| Potential API Product List | |||||||||||
| 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 | |||||
| 809 |
Imatinib Mesylate (α form）
甲磺酸伊马替尼（α 晶型）
|
220127-57-1 |
Oncology
抗肿瘤
|
In-house | √ | ||||||
|
Imatinib Mesylate (β form）
甲磺酸伊马替尼（β 晶型）
|
Oncology
抗肿瘤
|
In-house | √ | I | √ | CDE: Y20190021319 | √ | ||||
| 725 |
Pazopanib Hydrochloride
盐酸培唑帕尼
|
635702-64-6 |
Oncology
抗肿瘤
|
VB | |||||||
| / |
Ibrutinib
伊布替尼
|
936563-96-1 |
Oncology
抗肿瘤
|
VB | |||||||
| 849 |
Gemcitabine Hydrochloride
盐酸吉西他滨
|
122111-03-9 |
Oncology
抗肿瘤
|
USP、EP、CP | √ | CDE: Y20210000720 | |||||
| 801 |
Letrozole
来曲唑
|
112809-51-5 |
Oncology
抗肿瘤
|
USP、EP、CP | √ | I | CDE: Y20170000758 | ||||
| 869 |
Irinotecan Hydrochloride
盐酸伊立替康
|
136572-09-3 |
Oncology
抗肿瘤
|
In-house | I | CDE: Y20220000229 | |||||
| 703 |
Zoledronic acid
唑来膦酸
|
118072-93-8 |
Oncology
抗肿瘤
|
USP、EP、CP | √ | I | CDE: Y20210000867 | ||||
| 892 |
Cytarabine
阿糖胞苷
|
69-74-9 |
Oncology
抗肿瘤
|
In-house | √ | I | CDE: Y20210000591 | ||||
| 894 |
Fluorouracil
氟尿嘧啶
|
51-21-8 |
Oncology
抗肿瘤
|
USP、CP | √ | I | CDE: Y20210000605 | ||||
| 701 |
Milrinone
米力农
|
78415-72-2 |
Cardiovascular
心血管
|
USP、EP、CP | √ | I | CDE: Y20210000579 | ||||
| 708 |
Nicorandil
尼可地尔
|
65141-46-0 |
Vasodilatory
血管扩张
|
In-house | |||||||
| / |
Minoxidil
米诺地尔
|
38304-91-5 |
Minoxidil
米诺地尔
|
VB | |||||||
| 706 |
Diquafosol Sodium
地夸磷索钠
|
211427-08-6 |
dry eye
干眼症
|
In-house | √ | I | CDE: Y20220000228 | ||||
| 714 |
Granisetron
格拉司琼
|
109889-09-0 |
Antiemetic
止吐剂
|
In-house | |||||||
| 870 |
Tropisetron hydrochloride
盐酸托烷司琼
|
89565-68-4 |
Antiemetic
止吐剂
|
||||||||
| 713 |
Topiroxostat
托吡司特
|
577778-58-6 |
Anti-gout
抗痛风
|
VB | |||||||
| 716 |
Methocarbamol
美索巴莫
|
532-03-6 |
Muscle
relaxants
肌肉松弛
|
In-house | |||||||
| 717 |
Eperisone Hydrochloride
盐酸乙哌立松
|
56839-43-1 |
Muscle
relaxants
肌肉松弛
|
In-house | |||||||
| / |
Tofacitinib
托法替尼
|
477600-75-2 |
Anti-rheumatic
agent
抗风湿
|
VB | |||||||
| 702 |
Sodium Hyposulfite
硫代硫酸钠
|
7772-98-7 |
Antidote of
cyanide
氰化物的解毒
剂
|
CP | √ | I | CDE: Y20210001144 | ||||
| 705 |
Acetylcysteine
乙酰半胱氨酸
|
616-91-1 |
Mucolytic agent
黏液溶解剂
|
In-house | √ | I | CDE: Y20210001183 | ||||
| 707 |
3-butylphthalide
丁苯酞
|
6066-49-5 |
Anti-cerebral-
ischemia
抗脑缺血
|
In-house | √ | I | CDE: Y20220000401 | ||||
