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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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    01 Estradiol hemihydrate (4)

    02 Estradiol valerate (1)

    03 Micronized budesonide (1)

    04 Micronized progesterone (1)

    05 Mirtazapine (1)

    06 Remifentanyl hydrochloride (2)

    07 Sugammadex Sodium Salt (1)

    08 Testosterone Undecanoate (1)

    09 Tibolone (1)

    10 budesonide (1)

    11 fondaparinux sodium (1)

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    01 Abbott Korea Co., Ltd. (1)

    02 Aging Life Science Co., Ltd. (1)

    03 AstraZeneca Korea Co., Ltd. (1)

    04 Fresenius Kavi Korea Co., Ltd. (1)

    05 Handok Co., Ltd. (1)

    06 Korea Organon Co., Ltd. (1)

    07 MSD Korea Co., Ltd. (1)

    08 Sinex Co., Ltd. (8)

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    01 Aspen Oss B.V. (7)

    02 Aspen Oss BV@Aspen Oss BV (2)

    03 Aspen Oss BV@AstraZeneca AB (1)

    04 Aspen Oss BV_x000D_ (1)

    05 Aspen Oss. BV_x000D_ (1)

    06 Aspen notre dame de bondeville@Ajinomoto Omnichem@Aspen Oss BV@ORIL Industrie (1)

    07 Fine Chemicals Corporation (1)

    08 Fine Chemicals Corporation (pty) Limited (1)

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    01 Netherlands (13)

    02 South Africa (2)

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    • FDA
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    budesonide

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    NA Not Available For Sales
    Sinex Co., Ltd.
    2021-07-22
    20210722-209-J-1071
    Aspen Oss B.V.
    Netherlands
    Veersemeer 4, Oss, 5347 J...
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    Booth #548

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    Estradiol hemihydrate

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    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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    Booth #548

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    Estradiol hemihydrate

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    Sinex 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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    Sinex 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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    Booth #548

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    Estradiol hemihydrate

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

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    Sinex 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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    Booth #548

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    fondaparinux sodium

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    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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    Micronized budesonide

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    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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    Booth #548

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    Micronized progesterone

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    Sinex Co., Ltd.
    2023-12-26
    20231226-210-J-1589
    Aspen Oss B.V.
    Netherlands
    Veersemeer 4, 5347 JN Oss...
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    Booth #548

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    Mirtazapine

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    Sinex Co., Ltd.
    2022-01-12
    20220112-209-J-1207
    Aspen Oss B.V.
    Netherlands
    Veersemeer 4, 5347 JN Oss...
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    Booth #548

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