Peginterferon Alfa‑2a
| Product Overview | |
| Generic Name | Peginterferon Alfa‑2a |
| Brand Name(s) | Pegasys (Roche), Taspiance (Emcure), generics by Cipla, Emcure, etc |
| Form | 180 mcg/0.5 mL prefilled syringe / Vial liquid solution for injection |
| Strength | 180 µg/0.5 mL per dose |
| Therapeutic Class | Interferon alpha, immunomodulator |
| ATC Code | L03AB11 |
| Manufacturing & Regulatory | |
| Manufacturer | Roche, Cipla, Emcure, Zydus |
| Country | USA, Switzerland, India, Cuba |
| GMP Compliance | WHO‑GMP |
| DMF/CEP | Type II |
| COFEPRIS | 335M2006SSAIV, Officially registered; batch-level registration certificates required |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 20 vials |
| Shelf Life | 24 Months |
| Storage | 2–8 °C; protect from light; do not freeze |
| Incoterms | Ex-Works Mexico |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Provided by manufacturer/distributor |
| SDS | Immunomodulator handling-specific SDS available |
| CTD Summary | Summary CTD/BLA from Roche; generics have abridged dossiers – proprietary upon purchase |
Description
Indications & Usage: Long-acting interferon alfa‑2a indicated for chronic hepatitis C & B, and treatment of polycythemia vera / essential thrombocythemia.
*This molecule has been pulled from numerous global markets, there is no biosimilar or generic product available from our mfg/suppliers. (there is an Alpha 2b, but NO Alpha 2a generic).
