Peginterferon Beta‑1a
Product Overview
| Generic Name | Peginterferon Beta‑1a |
| Brand Name(s) | Plegridy |
| Category | Immuno Therapies |
| 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 |
| 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 Available Upon Request
| Certificate of Analysis (PDF) | Yes, Upon Request |
| SDS-Safety Data Sheet (PDF) | Yes – includes immunomodulator handling protocol and safety sections for injectable use |
| CTD Summary (PDF) | full CTD proprietary and accessible under NDA/licensing |
Special Notes
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