Verteporfin 15mg
Product Overview
| Generic Name | Verteporfin 15mg |
| Brand Name(s) | VISUDYNE® (verteporfin) 15mg |
| Category | Ophthalmological |
| Form | Injection (solution) |
| Strength | Each reconstituted vial provides 7.5 mL solution containing 2 mg/mL of verteporfin |
| Therapeutic Class | Photosensitizer for photodynamic therapy |
| ATC Code | S01LA01 |
Manufacturing & Regulatory
| Manufacturer | CHEPLAPHARM |
| GMP Compliance | FDA cGMP (21 CFR 210/211) |
| DMF/CEP | DMFs exist; numbers undisclosed |
| COFEPRIS | 010.000.4415.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
Logistics & Export
| MOQ | institutional ordering is by case/vial count |
| Shelf Life | 24 Months |
| Storage | 20–25 °C (68–77 °F); protect from light. |
| Incoterms | Ex-Works USA |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Yes—lot-specific Certificate of Analysis |
| SDS-Safety Data Sheet (PDF) | SDS available |
| CTD Summary (PDF) | Yes (public summaries): EMA SmPC & EPAR provide CTD-style |
Special Notes
This is the generic version of "VISUDYNE" Available upon request of the manufacturer. Access is two week lead-time.
Verteporfin is a photosensitizer used with non-thermal 689 nm diode laser to treat predominantly classic subfoveal CNV due to AMD, pathologic myopia, or presumed ocular histoplasmosis. Dose: 6 mg/m² IV over 10 min, light applied 15 min after infusion start; patients must avoid bright light/sunlight for 5 days due to photosensitivity.