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.
 
				