WHO-GMP Certified Commercial Pack · Product Code: AKP-046
Ceftriaxone Sodium 500mg & Sulbactam Sodium 250mg Injection
Formulation Overview: Mid-dose sterile 2:1 ceftriaxone-sulbactam dry powder injection formulated for intermediate IM/IV escalation therapy in hospital outpatient and inpatient wards. Formulated with Ceftriaxone Sodium IP (eq. 500 mg) + Sulbactam Sodium IP (eq. 250 mg) (500 mg + 250 mg (750 mg)) in Sterile Dry Powder Injection Vial dosage form under Anti-Infectives & Antibiotics, manufactured to IP / BP / USP Compendial standards and supplied in 750 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-046 |
|---|---|
| Therapeutic Sector | Anti-Infectives & Antibiotics |
| Dosage Form | Sterile Dry Powder Injection Vial |
| Active Ingredient | Ceftriaxone Sodium IP (eq. 500 mg) + Sulbactam Sodium IP (eq. 250 mg) |
| Strength / Purity | 500 mg + 250 mg (750 mg) |
| Clinical Indication | Beta-lactamase-producing respiratory infections, complicated UTIs, and gynecological sepsis |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 750 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 |