Dr. Reddy's Laboratories Limited — China drug registrations and re-registration deadlines
19 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-10-03.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20233149 | Sitagliptin Phosphate Tablets 磷酸西格列汀片 | 2028-04-03 | 2027-10-03 |
| 国药准字HJ20233150 | Sitagliptin Phosphate Tablets 磷酸西格列汀片 | 2028-04-03 | 2027-10-03 |
| 国药准字HJ20233151 | Sitagliptin Phosphate Tablets 磷酸西格列汀片 | 2028-04-03 | 2027-10-03 |
| 国药准字HJ20230043 | Carboprost Tromethamine Injection 卡前列素氨丁三醇注射液 | 2028-04-27 | 2027-10-27 |
| 国药准字HJ20180074 | Clopidogrel Bisulfate Tablets 硫酸氢氯吡格雷片 | 2028-07-06 | 2028-01-06 |
| 国药准字HJ20230104 | Lurasidone Hydrochloride Tablets 盐酸鲁拉西酮片 | 2028-09-04 | 2028-03-04 |
| 国药准字HJ20230131 | Tetrabenazine Tablets 丁苯那嗪片 | 2028-11-27 | 2028-05-27 |
| 国药准字HJ20240085 | Dasatinib Tablets 达沙替尼片 | 2029-08-19 | 2029-02-19 |
| 国药准字HJ20240086 | Dasatinib Tablets 达沙替尼片 | 2029-08-19 | 2029-02-19 |
| 国药准字HJ20240114 | Erlotinib Hydrochloride Tablets 盐酸厄洛替尼片 | 2029-10-21 | 2029-04-21 |
| 国药准字HJ20240115 | Erlotinib Hydrochloride Tablets 盐酸厄洛替尼片 | 2029-10-21 | 2029-04-21 |
| 国药准字HJ20150141 | Olanzapine Tablets 奥氮平片 | 2029-10-28 | 2029-04-28 |
| 国药准字HJ20150142 | Olanzapine Tablets 奥氮平片 | 2029-10-28 | 2029-04-28 |
| 国药准字HJ20240126 | Enzalutamide Soft Capsules 恩扎卢胺软胶囊 | 2029-10-28 | 2029-04-28 |
| 国药准字HJ20250067 | Nilotinib Capsules 尼洛替尼胶囊 | 2030-06-02 | 2029-12-02 |
| 国药准字HJ20250068 | Nilotinib Capsules 尼洛替尼胶囊 | 2030-06-02 | 2029-12-02 |
| 国药准字HJ20260009 | Dabigatran Etexilate Capsules 达比加群酯胶囊 | 2031-01-13 | 2030-07-13 |
| 国药准字HJ20260010 | Dabigatran Etexilate Capsules 达比加群酯胶囊 | 2031-01-13 | 2030-07-13 |
| 国药准字HJ20210014 | Abiraterone Acetate Tablets 醋酸阿比特龙片 | 2031-01-18 | 2030-07-18 |
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.