anti-infectives
| no. | product name | specification | us dmf | eu dmf | cep | jp dmf | cde status |
|---|---|---|---|---|---|---|---|
| 1 | daptomycin 达托霉素 |
in house | ● | ● | a | ||
| in house | the document has been approved | apis that have been approved for use in finished dosage in china | |||||
| 2 | imipenem cilastatin sodium 亚胺培南 西司他丁钠 |
in house | a | ||||
| in house | apis that have been approved for use in finished dosage in china | ||||||
| 3 | isepamicin sulfate 硫酸异帕米星 |
jp, cp, in house | ● | a | |||
| jp, cp, in house | the document has been approved | apis that have been approved for use in finished dosage in china | |||||
| 4 | linezolid 利奈唑胺 |
usp, in house | ● | a | |||
| usp, in house | the document has been approved | apis that have been approved for use in finished dosage in china | |||||
| 5 | meropenem 美罗培南 |
usp, jp, cp | ● | a | |||
| usp, jp, cp | the document has been approved | apis that have been approved for use in finished dosage in china | |||||
| 6 | micafungin sodium 米卡芬净钠 |
in house | ● | a | |||
| in house | the document has been approved | apis that have been approved for use in finished dosage in china | |||||
| 7 | moxifloxacin hcl 盐酸莫西沙星 |
usp, ep, in house | ● | ● | a | ||
| usp, ep, in house | the document has been approved | the document has been approved | apis that have been approved for use in finished dosage in china | ||||
| 8 | posaconazole 泊沙康唑 |
in house | i | ||||
| in house | apis that have not been reviewed and approved together with finished dosage in china | ||||||
| 9 | rifamycin o 利福霉素o |
in house | |||||
| in house | |||||||
| 10 | tazobactam acid 他唑巴坦 |
usp, cp, jp, in house | ● | ● | |||
| usp, cp, jp, in house | the document has been approved | ||||||
| 11 | teicoplanin 替考拉宁 |
cp | a | ||||
| cp | apis that have been approved for use in finished dosage in china | ||||||
| 12 | tigecycline 替加环素 |
usp, ep, in house | ● | a | |||
| usp, ep, in house | the document has been approved | apis that have been approved for use in finished dosage in china | |||||
| 13 | ivermectin 伊维菌素 |
usp, ep, in house | ● | ● | ● | a | |
| usp, ep, in house | the document has been approved | the document has been approved | the document has been approved | apis that have been approved for use in finished dosage in china |