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

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    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • Acetylcysteine

    • Balsalazide Disodium

    • Beclomethasone Dipropionate

    • Carbocisteine

    • Carbocysteine Lysine

    • Lysine

    • Lysine Acetate

    • Lysine Hydrochloride

    • Mesalazine

    • Methylene Blue

    • Olaparib

    • Propafenone Hydrochloride

    • Triamcinolone

    • Triamcinolone Acetonide

    • Triamcinolone Diacetate

    • Triamcinolone Hexacetonide

    • Ursodeoxycholic Acid

    • Zavegepant HCl

    INTERMEDIATES

    SERVICES

    Key Products KEY SERVICES

    • Complex API Development Services

    • CDMO for Small Molecule APIs

    • API Custom Synthesis

    • Hazardous Chemistry

    • Flow Chemistry

    • Industrial Chromatography

    • Contract Development & Manufacturing for ADCs

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

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    • FDA
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    Beclomethasone dipropionate

    PDF Supplier PDF
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    Other DMF CN, SAU
    Kolon Pharmaceutical Co., Ltd.
    2013-06-10
    20130610-186-I-285-01
    Farmabios SpA
    Italy
    Gropello Cairoli (PV) - V...
    Axplora CB

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    • FDA
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    budesonide

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    Samo Pharmaceutical Co., Ltd.
    2020-06-01
    20200601-209-J-448
    Farmabios SpA@Microchem S...
    Germany
    27027, via Pavia 1, GROPE...
    Axplora CB

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    • FDA
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    Cefmetazole Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    Samo Pharmaceutical Co., Ltd.
    2009-12-31
    20091231-126-G-14-04
    Farmabios SpA
    Italy
    via Pavia 1 27027 GROPELL...
    Axplora CB

    ChemOutsourcing

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    Cefminox Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    Samo Pharmaceutical Co., Ltd.
    2008-01-10
    20080110-24-A-210-06
    Farmabios SpA
    Italy
    via Pavia 1 27027 GROPELL...
    Axplora CB

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    Celecoxib

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    Other DMF EU, CA
    Samo Pharmaceutical Co., Ltd.
    2020-09-15
    20200915-209-J-721
    PharmaZell (India) Privat...
    India
    Plot No. 115, Ramky Pharm...
    Axplora CB

    ChemOutsourcing

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    • FDA
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    Clobetasol propionate

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    Other DMF SAU
    Galderma Korea Co., Ltd.
    2012-11-22
    20121123-93-E-100-06
    Farmabios SpA
    Italy
    via Pavia 1 27027 GROPELL...
    Axplora CB

    ChemOutsourcing

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    desoximethasone

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    Other DMF EU
    Samo Pharmaceutical Co., Ltd.
    2021-04-26
    20210426-211-J-952
    Farmabios SpA@Microchem S...
    Germany
    Via Pavia 1-27027 Gropell...
    Axplora CB

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    Fluocinonide

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    Other DMF EU
    Samo Pharmaceutical Co., Ltd.
    2020-05-14
    20200514-211-J-628
    Farmabios SpA@Microchem S...
    Germany
    Via Pavia 1-27027, Gropel...
    Axplora CB

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    fluorometholone

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    Other DMF EU
    Samo Pharmaceutical Co., Ltd.
    2021-02-18
    20210218-211-J-842
    Farmabios SpA@IMS srl
    Germany
    Via Pavia 1, 27027 Gropel...
    Axplora CB

    ChemOutsourcing

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    laying board

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    Other DMF SAU
    Pharma Science Korea Co., Ltd.
    2022-06-08
    20220608-210-J-1307
    Farmabios SpA
    Italy
    Via Pavia 1, Gropello Cai...
    Axplora CB

    ChemOutsourcing

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    letrozole

    PDF Supplier PDF
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    Novartis Korea Co., Ltd.
    2021-09-10
    20210910-209-J-1104
    FINORGA SAS@Jetpharma SA
    Germany
    route de Givors Chasse Su...
    Axplora CB

    ChemOutsourcing

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    Medroxyprogesterone acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Saehan Pharmaceutical Co., Ltd.
    2005-08-31
    20050831-58-B-142-01
    Farmabios SpA
    Italy
    Farmabios SpA via Pavia 1...
    Axplora CB

    ChemOutsourcing

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    Megestrol Acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Samo Pharmaceutical Co., Ltd.
    2021-04-09
    20210409-211-J-738
    Farmabios SpA@Micro-Macin...
    Germany
    Via Pavia 1-27027 Gropell...
    Axplora CB

    ChemOutsourcing

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    Mesalazine

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    Other DMF EU, CA, TW, BR, TH
    Eltech Pharmachem Co., Ltd.
    2020-06-02
    20200602-209-J-386
    PharmaZell GmbH
    Germany
    Rosenheimer Straße 43 83...
    Axplora CB

    ChemOutsourcing

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    Mesalazine

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    Other DMF EU, CA, TW, BR, TH
    Takeda Pharmaceutical Korea Co., Ltd.
    2021-10-05
    20210521-209-J-766(1)
    PharmaZell (India) Privat...
    India
    Plot No. 115, Visakha Pha...
    Axplora CB

    ChemOutsourcing

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    Mesalazine

    PDF Supplier PDF
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    Other DMF EU, CA, TW, BR, TH
    Takeda Pharmaceutical Korea Co., Ltd.
    2020-07-23
    20200602-209-J-386(2)
    PharmaZell GmbH
    Germany
    Rosenheimer Straße 43 83...
    Axplora CB

    ChemOutsourcing

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    Mesalazine

    PDF Supplier PDF
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    Other DMF EU, CA, TW, BR, TH
    Eltech Pharmachem Co., Ltd.
    2021-05-21
    20210521-209-J-766
    PharmaZell (India) Privat...
    India
    Plot No. 115, Visakha Pha...
    Axplora CB

    ChemOutsourcing

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    Mesalazine

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    Other DMF EU, CA, TW, BR, TH
    Daewoong Pharmaceutical Co., Ltd.
    2020-07-09
    20200602-209-J-386(1)
    PharmaZell GmbH
    Germany
    Rosenheimer Straße 43 83...
    Axplora CB

    ChemOutsourcing

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    Micronized fludrocortisone acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    Samil Pharmaceutical Co., Ltd.
    2021-12-02
    20211202-209-J-1149
    Farmabios SPA@MICROCHEM S...
    Germany
    Via Pavia 1 - 27027 Grope...
    Axplora CB

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    Prednisolone Valeroacetate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    Samo Pharmaceutical Co., Ltd.
    2020-07-07
    20200707-71-B-436-10
    Farmabios SpA@[micronized...
    Germany
    Via Pavia 1-27027 Gropell...
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Propafenone hydrochloride

    PDF Supplier PDF
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    Other DMF EU, CA, BR, TH, ID
    Abbott Korea Co., Ltd.
    2022-01-24
    20220124-209-J-1222
    PharmaZell GmbH
    Germany
    Rosenheimer Straße 43 83...
    Axplora CB

    ChemOutsourcing

    Booth #58

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    selinexor

    PDF Supplier PDF
    URL Supplier Web Content
    Antenjin Pharmaceutical Co., Ltd.
    2022-06-23
    20220623-211-J-1319
    Novasep Chasse sur Rhône...
    France
    Route de Givors, Chasse-s...
    Axplora CB

    ChemOutsourcing

    Booth #58

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    triamcinolone

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    Samo Pharmaceutical Co., Ltd.
    2005-08-31
    20050831-65-B-164-02
    Farmabios SpA
    Italy
    Via Pavia 1-27027 Gropell...
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
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    Triamcinolone acetonide

    PDF Supplier PDF
    URL Supplier Web Content
    Samo Pharmaceutical Co., Ltd.
    2019-12-09
    20150130-65-B-382-10(1)
    Farmabios SpA
    Italy
    Via Pavia 1-27027 Gropell...
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Triamcinolone acetonide

    PDF Supplier PDF
    URL Supplier Web Content
    Samo Pharmaceutical Co., Ltd.
    2015-01-30
    20150130-65-B-382-10
    Farmabios SpA
    Italy
    Via Pavia 1-27027 Gropell...
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
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    Ursodeoxycholic acid

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, BR
    Eltech Pharmachem Co., Ltd.
    2020-08-13
    20200813-211-J-501
    Farmabios SPA
    Italy
    Via Pavia 1-27027, GROPEL...
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

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