N.V. Organon — China drug registrations and re-registration deadlines
42 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-09-20.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20171161 | ZOCOR 辛伐他汀片 | 2027-03-20 | 2026-09-20 |
| 国药准字HJ20171162 | ZOCOR 辛伐他汀片 | 2027-03-20 | 2026-09-20 |
| 国药准字HJ20181026 | Arcoxia 依托考昔片 | 2027-09-22 | 2027-03-22 |
| 国药准字HJ20181027 | Arcoxia 依托考昔片 | 2027-09-22 | 2027-03-22 |
| 国药准字HJ20181028 | Arcoxia 依托考昔片 | 2027-09-22 | 2027-03-22 |
| 国药准字HJ20181029 | Arcoxia 依托考昔片 | 2027-09-22 | 2027-03-22 |
| 国药准字HJ20181030 | Arcoxia 依托考昔片 | 2027-09-22 | 2027-03-22 |
| 国药准字HJ20181031 | Arcoxia 依托考昔片 | 2027-09-22 | 2027-03-22 |
| 国药准字HJ20181032 | Arcoxia 依托考昔片 | 2027-09-22 | 2027-03-22 |
| 国药准字HJ20181033 | Arcoxia 依托考昔片 | 2027-09-22 | 2027-03-22 |
| 国药准字HJ20181100 | ZOCOR 辛伐他汀片 | 2027-10-24 | 2027-04-24 |
| 国药准字HJ20181101 | ZOCOR 辛伐他汀片 | 2027-10-24 | 2027-04-24 |
| 国药准字HJ20181187 | Singulair 孟鲁司特钠片 | 2027-11-03 | 2027-05-03 |
| 国药准字HJ20181188 | Singulair 孟鲁司特钠片 | 2027-11-03 | 2027-05-03 |
| 国药准字HJ20181208 | Singulair 孟鲁司特钠咀嚼片 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20181209 | Singulair 孟鲁司特钠咀嚼片 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20181210 | Singulair 孟鲁司特钠咀嚼片 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20181211 | Singulair 孟鲁司特钠咀嚼片 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20181220 | Alendronate Sodium and Vitamin D3 Tablets 阿仑膦酸钠维D3片 | 2028-01-18 | 2027-07-18 |
| 国药准字HJ20181221 | Alendronate Sodium and Vitamin D3 Tablets 阿仑膦酸钠维D3片 | 2028-01-18 | 2027-07-18 |
| 国药准字HJ20181222 | Alendronate Sodium and Vitamin D3 Tablets 阿仑膦酸钠维D3片 | 2028-01-18 | 2027-07-18 |
| 国药准字HJ20160574 | ORGALUTRAN 醋酸加尼瑞克注射液 | 2028-03-15 | 2027-09-15 |
| 国药准字HJ20170277 | VYTORIN 依折麦布辛伐他汀片 | 2028-05-03 | 2027-11-03 |
| 国药准字HJ20170278 | VYTORIN 依折麦布辛伐他汀片 | 2028-05-03 | 2027-11-03 |
| 国药准字HJ20170282 | VYTORIN 依折麦布辛伐他汀片 | 2028-05-03 | 2027-11-03 |
| 国药准字HJ20140450 | AERIUS 地氯雷他定片 | 2028-07-03 | 2028-01-03 |
| 国药准字HJ20140451 | AERIUS 地氯雷他定片 | 2028-07-03 | 2028-01-03 |
| 国药准字HJ20130884 | IMPLANON 依托孕烯植入剂 | 2028-07-18 | 2028-01-18 |
| 国药准字HJ20150109 | Alendronate Sodium and Vitamin D3 Tablets 阿仑膦酸钠维D3片（II） | 2028-07-23 | 2028-01-23 |
| 国药准字HJ20150467 | Alendronate Sodium and Vitamin D3 Tablets 阿仑膦酸钠维D3片（II） | 2028-07-23 | 2028-01-23 |
| 国药准字HJ20160100 | Fosamax 阿仑膦酸钠片 | 2028-07-31 | 2028-01-31 |
| 国药准字HJ20160101 | Fosamax 阿仑膦酸钠片 | 2028-07-31 | 2028-01-31 |
| 国药准字HJ20230109 | Ezetimibe and Atorvastatin Calcium Tablets（Ⅰ） 依折麦布阿托伐他汀钙片（Ⅰ） | 2028-09-11 | 2028-03-11 |
| 国药准字HJ20230110 | Ezetimibe and Atorvastatin Calcium Tablets（Ⅱ） 依折麦布阿托伐他汀钙片（Ⅱ） | 2028-09-11 | 2028-03-11 |
| 国药准字HJ20140031 | REMERON 米氮平片 | 2028-11-29 | 2028-05-29 |
| 国药准字HJ20150540 | REMERON 米氮平片 | 2028-11-29 | 2028-05-29 |
| 国药准字HJ20160676 | Mirtazapine Orally Disintegrating Tablets 米氮平口崩片 | 2028-12-17 | 2028-06-17 |
| 国药准字HJ20160677 | Mirtazapine Orally Disintegrating Tablets 米氮平口崩片 | 2028-12-17 | 2028-06-17 |
| 国药准字HJ20160688 | Mirtazapine Orally Disintegrating Tablets 米氮平口崩片 | 2028-12-17 | 2028-06-17 |
| 国药准字SJ20150065 | PUREGON 重组促卵泡素β注射液 | 2029-08-20 | 2029-02-20 |
| 国药准字SJ20150066 | PUREGON 重组促卵泡素β注射液 | 2029-08-20 | 2029-02-20 |
| 国药准字HJ20171176 | Marvelon 去氧孕烯炔雌醇片 | 2031-05-19 | 2030-11-19 |
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.