APIS
|
序号 S/N |
产品名称 Product Name |
质量标准 Quality Standard |
CAS Number |
登记号 Register No. |
与制剂共同审评审批结果 |
文件 Documentation |
|
| 1 | 氟比洛芬 |
Flurbiprofen |
EP/USP/JP |
5104-49-4 | Y20200001121 | I | / |
|
2 |
艾司奥美拉唑钠 |
Esomeprazole Sodium |
CP/EP/BP |
161796-78-7 |
Y20170001342 |
A |
/ |
|
3 |
盐酸咪达普利 |
Imidapril Hydrochloride |
JP |
89371-37-9 |
Y20170001151 |
A |
DMF |
|
4 |
琥珀酸亚铁 |
Ferrous Succinate |
In-House |
10030-90-7 |
Y20170001256 |
A |
DMF Processing |
|
5 |
铝镁加 |
Almagate |
EP/KP |
66827-12-1 |
Y20190000212 |
I |
DMF |
|
6 |
瑞舒伐他汀钙 |
Rosuvastatin Calcium |
EP/USP |
147098-20-2 |
Y20190021369 |
I |
DMF Processing |
|
7 |
依巴斯汀 |
Ebastine |
EP/JP |
90729-43-4 |
Y20190001098 |
I |
DMF Processing |
|
8 |
铝碳酸镁 |
Hydrotalcite |
BP |
12304-65-3 |
Y20190021360 |
I |
DMF Processing |
|
9 |
盐酸阿考替胺 |
Acotiamide Hydrochloride Hydrate |
In-House |
773092-05-0 |
Y20190000967 |
I |
DMF Processing |
|
10 |
利伐沙班 |
Rivaroxaban |
In-House |
366789-02-8 |
Y20190021192 |
I |
DMF Processing |
|
11 |
西甲硅油 |
Simethicone |
EP/USP |
8050-81-5 |
Y20200000329 |
I |
DMF |
|
12 |
盐酸吗啉胍 |
Moroxydine Hydrochloride |
In-House |
3160-91-6 |
Y20190002785 |
A |
DMF |
|
13 |
苹果酸氯波必利 |
Clebopride Malate |
EP/JP |
57645-91-7 |
Y20190001377 |
A |
DMF |
|
14 |
奥硝唑 |
Ornidazole |
In-House |
16773-42-5 |
Y20190001369 |
A |
DMF |
|
15 |
塞克硝唑 |
Secnidazole |
In-House |
3366-95-8 |
Y20190004644 |
A |
DMF |
|
16 |
地红霉素 |
Dirithromycin |
USP/EP |
62013-04-1 |
Y20190001368 |
A |
US DMF#20584 |
|
17 |
左羟丙哌嗪 |
Levodropropizine |
EP |
99291-25-5 |
Y20190004643 |
A |
DMF/KDMF |
|
18 |
盐酸左西替利嗪 |
Levocetirizine Dihydrochloride |
USP |
130018-87-0 |
Y20190004640 |
A |
DMF/KDMF |
|
19 |
盐酸班布特罗 |
Bambuterol Hydrochloride |
EP |
81732-46-9 |
Y20190001370 |
A |
DMF |
|
20 |
利拉萘酯 |
Liranaftate |
In-House |
88678-31-3 |
Y20190006937 |
A |
DMF Processing |
|
21 |
尿囊素 |
Allantoin |
EP/USP |
97-59-6 |
Y20190001463 |
A |
DMF |
|
22 |
西尼地平 |
Cilnidipine |
JP |
132203-70-4 |
Y20190006928 |
A |
DMF |
|
23 |
氯雷他定 |
Loratadine |
EP/USP |
79794-75-5 |
Y20190008134 |
A |
DMF Processing |
|
24 |
盐酸小檗碱 |
Berberine Hydrochloride |
JP |
141433-60-5 |
Y20190006553 |
A |
DMF Processing |
|
25 |
琥珀酸舒马普坦 |
Sumatriptan Succinate |
USP/EP |
103628-48-4 |
Y20190005923 |
A |
DMF |
|
26 |
马来酸桂哌齐特 |
Cinepazide Maleate |
In-House |
26328-04-1 |
Y20190006404 |
A |
DMF Processing |
|
27 |
磷酸氢二钠 |
Dibasic Sodium Phosphate |
USP/EP |
7558-79-4 |
Y20190004641 |
A |
DMF |
|
28 |
磷酸二氢钠 |
Monobasic Sodium Phosphate |
USP/BP |
10049-21-5 |
Y20190004642 |
A |
DMF |
|
29 |
甲磺酸帕珠沙星 |
Pazufloxacin Mesilate |
In-House |
163680-77-1 |
Y20190006096 |
A |
/ |
|
30 |
美洛昔康 |
Meloxicam |
CP/USP/EP/BP |
71125-38-7 |
Y20180001794 |
A |
/ |
|
31 |
阿奇霉素 |
Azithromycin |
CP/USP/EP/BP |
83905-01-5 |
Y20180001793 |
A |
/ |
|
32 |
克拉霉素 |
Clarithromycin |
CP/USP/EP/BP/JP |
81103-11-9 |
Y20190021566 |
A |
/ |
|
33 |
奥美拉唑 |
Omeprazole |
CP/USP/EP/BP/JP |
73590-58-6 |
Y20170002344 |
A |
/ |
|
34 |
兰索拉唑 |
Lansoprazole |
CP/USP/EP/BP/JP |
103577-45-3 |
Y20170002339 |
A |
/ |
|
35 |
甘磷酸胆碱 |
Choline Alfoscerate |
KP/In-House |
28319-77-9 |
/ |
/ |
DMF |
|
36 |
多库酯钠 |
Docusate Sodium |
USP/EP |
577-11-7 |
/ |
/ |
DMF |
待申报原料药品种
|
序号 S/N |
产品名称 Product Name |
质量标准 Sepcification |
CAS Number |
|
| 1 | 蛋白琥珀酸铁 | Iron Protein Succinylate | In-House | 93615-44-2 |
| 2 | 达格列净 | Dapagliflozin | In-House | 461432-26-8 |
| 3 | 熊去氧胆酸 | Ursodeoxycholic Acid | CP/JP/EP | 128-13-2 |
|
4 |
磷酸奥司他韦 |
Oseltamivir Phosphate |
In-House |
204255-11-8 |
|
5 |
盐酸普拉克索 |
Pramipexole dihydrochloride |
USP/EP |
104632-25-9 |
|
6 |
帕拉米韦 |
Peramivir |
In-House |
229614-55-5 |
|
7 |
枸橼酸托法替布 |
Tofacitinib citrate |
In-House |
540737-29-9 |
|
8 |
他达拉非 |
Tadalafil |
In-House |
171596-29-5 |
|
9 |
富马酸丙酚替诺福韦 |
Tenofovir Alafenamide Fumarate |
In-House |
1392275-56-7 |
|
10 |
非洛地平 |
Felodipine |
In-House |
72509-76-3 |
|
11 |
氟比洛芬钠 |
Flurbiprofen Sodium |
BP/USP |
56767-76-1 |
|
12 |
托匹司他 |
Topiroxostat |
In-House |
577778-58-6 |
|
13 |
盐酸达泊西汀 |
Dapoxetine hydrochloride |
EP/USP |
129938-20-1 |
|
14 |
塞来昔布 |
Celecoxib |
In-House |
169590-42-5 |
|
15 |
维格列汀 |
Vildagliptin |
In-House |
274901-16-5 |
|
16 |
盐酸鲁拉西酮 |
Lurasidone hydrochloride |
USP/EP/BP |
367514-88-3 |
|
17 |
磷酸西格列汀 |
Sitagliptin phosphate |
In-House |
654671-77-9 |
|
18 |
匹可硫酸钠 |
Sodium picosulfate |
In-House |
10040-45-6 |
|
19 |
阿齐沙坦 |
Azilsartan |
USP/EP/BP |
147403-03-0 |
|
20 |
恩格列净 |
Empagliflozin |
USP/EP/BP/JP |
864070-44-0 |
|
21 |
盐酸利多卡因 |
Linocaine hydrochloride |
In-House |
6108-05-0 |
|
22 |
丙胺卡因 |
Prilocaine |
In-House |
721-50-6 |
|
23 |
水杨酸甲酯 |
Methyl salicylate |
CP/USP/EP/BP |
119-36-8 |
|
24 |
右旋酮洛芬氨丁三醇 |
Dexketoprofen trometamol |
In-House |
156604-79-4 |
|
25 |
培比洛芬 |
Pelubiprofen |
In-House |
69956-77-0 |
|
26 |
硫酸镁 |
Magnesium Sulfate |
In-House |
7487-88-9 |
|
27 |
硫酸钾 |
Potassium Sulfate |
In-House |
7778-80-5 |
|
28 |
硫酸钠 |
Sodium Sulfate |
In-House |
7757-82-6 |
|
29 |
沙芬酰胺 |
Safinamide |
In-House |
133865-89-1 |
中间体
|
序号S/N |
产品名称 |
结构式 |
Cas Number |
|
|
1 |
加替环合酯 |
1-Cyclopropyl-6,7-Difluoro-1,4-Dihydro-8-Methoxy-4-oxo-3-Quinolinecarboxylic Acid Ethyl Ester |
|
112811-71-9 |
|
2 |
加替羧酸 |
1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3-Quinolinecarboxylic Acid |
|
112811-72-0 |
|
3 |
(-)1-[(4-氯苯基）苯甲基]哌嗪 |
(-)1-[(4-Chlorophenyl)Phenylmethyl]piperazine |
|
130018-88-1 |
|
4 |
2-氯乙氧基乙酸乙酯 |
Ethyl 2-Chloroethoxyacetate |
|
17229-14-0 |
|
5 |
4-氨基-5-咪唑甲酰胺（阿卡） |
4-Amino-5-Imidazolecarboxamide |
|
360-97-4 |
|
6 |
(R)-3-氯-1,2-丙二醇 |
(R)-(-)-3-Chloro-1,2-Propanediol |
|
57090-45-6 |
