Cefixime

Infectious diseases continue to pose significant health challenges globally, with bacterial infections leading the chart in both morbidity and mortality. Antibiotics remain the primary defense against such infections, and Cefixime, a widely used third-generation cephalosporin, has become a cornerstone in antimicrobial therapy. Known for its broad-spectrum activity and convenient oral dosage forms, Cefixime is preferred by clinicians across the globe for treating respiratory, urinary, and gastrointestinal infections.

BluepillExpress, a trusted name in pharmaceutical contract manufacturing, is proud to offer specialized third-party manufacturing services for Cefixime. With state-of-the-art facilities, regulatory certifications, and expertise in antibiotic formulations, we serve pharmaceutical companies, global importers, and government agencies seeking quality-assured Cefixime products for their markets.

About Cefixime

Cefixime is a third-generation oral cephalosporin antibiotic with broad-spectrum activity against both Gram-positive and Gram-negative bacteria. It works by inhibiting bacterial cell wall synthesis, resulting in cell death. Cefixime is stable in the presence of beta-lactamase enzymes and is effective against bacteria that are resistant to penicillin and other cephalosporins.

Cefixime is commonly prescribed for:

• Upper and lower respiratory tract infections
• Otitis media
• Urinary tract infections
• Gonorrhea
• Pharyngitis and tonsillitis
• Typhoid fever and bacterial gastroenteritis

Its once or twice-daily dosing, high bioavailability, and favorable safety profile make it an ideal option for both adult and pediatric patients.

Why Choose BluepillExpress for Cefixime Manufacturing?

1. WHO-GMP and ISO Certified Manufacturing Facilities
BluepillExpress operates cutting-edge manufacturing plants compliant with WHO-GMP, GMP, and ISO 9001:2015 standards. Our antibiotic production lines are designed to deliver contamination-free, consistent, and high-purity products, with strict adherence to global pharmacopeial standards.

2. Expertise in Oral Antibiotic Formulations
Our technical team is highly experienced in manufacturing oral cephalosporins like Cefixime in various dosage forms with optimal dissolution, stability, and bioequivalence. We offer products in line with IP, BP, USP, and EP specifications.

3. Comprehensive Third-Party and Private Label Services
Whether you’re launching a new brand, participating in tenders, or expanding your antibiotic range, we provide full support for:

• Product development and R&D
• Regulatory and documentation support
• Customized labeling and packaging
• Flexible MOQs and scalable production
• End-to-end quality management

Available Dosage Forms

We manufacture Cefixime in multiple oral dosage forms to suit market needs:

Cefixime Tablets

• 100 mg
• 200 mg
• 400 mg

Cefixime Dispersible Tablets (DT)

• 100 mg DT
• 200 mg DT

Cefixime Oral Suspension (Dry Syrup)

• 50 mg/5 ml
• 100 mg/5 ml
• Reconstitution volumes: 30 ml, 50 ml, 60 ml

Cefixime + Clavulanic Acid Combinations
Available on demand for specific therapeutic and export requirements.

All formulations are developed with child-friendly flavors, taste-masking technologies, and quick-dispersion features for enhanced patient compliance.

Technical Product Specifications

Product Name	Cefixime
Strengths Available	50 mg/5ml, 100 mg/5ml (Syrup); 100 mg, 200 mg, 400 mg (Tablet/DT)
Dosage Forms	Dispersible Tablets, Conventional Tablets, Dry Syrup
Route of Administration	Oral
Pharmacopoeial Standards	IP / BP / USP / EP
Packing	Blisters, Alu-Alu, HDPE bottles with measuring device
Shelf Life	24–36 months depending on formulation
Storage Conditions	Store below 25°C, protect from moisture and light

All batches undergo extensive validation, including stability testing, assay determination, and microbial analysis.

Therapeutic Indications

Cefixime is a first-line antibiotic for the treatment of:

• Respiratory tract infections: Bronchitis, pneumonia, sinusitis
• ENT infections: Pharyngitis, tonsillitis, otitis media
• Urinary tract infections: Acute and recurrent cystitis
• Gastrointestinal infections: Typhoid fever, traveler’s diarrhea
• STIs: Uncomplicated gonorrhea

Due to its oral administration and broad-spectrum efficacy, Cefixime is widely used in both outpatient and inpatient settings.

Quality Assurance and Control

At BluepillExpress, quality is non-negotiable. We implement a rigorous Quality Assurance (QA) and Quality Control (QC) framework, including:

• Raw material testing and API identification
• Granulation, compression, coating, and drying in controlled environments
• In-process quality checks for weight variation, hardness, and friability
• Microbial limit testing
• Uniformity of content
• Dissolution testing
• Stability studies as per ICH guidelines

All documentation, including Batch Manufacturing Records (BMR), Certificate of Analysis (CoA), Method of Analysis (MOA), and Process Validation Reports, is maintained for audit and regulatory purposes.

Packaging Options

We provide a variety of packaging formats to suit both retail and institutional markets:

• Tablets:
  • Blister packs (10×10, 1×10)
  • Alu-Alu packs
  • Mono-cartons with product leaflet
• Dry Syrups:
  • HDPE bottles with reconstitution mark
  • Aluminum-sealed caps and tamper-proof labels
  • Measuring spoons or cups
• Custom Export Packaging:
  • Country-specific artwork
  • QR code/Barcode integration
  • Multi-language labeling

All packaging is tamper-evident, moisture-resistant, and conforms to international export norms.

Export and International Compliance

BluepillExpress supports export of Cefixime formulations to more than 40 countries, with experience in both regulated and semi-regulated markets. We offer:

• Product dossiers (CTD/eCTD format)
• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Analysis (CoA)
• Free Sale Certificate
• Stability and Bioequivalence data (upon request)
• Import/export documentation
• Regulatory support for market authorization and tender participation

We actively export to:

• Africa (Nigeria, Kenya, Ghana, Tanzania)
• Southeast Asia (Philippines, Vietnam, Myanmar)
• Middle East (UAE, Iraq, Yemen)
• Latin America and Caribbean
• CIS countries and Pacific regions

Our regulatory and logistics team ensures smooth documentation and timely dispatch of all export consignments.

Client Profile and Target Segments

We manufacture Cefixime products for a wide spectrum of clients:

• Generic pharmaceutical companies
• Retail and hospital-based brands
• Institutional and government healthcare tenders
• Pediatric and general medicine-focused distributors
• Global importers requiring branded or unbranded generic formulations
• NGOs and public health organizations

Whether your focus is affordability, compliance, or high-volume production, BluepillExpress provides the right blend of quality and customization.

Research and Development Services

In addition to manufacturing, BluepillExpress offers collaborative R&D support for:

• New combination formulations (e.g., Cefixime + Ofloxacin, Cefixime + Clavulanic Acid)
• Pediatric product innovation (better flavors, reconstitution ease)
• Improved stability formulations for tropical zones
• Fixed Dose Combinations (FDCs) for AMR-focused programs

We also provide pilot batches, BE studies (in partnership), and technical dossiers for new product launches.

Ethical and Sustainable Manufacturing

BluepillExpress is committed to ethical business practices and environmentally responsible manufacturing, including:

• Zero liquid discharge systems
• Sustainable sourcing of APIs
• No use of harmful colorants or preservatives
• Child-safe packaging and labeling
• Compliance with labor and safety laws
• Adherence to WHO prequalification parameters

Our commitment extends beyond compliance—we aim to contribute positively to global public health.

Client Support and Services

When you choose BluepillExpress, you gain access to a dedicated client service experience:

• Non-disclosure agreements for project confidentiality
• Dedicated project manager for communication
• Regulatory and documentation support
• Transparent pricing and costing models
• Audit readiness and facility tours (virtual or in-person)
• On-time delivery with real-time updates

Our goal is to build long-term partnerships, not just transactions.

Conclusion

Cefixime is a critical, broad-spectrum antibiotic essential in the fight against bacterial infections. As antibiotic stewardship becomes increasingly important, the need for reliable, high-quality, and cost-effective manufacturers has never been greater.

BluepillExpress stands as your trusted partner in the third-party manufacturing of Cefixime. With our global-standard infrastructure, scientific expertise, and commitment to regulatory compliance, we ensure that every product meets the needs of both the prescriber and the patient.