WHO-GMP Certified Commercial Pack · Product Code: AKP-058
Ondansetron HCl 2mg Injection (per ml)
Formulation Overview: Selective 5-HT3 serotonin receptor antagonist parenteral antiemetic acting at both chemoreceptor trigger zone and vagal nerve terminals for rapid surgical and emergency emesis arrest. Formulated with Ondansetron Hydrochloride IP (eq. Ondansetron 2 mg per ml) (2 mg / 1 ml (4 mg / 2 ml pack)) in Sterile Liquid Injection Ampoule dosage form under Gastroenterology & PPIs, manufactured to IP / BP / USP Compendial standards and supplied in 10 x 2 ml Clear USP Type I Glass Ampoules 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-058 |
|---|---|
| Therapeutic Sector | Gastroenterology & PPIs |
| Dosage Form | Sterile Liquid Injection Ampoule |
| Active Ingredient | Ondansetron Hydrochloride IP (eq. Ondansetron 2 mg per ml) |
| Strength / Purity | 2 mg / 1 ml (4 mg / 2 ml pack) |
| Clinical Indication | Post-operative nausea and vomiting (PONV), chemotherapy-induced emesis, and acute refractory gastroenteritis vomiting |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 10 x 2 ml Clear USP Type I Glass Ampoules |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; protect from light; do not freeze |
| 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 |