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

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    ASPEN API

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    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    DOSSIERs // Finished Dosage Formulations

    Key Products KEY PRODUCTS

    • Azathioprine

    • Desogestrel

    • Dihydrotestosterone

    • Estriol

    • Etonogestrel

    • Fentanyl

    • Fentanyl Citrate

    • Fentanyl Hydrochloride

    • Ganirelix

    • Goserelin Acetate

    • Lanreotide Acetate

    • Norethisterone

    • Norethisterone Acetate

    • Norethisterone Enanthate

    • Oxytocin

    • Progesterone

    • Ropivacaine Hydrochloride

    • Ropivacaine Mesylate

    • Segesterone Acetate

    • Testosterone

    • Testosterone Acetate

    • Testosterone Cypionate

    • Testosterone Decanoate

    • Testosterone Enanthate

    • Testosterone Isocaproate

    • Testosterone Phenylpropionate

    • Testosterone Propionate

    • Testosterone Undecanoate

    SERVICES

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    INSPECTIONS & REGISTRATIONS

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    Aspen API 250
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    Country
    Country
    Netherlands
    Address
    Address
    Kloosterstraat 6, 5349 AB Oss
    Telephone
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    +31 (0) 88 2779 000
    Client Email
    Email
    api@nl.aspenpharma.com
    Client Website
    Website
    https://www.aspenapi.com/
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    Linkedin
    https://www.linkedin.com/company/aspen-oss-b.v./
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    • FDA
    • EDQM
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    Budesonide

    PDF Supplier PDF
    URL Supplier Web Content
    NA Not Available For Sales
    AstraZeneca Korea Co., Ltd.
    2022-11-24
    20221124-209-J-1410
    Aspen Oss BV@AstraZeneca ...
    Netherlands
    Veersemeer 4, Oss, 5347 J...
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    budesonide

    PDF Supplier PDF
    URL Supplier Web Content
    NA Not Available For Sales
    Synex Co., Ltd.
    2021-07-22
    20210722-209-J-1071
    Aspen Oss B.V.
    Netherlands
    Veersemeer 4, Oss, 5347 J...
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    Estradiol

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    Synex Co., Ltd.
    2022-01-13
    20220113-181-I-637-06
    Aspen Oss BV@Aspen Oss BV
    Netherlands
    Kloosterstraat 6, Oss, 53...
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    Estradiol hemihydrate

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    Synex Co., Ltd.
    2022-01-13
    20121221-181-I-217-02(A)
    Aspen Oss B.V.
    Netherlands
    Veersemeer 4, Oss, 5347 J...
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    Estradiol hemihydrate

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    Abbott Korea Ltd.
    2012-12-21
    20121221-181-I-217-02
    Aspen Oss B.V.
    Netherlands
    Veersemeer 4, 5347 JN Oss...
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    Estradiol hemihydrate

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    URL Supplier Web Content
    Korea Organon Co., Ltd.
    2012-11-02
    20121102-181-I-30-01
    Aspen Oss BV_x000D_
    Netherlands
    Veersemeer 4 5347 JN, Oss
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    Estradiol Valerate

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    URL Supplier Web Content
    Synex Co., Ltd.
    2022-05-26
    20220526-181-I-638-07
    Aspen Oss BV@Aspen Oss BV
    Netherlands
    Kloosterstraat 6, Oss, 53...
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    Fondaparinux Sodium

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    URL Supplier Web Content
    Handok Co., Ltd.
    2013-03-29
    20130329-193-I-126-01
    Aspen notre dame de bonde...
    Netherlands
    1, rue de l'Abbaye, 76960...
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    Fondaparinux Sodium

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    URL Supplier Web Content
    Handok Co., Ltd.
    2013-03-29
    20130329-193-I-127-02
    Aspen Oss_x000D_ @Sanofi ...
    Netherlands
    Manufacture : Veersemeer ...
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    Mirtazapine

    PDF Supplier PDF
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    Synex Co., Ltd.
    2022-01-12
    20220112-209-J-1207
    Aspen Oss B.V.
    Netherlands
    Veersemeer 4, 5347 JN Oss...
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    remifentanil hydrochloride

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    Fresenius Kavi Korea Co., Ltd.
    2016-08-18
    Wed 181-3-ND
    Fine Chemicals Corporatio...
    South Africa
    15 Hawkins Avenue, Epping...
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    Buenos Aires 2023

    Not Confirmed

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    remifentanil hydrochloride

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    Aging Life Science Co., Ltd.
    2019-02-26
    Wed 181-3-ND(1)
    Fine Chemicals Corporatio...
    South Africa
    15 Hawkins Avenue, Epping...
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    Buenos Aires 2023

    Not Confirmed

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    Sugammadex Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    MSD Korea Co., Ltd.
    2012-10-09
    Wed 906-12-ND
    Aspen Oss. BV_x000D_
    Netherlands
    Veersemeer 4, 5347 JN Oss
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    tibolone

    PDF Supplier PDF
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    Synex Co., Ltd.
    2010-08-31
    20100831-140-H-28-01
    Aspen Oss B.V.
    Netherlands
    Veersemeer 4, Oss, 5347 J...
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