Drug factory · FDA FEI 3012897823
Changzhou SynTheAll Pharmaceutical Co., Ltd.
No.589, North Yulong Road, Xinbei District, Changzhou, China
No problems found at FDA's last inspection, Mar 7, 2025.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2019: 2 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abiraterone and Niraparib | Makes it, makes the active ingredient and tests it | Janssen Biotech, Inc. | 57894-050, 57894-100 |
| Sonrotoclax | Makes the active ingredient and tests it | BeOne Medicines USA, Inc. | 72579-015, 72579-017, 72579-020 +2 |
| Tovorafenib | Makes the active ingredient | Day One Biopharmaceuticals, Inc. | 82950-001, 82950-012 |
| Vadadustat | Makes the active ingredient and tests it | Akebia Therapeutics, Inc. | 59922-641, 59922-642, 59922-643 |
| Zanubrutinib | Makes the active ingredient and tests it | BeOne Medicines USA, Inc. | 72579-011, 72579-122 |
| Ziftomenib | Makes the active ingredient and tests it | Kura Oncology, Inc. | 84696-200 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 7, 2025 | No problems found | Drug Quality Assurance | — |
| Jul 19, 2019 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.