SinoReg

Nobelpharma 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: 2027-09-27.

Approval numberProductCertificate expiresFiling line (Art. 82)
国药准字HJ20233148Sirolimus Gel
西罗莫司凝胶
2028-03-272027-09-27
国药准字HJ20240007Zinc Acetate Tablets
醋酸锌片
2029-02-052028-08-05
国药准字HJ20250083Melatonin Granules
褪黑素颗粒
2030-07-072030-01-07
国药准字HJ20250084Melatonin Granules
褪黑素颗粒
2030-07-072030-01-07

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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