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原料药

  • 详细介绍
  • 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
    Product Name

    结构式
    Chemical Structure

    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

    澳门皇冠体育

    112811-71-9

    2

    加替羧酸

    1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3-Quinolinecarboxylic Acid

    澳门皇冠体育

    112811-72-0

    3

    (-)1-[(4-氯苯基)苯甲基]哌嗪

    (-)1-[(4-Chlorophenyl)Phenylmethyl]piperazine

    澳门皇冠体育

    130018-88-1

    4

    2-氯乙氧基乙酸乙酯

    Ethyl 2-Chloroethoxyacetate

    澳门皇冠体育

    17229-14-0

    5

    4-氨基-5-咪唑甲酰胺(阿卡)

    4-Amino-5-Imidazolecarboxamide

    澳门皇冠体育

    360-97-4

    6

    (R)-3--1,2-丙二醇

    (R)-(-)-3-Chloro-1,2-Propanediol

    澳门皇冠体育

    57090-45-6