Human C1 Esterase Inhibitor
Where is Human C1-Esterase Inhibitor made?
2 companies sell it under their own name. Their labels name 4 factories in the United States, Germany, Austria and Italy.
United States 1Germany 1Austria 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. Cinryze500 [iU] per 5 mL · NDC 42227-081, 42227-083 | Baxalta Us Inc.Makes it and tests it | Los Angeles, CA, United States | Not inspected on record |
| Siegfried Hameln GmbHMakes it and tests it | Hameln, Germany | Problems found, fixed voluntarilyAug 2024 | |
| Takeda Manufacturing Austria AGMakes it, tests it, packages it and labels it | Wien, Austria | Not inspected on record | |
| Takeda Manufacturing Italia SPAMakes it and tests it | Cittaducale (Santa Rufina), Italy | Not inspected on record | |
| Csl HAEGARDAC1 Esterase Inhibitor Subcutaneous (Human), Berinert500 [iU] per 10 mL, 2000 [iU] per 4 mL, 3000 [iU] per 6 mL · NDC 63833-828, 63833-829, 63833-825 | The label doesn't name the factory. Plants this company names for other drugs | ||