Cefotaxime Sodium

The global demand for broad-spectrum antibiotics has seen a consistent rise due to the growing prevalence of bacterial infections, hospital-acquired diseases, and resistance concerns. Among these, Cefotaxime Sodium, a third-generation cephalosporin antibiotic, remains an essential component in hospital and clinical settings for the treatment of severe bacterial infections. With its potent bactericidal action against both Gram-positive and Gram-negative organisms, Cefotaxime Sodium has become a preferred parenteral antibiotic in intensive care units, surgical prophylaxis, and community-acquired infections.

BluepillExpress, a globally trusted name in pharmaceutical manufacturing, offers premium third-party manufacturing services for Cefotaxime Sodium injections and formulations. With GMP-certified facilities, WHO-GMP compliance, and an experienced technical team, we ensure that every product is manufactured to the highest standards of quality, safety, and efficacy—tailored for domestic and export markets.

About Cefotaxime Sodium

Cefotaxime Sodium is a semisynthetic, broad-spectrum third-generation cephalosporin antibiotic used primarily in the treatment of infections caused by susceptible strains of microorganisms. It is administered parenterally, typically via intravenous (IV) or intramuscular (IM) injection.

Cefotaxime Sodium acts by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. It exhibits strong activity against:

• Streptococcus pneumoniae
• Haemophilus influenzae
• Neisseria gonorrhoeae
• Escherichia coli
• Klebsiella species
• Enterobacter species
• Pseudomonas aeruginosa (with variable sensitivity)

It is especially effective in respiratory tract infections, urinary tract infections, bone and joint infections, septicemia, gynecologic infections, intra-abdominal infections, and meningitis.

Why Choose BluepillExpress for Cefotaxime Sodium Manufacturing?

1. WHO-GMP and ISO Certified Facilities
BluepillExpress operates fully equipped, WHO-GMP, GMP, and ISO 9001:2015 certified pharmaceutical manufacturing units. Our facilities maintain Class 100 and Class 10,000 cleanrooms for sterile injectable production, ensuring aseptic processing and contamination-free environments.

2. Regulatory-Compliant Production
All products are developed and manufactured in compliance with USP, EP, BP, and IP pharmacopeial standards. We maintain strict adherence to ICH guidelines and ensure global export compliance with agencies such as:

• US FDA (for registration-based projects)
• MHRA (UK)
• TGA (Australia)
• CDSCO (India)
• ANVISA (Brazil)

3. Injectable Expertise
BluepillExpress specializes in the manufacturing of parenteral formulations including lyophilized powders, dry powders for injection, and sterile liquid injectables. Cefotaxime Sodium is available as dry powder for reconstitution, typically in:

• 250 mg, 500 mg, 1 g, and 2 g vials

We offer both single-dose and multi-dose formats, along with bulk packaging options for hospital tenders and institutional supply.

4. Flexible Production Capacity
We are capable of manufacturing small, medium, and large batch volumes, catering to start-ups, distributors, government tenders, and multinational importers. Our production lines are equipped with high-speed vial filling, sealing, and labeling machines that ensure high productivity without compromising on quality.

Product Description and Specifications

Product Name	Cefotaxime Sodium for Injection
Strengths Available	250 mg, 500 mg, 1 g, 2 g
Dosage Form	Sterile powder for injection
Route of Administration	IV / IM
Pharmacopoeia	IP / BP / USP / EP
Packing	Glass vials with flip-off seal, rubber stopper, secondary carton
Shelf Life	24 to 36 months depending on packaging
Storage	Store below 25°C; protect from moisture and light

All formulations are stability tested, sterility assured, and pyrogen-free.

Therapeutic Indications

Cefotaxime Sodium is prescribed for the treatment of moderate to severe infections including:

• Lower respiratory tract infections (e.g., pneumonia, bronchitis)
• Genitourinary infections (e.g., cystitis, pyelonephritis)
• Gynecologic infections (e.g., pelvic inflammatory disease)
• Intra-abdominal infections (e.g., peritonitis)
• Skin and soft tissue infections
• Bone and joint infections (e.g., osteomyelitis)
• Septicemia and bacteremia
• Central nervous system infections (e.g., bacterial meningitis)
• Surgical prophylaxis

Target Markets and Clientele

We cater to a wide range of clients for Cefotaxime Sodium manufacturing:

• Pharmaceutical companies with hospital-focused product lines
• Distributors and exporters looking to register and market injectables globally
• Government and public health agencies procuring for emergency or institutional use
• NGOs and humanitarian agencies providing essential drug kits
• Private-label and contract manufacturing partners

Private Label and Contract Manufacturing Services

We provide full-service private label and contract manufacturing options for Cefotaxime Sodium. Services include:

• Customized labeling and branding
• Multilingual cartons and patient information leaflets
• Customized artwork and packaging configurations
• Country-specific regulatory compliance (labeling, documentation)
• Registration dossier support (CTD/eCTD format)

Whether you are looking to launch a new injectable brand or expand your existing antibiotic portfolio, BluepillExpress offers turnkey solutions that simplify your go-to-market process.

Quality Control and Assurance

Our commitment to quality is reflected in our comprehensive QA/QC processes, which include:

• Raw material verification (API identity, assay, purity)
• In-process controls during compounding and filling
• Terminal sterilization where required
• Sterility testing (USP <71>)
• Bacterial endotoxin testing (LAL test)
• pH and reconstitution testing
• Stability testing under ICH conditions
• Packaging integrity and leak testing

All processes are validated, and batch documentation is maintained as per cGMP and GDP protocols.

Certifications and Documentation Provided

BluepillExpress supports all Cefotaxime Sodium clients with a full range of certifications and export documentation:

• WHO-GMP certificate
• Certificate of Pharmaceutical Product (CoPP)
• Free Sale Certificate
• Certificate of Analysis (CoA)
• Stability data and batch manufacturing records
• MSDS (Material Safety Data Sheet)
• Method of analysis and master formula records
• Import/Export supporting documents

We also assist in dossier preparation for product registration in both regulated and semi-regulated markets.

Packaging Options

We offer a range of packaging configurations for Cefotaxime Sodium:

• Single-dose vials (250 mg to 2 g) in mono cartons
• Vials with sterile water for injection (WFI) as diluent
• 10-vial trays for hospital and institutional supplies
• Custom labeling and packaging for tender participation

All packaging materials are sourced from certified vendors and conform to international quality standards.

Global Export and Logistics Support

BluepillExpress is an experienced global exporter, with established supply chains in:

• Africa (Kenya, Ghana, Nigeria, South Africa)
• Asia (India, Philippines, Vietnam, Sri Lanka)
• Middle East (UAE, Saudi Arabia, Iraq)
• Latin America (Peru, Bolivia, Guatemala)
• CIS countries and Eastern Europe
• Caribbean Islands and humanitarian export zones

Our international business team provides complete export assistance including:

• Freight forwarding coordination
• Insurance and shipping documentation
• Compliance with destination country requirements
• Product registration and import license coordination

Sustainability and Ethical Practices

BluepillExpress adheres to environmentally sustainable and ethically sound manufacturing practices:

• Zero-discharge effluent treatment plants
• Minimal packaging waste and recycling policies
• Ethical sourcing of active pharmaceutical ingredients
• Fair labor practices and workforce safety compliance
• No child labor or unethical procurement practices

We are committed to producing life-saving medicines in a socially responsible manner.

Client Support and Collaboration

BluepillExpress values transparency and collaboration in every partnership. We offer:

• NDA protection for sensitive business transactions
• Pilot batches and stability trials
• Dedicated project managers and regulatory advisors
• Technical support throughout product lifecycle
• Post-marketing pharmacovigilance (on request)

Whether you are a pharmaceutical importer, distributor, or institutional buyer, we provide responsive, end-to-end support to help you scale your Cefotaxime Sodium business globally.

Conclusion

Cefotaxime Sodium continues to be a frontline injectable antibiotic in modern medicine. As the demand for quality injectable cephalosporins grows, BluepillExpress stands as a reliable third-party manufacturer delivering regulatory-compliant, cost-effective, and high-quality solutions for global healthcare providers.

With robust infrastructure, international certifications, and an expert formulation team, BluepillExpress is your ideal partner for third-party manufacturing of Cefotaxime Sodium in sterile injectable formats. Let us help you bring life-saving antibiotic formulations to markets that need them most—efficiently, safely, and professionally.