Gland Pharma Limited — 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: 2027-08-06.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20233122 | Dexrazoxane for Injection 注射用右雷佐生 | 2028-02-06 | 2027-08-06 |
| 国药准字HJ20230140 | Zoledronic Acid Injection 唑来膦酸注射液 | 2028-12-04 | 2028-06-04 |
| 国药准字HJ20240011 | Zoledronic Acid Concentrated Solution for Injection 注射用唑来膦酸浓溶液 | 2029-04-23 | 2028-10-23 |
| 国药准字HJ20240017 | Ondansetron Hydrochloride Injection 盐酸昂丹司琼注射液 | 2029-04-29 | 2028-10-29 |
| 国药准字HJ20250071 | Caspofungin Acetate for Injection 注射用醋酸卡泊芬净 | 2030-06-16 | 2029-12-16 |
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.