WHO-GMP Certified Commercial Pack · Product Code: AKP-063
Ofloxacin 0.3% w/v Eye/Ear Drops
Formulation Overview: Dual-utility sterile fluoroquinolone ophthalmic and otic solution buffered to physiological tear/ear pH for broad coverage against Staphylococcus, Streptococcus, and Pseudomonas. Formulated with Ofloxacin IP 0.3% w/v (0.3% w/v) in Sterile Ophthalmic / Otic Drops dosage form under Ophthalmic & Otic Care, manufactured to IP / BP / USP Compendial standards and supplied in 5 ml / 10 ml Sterile FFS LDPE Dropper Vial 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-063 |
|---|---|
| Therapeutic Sector | Ophthalmic & Otic Care |
| Dosage Form | Sterile Ophthalmic / Otic Drops |
| Active Ingredient | Ofloxacin IP 0.3% w/v |
| Strength / Purity | 0.3% w/v |
| Clinical Indication | Bacterial conjunctivitis, keratitis, acute otitis externa, and chronic suppurative otitis media |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 5 ml / 10 ml Sterile FFS LDPE Dropper Vial 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 |