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

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    01 Dieno Guest (1)

    02 Lima Frost Alphadex (1)

    03 Micronized budesonide (1)

    04 Micronized dienogest (1)

    05 Prednicarbate (1)

    06 Prednisolone Valeroacetate (4)

    07 Tibolone (1)

    08 Triamcinolone acetonide (8)

    09 Valerian acid Prednisolone acetic acid (2)

    10 Veraprost Sodium (2)

    11 drospirenone (1)

    12 fluorometholone (1)

    13 triamcinolone (5)

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    01 Ace Biopharm Co., Ltd. (2)

    02 Anguk Pharmaceutical Co., Ltd. (1)

    03 Chodang Pharmaceutical Industry Co., Ltd. (1)

    04 Daesin Pharmaceutical Co., Ltd. (2)

    05 Dongkook Pharmaceutical Co., Ltd. (1)

    06 Dongkwang Pharmaceutical Co., Ltd. (1)

    07 Hwail Pharmaceutical Co., Ltd. (2)

    08 IMCD Korea Co., Ltd. (3)

    09 Pharmapia Co., Ltd. (1)

    10 Sama Pharmaceutical Co., Ltd. (1)

    11 Sungjin Exim Co., Ltd. (11)

    12 Sungwoo Chemical Co., Ltd. (1)

    13 Taegeuk Pharmaceutical Co., Ltd. (1)

    14 Unimed Pharmaceutical Co., Ltd. (1)

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    01 NEWCHEM SPA (3)

    02 NEWCHEM SpA (9)

    03 NEWCHEM SpA@Henan Lihua Pharmaceutical Co., Ltd.@Tianjin Tianyao Pharmaceuticals Co., Ltd@Zhejiang Xianju Pharmaceutical Co., Ltd. Ltd. (2)

    04 NEWCHEM SpA@Henan Lihua Pharmaceutical Co., Ltd.@[Starting material (prednisolone) manufacturer②] Tianjin Tianyao Pharmaceuticals Co., Ltd@[Starting material (prednisolone) manufacturer③] Zhejiang Xianju Pharmaceutical Co., Ltd. (1)

    05 NEWCHEM SpA@Henan Lihua Pharmaceutical Co.,Ltd.@Tianjin Tianyao Pharmaceuticals Co., Ltd@Zhejiang Xianju Pharmaceutical Co., Ltd. (1)

    06 NEWCHEM SpA@IMS . SrI@Henan Lihua Pharmaceutical Co., Ltd@Zhejiang Xianju Pharmaceutical Co., Ltd (1)

    07 NEWCHEM SpA@Microchem SRL (1)

    08 NEWCHEM SpA@Microchem Srl (2)

    09 NEWCHEM SpA@[Prednisolone Manufacturing Plant①]Henan Lihua Pharmaceutical Co.,Ltd.@[Prednisolone Manufacturing Plant②] Tianjin Tianyao Pharmaceuticals Co., Ltd@[Prednisolone Manufacturing Plant③]Zhejiang Xianju Pharmaceutical Co. Ltd. (1)

    10 NewChem SpA (5)

    11 Newchem SPA (1)

    12 Newchem SpA@MICROCHEM Srl (1)

    13 Newchem SpA@[Microchemical Manufacturing Company] Microchem SRL (1)

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    01 Italy (29)

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    Dieno Guest

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    Dongkook Pharmaceutical Co., Ltd.
    2020-02-13
    Number 437-1-ND
    Newchem SpA@[Microchemica...
    Italy
    Via Roveggia, 47-37136 Ve...
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    drospirenone

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    Sungjin Exim Co., Ltd.
    2021-03-12
    Wed133-13-ND
    NEWCHEM SpA@Microchem SRL
    Italy
    Via Roveggia, 47, 37136 V...
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    fluorometholone

    PDF Supplier PDF
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    Sungjin Exim Co., Ltd.
    2021-05-27
    20210527-211-J-1001
    NEWCHEM SpA@Microchem Srl
    Italy
    Via Roveggia, 47-37136 VE...
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    Lima Frost Alphadex

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    Sungjin Exim Co., Ltd.
    2021-12-06
    20211206-209-J-1170
    NEWCHEM SPA
    Italy
    Via Parco del Ticino, 10-...
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    Micronized budesonide

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    Sungjin Exim Co., Ltd.
    2022-03-15
    20220315-209-J-1249
    Newchem SpA@MICROCHEM Srl
    Italy
    Via Roveggia, 47-37136 Ve...
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    Micronized dienogest

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    Sungjin Exim Co., Ltd.
    2021-05-24
    Number 437-1-ND(1)
    NEWCHEM SpA@Microchem Srl
    Italy
    Via Roveggia, 47-37136 VE...
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    Prednicarbate

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    Sungjin Exim Co., Ltd.
    2020-06-05
    20200605-211-J-650
    NEWCHEM SpA@IMS . SrI@Hen...
    Italy
    Via Roveggia, 47-37136 Ve...
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    Prednisolone Valeroacetate

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    Ace Biopharm Co., Ltd.
    2017-01-11
    20111209-71-B-322-06(6)
    NEWCHEM SpA@[Prednisolone...
    Italy
    Via Roveggia, 47 Verona (...
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    Prednisolone Valeroacetate

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    Taegeuk Pharmaceutical Co., Ltd.
    2012-01-13
    20111209-71-B-322-06(1)
    NEWCHEM SpA@Henan Lihua P...
    Italy
    Via Roveggia, 47 Verona (...
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    Prednisolone Valeroacetate

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    Sama Pharmaceutical Co., Ltd.
    2014-04-24
    20111209-71-B-322-06(5)
    NEWCHEM SpA@Henan Lihua P...
    Italy
    Via Roveggia, 47 Verona (...
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