Cefuroxime Axetil Tablets

Beta Lactams · Tablets / Suspension · 250mg / 500mg

Trade Information

Minimum Order Qty	1,000,000 tablets
Capacity	100 Million Tablets per month
Strength	250mg / 500mg
Private Labelling	Custom branding, artwork & market-specific labelling
Lead Time	45–60 days from order confirmation
Payment Terms	LC at sight, TT (advance / against documents)
Shipping	FOB / CIF to major international ports including Mombasa, Dar es Salaam, Lagos, Durban, Manila, Phnom Penh
Pharmacopoeia	BP, USP, IP compliant

Packing Options

Blister (Alu-Alu / Alu-PVC)
Strip pack
Hospital bulk pack
Custom packing as per buyer requirement

Regulatory & Quality

Registration Status	Registered in multiple African, Asian, and CIS markets. Dossier available for new market registration.
Regulatory Dossiers	CTD / ACTD format dossiers available for submission to national drug authorities.
Stability Data	Zone IVa & IVb stability data available (tropical climate conditions, 30°C/65% RH & 30°C/75% RH)
WHO Prequalification	WHO-GMP Certified

Product Details

Composition	Cefuroxime Axetil
Dosage Form	Tablets / Suspension
Pack Size	1x10, 10x10 / Custom packing available
Storage	Store below 25°C in a dry place, protected from light and moisture
Shelf Life	24 months from date of manufacture

Description

Cefuroxime Axetil is a second-generation oral cephalosporin that bridges the Gram-positive strength of earlier cephalosporins with broader Gram-negative coverage. It is widely used for respiratory tract infections, sinusitis, and otitis media, and is listed on the WHO Model List of Essential Medicines.

BioGalen manufactures Cefuroxime Axetil in 250mg and 500mg tablets and paediatric suspension, serving the high-demand outpatient respiratory and ENT segment across the markets we work in.

Mechanism of Action

Cefuroxime is a second-generation cephalosporin that inhibits bacterial cell wall synthesis by binding penicillin-binding proteins. As a second-generation agent it retains meaningful Gram-positive activity while extending coverage against several Gram-negative organisms beyond first-generation cephalosporins, and it has good stability against many beta-lactamases. The axetil ester form is hydrolysed after absorption to release active cefuroxime, giving the drug oral bioavailability suited to outpatient treatment.

Indications

Respiratory tract infections
Sinusitis
Otitis media (middle ear infection)
Uncomplicated skin and soft tissue infections
Uncomplicated urinary tract infections

Available Variants

Cefuroxime Axetil Tablets 250mg
Cefuroxime Axetil Tablets 500mg
Cefuroxime Axetil Oral Suspension

Frequently Asked Questions

What generation of cephalosporin is Cefuroxime?

Cefuroxime is a second-generation cephalosporin, bridging the Gram-positive activity of first-generation agents with broader Gram-negative coverage. The axetil ester form gives it oral bioavailability.

What is Cefuroxime Axetil used for?

Cefuroxime Axetil is commonly used for respiratory tract infections, sinusitis, otitis media, and uncomplicated skin infections, making it a frequent outpatient respiratory and ENT antibiotic.

What forms of Cefuroxime does BioGalen manufacture?

BioGalen manufactures Cefuroxime Axetil as 250 mg and 500 mg tablets and as a paediatric suspension, under WHO-GMP with CTD and ACTD dossiers available.

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