Ceftriaxone 100mg & Tazobactam 125 mg

The combination of Ceftriaxone 1000mg & Tazobactam 125mg represents a potent and widely prescribed formulation in the field of antimicrobial therapy. Designed to combat a wide range of bacterial infections, this synergistic antibiotic formulation is particularly effective in treating infections that are resistant to standard beta-lactam antibiotics.

At BluepillExpress, we offer comprehensive third-party manufacturing services for this essential parenteral antibiotic. As a globally recognized pharmaceutical manufacturer and exporter, we adhere to the highest standards of quality, safety, efficacy, and regulatory compliance. Our facilities are equipped to manufacture this combination in sterile conditions, ensuring that each unit meets the therapeutic requirements of international healthcare markets.

Product Overview

Product Name: Ceftriaxone 1000mg & Tazobactam 125mg
Category: Beta-lactam Antibiotic Combination
Form: Powder for Injection (Sterile Lyophilized or Dry Powder)
Route of Administration: Intravenous (IV) / Intramuscular (IM)
Packaging Format: Single-use vial with sterile water for injection (if required), packed in a monocarton

Composition

• Ceftriaxone Sodium Equivalent to Ceftriaxone 1000 mg
• Tazobactam Sodium Equivalent to Tazobactam 125 mg

This formulation combines a third-generation cephalosporin with a beta-lactamase inhibitor, offering broader spectrum activity and increased efficacy against resistant bacterial strains.

Therapeutic Indications

This injectable combination is commonly indicated for the treatment of the following infections:

• Lower respiratory tract infections (pneumonia, bronchitis)
• Urinary tract infections (including complicated UTIs)
• Intra-abdominal infections
• Skin and soft tissue infections
• Bone and joint infections
• Gynecological infections (including pelvic inflammatory disease)
• Sepsis and bacteremia
• Post-surgical or nosocomial infections
• Meningitis (off-label in select resistant cases)

Mechanism of Action

• Ceftriaxone is a broad-spectrum cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). It is effective against both gram-positive and gram-negative organisms.
• Tazobactam is a beta-lactamase inhibitor that enhances the activity of Ceftriaxone by preventing its degradation by beta-lactamase enzymes produced by resistant bacteria.

Together, this combination improves treatment outcomes by ensuring that the primary antibiotic retains its activity even in the presence of resistant bacterial strains.

Why Choose BluepillExpress for Third-Party Manufacturing of Ceftriaxone & Tazobactam?

1. WHO-GMP Certified Manufacturing Facilities

Our manufacturing units are WHO-GMP, ISO 9001:2015, and GLP-compliant, offering sterile injectables manufacturing in controlled environments. Equipped with high-efficiency air filtration, automated filling lines, and precision lyophilization units, we ensure contamination-free production of life-saving injectables like Ceftriaxone & Tazobactam.

2. Sterility and Quality Assurance

Sterile injectable production requires the highest levels of control, which we deliver consistently through:

• Class 100 cleanrooms and aseptic areas
• HEPA-filtered laminar airflow systems
• Regular microbial and particulate monitoring
• Water for injection (WFI) and clean steam systems
• Dedicated QA/QC laboratories
• Terminal sterilization and/or aseptic filling lines

All vials are visually inspected, leak tested, and subjected to in-process quality control and final batch release testing.

3. Regulatory Documentation and Dossiers

BluepillExpress provides complete regulatory and technical support, including CTD/ACTD dossiers, stability data, and quality certifications, to assist with product registration and regulatory submissions in both regulated and semi-regulated markets.

Available documents include:

• Certificate of Analysis (CoA)
• Certificate of Origin
• GMP and Manufacturing License
• Free Sale Certificate
• MSDS (Material Safety Data Sheet)
• Stability Study Reports
• Validation Reports (Process & Analytical)
• Product Dossier (on request)

4. Packaging and Labeling Customization

We offer complete packaging solutions tailored to your brand identity and market requirements. Options include:

• Clear or amber glass vials
• Flip-off seals and aluminum crimp caps
• Printed vial labels with regulatory information
• Single vial or combipack with sterile water for injection
• Multi-lingual outer cartons for international clients

Custom branding, batch coding, and serialization (if required) are available to meet country-specific regulations.

5. Global Supply Capability

We have successfully exported pharmaceuticals to over 35 countries in Asia, Africa, Latin America, CIS, and the Middle East. Our dedicated export team ensures:

• Compliance with export norms
• Document preparation for customs clearance
• Cold chain logistics (if required)
• Product registration support in target countries

We are committed to supplying quality-assured antibiotics to international distributors, hospitals, tenders, and government procurement agencies.

Product Development and Customization

Our R&D team can work with clients to develop:

• Alternative dosage strengths (e.g., Ceftriaxone 500mg + Tazobactam 62.5mg)
• Dual-chamber vials or prefilled syringes (based on market feasibility)
• Combination packs with infusion solutions or disposables
• Formulations aligned with your country’s formulary or tender specifications

Stability and Shelf Life

We conduct ICH-guided stability testing to ensure the long-term effectiveness of the formulation under various environmental conditions. Products typically have a shelf life of 24–36 months, depending on packaging and storage conditions.

Quality Control Protocols

All products undergo rigorous testing protocols, including:

• Assay of active ingredients
• pH and particulate matter testing
• Sterility test (per USP/BP/IP standards)
• Bacterial endotoxin test
• Water content analysis
• Container closure integrity testing
• Accelerated and real-time stability studies

All quality tests are carried out using validated methods in fully equipped laboratories with advanced HPLC, UV-VIS spectrophotometers, and sterility chambers.

Contract Manufacturing Process at BluepillExpress

Our process is transparent, scalable, and efficient:

1. Product Planning & Quotation
   • Clients finalize specifications, quantity, packaging, and regulatory needs.
2. Sample and Validation Batch
   • We prepare product samples for client evaluation or submission to local drug authorities.
3. Manufacturing & Quality Assurance
   • Production is initiated under sterile conditions with real-time monitoring.
4. Packaging & Branding
   • Products are packaged and labeled as per client or regulatory requirements.
5. Logistics & Documentation
   • Final product is dispatched with all regulatory documentation, and global delivery is arranged.

Average manufacturing lead time: 30 to 40 days depending on batch size and packaging.

Applications and Market Demand

Ceftriaxone & Tazobactam is highly demanded in various therapeutic and healthcare environments:

• Government hospital tenders
• Emergency and critical care units
• ICU protocols for severe infections
• Treatment of multi-drug resistant infections
• Post-surgical prophylactic use
• Pediatric and adult infectious disease therapy

This combination is recognized in standard treatment guidelines and essential medicine lists in several countries, driving continuous demand in both institutional and retail settings.

Advantages of Partnering with BluepillExpress

• Global Export Capability: Export-ready documentation, multilingual labels, and international compliance
• Flexible MOQs: Scalable production from small commercial lots to large tender supplies
• Trusted Quality: WHO-GMP compliance, stringent QC protocols, and end-to-end traceability
• Technical Support: Dossier preparation, regulatory advice, and R&D customization
• Responsive Supply Chain: Fast turnaround times and coordinated delivery for global clients

Conclusion

The combination of Ceftriaxone 1000mg and Tazobactam 125mg remains a cornerstone of effective antibacterial therapy, especially in the face of growing antimicrobial resistance. Its clinical utility, spectrum of activity, and established safety profile make it a vital product in both hospital and outpatient care settings.

At BluepillExpress, we are proud to offer third-party manufacturing services for this important injectable antibiotic. With a sharp focus on sterile compliance, global quality standards, and client satisfaction, we are equipped to serve your pharmaceutical business needs—whether you’re a distributor, hospital, or government buyer.