WHO-GMP Certified Commercial Pack · Product Code: AKP-078
Oxymetazoline HCl 0.01% w/v Nasal Spray
Formulation Overview: Ultra-mild 0.01% neonatal sympathomimetic nasal formulation engineered for delicate infant nasal mucosa to restore effortless breathing before feeds. Formulated with Oxymetazoline Hydrochloride USP / IP 0.01% w/v (0.01% w/v) in Neonatal / Infant Nasal Spray / Drops dosage form under Respiratory & Allergy, manufactured to IP / BP / USP Compendial standards and supplied in 10 ml Dropper-Controlled Squeeze Bottle with Safety Cap 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-078 |
|---|---|
| Therapeutic Sector | Respiratory & Allergy |
| Dosage Form | Neonatal / Infant Nasal Spray / Drops |
| Active Ingredient | Oxymetazoline Hydrochloride USP / IP 0.01% w/v |
| Strength / Purity | 0.01% w/v |
| Clinical Indication | Neonatal and infant nasal blockage interfering with feeding and breathing |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 10 ml Dropper-Controlled Squeeze Bottle with Safety Cap |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; keep upright; short-term paediatric use under medical supervision |
| 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 |