| ●Medical device manufacturing license certified and registrerd in 1996 |
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| ●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 |
You can see the ISO, DMF, and other certifications below.
Certicifations
| ISO9001 | Registration No.:JSAQ2041- JapaneseCertificate of the registration |
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| 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 |