WHO-GMP Certified Commercial Pack · Product Code: AKP-045
Ceftriaxone Sodium 250mg & Sulbactam Sodium 125mg Injection
Formulation Overview: 2:1 ratio cephalosporin and beta-lactamase inhibitor sterile vial restoring bactericidal efficacy against resistant pediatric and low-body-weight clinical isolates. Formulated with Ceftriaxone Sodium IP (eq. 250 mg) + Sulbactam Sodium IP (eq. 125 mg) (250 mg + 125 mg (375 mg)) in Sterile Dry Powder Injection Vial dosage form under Anti-Infectives & Antibiotics, manufactured to IP / BP / USP Compendial standards and supplied in 375 mg USP Type I Glass Vial + 5 ml Sterile WFI Ampoule with complete eCTD/ACTD regulatory dossiers, Zone IVb stability, and batch CoA for African NRAs (NAFDAC, PPB, SAHPRA, TMDA, FDA Ghana) and global tenders.
| Item Code (SKU) | AKP-045 |
|---|---|
| Therapeutic Sector | Anti-Infectives & Antibiotics |
| Dosage Form | Sterile Dry Powder Injection Vial |
| Active Ingredient | Ceftriaxone Sodium IP (eq. 250 mg) + Sulbactam Sodium IP (eq. 125 mg) |
| Strength / Purity | 250 mg + 125 mg (375 mg) |
| Clinical Indication | Paediatric beta-lactamase producing bacterial pneumonia, skin/soft tissue infection, and UTI |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 375 mg USP Type I Glass Vial + 5 ml Sterile WFI Ampoule |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; protect from light |
| Minimum Order Quantity | 1000 Packs |
| Regulatory / Analytical Docs | Full eCTD / ACTD Modules 1–5 + Zone IVb Stability Available |
| African & Global NRA Readiness | NAFDAC (Nigeria), PPB (Kenya), SAHPRA (SA), TMDA (Tanzania), FDA Ghana, AIRP, ARP, EFDA |
| Stock Availability | In Stock · Immediate Commercial Dispatch |
| Supply Status | Commercial Export Ready |