Peginterferon Beta‑1a
| Product Overview | |
| Generic Name | Peginterferon Beta‑1a |
| Brand Name(s) | Plegridy |
| Form | Subcutaneous/intramuscular Injection; |
| Strength | 125 µg per 0.5 mL dose |
| Therapeutic Class | Interferon beta, immunostimulant |
| ATC Code | L03AB11 |
| Manufacturing & Regulatory | |
| Manufacturer | Biogen (originator); Eisai Pharma India |
| Country | USA, Switzerland, India, UK |
| GMP Compliance | WHO-GMP compliance |
| DMF/CEP | Type II DMF |
| COFEPRIS | Registered in Mexico |
| Free Sale Certificate | can provide upon request |
| Logistics & Export | |
| MOQ | 24 vials |
| Shelf Life | 24 Months |
| Storage | 2–8 °C; protect from light; do not freeze, allow warming to room temperature before administration |
| Incoterms | FOB / CIF / DDP standard |
| Lead Time | 2 Weeks |
| Documentation | |
| Certificate of Analysis (COA) | Yes, Upon Request |
| SDS | Yes – includes immunomodulator handling protocol and safety sections for injectable use |
| CTD Summary | full CTD proprietary and accessible under NDA/licensing |
Description
Indications & Usage: Indicated for relapsing forms of multiple sclerosis (relapsing‑remitting, clinically isolated syndrome, and active secondary progressive MS) with every‑2‑week dosing regime to reduce relapse frequency and delay disability progression
