Cefuroxime Axetil USP 500 mg Film-Coated Tablets
FlemmingCef™ 500 is a high-precision, broad-spectrum second-generation cephalosporin antibiotic. Manufactured in a dedicated contamination-free cephalosporin block equipped with positive pressure HEPA air handling systems.
| Active Ingredient (API) | Cefuroxime Axetil USP eq. to Cefuroxime 500 mg |
|---|---|
| Dosage Form | Film-Coated Tablet |
| Therapeutic Category | Anti-Infective / Cephalosporin Antibiotic |
| Packaging Standard | 10 x 1 x 10 Alu-Alu Blister Pack / Export Carton |
| Shelf Life | 36 Months (3 Years) |
| Dossier Availability | Ready CTD / eCTD Format |
FlemmingCef™ 500 is indicated for the treatment of acute bacterial sinusitis, acute otitis media, pharyngitis, tonsillitis, acute bacterial exacerbations of chronic bronchitis, and uncomplicated skin structure infections.
Formulated to match the innovator dissolution profile in multi-pH media (pH 1.2, pH 4.5, pH 6.8). Manufactured using USP-grade active pharmaceutical ingredients sourced from certified API partners.
Complete Module 1 to 5 CTD dossiers available with zone IVb stability data (30°C / 75% RH) ready for submission to MOH regulatory authorities in Latin America, Africa, and CIS countries.