| Taxanes Product List ,2023 | |||||||||||||
| APIs | |||||||||||||
| 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 | |||||
| 902 |
Paclitaxel
半合成紫杉醇
|
33069-62-4 |
Oncology
抗肿瘤
|
USP、EP、CP | √ | A | √ | √ |
USDMF#25822
R0-CEP 2019-110-Rev 02
CDE#Y20190000514
|
√ | COFEPRIS GMP | ||
| 903 |
Docetaxel anhydrous
多西他赛无水
|
114977-28-5 |
Oncology
抗肿瘤
|
USP、EP、CP | √ | A | √ | √ |
USDMF#25295
R0-CEP 2016-204-Rev 02
CDE#Y20170001931
|
√ | EU-GMP | ||
| 904 |
Docetaxel Trihydrate
多西他赛三水
|
148408-66-6 |
Oncology
抗肿瘤
|
USP、EP、CP | √ | I | √ | CDE#Y20180001153 | |||||
| Taxanes Intermediate | |||||||||||||
|
Product
code
|
Intermediate name | CAS No. | Taxanes | Specification | Tech Pack | CMC | DMF No. | ||||||
| 905 | 10-Deacetyl BaccatinIII | 32981-86-5 | KSM for Paclitaxel,Docetaxel,Cabazitaxel | In-house | √ | √ | √ | USDMF# 25294 | |||||
| 902-I1 | Baccatin III | 27548-93-2 | Paclitaxel | In-house | √ | √ | |||||||
| 902N-1 | 7-Troc Paclitaxel | 114915-17-2 | Paclitaxel | In-house | √ | √ | |||||||
| 903 I1 | 7,10-DiTroc-10-DAB III | 95603-44-4 | Docetaxel | In-house | √ | √ | |||||||
| 903N-1 | 7,10-Di Troc Docetaxel | 114915-14-9 | Docetaxel | In-house | √ | √ | |||||||
| 910-D |
(4S,5R)-3-(tert-Butoxycarbonyl)-2,2-
dimethyl-4-phenyloxazolidine-5-
carboxylic acid
|
143527-70-2 | Docetaxel | In-house | √ | √ | |||||||
| 912 |
（4S,5R）-3-benzoyl-2-(4-methoxyphenyl)-4-
phenyl-5-oxazolidinecarboxylic acid
|
949023-16-9 | Paclitaxel | In-house | √ | √ | |||||||
| 913 |
(4S,5R)-3-tert-butoxycarbonyl-2-
(4-anisyl)-4-phenyl-5-oxazolidinecarboxylic acid
|
196404-55-4 | Docetaxel | In-house | √ | √ | |||||||
| 917-D | (3R,4S)-3-triethylsilanyloxy-4-phenyl-N-Boc-2-azetidinone | 149198-47-0 | Docetaxel,Cabazitaxel | In-house | √ | √ | |||||||
| 918-I3 |
(3R,4S)-3-hydroxy-4-phenyl-
azetidin-2-one
|
132127-34-5 | Paclitaxel,Docetaxel | In-house | √ | √ | |||||||
| 918 |
(3R,4S)-3-(1-ethoxyethoxy)-4-phenyl
-N-benzoyl-2-azetidinone
|
201856-53-3 | Paclitaxel | In-house | √ | √ | |||||||
