Company on the label
Astellas Pharma US, Inc.
10 prescription drugs on current FDA listings. Its labels name 11 plants.
Plants named on its labels
| Plant | Where | Role | Last FDA inspection |
|---|---|---|---|
| Astellas Pharma Inc. | Yaizu, Japan | Makes it and tests it | Problems found, fixed voluntarilyOct 2023 |
| Astellas Pharma Inc. | Takahagi, Japan | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJun 2025 |
| Sumitomo Chemical Company, Limited | Kurashiki, Japan | Makes the active ingredient | No problems foundNov 2023 |
| Astellas Ireland Co., Limited | Dublin, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJun 2022 |
| Juzen Chemical Corporation | Toyama-city, Japan | Makes the active ingredient and tests it | Problems found, fixed voluntarilyAug 2025 |
| Astellas Ireland Co., Ltd. | Killorglin, Ireland | Makes it and tests it | Problems found, fixed voluntarilySep 2022 |
| Astellas Pharma Inc. | Toyama, Japan | Makes it, makes the active ingredient and tests it | No problems foundApr 2024 |
| Fujimoto Chemicals Co., Ltd. | Izumiotsu, Japan | Makes the active ingredient | Problems found, fixed voluntarilyMay 2023 |
| AndersonBrecon Inc. | Rockford, IL, United States | Packages it and labels it | No problems foundAug 2026 |
| Delpharm Meppel B.V. | Meppel, Netherlands | Tests it | Problems found, fixed voluntarilyOct 2024 |
| J. Knipper and Company, Inc. | Charlestown, IN, United States | Packages it and labels it | Not inspected on record |
Drugs
- Amphotericin B 0469-3051
- Avacincaptad Pegol 82829-002
- Enzalutamide 0469-0125, 0469-0625, 0469-1125 +2
- Fezolinetant 0469-2660, 0469-2460, 0469-2760
- Gilteritinib 0469-1425
- Isavuconazole 0469-0520, 0469-2860, 0469-0420
- Mirabegron 0469-2601, 0469-2602, 0469-5020
- Regadenoson 0469-6501
- Tacrolimus 0469-1230, 0469-0607, 0469-0647 +6
- Zolbetuximab 0469-3425, 0469-4425