
Packaging Options	Blisters, strips, HDPE bottles with spoon or cup
Shelf Life	24 to 36 months depending on formulation
Storage Conditions	Store below 25°C, protect from light and moisture

All raw materials are sourced from approved vendors, with validated analytical methods and full traceability across supply chains.

Therapeutic Applications and Indications

Co-Trimoxazole is prescribed for various bacterial infections due to its excellent tissue penetration and broad-spectrum efficacy:

Respiratory Infections

• Acute and chronic bronchitis
• Pneumonia (including PCP in immunocompromised patients)
• Sinusitis and pharyngitis (as per sensitivity)

Urinary Tract Infections

• Acute cystitis
• Recurrent urinary tract infections
• Pyelonephritis and urethritis

Gastrointestinal and Enteric Infections

• Traveler’s diarrhea
• Cholera (supportive treatment)
• Shigellosis and typhoid fever

Skin and Soft Tissue Infections

• Abscesses, furuncles, and cellulitis (especially MRSA-prone cases)

Prophylactic Use

• Pneumocystis jirovecii pneumonia in HIV/AIDS patients
• Toxoplasmosis (as per clinician guidance)

Manufacturing Capabilities and Equipment

Our production capabilities are backed by advanced equipment and systems for oral solid and liquid dosage forms, including:

• High-speed tablet compression and coating machines
• Fluid bed dryers and granulators
• Automatic syrup filling and sealing lines
• Blister packing and strip packing machines
• Stability chambers for all climatic zones
• In-house analytical and microbiological testing laboratories

All equipment is 21 CFR Part 11 compliant for data integrity and is routinely qualified and validated.

Quality Assurance and Control

BluepillExpress employs a stringent QA/QC framework that covers every stage of production:

• Raw Material Testing: API assay, identity, and impurity profile
• In-process Controls: Granulation, blending, compression, and coating monitoring
• Finished Product Testing: Uniformity of dosage, dissolution, microbial limits, content assay
• Packaging Testing: Leak testing, print clarity, packaging integrity
• Stability Studies: ICH Zone II and Zone IV conditions

Batch-specific Certificate of Analysis (CoA), Method of Analysis (MOA), and Batch Manufacturing Records (BMR) are provided to all clients.

Packaging and Labeling Options

Our packaging is tailored to meet the needs of retail, institutional, and export markets. Formats include:

Tablets:

• Blister packs (10×10, 1×10)
• Strip packs with printed foil
• Mono-cartons with inserts

Oral Suspension:

• HDPE bottles (60 ml, 100 ml)
• Sealed caps with tamper-evident ring
• Measuring spoons or dosing cups
• Multi-language labeling as required

We use food-grade and pharmaceutical-grade packaging materials, ensuring product safety and stability throughout the shelf life.

Target Markets and Client Segments

BluepillExpress serves a diverse range of clients through its Co-Trimoxazole manufacturing services:

• Generic pharmaceutical companies
• Pediatric-focused medicine brands
• Public health agencies and government procurement departments
• Global distributors and importers
• Hospital-based institutional suppliers
• Humanitarian NGOs and emergency relief organizations

Our pricing structures are competitive, with attractive terms for bulk buyers and repeat customers.

Global Export Expertise

We currently export Co-Trimoxazole formulations to more than 40 countries, with strong logistics and documentation support. Export clients benefit from:

• Timely dispatch and real-time updates
• Country-specific document sets
• Regulatory registration and renewal support
• DDP, CIF, and FOB shipping options
• Assistance with import licensing and product approvals

We also participate in government tenders, institutional bulk supplies, and global health procurement programs.

Research & Development and Customization

Our in-house R&D capabilities support:

• Development of pediatric-friendly flavored suspensions
• Taste-masking technology for improved compliance
• Modified dosage forms and FDCs (e.g., Co-Trimoxazole + Metronidazole)
• Bioequivalence study support
• Packaging customization for humid or hot climates

We assist clients in formulation transfers, pilot batch trials, and analytical method validation for Co-Trimoxazole-related products.

Ethical, Sustainable, and Responsible Manufacturing

BluepillExpress is committed to ethical manufacturing and sustainability:

• Zero liquid discharge effluent systems
• Responsible sourcing of raw materials
• Waste minimization and recycling initiatives
• Child-safe, non-toxic packaging components
• No animal testing
• Compliance with labor and workplace safety regulations

We aim to make a positive impact on public health while protecting the environment and our communities.

Client Support and Confidentiality

Our service model is built on trust, professionalism, and transparency. With BluepillExpress, clients receive:

• Non-disclosure agreements to protect proprietary interests
• Dedicated project managers
• End-to-end production updates
• Transparent quotations and lead times
• Facility audits (virtual or onsite) upon request
• Regulatory and pharmacovigilance support

We are committed to fostering long-term partnerships based on performance, quality, and mutual growth.

Conclusion

Co-Trimoxazole continues to be a vital antibiotic in the global treatment arsenal against bacterial infections. Its effectiveness, affordability, and versatile indications make it an essential product in any pharmaceutical portfolio.

BluepillExpress stands as your trusted partner for the third-party manufacturing of Co-Trimoxazole, delivering excellence in formulation, quality, and compliance. Whether you are a domestic distributor, international exporter, or institutional procurement body, our customized manufacturing services are designed to meet your needs with speed, precision, and reliability.