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 |
