Baxter Deutschland GmbH — China drug registrations and re-registration deadlines
5 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2028-04-29.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20140099 | Holoxan 注射用异环磷酰胺 | 2028-10-29 | 2028-04-29 |
| 国药准字HJ20160239 | UROMITEXAN 美司钠注射液 | 2030-12-29 | 2030-06-29 |
| 国药准字HJ20260019 | Cyclophosphamide Tablets 环磷酰胺片 | 2031-01-26 | 2030-07-26 |
| 国药准字HJ20160467 | Endoxan 注射用环磷酰胺 | 2031-03-13 | 2030-09-13 |
| 国药准字HJ20160468 | Endoxan 注射用环磷酰胺 | 2031-03-13 | 2030-09-13 |
Under the Provisions for Drug Registration (药品注册管理办法) Art. 82, an application to renew an overseas-manufactured drug registration is filed with the Center for Drug Evaluation no later than 6 months before the certificate expires; the filing line column is that arithmetic applied to the expiry cell. Art. 84(1): a certificate with no application by expiry is not re-registered and is cancelled at expiry. Every figure is taken from the public NMPA database as of 2026-06-28, or computed from it. Registration data changes; the NMPA portal governs. This page states no view on whether any of these products' Domestic Responsible Person (境内责任人) arrangements meet NMPA Announcement No. 137 — that cannot be determined from a public entry.