Amifostine
| Product Overview |
| Generic Name | Amifostine |
| Brand Name(s) | Ethyol (Clinigen) |
| Form | Powder for intravenous injection (tri-hydrate/API) |
| Strength | 500 mg |
| Therapeutic Class | Radioprotective/chemoprotective adjuvant |
| ATC Code | V03AF05 |
| Manufacturing & Regulatory |
| Manufacturer | Clinigen, Sun Pharma, Albemarle, LGM Pharma |
| Country | UK/India/USA/China |
| GMP Compliance | cGMP / WHO‑GMP |
| DMF/CEP | USDMF active |
| COFEPRIS | Pending |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export |
| MOQ | 10 Vials |
| Shelf Life | 24 months |
| Storage | Refrigerate at 2 – 8 °C; hygroscopic powder, store under inert atmosphere |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation |
| Certificate of Analysis (COA) | Provided per batch |
| SDS | Upon Request |
| CTD Summary | Upon Request |
Description
Indications & Usage: Amifostine is a prodrug hydrolyzed by alkaline phosphatase to active metabolite WR‑1065. It’s indicated to reduce nephrotoxicity from cisplatin and radiation‑induced xerostomia in head/neck cancer. Typical dosing: 500 mg IV prior to platinum chemotherapy.
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