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Non-Onco API PRODUCT LIST,2023
 
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              

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