SinoReg

Santen Pharmaceutical Co., Ltd. — China drug registrations and re-registration deadlines

14 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-12-27.

Approval numberProductCertificate expiresRe-registration deadline (Art. 82)
国药准字HJ20170378Diquafosol Sodium Eye Drops
地夸磷索钠滴眼液
2027-06-272026-12-27
国药准字HJ20181012Diquafosol Sodium Eye Drops
地夸磷索钠滴眼液
2027-06-272026-12-27
国药准字HJ20181108Alegysal
吡嘧司特钾滴眼液
2027-10-242027-04-24
国药准字HJ20181109Alegysal
吡嘧司特钾滴眼液
2027-10-242027-04-24
国药准字HJ20181090Flumetholon
氟米龙滴眼液
2027-11-032027-05-03
国药准字HJ20181091Flumetholon
氟米龙滴眼液
2027-11-032027-05-03
国药准字HJ20181092Flumetholon
氟米龙滴眼液
2027-11-032027-05-03
国药准字HJ20181093Flumetholon
氟米龙滴眼液
2027-11-032027-05-03
国药准字HJ20150071Kary Uni
吡诺克辛滴眼液
2029-06-262028-12-26
国药准字HJ20150072Kary Uni
吡诺克辛滴眼液
2029-06-262028-12-26
国药准字HJ20150390Vitamin B12 Eye Drops
维生素B12滴眼液
2029-07-222029-01-22
国药准字HJ20140386Tarivid
氧氟沙星滴眼液
2029-10-282029-04-28
国药准字HJ20150278Cravit
左氧氟沙星滴眼液
2029-10-282029-04-28
国药准字HJ20215002Benoxil
盐酸奥布卡因滴眼液
2030-07-272030-01-27

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.

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