WHO-GMP Certified Commercial Pack · Product Code: AKP-066
Moxifloxacin 0.5% & Ketorolac Tromethamine 0.5% Eye Drops
Formulation Overview: Steroid-free antibiotic and ocular NSAID eye drop controlling post-surgical ocular pain and prostaglandin inflammation without elevating intraocular pressure. Formulated with Moxifloxacin Hydrochloride 0.5% w/v + Ketorolac Tromethamine IP 0.5% w/v (0.5% + 0.5% w/v) in Sterile Ophthalmic Combination 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-066 |
|---|---|
| Therapeutic Sector | Ophthalmic & Otic Care |
| Dosage Form | Sterile Ophthalmic Combination Drops |
| Active Ingredient | Moxifloxacin Hydrochloride 0.5% w/v + Ketorolac Tromethamine IP 0.5% w/v |
| Strength / Purity | 0.5% + 0.5% w/v |
| Clinical Indication | Post-cataract ocular inflammation/pain prophylaxis, seasonal allergic conjunctivitis with secondary bacterial infection |
| 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 within 30 days of opening |
| 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 |