Sun Pharmaceutical Industries Ltd. — 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: 2027-12-06.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20230068 | Letrozole Tablets 来曲唑片 | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20150070 | Nutrex 头孢克洛干混悬剂 | 2029-01-14 | 2028-07-14 |
| 国药准字HJ20240070 | Fulvestrant Injection 氟维司群注射液 | 2029-07-08 | 2029-01-08 |
| 国药准字HJ20140908 | Octride 醋酸奥曲肽注射液 | 2029-09-29 | 2029-03-29 |
| 国药准字HJ20260024 | Temozolomide Capsules 替莫唑胺胶囊 | 2031-03-02 | 2030-09-02 |
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.