NDC 42227-081
Cinryze 500 [iU] per 5 mL injection, powder, lyophilized, for solution
On the label: Takeda Pharmaceuticals America, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxalta Us Inc. | Los Angeles, CA, United States | Makes it and tests it | Not inspected on record |
| Siegfried Hameln GmbH | Hameln, Germany | Makes it and tests it | Problems found, fixed voluntarilyAug 29, 2024 · 7 inspections, 1 with FDA action |
| Takeda Manufacturing Austria AG | Wien, Austria | Makes it, tests it, packages it and labels it | Not inspected on record |
| Takeda Manufacturing Italia SPA | Cittaducale (Santa Rufina), Italy | Makes it and tests it | Not inspected on record |
| Prothya Biosolutions Belgium | Bruxelles, Belgium | Tests it | Not inspected on record |
| Prothya Biosolutions Netherlands B.V. | Amsterdam, Netherlands | Tests it | Not inspected on record |
| Takeda Manufacturing Austria AG | Orth an der Donau, Austria | Tests it | No problems foundApr 24, 2024 · 1 inspection |
Product details
- Generic drug
- Human C1-Esterase Inhibitor: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 500 [iU] per 5 mL
- Approval
- BLA BLA125267
- On the market since
- Dec 1, 2008
- Package NDCs
42227-081-01- Official label
- DailyMed (National Library of Medicine), updated Nov 28, 2025
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