Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Takeda Manufacturing Austria AG | Wien, Austria | Makes it, tests it, packages it and labels it | Not inspected on record |
| Takeda Manufacturing Singapore Pte. Ltd. | Singapore, Singapore | Makes the active ingredient and tests it | Not inspected on record |
| Bioreliance Ltd. | Glasgow Lanarkshire, United Kingdom | Tests it | Problems found, fixed voluntarilyMay 13, 2026 · 7 inspections |
| Charles River Laboratories Germany GmbH | Erkrath, Germany | Tests it | Problems found, fixed voluntarilyAug 20, 2025 · 5 inspections |
| OFI Technologie & Innovation GmbH | Vienna, Austria | Tests it | Problems found, fixed voluntarilyOct 3, 2018 · 1 inspection |
| SGS Lab Simon | Wavre (Bierges), Belgium | Tests it | Problems found, fixed voluntarilyMar 10, 2025 · 5 inspections |
| Shire Human Genetic Therapies, Inc. | North Reading, MA, United States | Tests it | No problems foundJan 5, 2017 · 4 inspections |
| Sigma-Aldrich Pte Ltd | Singapore, Singapore | Tests it | No problems foundAug 21, 2026 · 2 inspections |
| Takeda Manufacturing Austria AG | Orth an der Donau, Austria | Tests it | No problems foundApr 24, 2024 · 1 inspection |
Product details
- Generic drug
- Apadamtase Alfa: every company that makes it
- Form
- kit
- Strength
- 1500 [iU] per 1 [iU]
- Approval
- BLA BLA125795
- On the market since
- Nov 9, 2023
- Package NDCs
64764-135-0164764-145-0564764-515-50- Official label
- DailyMed (National Library of Medicine), updated Oct 30, 2026
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