WHO-GMP Certified Commercial Pack · Product Code: AKP-016
Cinitapride 3mg (Sustained Release) & Pantoprazole Sodium (eq. Pantoprazole 40mg) Capsules
Formulation Overview: 5-HT4 receptor agonist prokinetic and proton pump inhibitor capsule engineered to stimulate acetylcholine-mediated GI peristalsis while suppressing 24-hour gastric acid secretion. Formulated with Cinitapride Hydrogen Tartrate 3 mg (SR) + Pantoprazole Sodium (eq. 40 mg EC) (3 mg (SR) + 40 mg) in Sustained-Release Pellet Capsules dosage form under Gastroenterology & PPIs, manufactured to IP / BP / USP Compendial standards and supplied in 10 x 10 Alu-Alu Blister Pack 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-016 |
|---|---|
| Therapeutic Sector | Gastroenterology & PPIs |
| Dosage Form | Sustained-Release Pellet Capsules |
| Active Ingredient | Cinitapride Hydrogen Tartrate 3 mg (SR) + Pantoprazole Sodium (eq. 40 mg EC) |
| Strength / Purity | 3 mg (SR) + 40 mg |
| Clinical Indication | Motility-associated GERD, delayed gastric emptying, and non-ulcer functional dyspepsia |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 10 x 10 Alu-Alu Blister Pack |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C, protect from moisture & direct sunlight |
| 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 |