NDC 59353-405
Mircera 200 ug per 0.3 mL injection, solution
On the label: Vifor (International) Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| F. Hoffmann-La Roche AG | Kaiseraugst, Switzerland | Makes it and tests it | Problems found, fixed voluntarilyMar 21, 2025 · 8 inspections |
| Roche Diagnostics GmbH | Mannheim, Germany | Makes it and tests it | Problems found, fixed voluntarilyOct 29, 2021 · 5 inspections |
| Roche Diagnostics GmbH | Penzberg, Germany | Makes the active ingredient | Problems found, fixed voluntarilyMay 22, 2025 · 6 inspections |
Product details
- Generic drug
- Methoxy Polyethylene Glycol-Epoetin Beta: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 200 ug per 0.3 mL
- Approval
- BLA BLA125164
- On the market since
- Oct 24, 2014
- Package NDCs
59353-405-09- Official label
- DailyMed (National Library of Medicine), updated Aug 14, 2026
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