SinoReg

LTL Pharma Co., Ltd. — China registrations and re-registration filing lines

4 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest filing line: 2026-09-29.

Approval numberProductCertificate expiresFiling line (Art. 82)
国药准字HJ20171006Perdipine
盐酸尼卡地平注射液
2027-03-292026-09-29
国药准字HJ20160518Cefzon
头孢地尼胶囊
2028-07-232028-01-23
国药准字HJ20160519Cefzon
头孢地尼胶囊
2028-07-232028-01-23
国药准字HJ20160520Cefzon
头孢地尼胶囊
2028-07-232028-01-23

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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