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原料药
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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
铝碳酸镁
Hydrotalcite
CP/BP 12304-65-3
Y20190021360
A DMF Processing
2 他达拉非 Tadalafil In-House 171596-29-5 Y20210000017 I / 3 盐酸普拉克索 Pramipexole dihydrochloride USP/EP 104632-25-9 Y20200001472 I / 4 枸橼酸托法替布 Tofacitinib citrate In-House 540737-29-9 Y20210000081 I / 5
氟比洛芬 Flurbiprofen
EP/USP/JP
5104-49-4
Y20200001121
I
/
6
艾司奥美拉唑钠
Esomeprazole Sodium
CP/EP/BP
161796-78-7
Y20170001342
A
/
7
盐酸咪达普利
Imidapril Hydrochloride
JP
89371-37-9
Y20170001151
A
DMF
8
琥珀酸亚铁
Ferrous Succinate
In-House
10030-90-7
Y20170001256
A
DMF Processing
9
铝镁加
Almagate
EP/KP
66827-12-1
Y20190000212
I
DMF
10
瑞舒伐他汀钙
Rosuvastatin Calcium
EP/USP
147098-20-2
Y20190021369
I
DMF Processing
11
依巴斯汀
Ebastine
EP/JP
90729-43-4
Y20190001098
I
DMF Processing
12
盐酸阿考替胺
Acotiamide Hydrochloride Hydrate
In-House
773092-05-0
Y20190000967
I
DMF Processing
13
利伐沙班
Rivaroxaban
In-House
366789-02-8
Y20190021192
I
DMF Processing
14
西甲硅油
Simethicone
EP/USP
8050-81-5
Y20200000329
I
DMF
15 硫酸镁 Magnesium Sulfate In-House 7487-88-9 Y20200001238 I / 16
盐酸吗啉胍
Moroxydine Hydrochloride
In-House
3160-91-6
Y20190002785
A
DMF
17
苹果酸氯波必 利
Clebopride Malate
EP/JP
57645-91-7
Y20190001377
A
DMF
18
奥硝唑
Ornidazole
In-House
16773-42-5
Y20190001369
A
DMF
19
塞克硝唑
Secnidazole
In-House
3366-95-8
Y20190004644
A
DMF
20
地红霉素
Dirithromycin
USP/EP
62013-04-1
Y20190001368
A
US DMF#20584
21
左羟丙哌嗪
Levodropropizine
EP
99291-25-5
Y20190004643
A
DMF/KDMF
22
盐酸左西替利嗪
Levocetirizine Dihydrochloride
USP
130018-87-0
Y20190004640
A
DMF/KDMF
23
盐酸班布特罗
Bambuterol Hydrochloride
EP
81732-46-9
Y20190001370
A
DMF
24
利拉萘酯
Liranaftate
In-House
88678-31-3
Y20190006937
A
DMF Processing
25
尿囊素
Allantoin
EP/USP
97-59-6
Y20190001463
A
DMF
26
西尼地平
Cilnidipine
JP
132203-70-4
Y20190006928
A
DMF
27
氯雷他定
Loratadine
EP/USP
79794-75-5
Y20190008134
A
DMF Processing
28
盐酸小檗碱
Berberine Hydrochloride
JP
141433-60-5
Y20190006553
A
DMF Processing
29
琥珀酸舒马普坦
Sumatriptan Succinate
USP/EP
103628-48-4
Y20190005923
A
DMF
30
马来酸桂哌齐特
Cinepazide Maleate
In-House
26328-04-1
Y20190006404
A
DMF Processing
31
磷酸氢二钠
Dibasic Sodium Phosphate
USP/EP
7558-79-4
Y20190004641
A
DMF
32
磷酸二氢钠
Monobasic Sodium Phosphate
USP/BP
10049-21-5
Y20190004642
A
DMF
33
甲磺酸帕珠沙星
Pazufloxacin Mesilate
In-House
163680-77-1
Y20190006096
A
/
34
美洛昔康
Meloxicam
CP/USP/EP/BP
71125-38-7
Y20180001794
A
/
35
阿奇霉素
Azithromycin
CP/USP/EP/BP
83905-01-5
Y20180001793
A
/
36
克拉霉素
Clarithromycin
CP/USP/EP/BP/JP
81103-11-9
Y20190021566
A
/
37
奥美拉唑
Omeprazole
CP/USP/EP/BP/JP
73590-58-6
Y20170002344
A
/
38
兰索拉唑
Lansoprazole
CP/USP/EP/BP/JP
103577-45-3
Y20170002339
A
/
39
甘磷酸胆碱
Choline Alfoscerate
KP/In-house
28319-77-9
/
/
DMF
40
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
帕拉米韦
Peramivir
In-House
229614-55-5
6
富马酸丙酚替诺福韦
Tenofovir Alafenamide Fumarate
In-House
1392275-56-7
7
非洛地平
Felodipine
In-House
72509-76-3
8
氟比洛芬钠
Flurbiprofen Sodium
BP/USP
56767-76-1
9
托匹司他
Topiroxostat
In-House
577778-58-6
10
盐酸达泊西汀
Dapoxetine hydrochloride
EP/USP
129938-20-1
11
塞来昔布
Celecoxib
In-House
169590-42-5
12
维格列汀
Vildagliptin
In-House
274901-16-5
13
盐酸鲁拉西酮
Lurasidone hydrochloride
USP/EP/BP
367514-88-3
14
磷酸西格列汀
Sitagliptin phosphate
In-House
654671-77-9
15
匹可硫酸钠
Sodium picosulfate
In-House
10040-45-6
16
阿齐沙坦
Azilsartan
USP/EP/BP
147403-03-0
17
恩格列净
Empagliflozin
USP/EP/BP/JP
864070-44-0
18
盐酸利多卡因
Linocaine hydrochloride
In-House
6108-05-0
19
丙胺卡因
Prilocaine
In-House
721-50-6
20
水杨酸甲酯
Methyl salicylate
CP/USP/EP/BP
119-36-8
21
右旋酮洛芬氨丁三醇
Dexketoprofen trometamol
In-House
156604-79-4
22
培比洛芬
Pelubiprofen
In-House
69956-77-0
23
硫酸钾
Potassium Sulfate
In-House
7778-80-5
24
硫酸钠
Sodium Sulfate
In-House
7757-82-6
25
沙芬酰胺
Safinamide
In-House
133865-89-1
中间体
序号S/N
产品名称
Product Name结构式
Chemical StructureCas 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