WHO-GMP Certified Commercial Pack · Product Code: AKP-051
Amikacin Sulphate 100mg Injection (per 2ml)
Formulation Overview: Ready-to-use neonatal/paediatric strength 100 mg/2 ml aminoglycoside sterile solution engineered with strict bacterial endotoxin limits for critical gram-negative infections. Formulated with Amikacin Sulphate IP (eq. Amikacin 100 mg per 2 ml) (100 mg / 2 ml) in Sterile Liquid Injection Vial / Ampoule dosage form under Anti-Infectives & Antibiotics, manufactured to IP / BP / USP Compendial standards and supplied in 2 ml Amber / Clear Glass Vial or Ampoule (Box of 5 / 10) 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-051 |
|---|---|
| Therapeutic Sector | Anti-Infectives & Antibiotics |
| Dosage Form | Sterile Liquid Injection Vial / Ampoule |
| Active Ingredient | Amikacin Sulphate IP (eq. Amikacin 100 mg per 2 ml) |
| Strength / Purity | 100 mg / 2 ml |
| Clinical Indication | Neonatal sepsis, paediatric serious gram-negative bacteremia, and gentamicin-resistant UTI |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 2 ml Amber / Clear Glass Vial or Ampoule (Box of 5 / 10) |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; protect from freezing |
| 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 |