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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by EUROAPI to the Review Authority in Korea.

    Client Virtual Booth

    EUROAPI

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

    VIDEO(s)

    DIGITAL CONTENT

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    DOSSIERs // Finished Dosage Formulations

    Key Products KEY PRODUCTS

    • Apomorphine Hydrochloride

    • Dexamethasone

    • Dexamethasone 9,11-Epoxide

    • Dexamethasone Acetate

    • Dexamethasone Sodium Phosphate

    • Fluticasone Furoate

    • Fluticasone Propionate

    • Furosemide

    • Hydrocortisone

    • Hydrocortisone (Cortisol)

    • Hydrocortisone Acetate

    • Hydrocortisone Hemisuccinate Hydrate

    • Rifampicin

    • Spironolactone

    INTERMEDIATES

    SERVICES

    Key Products KEY SERVICES

    • Microbial Fermentation (Yeast & Bacteria)

    • Oligosaccharides Manufacturing

    • Microbial Fermentation

    • Therapeutic Protein Extraction & Isolation

    • Synthesis of Organometallic Compounds

    • Oligosaccharide API Development

    • Microbial Fermentation for Small Molecules

    • Fermentation Biotech CDMO

    • API Microbial Fermentation

    • Microbial Fermentation Contract Manufacturing

    • CDMO for Industrial Fermentation Services

    • Azide Chemistry

    • Oligosaccharide API Manufacturing

    • Oligonucleotides DNA/RNA or Peptide

    • Oligonucleotides Double Stranded RNA

    • Phosphorodiamidate Morpholino Oligomer

    • Oligonucleotides microRNA

    • Steroid API Development

    • Purification of Therapeutic Proteins

    • Oligosaccharide API Development CDMO

    • Contract Manufacturer for Fermentation

    • Small Molecule API Manufacturing

    • Hazardous Raw Material Synthesis

    INSPECTIONS & REGISTRATIONS

    PharmaCompass
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    EUROAPI VB RM
    EUROAPI
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    France
    Address
    Address
    15 rue Traversière , 75012 Paris
    Telephone
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    +33 189206200
    Client Email
    Email
    contact@euroapi.com
    Client Website
    Website
    https://www.euroapi.com/en
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    https://www.linkedin.com/company/euroapi/
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    • FDA
    • EDQM
    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    Alfuzosin hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Handok Co., Ltd.
    2022-10-05
    20221005-209-J-1372
    Sanofi Chimie
    France
    45 Chemin de Meteline BP ...
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    Booth #917

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    Alprostadil

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    Other DMF CN, RU, ROW
    Samo Pharmaceutical Co., Ltd.
    2023-02-02
    20230202-210-J-1440
    EUROAPI Hungary Ltd.
    Hungary
    To utca 1-5., Budapest, 1...
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    CPhI North America

    Booth #917

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    Amisulpiride

    PDF Supplier PDF
    URL Supplier Web Content
    Sanofi-Aventis Korea Co., Ltd.
    2022-09-22
    20220922-209-J-1388
    Sanofi Chimie
    France
    45, chemin de Météline,...
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    clopidogrel sulfate

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    Other DMF EU, ROW
    Handok Co., Ltd.
    2010-11-30
    20101130-129-H-39-07
    Sanofi Chimie
    France
    45, chemin de Météline,...
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    codeine phosphate hydrate

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    Other DMF IN, ROW
    Nosa Chemical Co., Ltd.
    2020-06-16
    20200616-209-J-616
    Saneca Pharmaceuticals as
    Slovakia
    Nitrianska 100, 920 27 Hl...
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    Booth #917

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    dexamethasone

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    Other DMF RU, ROW
    AbbVie Korea Co., Ltd.
    2023-07-03
    20230405-209-J-1469(A)
    EUROAPI France
    France
    4 Lieu Dit La Paterie, Ve...
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    dexamethasone

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    Other DMF RU, ROW
    Novartis Korea Co., Ltd.
    2023-04-05
    20230405-209-J-1469
    EUROAPI France
    France
    4 Lieu Dit La Paterie, Ve...
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    Dexamethasone Phosphate Disodium

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    Bausch Health Korea Co., Ltd.
    2023-01-06
    20230106-209-J-1432
    EUROAPI France
    France
    4 La Paterie, 63480 VERTO...
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    dinoprostone

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    Other DMF EU, IN, ROW
    Korea Ferring Pharmaceutical Co., Ltd.
    2022-11-02
    20221102-209-J-1396
    EUROAPI Hungary Ltd.
    Hungary
    To u. 1-5., Budapest, 104...
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    CPhI North America

    Booth #917

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    Docetaxel Trihydrate

    PDF Supplier PDF
    URL Supplier Web Content
    Sanofi-Aventis Korea Co., Ltd.
    2023-06-07
    20230607-210-J-1506
    SANOFI CHIMIE
    France
    9, quai Jules Guesde, Vit...
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    Booth #917

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    dronedarone hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Sanofi-Aventis Korea Co., Ltd.
    2009-09-24
    3052-3-ND
    SANOFI CHIMIE_x000D_
    France
    Route d'Avignon 30390 ARA...
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    Booth #917

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    Dronedarone hydrochloride (micronized)

    PDF Supplier PDF
    URL Supplier Web Content
    Sanofi-Aventis Korea Co., Ltd.
    2009-09-24
    3052-4-ND
    SANOFI CHIMIE@EUROAPI Fra...
    France
    45 chemin de Meteline BP ...
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    Booth #917

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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    Fexofenadine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF IN, ROW
    Handok Co., Ltd.
    2021-04-23
    20210423-209-J-951
    EUROAPI Germany GmbH
    Germany
    Brüningstraße 50, D711,...
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    CPhI North America

    Booth #917

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    fluorometholone

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    Other DMF EU, IN, ROW
    Samo Pharmaceutical Co., Ltd.
    2021-05-06
    20210506-211-J-808
    EUROAPI France
    France
    4 La Paterie, VERTOLAYE, ...
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    hydrocortisone

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    Other DMF ROW
    Novartis Korea Co., Ltd.
    2023-07-25
    20230725-209-J-1524
    EUROAPI France
    France
    4 Lieu Dit La Paterie, Ve...
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    Hydroxychloroquine Sulfate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, RU
    Samo Pharmaceutical Co., Ltd.
    2021-03-10
    20210310-209-J-787
    EUROAPI Hungary Ltd.
    Hungary
    To utca 1-5, Budapest, 10...
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    Booth #917

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    Irbesartan

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, ROW
    Handok Co., Ltd.
    2010-11-16
    20101116-133-H-29-02
    SANOFI Chimie
    France
    Route d'Avignon 30390 ARA...
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    CPhI North America

    Booth #917

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    Irbesartan

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    URL Supplier Web Content
    Other DMF CN, ROW
    Hanmi Pharmaceutical Co., Ltd.
    2013-10-20
    20101116-133-H-29-02(1)
    SANOFI Chimie
    France
    Route d'Avignon 30390 ARA...
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    Booth #917

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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    Irbesartan

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, ROW
    Sanofi-Aventis Korea Co., Ltd.
    2013-10-20
    20101116-133-H-29-02(2)
    SANOFI Chimie
    France
    Route d'Avignon 30390 ARA...
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    Booth #917

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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    Irbesartan

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, ROW
    Sanofi-Aventis Korea Co., Ltd.
    2016-07-20
    20160720-133-H-302-27
    EUROAPI Hungary Ltd.
    Hungary
    To utca 1-5, Budapest, 10...
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    CPhI North America

    Booth #917

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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    Latanoprost

    PDF Supplier PDF
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    Other DMF EU, IN, RU, ROW
    Samil Pharmaceutical Co., Ltd.
    2022-10-18
    20221018-211-J-1382
    EUROAPI Hungary Ltd.
    Hungary
    To utca 1-5., Budapest, 1...
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    CPhI North America

    Booth #917

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    Latanoprostinbunod

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    Bausch Health Korea Co., Ltd.
    2021-02-05
    Number 807-1-ND
    EUROAPI Hungary Ltd
    Hungary
    To utca 1-5, Budapest, H-...
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    Booth #917

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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    Leflunomide

    PDF Supplier PDF
    URL Supplier Web Content
    Sanofi-Aventis Korea Co., Ltd.
    2022-05-17
    20220517-209-J-1294
    EUROAPI Germany GmbH@EURO...
    France
    Brüningstraße 50 D711, ...
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    Booth #917

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    Lima Frost Alphadex

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    Other DMF CN, ROW
    Samo Pharmaceutical Co., Ltd.
    2018-10-14
    20181014-209-J-120
    EUROAPI Hungary Ltd.
    Hungary
    To utca 1-5., Budapest, 1...
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    Lima Frost Alphadex

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    Other DMF CN, ROW
    Korea United Pharmaceutical Co., Ltd.
    2020-06-11
    20181014-209-J-120(1)
    CHINOIN Pharmaceutical an...
    Hungary
    To u. 1-5., Budapest, H-1...
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    Lixisenated

    PDF Supplier PDF
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    Sanofi-Aventis Korea Co., Ltd.
    2014-02-13
    Number 3025-6-ND
    EUROAPI Germany GmbH
    Germany
    Bruningstraße 50, D711, ...
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    CPhI North America

    Booth #917

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    naloxone hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, ROW
    Korea Mundi Pharma Co., Ltd.
    2013-06-14
    20130507-176-I-164-01(1)
    Sanofi Chimie
    France
    Route d'Avignon 30390 Ara...
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    Booth #917

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    naloxone hydrochloride

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    Other DMF CN, ROW
    Samo Pharmaceutical Co., Ltd.
    2013-05-07
    20130507-176-I-164-01
    Sanofi Chimie
    France
    Route d'Avignon 30390 Ara...
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    naltrexone hydrochloride

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    Other DMF ROW
    Samo Pharmaceutical Co., Ltd.
    2019-05-30
    20190530-209-J-359
    SANOFI Chimie
    France
    Route d'Avignon, ARAMON, ...
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    Olmesartan medoxomil

    PDF Supplier PDF
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    Daiichi Sankyo Korea Co., Ltd.
    2017-12-15
    Number 256-3-ND
    EUROAPI Hungary Ltd.
    Hungary
    To utca 1-5., Budapest, 1...
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    CPhI North America

    Booth #917

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    Prednisolone

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    Other DMF ROW
    Handok Co., Ltd.
    2005-08-31
    20050831-71-B-197-03
    EUROAPI France
    France
    63480 Vertolyae, France
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    Prednisolone Acetate

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    Other DMF ROW
    AbbVie Korea Co., Ltd.
    2019-11-26
    20191126-71-B-422-09
    EUROAPI France
    France
    4 La Paterie, VERTOLAYE, ...
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    Ramipril

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    Other DMF IN, ROW
    Handok Co., Ltd.
    2024-02-06
    20240206-209-J-1365
    EUROAPI Germany GmbH@Sano...
    Germany
    Brueningstrasse 50, D711,...
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    ramipril

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    Handok Co., Ltd.
    2021-05-11
    20210511-209-J-983
    EUROAPI Germany GmbH@Sano...
    France
    Brueningstrasse 50, D711,...
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    ramipril

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    Handok Co., Ltd.
    2021-04-27
    20210427-209-J-953
    EUROAPI Germany GmbH
    Germany
    Brueningstrasse 50, D711,...
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    Rifaximin

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    Samo Pharmaceutical Co., Ltd.
    2022-05-04
    20220504-209-J-1285
    EUROAPI ITALY SRL
    Italy
    Via Angelo TiTi, 22/26 - ...
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    Booth #917

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    Riluzole

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    Sanofi-Aventis Korea Co., Ltd.
    2012-08-31
    3025-5-ND
    EUROAPI FRANCE
    France
    4 La Paterie, 63480, Vert...
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    Booth #917

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    Riluzole

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    Sanofi-Aventis Korea Co., Ltd.
    2008-05-07
    3025-2-ND
    Sanofi Chimie
    France
    Center de production de V...
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    Booth #917

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    roxithromycin

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    Other DMF EU, ROW
    Handok Co., Ltd.
    2005-08-31
    20050831-9-A-4-04
    EUROAPI France
    France
    4 La Paterie, Vertolaye, ...
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    CPhI North America

    Booth #917

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    Sevelamer carbonate

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    Other DMF ROW
    Sanofi-Aventis Korea Co., Ltd.
    2022-10-18
    20221018-209-J-1383
    EUROAPI UK Limited
    United Kingdom
    37 Hollands Road, Haverhi...
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    CPhI North America

    Booth #917

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    Sodium valproate

    PDF Supplier PDF
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    Other DMF ROW
    Bukwang Pharmaceutical Co., Ltd.
    2022-01-10
    20210604-209-J-1010(1)
    Sanofi Chimie
    France
    Chem'pôle 64 Avenue du L...
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    Sodium valproate

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    Sanofi-Aventis Korea Co., Ltd.
    2021-06-04
    20210604-209-J-1010
    Sanofi Chimie
    France
    Chem'pôle 64 Avenue du L...
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    Spironolactone

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF IN, ROW
    Samo Pharmaceutical Co., Ltd.
    2021-04-26
    20210426-209-J-809
    EUROAPI France
    France
    4 La Paterie, VERTOLAYE, ...
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    Triamcinolone acetonide

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    Opella Healthcare Korea Co., Ltd.
    2012-05-25
    20120525-65-B-330-07
    EuroAPI France
    France
    4 Lieu Dit La Paterie, Ve...
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    valproic acid

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    Sanofi-Aventis Korea Co., Ltd.
    2021-03-10
    20210310-209-J-870
    Sanofi Chimie
    France
    Chem'pôle 64 Avenue du L...
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    Veraprost Sodium

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    Samo Pharmaceutical Co., Ltd.
    2021-06-09
    20210609-209-J-1017
    EUROAPI Hungary Ltd.
    Hungary
    To utca 1-5., Budapest, 1...
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    Zolpidem Tartrate

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    Handok Co., Ltd.
    2021-03-22
    20210322-209-J-901
    Sanofi Chimie
    France
    45, chemin de Météline ...
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    Booth #917

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    Sulprostone

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    Saehan Pharmaceutical Co., Ltd.
    2019-06-24
    20190624-210-J-378
    EUROAPI Hungary Ltd.
    Hungary
    To utca 1-5., Budapest, 1...
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    Booth #917

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