WHO-GMP Certified Commercial Pack · Product Code: AKP-036
Magaldrate 400mg, Simethicone 20mg & Oxetacaine 10mg Oral Suspension (per 5ml)
Formulation Overview: Topical mucosal anaesthetic-fortified antacid suspension providing instant local numbing relief from acute gastric burning while neutralizing acid and eliminating entrapped gas. Formulated with Magaldrate IP 400 mg + Simethicone IP 20 mg + Oxetacaine BP 10 mg (400 mg + 20 mg + 10 mg / 5 ml) in Oral Antacid & Anaesthetic Suspension dosage form under Gastroenterology & PPIs, manufactured to IP / BP / USP Compendial standards and supplied in 170 ml / 200 ml Amber PET Bottle with Dosing 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-036 |
|---|---|
| Therapeutic Sector | Gastroenterology & PPIs |
| Dosage Form | Oral Antacid & Anaesthetic Suspension |
| Active Ingredient | Magaldrate IP 400 mg + Simethicone IP 20 mg + Oxetacaine BP 10 mg |
| Strength / Purity | 400 mg + 20 mg + 10 mg / 5 ml |
| Clinical Indication | Severe painful esophagitis, acute gastritis, peptic ulcer pain, and reflux-induced throat burn |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 170 ml / 200 ml Amber PET Bottle with Dosing Cap |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; shake well before use; 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 |