Medical device manufacturing license certified and registrerd in 1996
ISO9001:2000 certified and registrerd in 2004
FDA/Health Canada DMF Type III (ampoule/vial) certified and registrerd in 2006
CDMF(China DMF) certified and registrerd in 2019
Third-Class Medical Devices Manufacturing Permit Sales certified and registrerd in 2008
Compatible with Pharmacopoeia of JP, USP, and EP
Registered under the Chiba SDGs Partner Registration Program (2024)
Certicifations
ISO9001
Registration No.:JSAQ2041- JapaneseCertificate of the registration
ISO9001
Registration No.:JSAQ2041 - EnglishAppendix to the certificate of the registration
Medical device manufacturing registration certificate
Registration No.:12BZ000289Certificate of the registration
Class III Medical Device Manufacture and Sale License
Registration No.:12B3X10003Certificate of the registration
Drug Master File USA
Registration No.:19895Certificate of the registration
Drug Master File Canada
Registration No.:2007-079Certificate of the registration
Drug Master File China
Registration No.:B20180003479Procedure for Confirmation of Registration