Oncology
| No. | Product Name | Specification | US DMF | EU DMF | CEP | JP DMF | CDE Status |
|---|---|---|---|---|---|---|---|
| 1 | Anastrozole 阿那曲唑 |
USP, CP | ● | A | |||
| USP, CP | The document has been approved | APIs that have been approved for use in finished dosage in China | |||||
| 2 | Ansamitocin 安沙菌素（AP3） |
In house | |||||
| In house | |||||||
| 3 | Bicalutamide 比卡鲁胺 |
USP, EP, YBH | ● | A | |||
| USP, EP, YBH | The document has been approved | APIs that have been approved for use in finished dosage in China | |||||
| 4 | Bleomycin HCl 盐酸博来霉素 |
YBH | A | ||||
| YBH | APIs that have been approved for use in finished dosage in China | ||||||
| 5 | Bleomycin Sulfate 硫酸博来霉素 |
USP, EP, IP, In house | ● | ● | |||
| USP, EP, IP, In house | The document has been approved | The document has been approved | |||||
| 6 | Cladribine 克拉屈滨 |
USP, EP, YBH | ● | A | |||
| USP, EP, YBH | The document has been approved | APIs that have been approved for use in finished dosage in China | |||||
| 7 | Cyclophosphamide 环磷酰胺 |
USP, EP, CP | ● | A | |||
| USP, EP, CP | The document has been approved | APIs that have been approved for use in finished dosage in China | |||||
| 8 | Cytarabine 阿糖胞苷 |
USP, EP | ● | ||||
| USP, EP | The document has been approved | ||||||
| 9 | Dactinomycin 放线菌素D |
USP, CP | ● | A | |||
| USP, CP | The document has been approved | APIs that have been approved for use in finished dosage in China | |||||
| 10 | Daunorubicin HCl 盐酸柔红霉素 |
USP, EP, CP | ● | ● | A | ||
| USP, EP, CP | The document has been approved | The document has been approved | APIs that have been approved for use in finished dosage in China | ||||
| 11 | Doxorubicin HCl 盐酸多柔比星 |
USP, EP, CP, JP | ● | ● | ● | A | |
| USP, EP, CP, JP | 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 | |||
| 12 | Epirubicin HCl 盐酸表柔比星 |
USP, EP, CP | ● | ● | A | ||
| USP, EP, CP | The document has been approved | APIs that have been approved for use in finished dosage in China | |||||
| 13 | Fludarabine Phosphate 磷酸氟达拉滨 |
USP, EP, CP | ● | A | |||
| USP, EP, CP | The document has been approved | APIs that have been approved for use in finished dosage in China | |||||
| 14 | Idarubicin HCl 盐酸伊达比星 |
USP, EP,CP | ● | A | |||
| USP, EP,CP | The document has been approved | APIs that have been approved for use in finished dosage in China | |||||
| 15 | Letrozole 来曲唑 |
USP, EP, CP | ● | A | |||
| USP, EP, CP | The document has been approved | APIs that have been approved for use in finished dosage in China | |||||
| 16 | Mesna 美司那 |
USP | ● | ||||
| USP | The document has been approved | ||||||
| 17 | Mitomycin 丝裂霉素 |
USP, EP, CP | ● | ● | A | ||
| USP, EP, CP | The document has been approved | The document has been approved | APIs that have been approved for use in finished dosage in China | ||||
| 18 | Pirarubicin 吡柔比星 |
YBH | A | ||||
| YBH | APIs that have been approved for use in finished dosage in China | ||||||
| 19 | Cytarabine Hydrochloride 盐酸阿糖胞苷 |
CP | A | ||||
| CP | APIs that have been approved for use in finished dosage in China |
