Human alpha-1 Proteinase Inhibitor
Where is .alpha.1-Proteinase Inhibitor Human made?
4 companies sell it under their own name. Their labels name 10 factories in the United States, Austria, Spain and Belgium.
United States 5Austria 3Spain 1Belgium 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. Glassia, AralastNP1 g per 50 mL, 16 mg per 1 mL · NDC 0944-2884, 0944-2814, 0944-2815 | Baxalta Belgium Manufacturing SAMakes it, makes the active ingredient, tests it, packages it and labels it | Lessines, Belgium | Problems found, fixed voluntarilyJun 2013 |
| Baxalta Us Inc.Makes the active ingredient | Los Angeles, CA, United States | Not inspected on record | |
| Takeda Manufacturing Austria AGMakes it, tests it, packages it and labels it | Wien, Austria | Not inspected on record | |
| Takeda Manufacturing Austria AGMakes it | Wien, Austria | Not inspected on record | |
| Takeda Manufacturing Austria AGMakes it | Wien, Austria | Not inspected on record | |
| Grifols Usa, LLC Prolastin-C Liquid, Prolastin-C1000 mg per 20 mL · NDC 13533-705, 13533-700, 13533-703 | Grifols Biologicals LLCMakes it | Los Angeles, CA, United States | Not inspected on record |
| Grifols Therapeutics LLCMakes it | Clayton, NC, United States | Not inspected on record | |
| Instituto Grifols, S.A.Makes it | Parets Del Valles, Spain | Not inspected on record | |
| CSL Behring Zemaira1000 mg per 20 mL, 4000 mg per 76 mL, 5000 mg per 95 mL · NDC 0053-7201, 0053-7202, 0053-7203 | CSL Behring L.L.C.Makes it | Bradley, IL, United States | Problems found, fixed voluntarilyJul 2014 |
| Fisher Clinical Services Inc. Zemaira1000 mg per 20 mL, 4000 mg per 76 mL, 5000 mg per 95 mL · NDC 57516-101, 57516-110, 57516-113 | Fisher Clinical Services Inc.Makes it, packages it and labels it | Allentown, PA, United States | No problems foundMay 2026 |