|
Other Onco Product List,2023 |
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| Product code |
API name 原料药中文名称 |
CAS No. |
Indications and Usage 适应症 |
Specification | Regulatory Documentation | GMP STATUS | |||||
| Open Part | NMPA CDE Status | CEP | USDMF | DMF No. |
NMPA GMP |
International GMP | |||||
| 893 |
Bendamustine HCL Monohydrate 盐酸苯达莫司汀一水合物 |
1374784-02-7 |
Oncology 抗肿瘤 |
in-house | √ | A |
CDE#Y20180001674 JAPAN PMDA #303MF10041 |
√ | |||
| 807 |
Pemetrexed Disodium 2.5 Hydrate 培美曲塞二钠2.5水 |
357166-30-4 |
Oncology 抗肿瘤 |
USP、EP、CP | √ | I | CDE#Y20200001442 | ||||
| 806 |
Pemetrexed Disodium 7 Hydrate 培美曲塞二钠7水合物 |
357166-29-1 |
Oncology 抗肿瘤 |
EP, In-house | √ | ||||||
| 849 |
Gemcitabine HCL 盐酸吉西他滨 |
122111-03-9 |
Oncology 抗肿瘤 |
USP、EP、CP | √ | I | CDE#Y20210000720 | ||||
| 895 |
Decitabine 地西他滨 |
2353-33-5 |
Oncology 抗肿瘤 |
In-house | I | CDE#Y20220000704 | |||||
| 896 |
Azacitidine 阿扎胞苷 |
320-67-2 |
Oncology 抗肿瘤 |
USP、EP、CP | √ | I | CDE#Y20210000243 | √ | |||
| 899 |
Apalutamide 阿帕鲁胺 |
956104-40-8 |
Oncology 抗肿瘤 |
In-house | |||||||
