Non-Onco API 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 | Tech Pack | CMC | NMPA CDE Status | CEP | USDMF | DMF No. |
NMPA GMP |
International GMP | |||||
719 |
Relugolix 瑞卢戈利 |
737789-87-6 |
Gonadotropins
促激素类
|
in-house | |||||||||
722 |
Relugolix
瑞卢戈利
|
906673-24-3 |
dermatitis or eczema
皮肤湿疹
|
VB | |||||||||
724 |
Lanthanum carbonate
碳酸镧
|
6487-39-4 |
高磷酸盐血症
Hyperphosphatemia
|
RD | |||||||||
709 |
Brivaracetam
布立西坦
|
357336-20-0 |
epilepsy
抗癫痫
|
in-house | |||||||||
711 |
Avatrombopag Meleate
马来酸阿伐曲波帕
|
677007-74-8 |
Thrombocytope
提升血小板
|
In-house | I | CED#Y20220000791 | |||||||
720 |
Eltrombopag Olamine
艾曲波帕乙醇胺
|
496775-62-3 |
Thrombocytope
提升血小板
|
VB | |||||||||
715 |
Vonoprazan Fumarate
富马酸伏诺拉生
|
1260141-27-2 |
Reflux esophagitis
反流性食管炎
|
In-house | |||||||||
721 |
Baricitinib
巴瑞替尼
|
1187594-09-7 |
Anti-rheumatic agent
抗风湿,严重斑秃
|
In-house | |||||||||
528 |
Tenofovir Alafenamide Fumarate
富马酸丙分替诺福韦
|
1392275-56-7 |
Anti-virus
抗病毒
|
In-house | √ | A | √ | CED#Y20200000983 | |||||
709 |
Brivaracetam 布立西坦 |
357336-20-0 |
epilepsy 抗癫痫 |
in-house | |||||||||
711 |
Avatrombopag Meleate 马来酸阿伐曲波帕 |
677007-74-8 |
Thrombocytope 提升血小板 |
in-house | I | CED#Y20220000791 | |||||||
720 |
Eltrombopag Olamine 艾曲波帕乙醇胺 |
496775-62-3 |
Thrombocytope 提升血小板 |
VB | |||||||||
715 |
Vonoprazan Fumarate 富马酸伏诺拉生 |
1260141-27-2 |
Reflux esophagitis 反流性食管炎 |
in-house | |||||||||
721 |
Baricitinib 巴瑞替尼 |
1187594-09-7 |
Anti-rheumatic agent 抗风湿,严重斑秃 |
in-house | |||||||||
528 |
Tenofovir Alafenamide Fumarate 富马酸丙分替诺福韦 |
1392275-56-7 |
Anti-virus 抗病毒 |
in-house | √ | A | √ | CED#Y20200000983 | |||||
Intermediate & Side chain | |||||||||||||
Product code | Intermediate name | CAS No. | Non-Onco | Specification | Tech Pack | CMC | DMF No. | ||||||
813-I1 |
3-(dimethylamino)-1- (3-pyridinyl)-2-propen-1-one |
55314-16-4 | Nilotinib | in-house | √ | √ | |||||||
813-I2 |
3-[(aminoiminomethyl)amino] -4-methyl-benzoic acid methyl ester nitrate |
1025716-99-7 | Sunitinib | in-house | √ | √ | |||||||
816-I2 | 5-Fluoroisatin | 443-69-6 | Sunitinib | in-house | √ | √ | |||||||
816 I5 | 5-Fluoro-2-oxindole | 56341-41-4 | Sunitinib | in-house | √ | √ | |||||||
816-I9 |
5-Formyl-2,4-dimethyl-1H- pyrrole-3 -carboxylic acid |
253870-02-9 | Sunitinib | in-house | √ | √ | |||||||
817 |
N-(2-(Diethylamino)ethyl) -5-formyl-2,4-dimethyl-1H- pyrrole-3-carboxamide |
356068-86-5 | Sunitinib | in-house | √ | √ |