SinoReg

Sanofi Winthrop Industrie — China drug registrations and re-registration deadlines

52 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-09-20.

Approval numberProductCertificate expiresRe-registration deadline (Art. 82)
国药准字HJ20171182APROVEL
厄贝沙坦片
2027-03-202026-09-20
国药准字HJ20171184APROVEL
厄贝沙坦片
2027-03-202026-09-20
国药准字HJ20171185APROVEL
厄贝沙坦片
2027-03-202026-09-20
国药准字HJ20171186APROVEL
厄贝沙坦片
2027-03-202026-09-20
国药准字HJ20171187APROVEL
厄贝沙坦片
2027-03-202026-09-20
国药准字HJ20171237Plavix
硫酸氢氯吡格雷片
2027-05-052026-11-05
国药准字HJ20171238Plavix
硫酸氢氯吡格雷片
2027-05-052026-11-05
国药准字HJ20181237Stilnox
酒石酸唑吡坦片
2027-08-302027-02-28
国药准字HJ20181238Stilnox
酒石酸唑吡坦片
2027-08-302027-02-28
国药准字HJ20225004Cordarone
盐酸胺碘酮注射液
2027-11-142027-05-14
国药准字HJ20225005Cordarone
盐酸胺碘酮注射液
2027-11-142027-05-14
国药准字SJ20230002Insulin Glargine and Lixisenatide Injection(Ⅱ)
甘精胰岛素利司那肽注射液(Ⅱ)
2028-01-092027-07-09
国药准字HJ20140194COAPROVEL
厄贝沙坦氢氯噻嗪片
2028-01-112027-07-11
国药准字HJ20140195COAPROVEL
厄贝沙坦氢氯噻嗪片
2028-01-112027-07-11
国药准字HJ20140196COAPROVEL
厄贝沙坦氢氯噻嗪片
2028-01-112027-07-11
国药准字HJ20140197COAPROVEL
厄贝沙坦氢氯噻嗪片
2028-01-112027-07-11
国药准字HJ20171121Solian
氨磺必利片
2028-01-272027-07-27
国药准字HJ20171122Solian
氨磺必利片
2028-01-272027-07-27
国药准字HJ20140085TAXOTERE
多西他赛注射液
2028-03-282027-09-28
国药准字HJ20140086TAXOTERE
多西他赛注射液
2028-03-282027-09-28
国药准字HJ20170035Xatral XL
盐酸阿夫唑嗪缓释片
2028-04-102027-10-10
国药准字HJ20170036Xatral XL
盐酸阿夫唑嗪缓释片
2028-04-102027-10-10
国药准字SJ20180024Fasturtec
注射用拉布立海
2028-04-122027-10-12
国药准字SJ20181018Fasturtec
注射用拉布立海
2028-04-122027-10-12
国药准字HJ20140172Rilutek
利鲁唑片
2028-08-282028-02-28
国药准字HJ20140173Rilutek
利鲁唑片
2028-08-282028-02-28
国药准字HJ20170183Imovane
佐匹克隆片
2028-12-102028-06-10
国药准字HJ20171064Eloxatin
注射用奥沙利铂
2028-12-102028-06-10
国药准字HJ20171065Eloxatin
注射用奥沙利铂
2028-12-102028-06-10
国药准字SJ20230021Beyfortus
尼塞韦单抗注射液
2028-12-252028-06-25
国药准字SJ20230022Beyfortus
尼塞韦单抗注射液
2028-12-252028-06-25
国药准字SJ20190042Praluent
阿利西尤单抗注射液
2029-05-282028-11-28
国药准字SJ20190043Praluent
阿利西尤单抗注射液
2029-05-282028-11-28
国药准字HJ20170268Clexane
依诺肝素钠注射液
2029-05-292028-11-29
国药准字HJ20170269Clexane
依诺肝素钠注射液
2029-05-292028-11-29
国药准字HJ20170270Clexane
依诺肝素钠注射液
2029-05-292028-11-29
国药准字HJ20170271Clexane
依诺肝素钠注射液
2029-05-292028-11-29
国药准字HJ20170272Clexane
依诺肝素钠注射液
2029-05-292028-11-29
国药准字HJ20170273Clexane
依诺肝素钠注射液
2029-05-292028-11-29
国药准字HJ20170274Clexane
依诺肝素钠注射液
2029-05-292028-11-29
国药准字HJ20150256Plavix
硫酸氢氯吡格雷片
2029-12-122029-06-12
国药准字HJ20150257Plavix
硫酸氢氯吡格雷片
2029-12-122029-06-12
国药准字HJ20150258Plavix
硫酸氢氯吡格雷片
2029-12-122029-06-12
国药准字SJ20250001SARCLISA
艾沙妥昔单抗注射液
2030-01-072029-07-07
国药准字SJ20250002SARCLISA
艾沙妥昔单抗注射液
2030-01-072029-07-07
国药准字SJ20150033PENTAXIM
吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗
2030-01-082029-07-08
国药准字SJ20150034PENTAXIM
吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗
2030-01-082029-07-08
国药准字SJ20200017Dupixent
度普利尤单抗注射液
2030-01-232029-07-23
国药准字SJ20235004Dupixent
度普利尤单抗注射液
2030-01-232029-07-23
国药准字HJ20181050Cordarone
盐酸胺碘酮片
2030-02-252029-08-25
国药准字HJ20181243Cordarone
盐酸胺碘酮片
2030-02-252029-08-25
国药准字SJ20210024Dupixent
度普利尤单抗注射液
2031-01-292030-07-29

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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