Mylan Laboratories Limited — China registrations and re-registration filing lines
7 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest filing line: 2028-04-17.
| Approval number | Product | Certificate expires | Filing line (Art. 82) |
|---|---|---|---|
| 国药准字HJ20230116 | Lanthanum Carbonate Chewable Tablets 碳酸镧咀嚼片 | 2028-10-17 | 2028-04-17 |
| 国药准字HJ20240099 | Pantoprazole Sodium Enteric-Coated Tablets 泮托拉唑钠肠溶片 | 2029-09-18 | 2029-03-18 |
| 国药准字HJ20250011 | Desloratadine Tablets 地氯雷他定片 | 2030-01-13 | 2029-07-13 |
| 国药准字HJ20250028 | Mycophenolate Sodium Enteric-coated Tablets 麦考酚钠肠溶片 | 2030-03-10 | 2029-09-10 |
| 国药准字HJ20250044 | Mirtazapine Tablets 米氮平片 | 2030-04-14 | 2029-10-14 |
| 国药准字HJ20250045 | Mirtazapine Tablets 米氮平片 | 2030-04-14 | 2029-10-14 |
| 国药准字HJ20250098 | Mycophenolate Mofetil Capsules 吗替麦考酚酯胶囊 | 2030-08-18 | 2030-02-18 |
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.