SinoReg

Pfizer Inc. — China registrations and re-registration filing lines

15 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest filing line: 2026-10-07.

Approval numberProductCertificate expiresFiling line (Art. 82)
国药准字HJ20220029CIBINQO
阿布昔替尼片
2027-04-072026-10-07
国药准字HJ20220030CIBINQO
阿布昔替尼片
2027-04-072026-10-07
国药准字HJ20220031CIBINQO
阿布昔替尼片
2027-04-072026-10-07
国药准字HJ20130830Zithromax
注射用阿奇霉素
2028-07-032028-01-03
国药准字HJ20130831Zithromax
注射用阿奇霉素
2028-07-032028-01-03
国药准字HJ20140685Zithromax
注射用阿奇霉素
2028-07-032028-01-03
国药准字HJ20230118LITFULO
甲苯磺酸利特昔替尼胶囊
2028-10-172028-04-17
国药准字HJ20240004NURTEC
硫酸瑞美吉泮口崩片
2029-01-222028-07-22
国药准字HJ20150360Glucotrol XL
格列吡嗪控释片
2029-10-132029-04-13
国药准字HJ20150361Glucotrol XL
格列吡嗪控释片
2029-10-132029-04-13
国药准字HJ20160139Glucotrol XL
格列吡嗪控释片
2029-10-132029-04-13
国药准字HJ20160140Glucotrol XL
格列吡嗪控释片
2029-10-132029-04-13
国药准字SJ20250010ELREXFIO
埃纳妥单抗注射液
2030-03-032029-09-03
国药准字SJ20250011ELREXFIO
埃纳妥单抗注射液
2030-03-032029-09-03
国药准字HJ20210071Tofacitinib Citrate Sustained-release Tablets
枸橼酸托法替布缓释片
2031-05-052030-11-05

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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