WHO-GMP Certified Commercial Pack · Product Code: AKP-048
Ceftriaxone Sodium 1000mg & Sulbactam Sodium 500mg Injection
Formulation Overview: Full-strength 1.5 g critical-care injectable antibiotic vial protecting ceftriaxone against enzymatic hydrolysis by ESBL-producing gram-negative hospital pathogens. Formulated with Ceftriaxone Sodium USP (eq. 1000 mg) + Sulbactam Sodium USP (eq. 500 mg) (1000 mg + 500 mg (1.5 g)) in Sterile Dry Powder Injection Vial dosage form under Anti-Infectives & Antibiotics, manufactured to IP / BP / USP Compendial standards and supplied in 1.5 g USP Type I Glass Vial + 10 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-048 |
|---|---|
| Therapeutic Sector | Anti-Infectives & Antibiotics |
| Dosage Form | Sterile Dry Powder Injection Vial |
| Active Ingredient | Ceftriaxone Sodium USP (eq. 1000 mg) + Sulbactam Sodium USP (eq. 500 mg) |
| Strength / Purity | 1000 mg + 500 mg (1.5 g) |
| Clinical Indication | Severe nosocomial pneumonia, sepsis, bacterial meningitis, bone/joint infections, and surgical prophylaxis |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 1.5 g USP Type I Glass Vial + 10 ml Sterile WFI Ampoule |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; protect from light & moisture |
| 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 |