Verteporfin 15mg
| Product Overview | |
| Generic Name | Verteporfin 15mg |
| Brand Name(s) | VISUDYNE ®(verteporfin) 15mg |
| 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 |
| Country | Germany & USA |
| GMP Compliance | FDA cGMP (21 CFR 210/211) |
| DMF/CEP | DMFs exist; numbers undisclosed |
| COFEPRIS | Registro Sanitario: 507M2000 SSA |
| Free Sale Certificate | available upon request via FDA CDER systems. |
| 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 Mexico |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes—lot-specific Certificate of Analysis |
| SDS | SDS available |
| CTD Summary | Yes (public summaries): EMA SmPC & EPAR provide CTD-style |
Description
Available on a per manufacturer’s permission upon request of moleue/product the manufacturer has to approve the request (they have changed their distribution model from the way it use to be)
If supplier is allowed access to product it’s a two week lead-time.
Visudyne (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.
