Kowa Company, Ltd. — China drug registrations and re-registration deadlines
12 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2028-02-28.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20130224 | VANTELINKOWA 吲哚美辛凝胶 | 2028-08-28 | 2028-02-28 |
| 国药准字HJ20250041 | PARMODIA 佩玛贝特片 | 2030-04-07 | 2029-10-07 |
| 国药准字HJ20140101 | Pitavastatin Calcium Tablets 匹伐他汀钙片 | 2030-08-12 | 2030-02-12 |
| 国药准字HJ20140416 | LIVALO KOWA 匹伐他汀钙片 | 2030-08-12 | 2030-02-12 |
| 国药准字HJ20140417 | LIVALO KOWA 匹伐他汀钙片 | 2030-08-12 | 2030-02-12 |
| 国药准字HJ20140937 | LIVALO KOWA 匹伐他汀钙片 | 2030-08-12 | 2030-02-12 |
| 国药准字HJ20181246 | Pitavastatin Calcium Tablets 匹伐他汀钙片 | 2030-08-12 | 2030-02-12 |
| 国药准字HJ20150427 | Calcium Polystyrene Sulfonate Powder 聚苯乙烯磺酸钙散剂 | 2030-09-16 | 2030-03-16 |
| 国药准字HJ20150428 | Calcium Polystyrene Sulfonate Powder 聚苯乙烯磺酸钙散剂 | 2030-09-16 | 2030-03-16 |
| 国药准字HJ20150442 | Calcium Polystyrene Sulfonate Powder 聚苯乙烯磺酸钙散剂 | 2030-09-16 | 2030-03-16 |
| 国药准字HJ20150443 | Calcium Polystyrene Sulfonate Powder 聚苯乙烯磺酸钙散剂 | 2030-09-16 | 2030-03-16 |
| 国药准字HJ20150628 | VANTELINKOWA 吲哚美辛搽剂 | 2031-05-10 | 2030-11-10 |
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.