WHO-GMP Certified Commercial Pack · Product Code: AKP-070
Moxifloxacin 0.5% & Dexamethasone Sodium 0.1% Eye Drops
Formulation Overview: Synergistic fourth-generation fluoroquinolone and potent corticosteroid ophthalmic solution preventing secondary bacterial colonization during acute ocular inflammatory recovery. Formulated with Moxifloxacin Hydrochloride 0.5% w/v + Dexamethasone Sodium Phosphate IP 0.1% w/v (0.5% + 0.1% w/v) in Sterile Antibiotic-Steroid Eye Drops dosage form under Ophthalmic & Otic Care, manufactured to IP / BP / USP Compendial standards and supplied in 5 ml Sterile Opaque LDPE Dropper Bottle with Carton 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-070 |
|---|---|
| Therapeutic Sector | Ophthalmic & Otic Care |
| Dosage Form | Sterile Antibiotic-Steroid Eye Drops |
| Active Ingredient | Moxifloxacin Hydrochloride 0.5% w/v + Dexamethasone Sodium Phosphate IP 0.1% w/v |
| Strength / Purity | 0.5% + 0.1% w/v |
| Clinical Indication | Post-operative cataract/ocular inflammation, steroid-responsive anterior uveitis, and severe bacterial blepharoconjunctivitis |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 5 ml Sterile Opaque LDPE Dropper Bottle with Carton |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; protect from light; use strictly under ophthalmic supervision |
| 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 |