H. Lundbeck A/S — China drug registrations and re-registration deadlines
11 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-01-28.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20170381 | Brintellix 氢溴酸伏硫西汀片 | 2027-07-28 | 2027-01-28 |
| 国药准字HJ20170382 | Brintellix 氢溴酸伏硫西汀片 | 2027-07-28 | 2027-01-28 |
| 国药准字HJ20170383 | Brintellix 氢溴酸伏硫西汀片 | 2027-07-28 | 2027-01-28 |
| 国药准字HJ20170384 | Brintellix 氢溴酸伏硫西汀片 | 2027-07-28 | 2027-01-28 |
| 国药准字HJ20202001 | Brintellix 氢溴酸伏硫西汀片 | 2027-07-28 | 2027-01-28 |
| 国药准字HJ20120268 | Ebixa 盐酸美金刚片 | 2027-12-15 | 2027-06-15 |
| 国药准字HJ20130372 | Ebixa 盐酸美金刚片 | 2027-12-15 | 2027-06-15 |
| 国药准字HJ20225001 | Ebixa 盐酸美金刚片 | 2027-12-15 | 2027-06-15 |
| 国药准字HJ20140121 | Lexapro 草酸艾司西酞普兰片 | 2028-08-01 | 2028-02-01 |
| 国药准字HJ20150161 | Lexapro 草酸艾司西酞普兰片 | 2029-02-28 | 2028-08-28 |
| 国药准字HJ20150163 | Lexapro 草酸艾司西酞普兰片 | 2029-02-28 | 2028-08-28 |
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.