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  • 序號

    S/N

    產品名稱

    Product Name

    質量標準

    Quality Standard

    CAS Number

    登記號

    Register No.

    與制劑共同審評審批結果

    文件

    Documentation

    1

    鋁碳酸鎂

    Hydrotalcite

    CP/BP

    12304-65-3

    Y20190021360

    A

    DMF Processing

    2 他達拉非 Tadalafil In-House 171596-29-5 Y20210000017  I /
    3 鹽酸普拉克索 Pramipexole dihydrochloride USP/EP 104632-25-9 Y20200001472  I /
    4 枸櫞酸托法替布 Tofacitinib citrate In-House 540737-29-9 Y20210000081 I /

    5

    氟比洛芬

    Flurbiprofen

    EP/USP/JP

    5104-49-4

    Y20200001121

    I

    /

    6

    艾司奧美拉唑鈉

    Esomeprazole Sodium

    CP/EP/BP

    161796-78-7

    Y20170001342

    A

    /

    7

    鹽酸咪達普利

    Imidapril Hydrochloride

    JP

    89371-37-9

    Y20170001151

    A

    DMF

    8

    琥珀酸亞鐵

    Ferrous Succinate

    In-House

    10030-90-7

    Y20170001256

    A

    DMF Processing

    9

    鋁鎂加

    Almagate

    EP/KP

    66827-12-1

    Y20190000212

    I

    DMF

    10

    瑞舒伐他汀鈣

    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

    鹽酸阿考替胺

    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 硫酸鎂 Magnesium Sulfate In-House 7487-88-9 Y20200001238  I /

    16

    鹽酸嗎啉胍

    Moroxydine Hydrochloride

    In-House

    3160-91-6

    Y20190002785

    A

    DMF

    17

    蘋果酸氯波必 

    Clebopride Malate

    EP/JP

    57645-91-7

    Y20190001377

    A

    DMF

    18

    奧硝唑

    Ornidazole

    In-House

    16773-42-5

    Y20190001369

    A

    DMF

    19

    塞克硝唑

    Secnidazole

    In-House

    3366-95-8

    Y20190004644

    A

    DMF

    20

    地紅霉素

    Dirithromycin

    USP/EP

    62013-04-1

    Y20190001368

    A

    US DMF#20584

    21

    左羥丙哌嗪

    Levodropropizine

    EP

    99291-25-5

    Y20190004643

    A

    DMF/KDMF

    22

    鹽酸左西替利嗪

    Levocetirizine Dihydrochloride

    USP

    130018-87-0

    Y20190004640

    A

    DMF/KDMF

    23

    鹽酸班布特羅

    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

    鹽酸小檗堿

    Berberine Hydrochloride

    JP

    141433-60-5

    Y20190006553

    A

    DMF Processing

    29

    琥珀酸舒馬普坦

    Sumatriptan Succinate

    USP/EP

    103628-48-4

    Y20190005923

    A

    DMF

    30

    馬來酸桂哌齊特

    Cinepazide Maleate

    In-House

    26328-04-1

    Y20190006404

    A

    DMF Processing

    31

    磷酸氫二鈉

    Dibasic Sodium Phosphate

    USP/EP

    7558-79-4

    Y20190004641

    A

    DMF

    32

    磷酸二氫鈉

    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

    奧美拉唑

    Omeprazole

    CP/USP/EP/BP/JP

    73590-58-6

    Y20170002344

    A

    /

    38

    蘭索拉唑

    Lansoprazole

    CP/USP/EP/BP/JP

    103577-45-3

    Y20170002339

    A

    /

    39

    甘磷酸膽堿

    Choline Alfoscerate

    KP/In-house

    28319-77-9

    /

    /

    DMF

    40

    多庫酯鈉

    Docusate Sodium

    USP/EP

    577-11-7

    /

    /

    DMF

     

     

    待申報原料藥品種

     

    序號

    S/N

    產品名稱

    Product Name

    質量標準

    Sepcification

    CAS Number

    1 蛋白琥珀酸鐵 Iron Protein Succinylate In-House 93615-44-2
    2 達格列凈 Dapagliflozin In-House 461432-26-8
    3 熊去氧膽酸 Ursodeoxycholic Acid CP/JP/EP 128-13-2

    4

    磷酸奧司他韋

    Oseltamivir Phosphate

    In-House

    204255-11-8

    5

    帕拉米韋

    Peramivir

    In-House

    229614-55-5

    6

    富馬酸丙酚替諾福韋

    Tenofovir Alafenamide Fumarate

    In-House

    1392275-56-7

    7

    非洛地平

    Felodipine

    In-House

    72509-76-3

    8

    氟比洛芬鈉

    Flurbiprofen Sodium

    BP/USP

    56767-76-1

    9

    托匹司他

    Topiroxostat

    In-House

    577778-58-6

    10

    鹽酸達泊西汀

    Dapoxetine hydrochloride

    EP/USP

    129938-20-1

    11

    塞來昔布

    Celecoxib

    In-House

    169590-42-5

    12

    維格列汀

    Vildagliptin

    In-House

    274901-16-5

    13

    鹽酸魯拉西酮

    Lurasidone hydrochloride

    USP/EP/BP

    367514-88-3

    14

    磷酸西格列汀

    Sitagliptin phosphate

    In-House

    654671-77-9

    15

    匹可硫酸鈉

    Sodium picosulfate

    In-House

    10040-45-6

    16

    阿齊沙坦

    Azilsartan

    USP/EP/BP

    147403-03-0

    17

    恩格列凈

    Empagliflozin

    USP/EP/BP/JP

    864070-44-0

    18

    鹽酸利多卡因

    Linocaine hydrochloride

    In-House

    6108-05-0

    19

    丙胺卡因

    Prilocaine

    In-House

    721-50-6

    20

    水楊酸甲酯

    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

    硫酸鉀

    Potassium Sulfate

    In-House

    7778-80-5

    24

    硫酸鈉

    Sodium Sulfate

    In-House

    7757-82-6

    25

    沙芬酰胺

    Safinamide

    In-House

    133865-89-1

     

    中間體

     

    序號S/N

    產品名稱
    Product Name

    結構式
    Chemical Structure

    Cas Number

    1

    加替環合酯

    1-Cyclopropyl-6,7-Difluoro-1,4-Dihydro-8-Methoxy-4-oxo-3-Quinolinecarboxylic Acid Ethyl Ester

    湖南九典制藥股份有限公司

    112811-71-9

    2

    加替羧酸

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

    湖南九典制藥股份有限公司

    112811-72-0

    3

    (-)1-[(4-氯苯基)苯甲基]哌嗪

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

    湖南九典制藥股份有限公司

    130018-88-1

    4

    2-氯乙氧基乙酸乙酯

    Ethyl 2-Chloroethoxyacetate

    湖南九典制藥股份有限公司

    17229-14-0

    5

    4-氨基-5-咪唑甲酰胺(阿卡)

    4-Amino-5-Imidazolecarboxamide

    湖南九典制藥股份有限公司

    360-97-4

    6

    (R)-3--1,2-丙二醇

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

    湖南九典制藥股份有限公司

    57090-45-6

     

     

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