BIOTON S.A. — China registrations and re-registration filing lines
8 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest filing line: 2027-01-21.
| Approval number | Product | Certificate expires | Filing line (Art. 82) |
|---|---|---|---|
| 国药准字SJ20171027 | SciLin N 精蛋白人胰岛素注射液 | 2027-07-21 | 2027-01-21 |
| 国药准字SJ20171028 | SciLin N 精蛋白人胰岛素注射液 | 2027-07-21 | 2027-01-21 |
| 国药准字SJ20130098 | SciLin M30 精蛋白人胰岛素混合注射液（30R） | 2028-04-22 | 2027-10-22 |
| 国药准字SJ20130099 | SciLin M30 精蛋白人胰岛素混合注射液（30R） | 2028-04-22 | 2027-10-22 |
| 国药准字SJ20130106 | SciLin R 人胰岛素注射液 | 2028-07-10 | 2028-01-10 |
| 国药准字SJ20130107 | SciLin R 人胰岛素注射液 | 2028-07-10 | 2028-01-10 |
| 国药准字SJ20130108 | SciLin R 人胰岛素注射液 | 2028-07-10 | 2028-01-10 |
| 国药准字SJ20130109 | SciLin R 人胰岛素注射液 | 2028-07-10 | 2028-01-10 |
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.