Hanmi Pharm. Co.,Ltd. — China drug registrations and re-registration deadlines
7 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2028-05-23.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20140135 | Aceclofenac Tablets 醋氯芬酸片 | 2028-11-23 | 2028-05-23 |
| 国药准字HJ20140136 | Aceclofenac Tablets 醋氯芬酸片 | 2028-11-23 | 2028-05-23 |
| 国药准字HJ20140137 | Aceclofenac Tablets 醋氯芬酸片 | 2028-11-23 | 2028-05-23 |
| 国药准字HJ20190041 | Ambroxol Hydrochloride Solution for Inhalation 吸入用盐酸氨溴索溶液 | 2029-05-28 | 2028-11-28 |
| 国药准字HJ20191018 | Ambroxol Hydrochloride Solution for Inhalation 吸入用盐酸氨溴索溶液 | 2029-05-28 | 2028-11-28 |
| 国药准字HJ20140724 | Mujonal 盐酸特比萘芬喷雾剂 | 2029-12-12 | 2029-06-12 |
| 国药准字HJ20140725 | Mujonal 盐酸特比萘芬喷雾剂 | 2029-12-12 | 2029-06-12 |
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.