WHO-GMP Certified Commercial Pack · Product Code: AKP-100-DM
Dapagliflozin 10 mg & Metformin HCl 1000 mg ER Tablets
Formulation Overview: Once-daily insulin-independent SGLT2 inhibitor dapagliflozin 10 mg combined with extended-release metformin HCl (1000 mg) promoting urinary glucose excretion alongside hepatic gluconeogenesis suppression. Formulated with Dapagliflozin 10 mg + Metformin HCl 1000 mg (ER) (10 mg + 1000 mg (ER)) in Extended-Release Bilayer Tablets dosage form under Anti-Diabetic 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-100-DM |
|---|---|
| Catalog Reference | AKP-100 · SN 100 |
| Therapeutic Sector | Anti-Diabetic Medication |
| Dosage Form | Extended-Release Bilayer Tablets |
| Active Ingredient | Dapagliflozin 10 mg + Metformin HCl 1000 mg (ER) |
| Strength / Purity | 10 mg + 1000 mg (ER) |
| Clinical Indication | Type 2 diabetes mellitus glycemic control, cardiovascular-renal risk reduction, and weight-favorable glucose lowering |
| 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 |