Cefuroxime Axetil

Antibiotic therapy remains one of the pillars of modern medicine, especially in the treatment of community-acquired and hospital-acquired infections. Cefuroxime Axetil, a second-generation cephalosporin antibiotic, is widely used for treating a variety of bacterial infections, especially those caused by gram-positive and gram-negative organisms. With increasing resistance to older antibiotics, the demand for high-quality, broad-spectrum agents like Cefuroxime Axetil has grown significantly.

At BluepillExpress, we offer comprehensive third-party manufacturing services for Cefuroxime Axetil tablets and oral suspensions, developed under WHO-GMP and ISO-certified infrastructure. Our scientifically robust manufacturing process, quality controls, and export capabilities ensure reliable delivery of this essential antibiotic to global markets.

About BluepillExpress

BluepillExpress is a globally renowned name in pharmaceutical third-party manufacturing and export, offering a broad portfolio of antibiotics, antivirals, nutraceuticals, and chronic disease medications. We serve clients in Asia, Africa, CIS countries, Latin America, and the Middle East, helping them build, launch, and scale their pharmaceutical product lines with confidence.

With state-of-the-art infrastructure, global certifications, and technical expertise, we provide end-to-end solutions—from product development and formulation to customized packaging, labeling, regulatory documentation, and export compliance.

Product Overview: Cefuroxime Axetil

Cefuroxime Axetil is the orally administered prodrug of Cefuroxime, a second-generation cephalosporin antibiotic that works by inhibiting bacterial cell wall synthesis. Upon absorption, Cefuroxime Axetil is hydrolyzed in the body to its active form, Cefuroxime, providing systemic antibacterial action.

This antibiotic is widely prescribed for:

• Respiratory tract infections (upper and lower)
• Acute bacterial sinusitis
• Otitis media
• Skin and soft tissue infections
• Urinary tract infections
• Pharyngitis and tonsillitis
• Gonorrhea
• Lyme disease (early stage)
• Surgical prophylaxis (in some cases)

It is highly effective against beta-lactamase-producing strains, making it a valuable option in antimicrobial stewardship.

Mechanism of Action

Cefuroxime Axetil belongs to the β-lactam class of antibiotics and functions by:

• Binding to penicillin-binding proteins (PBPs) located inside the bacterial cell wall.
• Inhibiting the final step of peptidoglycan synthesis, an essential component of the bacterial cell wall.
• Leading to cell lysis and death of the bacterium.

It offers a broader spectrum of coverage than first-generation cephalosporins, particularly against Haemophilus influenzae, Streptococcus pneumoniae, and other common respiratory pathogens.

Dosage Forms Offered

BluepillExpress manufactures Cefuroxime Axetil in multiple dosage forms to meet diverse market requirements:

• Cefuroxime Axetil Tablets
  • 125 mg
  • 250 mg
  • 500 mg
• Cefuroxime Axetil Oral Suspension (Dry Syrup)
  • 125 mg/5ml (Reconstituted)
  • 250 mg/5ml (Reconstituted)
  • Available in 30ml, 60ml, and 100ml bottle sizes

All dosage forms are developed to ensure optimal stability, absorption, and bioavailability.

Packaging Options

BluepillExpress provides flexible, export-compliant packaging formats tailored to your market’s needs:

For Tablets:

• Alu-Alu and Blister Strips (10x1x10, 1×6, or 1×10 formats)
• Mono-cartons and bulk packs
• Multilingual outer packaging for international markets

For Oral Suspension:

• Dry syrup in HDPE bottles with measuring cups
• Child-resistant caps and tamper-evident seals
• Labeling as per local regulations

We support full private labeling and brand customization, allowing you to offer the product under your own trademark.

Manufacturing Infrastructure

Our dedicated antibiotic manufacturing zones are designed to ensure contamination-free production, compliant with Good Manufacturing Practices (GMP):

• Segregated production areas for beta-lactam antibiotics
• HVAC-controlled cleanrooms and Class 100,000 sterile environments
• High-speed granulation, compression, and blister packing equipment
• Dry syrup filling and capping lines
• In-house purified water generation systems
• QA/QC and microbiology labs equipped with HPLC, UV spectrophotometers, and stability chambers

All batches are monitored in real-time for in-process quality parameters, consistency, and traceability.

Quality Assurance and Certifications

At BluepillExpress, our quality assurance system ensures that every product meets or exceeds international standards. Our facilities are certified and audited for compliance with:

• WHO-GMP
• ISO 9001:2015
• GLP (Good Laboratory Practices)
• FSSAI License (for applicable formulations)
• EU-GMP and USFDA approval (select plants)

Each batch of Cefuroxime Axetil undergoes rigorous testing for:

• Identification and assay of active ingredients
• Dissolution and disintegration
• Stability (accelerated and real-time)
• Microbial contamination and endotoxin testing
• Uniformity of dosage units

Regulatory Documentation Support

We provide full regulatory documentation support to clients, helping them register Cefuroxime Axetil in both regulated and semi-regulated markets. Available documentation includes:

• Certificate of Analysis (CoA)
• Certificate of Pharmaceutical Product (CoPP)
• Stability data reports
• Product Master File / Dossier (CTD format)
• Manufacturing License and GMP Certificates
• Free Sale Certificate
• MSDS (Material Safety Data Sheet)
• WHO Prequalification assistance (on request)

We ensure compliance with the latest standards of pharmacopeias such as USP, BP, IP, and Ph. Eur.

Global Export & Logistics Capability

With decades of experience in international pharma exports, BluepillExpress serves clients across:

• Africa: Kenya, Uganda, Ghana, Nigeria, South Africa
• Middle East: Iraq, Jordan, Saudi Arabia, UAE
• Asia: Vietnam, Philippines, Sri Lanka, Myanmar
• CIS: Uzbekistan, Kazakhstan, Georgia
• Latin America and Caribbean: Bolivia, Peru, Dominican Republic

We offer:

• Export-optimized packaging
• Temperature-sensitive shipping (if required)
• Customs clearance documentation
• Regulatory registration assistance
• Country-specific labeling and batch coding

Our logistic teams ensure timely delivery and complete product integrity throughout the shipment lifecycle.

Client Profiles We Serve

We manufacture Cefuroxime Axetil for a wide range of clients:

• Generic and branded pharmaceutical companies
• Government and institutional tender suppliers
• Hospitals and healthcare networks
• International distributors and wholesalers
• Retail pharmacy chains and digital health platforms

Our low minimum order quantities (MOQ) and scalable batch sizes make us ideal for both startups and established enterprises.

Why Choose BluepillExpress for Cefuroxime Axetil Manufacturing?

1. WHO-GMP and ISO-Certified Production Facilities
   Manufacturing meets global standards and passes regular quality audits.
2. End-to-End Third-Party Manufacturing Support
   From formulation to final shipment, all services under one roof.
3. Custom Branding and Private Labeling
   Tailored to your marketing vision and regional compliance needs.
4. Flexible MOQ and Competitive Pricing
   Catering to small, medium, and bulk orders with international affordability.
5. Expert Regulatory Assistance
   Full documentation support for smooth product registration.
6. Fast Turnaround and Delivery
   Committed to timely production cycles and on-time delivery worldwide.

Conclusion

As the global burden of respiratory, urinary, and skin infections increases, the role of Cefuroxime Axetil as a reliable, broad-spectrum oral antibiotic becomes even more critical. With proven efficacy, patient tolerability, and broad-spectrum coverage, it remains a core product in the essential medicines category of many countries.

At BluepillExpress, we offer reliable, compliant, and high-quality third-party manufacturing of Cefuroxime Axetil, empowering partners to launch trusted formulations under their own brand names. Whether you’re targeting hospitals, retail markets, or government tenders, our solutions ensure you have the quality, support, and scalability to succeed.