Luye Pharma Limited — China registrations and re-registration filing lines
11 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest filing line: 2027-08-13.
| Approval number | Product | Certificate expires | Filing line (Art. 82) |
|---|---|---|---|
| 国药准字HJ20130733 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20130734 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20130735 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20130736 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20130738 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20130739 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20130740 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20130741 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20130885 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20130886 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20130887 | Quetiapine Fumarate Extended-Release Tablets 富马酸喹硫平缓释片 | 2028-02-13 | 2027-08-13 |
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.