About Us
Product Certification System
Product certification system
Domestic Certification
Varieties | Certified Country | Certificate No. |
Enoxaparin sodium | China NMPA | JS20160527 |
Dalteparin sodium | China NMPA | JS20160592 |
Nadroparin calcium | China NMPA | JS20191027 |
Small volume injection (non-terminally sterilized), lyophilized powder for injection (including antineoplastic agents), tablets, hard capsules | China NMPA | JS20160588 |
Small volume injection (prefilled injection) | China NMPA | JS20160586 |
Small volume injection (collinear with non-terminally sterilized) | China NMPA | JS20180846 |
Heparin sodium, heparin calcium, chondroitin sulfate sodium, chondroitin sulfate (for injection), asparaginase (Escherichia), kallidinogenase, elastase, pancreatin | China NMPA | JS20180845 |
Foreign Certification
Varieties | Certified Country | Certificate No. |
Heparin sodium | EU EDQM | R1-CEP 2002-012-Rev 04 |
Heparin sodium | US FDA | Confirmation Letter |
Heparin sodium, asparaginase | Indian National Drug Standard Control Organization (CDSCO) | BD-1144 |
Heparin sodium | Germany BGV | DE_HH_01_GMP_2018_0012 |
Dalteparin sodium | Japan PMDA | AG10500049 |
Heparin sodium | Australia TGA | MI-2009-CE-05442-3 |
Heparin sodium | BrazilANVISA | 3.437，DE 29 DE DEZEMBRO DE 2017 |
Heparin sodium | Korea KFDA | 20090409117 |
Heparin sodiuminjection | Philippines FDA | 3720 |
Product Certification System
Product certification system
Domestic Certification
Varieties | Certified Country | Certificate No. |
Enoxaparin sodium | China NMPA | JS20160527 |
Dalteparin sodium | China NMPA | JS20160592 |
Nadroparin calcium | China NMPA | JS20191027 |
Small volume injection (non-terminally sterilized), lyophilized powder for injection (including antineoplastic agents), tablets, hard capsules | China NMPA | JS20160588 |
Small volume injection (prefilled injection) | China NMPA | JS20160586 |
Small volume injection (collinear with non-terminally sterilized) | China NMPA | JS20180846 |
Heparin sodium, heparin calcium, chondroitin sulfate sodium, chondroitin sulfate (for injection), asparaginase (Escherichia), kallidinogenase, elastase, pancreatin | China NMPA | JS20180845 |
Foreign Certification
Varieties | Certified Country | Certificate No. |
Heparin sodium | EU EDQM | R1-CEP 2002-012-Rev 04 |
Heparin sodium | US FDA | Confirmation Letter |
Heparin sodium, asparaginase | Indian National Drug Standard Control Organization (CDSCO) | BD-1144 |
Heparin sodium | Germany BGV | DE_HH_01_GMP_2018_0012 |
Dalteparin sodium | Japan PMDA | AG10500049 |
Heparin sodium | Australia TGA | MI-2009-CE-05442-3 |
Heparin sodium | BrazilANVISA | 3.437，DE 29 DE DEZEMBRO DE 2017 |
Heparin sodium | Korea KFDA | 20090409117 |
Heparin sodiuminjection | Philippines FDA | 3720 |
