Fresenius Kabi Austria GmbH — China drug registrations and re-registration deadlines
25 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-03-01.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20181017 | Glamin 复方氨基酸(15)双肽(2)注射液 | 2027-09-01 | 2027-03-01 |
| 国药准字HJ20181018 | Glamin 复方氨基酸(15)双肽(2)注射液 | 2027-09-01 | 2027-03-01 |
| 国药准字HJ20181019 | Glamin 复方氨基酸(15)双肽(2)注射液 | 2027-09-01 | 2027-03-01 |
| 国药准字HJ20181020 | Glamin 复方氨基酸(15)双肽(2)注射液 | 2027-09-01 | 2027-03-01 |
| 国药准字HJ20230062 | Compound Amino Acid(16AA), Glucose(12.6%) and Electrolyte Injection 复方氨基酸（16AA）/葡萄糖（12.6%）电解质注射液 | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20230063 | Compound Amino Acid(16AA), Glucose(12.6%) and Electrolyte Injection 复方氨基酸（16AA）/葡萄糖（12.6%）电解质注射液 | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20230064 | Compound Amino Acid(16AA), Glucose(12.6%) and Electrolyte Injection 复方氨基酸（16AA）/葡萄糖（12.6%）电解质注射液 | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20170152 | Lactulose Oral Solution 乳果糖口服溶液 | 2028-06-08 | 2027-12-08 |
| 国药准字HJ20140949 | Omegaven ω-3鱼油脂肪乳注射液 | 2029-04-01 | 2028-10-01 |
| 国药准字HJ20140950 | Omegaven ω-3鱼油脂肪乳注射液 | 2029-04-01 | 2028-10-01 |
| 国药准字HJ20140951 | Omegaven ω-3鱼油脂肪乳注射液 | 2029-04-01 | 2028-10-01 |
| 国药准字HJ20140952 | Omegaven ω-3鱼油脂肪乳注射液 | 2029-04-01 | 2028-10-01 |
| 国药准字HJ20150558 | Dipeptiven 丙氨酰谷氨酰胺注射液 | 2029-09-28 | 2029-03-28 |
| 国药准字HJ20150559 | Dipeptiven 丙氨酰谷氨酰胺注射液 | 2029-09-28 | 2029-03-28 |
| 国药准字HJ20150560 | Dipeptiven 丙氨酰谷氨酰胺注射液 | 2029-09-28 | 2029-03-28 |
| 国药准字HJ20150561 | Dipeptiven 丙氨酰谷氨酰胺注射液 | 2029-09-28 | 2029-03-28 |
| 国药准字HJ20160469 | Laevolac 乳果糖口服溶液 | 2031-02-24 | 2030-08-24 |
| 国药准字HJ20160470 | Laevolac 乳果糖口服溶液 | 2031-02-24 | 2030-08-24 |
| 国药准字HJ20170248 | Laevolac 乳果糖口服溶液 | 2031-02-24 | 2030-08-24 |
| 国药准字HJ20170046 | ———— 多种油脂肪乳注射液（C6~24） | 2031-05-06 | 2030-11-06 |
| 国药准字HJ20170047 | Multi-oil Fat Emulsion Injection(C6~24) 多种油脂肪乳注射液（C6~24） | 2031-05-06 | 2030-11-06 |
| 国药准字HJ20170048 | Multi-oil Fat Emulsion Injection(C6~24) 多种油脂肪乳注射液（C6~24） | 2031-05-06 | 2030-11-06 |
| 国药准字HJ20170049 | Multi-oil Fat Emulsion Injection(C6~24) 多种油脂肪乳注射液（C6~24） | 2031-05-06 | 2030-11-06 |
| 国药准字HJ20170050 | Multi-oil Fat Emulsion Injection(C6~24) 多种油脂肪乳注射液（C6~24） | 2031-05-06 | 2030-11-06 |
| 国药准字HJ20170051 | Multi-oil Fat Emulsion Injection(C6~24) 多种油脂肪乳注射液（C6~24） | 2031-05-06 | 2030-11-06 |
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.