SinoReg

ODOMZO / 奥昔朵

国药准字HJ20210061 · 胶囊剂

Re-registration deadline: 2030-12-15

The certificate expires 2031-06-15. Under the Provisions for Drug Registration (药品注册管理办法) Art. 82, an application to renew is filed no later than 6 months before expiry.

Approval number (批准文号)国药准字HJ20210061
Generic name (通用名)Sonidegib Phosphate Capsules
磷酸索立德吉胶囊
Marketing Authorisation Holder (上市许可持有人)Sun Pharmaceutical Industries Limited
India
Certificate valid until (有效期至)2031-06-15
Re-registration deadline, Art. 82 (法定申报时限)2030-12-15
Data as of (数据快照日)2026-09-10
Check another product →

Every figure above is taken from the public NMPA overseas-drug database (境外生产药品库) as of 2026-09-10, or computed from it under Art. 82. Registration data changes; the NMPA portal governs. This page states no view on whether this product’s Domestic Responsible Person (境内责任人) arrangement meets NMPA Announcement No. 137 — that cannot be determined from a single public entry.