Hetero Labs Limited — China drug registrations and re-registration deadlines
40 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-01-06.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20220063 | Oseltamivir Phosphate Capsules 磷酸奥司他韦胶囊 | 2027-07-06 | 2027-01-06 |
| 国药准字HJ20220064 | Oseltamivir Phosphate Capsules 磷酸奥司他韦胶囊 | 2027-07-06 | 2027-01-06 |
| 国药准字HJ20220065 | Oseltamivir Phosphate Capsules 磷酸奥司他韦胶囊 | 2027-07-06 | 2027-01-06 |
| 国药准字HJ20230002 | Valganciclovir Hydrochloride Tablets 盐酸缬更昔洛韦片 | 2028-01-18 | 2027-07-18 |
| 国药准字HJ20230096 | Lacosamide Oral Solution 拉考沙胺口服溶液 | 2028-07-31 | 2028-01-31 |
| 国药准字HJ20230133 | Pantoprazole Sodium Enteric-Coated Tablets 泮托拉唑钠肠溶片 | 2028-12-04 | 2028-06-04 |
| 国药准字HJ20230134 | Pantoprazole Sodium Enteric-Coated Tablets 泮托拉唑钠肠溶片 | 2028-12-04 | 2028-06-04 |
| 国药准字HJ20240028 | Levetiracetam Oral Solution 左乙拉西坦口服溶液 | 2029-05-27 | 2028-11-27 |
| 国药准字HJ20240029 | Levetiracetam Oral Solution 左乙拉西坦口服溶液 | 2029-05-27 | 2028-11-27 |
| 国药准字HJ20240068 | Escitalopram Oxalate Oral Solution 草酸艾司西酞普兰口服溶液 | 2029-06-27 | 2028-12-27 |
| 国药准字HJ20240092 | Duloxetine Hydrochloride Enteric Capsules 盐酸度洛西汀肠溶胶囊 | 2029-09-18 | 2029-03-18 |
| 国药准字HJ20240093 | Duloxetine Hydrochloride Enteric Capsules 盐酸度洛西汀肠溶胶囊 | 2029-09-18 | 2029-03-18 |
| 国药准字HJ20240095 | Letrozole Tablets 来曲唑片 | 2029-09-18 | 2029-03-18 |
| 国药准字HJ20240139 | Posaconazole Enteric-coated Tablets 泊沙康唑肠溶片 | 2029-11-30 | 2029-05-30 |
| 国药准字HJ20240154 | Dabigatran Etexilate Capsules 达比加群酯胶囊 | 2029-11-30 | 2029-05-30 |
| 国药准字HJ20240155 | Dabigatran Etexilate Capsules 达比加群酯胶囊 | 2029-11-30 | 2029-05-30 |
| 国药准字HJ20240156 | Dabigatran Etexilate Capsules 达比加群酯胶囊 | 2029-11-30 | 2029-05-30 |
| 国药准字HJ20250002 | Clobazam Tablets 氯巴占片 | 2030-01-01 | 2029-07-01 |
| 国药准字HJ20250003 | Clobazam Tablets 氯巴占片 | 2030-01-01 | 2029-07-01 |
| 国药准字HJ20250013 | Tadalafil Tablets 他达拉非片 | 2030-01-23 | 2029-07-23 |
| 国药准字HJ20250014 | Tadalafil Tablets 他达拉非片 | 2030-01-23 | 2029-07-23 |
| 国药准字HJ20250015 | Tadalafil Tablets 他达拉非片 | 2030-01-23 | 2029-07-23 |
| 国药准字HJ20250023 | Voriconazole for Oral Suspension 伏立康唑干混悬剂 | 2030-03-03 | 2029-09-03 |
| 国药准字HJ20250029 | Dapagliflozin Tablets 达格列净片 | 2030-03-17 | 2029-09-17 |
| 国药准字HJ20250030 | Dapagliflozin Tablets 达格列净片 | 2030-03-17 | 2029-09-17 |
| 国药准字HJ20250069 | Lansoprazole Enteric Capsules 兰索拉唑肠溶胶囊 | 2030-06-09 | 2029-12-09 |
| 国药准字HJ20250074 | Montelukast Sodium Tablets 孟鲁司特钠片 | 2030-06-23 | 2029-12-23 |
| 国药准字HJ20250093 | Sildenafil Citrate Tablets 枸橼酸西地那非片 | 2030-08-18 | 2030-02-18 |
| 国药准字HJ20250094 | Sildenafil Citrate Tablets 枸橼酸西地那非片 | 2030-08-18 | 2030-02-18 |
| 国药准字HJ20250095 | Sildenafil Citrate Tablets 枸橼酸西地那非片 | 2030-08-18 | 2030-02-18 |
| 国药准字HJ20250096 | Sildenafil Citrate Tablets 枸橼酸西地那非片 | 2030-08-18 | 2030-02-18 |
| 国药准字HJ20250116 | Atorvastatin Calcium Tablets 阿托伐他汀钙片 | 2030-09-22 | 2030-03-22 |
| 国药准字HJ20250140 | Irbesartan Tablets 厄贝沙坦片 | 2030-12-02 | 2030-06-02 |
| 国药准字HJ20250141 | Irbesartan Tablets 厄贝沙坦片 | 2030-12-02 | 2030-06-02 |
| 国药准字HJ20250142 | Irbesartan Tablets 厄贝沙坦片 | 2030-12-02 | 2030-06-02 |
| 国药准字HJ20260023 | Dolutegravir Sodium Tablets 多替拉韦钠片 | 2031-02-09 | 2030-08-09 |
| 国药准字HJ20260025 | Ritonavir Tablets 利托那韦片 | 2031-03-09 | 2030-09-09 |
| 国药准字HJ20260030 | Lopinavir and Ritonavir Tablets 洛匹那韦利托那韦片 | 2031-03-30 | 2030-09-30 |
| 国药准字HJ20260031 | Lopinavir and Ritonavir Tablets 洛匹那韦利托那韦片 | 2031-03-30 | 2030-09-30 |
| 国药准字HJ20260034 | Ezetimibe Tablets 依折麦布片 | 2031-04-13 | 2030-10-13 |
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.