Ipsen Pharma — China registrations and re-registration filing lines
10 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest filing line: 2027-11-15.
| Approval number | Product | Certificate expires | Filing line (Art. 82) |
|---|---|---|---|
| 国药准字HJ20130797 | Diphereline 注射用醋酸曲普瑞林 | 2028-05-15 | 2027-11-15 |
| 国药准字HJ20130842 | Triptorelin pamoate for injection 注射用双羟萘酸曲普瑞林 | 2028-05-15 | 2027-11-15 |
| 国药准字HJ20140298 | Diphereline 注射用醋酸曲普瑞林 | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20230075 | Triptorelin Pamoate for Injection 注射用双羟萘酸曲普瑞林 | 2028-06-20 | 2027-12-20 |
| 国药准字HJ20190058 | Lanreotide acetate sustained-release injection (a pre-filled syringe) 醋酸兰瑞肽缓释注射液（预充式） | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20190059 | Lanreotide acetate sustained-release injection (a pre-filled syringe) 醋酸兰瑞肽缓释注射液（预充式） | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20240145 | Bylvay 奥德昔巴特胶囊 | 2029-11-30 | 2029-05-30 |
| 国药准字HJ20240146 | Bylvay 奥德昔巴特胶囊 | 2029-11-30 | 2029-05-30 |
| 国药准字HJ20240147 | Bylvay 奥德昔巴特胶囊 | 2029-11-30 | 2029-05-30 |
| 国药准字HJ20240148 | Bylvay 奥德昔巴特胶囊 | 2029-11-30 | 2029-05-30 |
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.