Dr. Reddy’s Laboratories Limited — China drug registrations and re-registration deadlines
9 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-11-25.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20230057 | Fulvestrant Injection 氟维司群注射液 | 2028-05-25 | 2027-11-25 |
| 国药准字HJ20230097 | Pregabalin Capsules 普瑞巴林胶囊 | 2028-07-31 | 2028-01-31 |
| 国药准字HJ20230098 | Pregabalin Capsules 普瑞巴林胶囊 | 2028-07-31 | 2028-01-31 |
| 国药准字HJ20240088 | Levetiracetam Tablets 左乙拉西坦片 | 2029-09-02 | 2029-03-02 |
| 国药准字HJ20240089 | Levetiracetam Tablets 左乙拉西坦片 | 2029-09-02 | 2029-03-02 |
| 国药准字HJ20240157 | Sunitinib Malate Capsules 苹果酸舒尼替尼胶囊 | 2029-11-30 | 2029-05-30 |
| 国药准字HJ20250001 | Bosentan Tablets 波生坦片 | 2030-01-01 | 2029-07-01 |
| 国药准字HJ20250115 | Lansoprazole Orally Disintegrating Tablets 兰索拉唑口崩片 | 2030-09-22 | 2030-03-22 |
| 国药准字HJ20250156 | Fingolimod Hydrochloride Capsules 盐酸芬戈莫德胶囊 | 2030-12-29 | 2030-06-29 |
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.