Cefuroxime Axetil

Cefuroxime Axetil is a second-generation oral cephalosporin antibiotic that offers broad-spectrum efficacy against various Gram-positive and Gram-negative bacteria. It is widely prescribed to treat infections of the respiratory tract, urinary tract, ear, throat, skin, and soft tissues. Its excellent safety profile, well-established efficacy, and availability in oral tablet and suspension forms make it an ideal choice for both pediatric and adult patients.

BluepillExpress, a globally recognized pharmaceutical manufacturer and exporter, offers end-to-end third-party manufacturing services for Cefuroxime Axetil under stringent international quality standards. Whether for generic pharmaceutical lines, contract manufacturing, or private-label brands, we provide high-quality formulations that are compliant, cost-effective, and market-ready.

What is Cefuroxime Axetil?

Cefuroxime Axetil is the oral prodrug of Cefuroxime, a second-generation cephalosporin antibiotic. Upon oral administration, Cefuroxime Axetil is hydrolyzed in the intestinal mucosa to release active Cefuroxime, which exerts its bactericidal effect by inhibiting bacterial cell wall synthesis.

Therapeutic Class: Cephalosporin Antibiotics (2nd Generation)
Mechanism of Action: Inhibits peptidoglycan synthesis in bacterial cell walls
Activity: Broad-spectrum; effective against Streptococcus pneumoniae, Haemophilus influenzae, E. coli, and more

Common Indications Include:

• Upper and lower respiratory tract infections
• Otitis media (middle ear infections)
• Pharyngitis and tonsillitis
• Urinary tract infections
• Skin and soft tissue infections
• Gonorrhea
• Sinusitis
• Lyme disease (early stage)

Why Choose BluepillExpress for Cefuroxime Axetil Manufacturing?

At BluepillExpress, we bring years of technical expertise, cutting-edge manufacturing infrastructure, and a global regulatory understanding to every third-party manufacturing partnership. Our Cefuroxime Axetil production is driven by:

• State-of-the-art facilities certified by WHO-GMP, ISO 9001:2015, and FSSAI
• Dedicated antibiotic manufacturing blocks with stringent microbial control
• Robust formulation and R&D support
• International-grade packaging and labeling options
• Full regulatory documentation and export facilitation

We cater to pharmaceutical companies, distributors, hospitals, and tender clients across Asia, Africa, the Middle East, and Latin America.

Product Specifications

We manufacture Cefuroxime Axetil in multiple dosage forms and strengths, meeting the needs of different markets and patient segments.

Available Forms

• Tablets (Film-coated)
• Oral Suspension (Dry Syrup)
• Dispersible Tablets (on request)

Tablet Strengths

• Cefuroxime Axetil 125 mg
• Cefuroxime Axetil 250 mg
• Cefuroxime Axetil 500 mg

Dry Syrup Strengths

• Cefuroxime Axetil 125 mg/5 ml (Reconstitution volume: 30 ml or 60 ml)
• Cefuroxime Axetil 250 mg/5 ml (Pediatric & Adult formulations)

All products comply with British Pharmacopoeia (BP), United States Pharmacopoeia (USP), or client-specified monographs, ensuring global market compatibility.

Composition and Excipients

Each formulation is precisely developed for stability, bioavailability, and patient compliance.

Tablet Composition (Example – 250 mg)

• Active Ingredient: Cefuroxime Axetil 250 mg
• Excipients: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, and appropriate colorants

Dry Syrup Composition (Example – 125 mg/5 ml)

• Active Ingredient: Cefuroxime Axetil equivalent to Cefuroxime 125 mg per 5 ml after reconstitution
• Excipients: Sucrose, sodium benzoate, xanthan gum, flavoring agents, and stabilizers

Taste masking, flavor customization, and sugar-free pediatric variants are also available for client-specific requirements.

Manufacturing Process

Our antibiotic manufacturing units operate under controlled cleanroom environments with HEPA filtration and dedicated HVAC systems to prevent cross-contamination.

Key Steps:

1. Procurement of Raw Materials: Sourced from certified API manufacturers with validated COAs.
2. Granulation and Blending: Accurate wet or dry granulation methods used for uniformity and flow properties.
3. Compression / Filling: High-speed rotary compression and powder filling machines ensure consistent dosing.
4. Film Coating / Suspension Reconstitution Testing: Coating and reconstitution evaluated for taste, stability, and dispersion.
5. Packing and Labeling: Carried out under cGMP conditions using automated lines.
6. Quality Control Testing: Microbiological, chemical, dissolution, and stability testing per batch.

The entire production cycle adheres to ICH and GMP guidelines, with complete traceability and quality assurance protocols.

Packaging and Labeling Options

We offer flexible packaging options tailored for retail, institutional, and export markets:

Tablets

• Blister Packs: Aluminum-PVC or Alu-Alu 10×10 or 1×10 formats
• Bottled Packs: Available on request
• Cartons with inserts: Fully customizable with brand design

Oral Suspension

• HDPE Bottles with Measuring Cap
• Tamper-Evident Seals and Flavor Masking
• Carton Box with Dosing Instruction Leaflet

Multilingual labeling, barcoding, and serialization services are available based on the country of export and client preferences.

Regulatory and Export Documentation

BluepillExpress provides full regulatory support for global markets. Our documentation package includes:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Stability Studies (Real-time and Accelerated)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Product Dossier (CTD format)
• MSDS and Free Sale Certificate
• GMP and ISO Certification Copies

We also assist in product registration, dossier submission, and import clearance for various regulated and semi-regulated markets.

Therapeutic Benefits of Cefuroxime Axetil

• Broad-Spectrum Coverage: Effective against both Gram-positive and Gram-negative bacteria
• Well Tolerated: Fewer gastrointestinal side effects compared to earlier antibiotics
• Convenient Dosing: Once or twice daily depending on indication
• Pediatric-Friendly: Dry syrup forms with child-approved flavors
• Effective Resistance Management: Useful in antibiotic stewardship programs

Its clinical versatility and safety make it a vital component of formulary medicines across hospitals, clinics, and retail pharmacies.

Target Markets and Customer Segments

We manufacture Cefuroxime Axetil for:

• Generic Medicine Brands
• Hospital and Institutional Supply Chains
• Government and NGO Procurement Programs
• Pediatric Formulation Distributors
• Pharmacy Chains and E-commerce Platforms
• Private Label and White Label Requirements

Our clients span across India, Asia-Pacific, Africa, Middle East, Latin America, and select parts of Europe.

Global Export and Market Reach

BluepillExpress is a recognized exporter of antibiotic and therapeutic medications to over 30 countries, including:

• Africa: Kenya, Nigeria, Ghana, Uganda, Tanzania
• Asia: Philippines, Sri Lanka, Bangladesh, Vietnam
• Middle East: Saudi Arabia, UAE, Iraq, Oman
• CIS and Latin America: Kazakhstan, Bolivia, Peru
• Island Nations and Remote Territories: Papua New Guinea, Fiji, Mauritius

We provide complete shipping documentation, including commercial invoice, packing list, airway bill/bill of lading, and customs clearance support.

Why Partner with BluepillExpress?

• WHO-GMP, ISO, and FSSAI certified infrastructure
• Experienced R&D and formulation specialists
• Competitive pricing with high-margin potential
• End-to-end supply chain support
• Low Minimum Order Quantities (MOQs)
• Dedicated account and documentation teams
• Confidentiality and white-label manufacturing assurance