NDC 42227-083

Cinryze 500 [iU] per 5 mL kit

On the label: Takeda Pharmaceuticals America, Inc..

United States: 1Germany: 1Austria: 1Italy: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Baxalta Us Inc.Los Angeles, CA, United StatesMakes it and tests it Not inspected on record
Siegfried Hameln GmbHHameln, GermanyMakes it and tests it Problems found, fixed voluntarilyAug 29, 2024 · 7 inspections, 1 with FDA action
Takeda Manufacturing Austria AGWien, AustriaMakes it, tests it, packages it and labels it Not inspected on record
Takeda Manufacturing Italia SPACittaducale (Santa Rufina), ItalyMakes it and tests it Not inspected on record
Prothya Biosolutions BelgiumBruxelles, BelgiumTests it Not inspected on record
Prothya Biosolutions Netherlands B.V.Amsterdam, NetherlandsTests it Not inspected on record
Takeda Manufacturing Austria AGOrth an der Donau, AustriaTests it No problems foundApr 24, 2024 · 1 inspection

Product details

Generic drug
Human C1-Esterase Inhibitor: every company that makes it
Form
kit
Strength
500 [iU] per 5 mL
Approval
BLA BLA125267
On the market since
Jan 15, 2021
Package NDCs
42227-081-01 42227-083-01 64764-515-50
Official label
DailyMed (National Library of Medicine), updated Nov 28, 2025

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