WHO-GMP Certified Commercial Pack · Product Code: AKP-010
Montelukast Sodium 10mg & Levocetirizine Hydrochloride 5mg Tablets
Formulation Overview: Dual-pathway anti-allergic and anti-leukotriene film-coated tablet combining cysteinyl leukotriene receptor antagonism with H1 blockade to relieve nasal congestion, wheezing, and airway inflammation. Formulated with Montelukast Sodium IP 10 mg + Levocetirizine Hydrochloride IP 5 mg (10 mg + 5 mg) in Film-Coated Tablets dosage form under Respiratory & Allergy, 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-010 |
|---|---|
| Therapeutic Sector | Respiratory & Allergy |
| Dosage Form | Film-Coated Tablets |
| Active Ingredient | Montelukast Sodium IP 10 mg + Levocetirizine Hydrochloride IP 5 mg |
| Strength / Purity | 10 mg + 5 mg |
| Clinical Indication | Persistent allergic rhinitis, chronic bronchial asthma prophylaxis, and exercise-induced bronchospasm |
| 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 |