WHO-GMP Certified Commercial Pack · Product Code: AKP-343
Silodosin 8 mg & Dutasteride 0.5 mg Tablets
Formulation Overview: Combined uroselective alpha-1A adrenoceptor blocker silodosin 8 mg and 5-alpha-reductase inhibitor dutasteride 0.5 mg tablet providing immediate urinary flow relief while progressively shrinking prostate volume. Formulated with Silodosin 8 mg + Dutasteride 0.5 mg (8 mg + 0.5 mg) in Film-Coated Tablets dosage form under Sexual Wellness Medication, 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-343 |
|---|---|
| Catalog Reference | AKP-343 · SN 343 |
| Therapeutic Sector | Sexual Wellness Medication |
| Dosage Form | Film-Coated Tablets |
| Active Ingredient | Silodosin 8 mg + Dutasteride 0.5 mg |
| Strength / Purity | 8 mg + 0.5 mg |
| Clinical Indication | Moderate-to-severe benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) |
| 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 in a dry place, protect from light and moisture |
| 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 |