Ceftriaxone 0.5 gm & Sulbactam 0.250 gm

Ceftriaxone and Sulbactam combination injection is a broad-spectrum antibacterial formulation used to treat severe bacterial infections. This synergistic blend of a third-generation cephalosporin (Ceftriaxone) and a beta-lactamase inhibitor (Sulbactam) enhances the efficacy of antibiotic therapy against resistant bacterial strains. It is commonly used in hospitals and clinical settings for treating respiratory tract infections, urinary tract infections, intra-abdominal infections, septicemia, meningitis, skin infections, and postoperative infections.

BluepillExpress provides world-class third-party manufacturing services for Ceftriaxone 0.5 gm & Sulbactam 0.250 gm injections, adhering to stringent global quality standards and regulatory compliance. As a globally recognized pharmaceutical manufacturer and exporter, we bring together science, innovation, and precision manufacturing to deliver safe and effective injectable solutions for healthcare professionals and institutions worldwide.

About BluepillExpress

BluepillExpress is a WHO-GMP and ISO 9001:2015 certified pharmaceutical manufacturing company with a global footprint. We specialize in third-party contract manufacturing of injectable formulations, oral solids, liquids, and nutraceuticals. With robust infrastructure, a highly experienced technical team, and a reputation for excellence, we serve pharmaceutical brands, hospitals, and distributors across North America, Europe, Africa, Asia, and the Middle East.

Our facilities operate under strict regulatory environments, ensuring every product batch meets the highest quality, efficacy, and safety benchmarks.

Therapeutic Classification

• Pharmacological Class: Cephalosporin Antibiotic + Beta-lactamase Inhibitor
• Route of Administration: Intravenous (IV) / Intramuscular (IM)
• Indications: Broad-spectrum antibacterial therapy for moderate to severe infections

Mechanism of Action

• Ceftriaxone: A third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis, leading to cell lysis and death. It is highly effective against both Gram-positive and Gram-negative bacteria.
• Sulbactam: A beta-lactamase inhibitor that protects Ceftriaxone from enzymatic degradation by beta-lactamase-producing bacteria, thereby broadening its antimicrobial activity.

The combination ensures enhanced bactericidal action, reduced resistance, and improved clinical outcomes.

Clinical Indications

Ceftriaxone 0.5 gm + Sulbactam 0.250 gm injection is used for the treatment of:

• Lower respiratory tract infections (bronchitis, pneumonia)
• Urinary tract infections (including pyelonephritis)
• Skin and soft tissue infections
• Intra-abdominal infections (peritonitis, appendicitis)
• Septicemia and bacteremia
• Central nervous system infections (meningitis)
• Bone and joint infections
• Post-surgical infections
• Gynecological infections
• ENT infections (sinusitis, otitis media)

Manufacturing Capabilities at BluepillExpress

1. WHO-GMP Certified Sterile Injectable Facilities

BluepillExpress manufactures all injectable formulations in ultra-modern sterile environments compliant with:

• WHO-GMP guidelines
• Schedule M (India)
• EU-GMP and US FDA-aligned practices (for export markets)

Each production area is supported with:

• Cleanrooms with HEPA filtration (Class 100/ISO 5)
• Laminar airflow systems
• Automated vial filling, sealing, and labeling lines
• Lyophilization (freeze-drying) capabilities
• Water for Injection (WFI) systems and autoclaves

2. Product Form Details

• Formulation: Ceftriaxone 500 mg + Sulbactam 250 mg
• Dosage Form: Dry powder for injection
• Pack Size: Single-use vial with sterile water ampoule (optional)
• Route: IV or IM administration
• Reconstitution Required: Yes

We also offer flexible pack combinations (with/without solvent) based on the client’s branding and distribution model.

Quality Assurance and Compliance

At BluepillExpress, quality is the cornerstone of every manufacturing process. Our quality assurance and control protocols include:

• Raw material testing (API and excipients)
• In-process control
• Finished product testing
• Microbial and endotoxin testing
• Stability testing (ICH guidelines)
• Environmental monitoring
• Sterility and pyrogen testing

All products are supported by:

• Certificate of Analysis (COA)
• Batch Manufacturing Records (BMR)
• Validation protocols (process, cleaning, sterilization)
• GMP certification and audit-ready documentation

Formulation Development & Customization

BluepillExpress offers clients flexibility in:

• Formulation type: We can produce additional strengths such as 1 gm/0.5 gm or pediatric versions on demand.
• Packaging formats: Glass vials, flip-off aluminum seals, shrink-wrapped trays or mono-cartons
• Solvent inclusion: With or without sterile water ampoules as per export/import regulation
• Label and branding: Multilingual packaging, export-compliant labeling, private label design

Clients can also develop extended lines with related cephalosporin combinations or tailor existing product ranges.

Packaging and Labeling Solutions

Our packaging division provides durable, contamination-proof, and transport-stable options:

• Type I/II glass vials
• Rubber stoppers and aluminum flip-off seals
• Blister or tray packing (for bulk handling)
• High-quality cartons with product information leaflets
• Tamper-proof and traceable barcoding
• 100% customizable private-label support

We adhere to country-specific labeling norms, including:

• US FDA labeling compliance
• EMA/UK MHRA format
• Middle Eastern Arabic/English dual-language packaging
• African and ASEAN market standards

Regulatory and Export Documentation

With over a decade of experience in international trade, BluepillExpress ensures your product is backed by complete documentation for smooth regulatory approval and cross-border shipment.

We provide:

• GMP and ISO certificates
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Origin
• Certificate of Analysis (COA)
• Free Sale Certificate
• MSDS (Material Safety Data Sheet)
• Stability Data (on request)
• Product Dossiers (as per CTD/ACTD)

We have successful registration and export partnerships in:

• Africa (Kenya, Nigeria, Ghana, Sudan, Ethiopia)
• CIS (Russia, Kazakhstan, Uzbekistan)
• Latin America
• Southeast Asia (Vietnam, Philippines, Cambodia)
• Middle East (UAE, Iraq, Saudi Arabia)

Client Segments We Serve

Our Ceftriaxone and Sulbactam injection manufacturing services are ideal for:

• Generic pharmaceutical companies
• Hospital and institutional suppliers
• Government tenders and procurement bodies
• NGOs and humanitarian supply chains
• Importers and national distributors
• Private-label medicine brands

Sustainability and Ethical Manufacturing

At BluepillExpress, our commitment extends beyond product efficacy. We adopt:

• Sustainable waste management and effluent treatment systems
• Green energy usage in production units
• Ethical labor practices and equal opportunity employment
• Animal testing-free development (for applicable dosage forms)
• Environmentally friendly packaging materials

We believe in long-term health not only for patients, but for the planet.

Manufacturing Process Workflow

Our streamlined third-party manufacturing process ensures:

1. Requirement Analysis: Understanding the client’s specification, target market, and regulatory needs.
2. Quotation and Finalization: Transparent cost structure, timelines, and MOQ agreement.
3. Product Development: Manufacturing the batch under GMP guidelines with full QC monitoring.
4. Packaging and Labeling: Based on client branding and country-specific regulations.
5. Dispatch and Documentation: Timely delivery with all required certificates for import and marketing.

Advantages of Partnering with BluepillExpress

• Fast turnaround times for domestic and international markets
• Low Minimum Order Quantities (MOQs) to support startups and medium-sized businesses
• Robust inventory and API sourcing network for uninterrupted supply
• Dedicated account managers to handle custom requests and real-time updates
• Confidentiality agreements to protect intellectual property and brand identity

Conclusion

The combination of Ceftriaxone 0.5 gm & Sulbactam 0.250 gm offers an effective and widely accepted therapeutic solution for severe infections requiring parenteral antibiotic therapy. With increasing bacterial resistance, healthcare systems worldwide continue to rely on broad-spectrum, beta-lactamase-resistant injectable antibiotics.

BluepillExpress, with its scientific rigor, global certifications, and pharmaceutical expertise, stands ready to serve as your manufacturing partner for this critical formulation. Whether for domestic supply, private label exports, or institutional procurement, BluepillExpress guarantees precision, purity, and professionalism in every vial produced.