Orion Corporation — China drug registrations and re-registration deadlines
12 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-12-12.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20171148 | Stalevo 恩他卡朋双多巴片（Ⅱ） | 2027-06-12 | 2026-12-12 |
| 国药准字HJ20181001 | Stalevo 恩他卡朋双多巴片 | 2027-06-12 | 2026-12-12 |
| 国药准字HJ20181002 | Stalevo 恩他卡朋双多巴片（Ⅲ） | 2027-06-12 | 2026-12-12 |
| 国药准字HJ20181219 | Stalevo 恩他卡朋双多巴片（Ⅳ） | 2027-06-12 | 2026-12-12 |
| 国药准字HJ20171095 | Marevan 华法林钠片 | 2027-10-24 | 2027-04-24 |
| 国药准字HJ20130705 | Fareston 枸橼酸托瑞米芬片 | 2028-05-09 | 2027-11-09 |
| 国药准字HJ20130596 | Salbutamol Sulfate Inhalation Powder 硫酸沙丁胺醇吸入粉雾剂 | 2028-12-10 | 2028-06-10 |
| 国药准字HJ20160680 | Comtan 恩他卡朋片 | 2029-01-07 | 2028-07-07 |
| 国药准字HJ20140421 | Budesonide Inhalation Powder 布地奈德吸入粉雾剂 | 2029-07-22 | 2029-01-22 |
| 国药准字HJ20140422 | Budesonide Inhalation Powder 布地奈德吸入粉雾剂 | 2029-07-22 | 2029-01-22 |
| 国药准字HJ20160342 | Eldepryl 盐酸司来吉兰片 | 2030-07-03 | 2030-01-03 |
| 国药准字HJ20200028 | Levosimendan Injection 左西孟旦注射液 | 2030-07-23 | 2030-01-23 |
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.