SinoReg

Bausch & Lomb Incorporated — China drug registrations and re-registration deadlines

7 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-09-28.

Approval numberProductCertificate expiresRe-registration deadline (Art. 82)
国药准字HJ20180059Loteprednol Etabonate Ophthalmic Suspension
氯替泼诺混悬滴眼液
2028-03-282027-09-28
国药准字HJ20191002Loteprednol Etabonate Ophthalmic Suspension
氯替泼诺混悬滴眼液
2028-03-282027-09-28
国药准字HJ20160349Loteprednol Etabonate and Tobramycin Eye Drops
氯替泼诺妥布霉素滴眼液
2029-10-282029-04-28
国药准字HJ20160350Loteprednol Etabonate and Tobramycin Eye Drops
氯替泼诺妥布霉素滴眼液
2029-10-282029-04-28
国药准字HJ20160346Lotemax
氯替泼诺混悬滴眼液
2029-11-032029-05-03
国药准字HJ20160347Lotemax
氯替泼诺混悬滴眼液
2029-11-032029-05-03
国药准字HJ20160348Lotemax
氯替泼诺混悬滴眼液
2029-11-032029-05-03

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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