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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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    NEWCHEM SPA
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    Via E. De Amicis, 47 20123 Milano
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    +39 02 58.15.16
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    Dieno Guest

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    Dongkook Pharmaceutical Co., Ltd.
    2020-02-13
    Number 437-1-ND
    Newchem SpA@[Microchemica...
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    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

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    Sungjin Exim Co., Ltd.
    2021-05-27
    20210527-211-J-1001
    NEWCHEM SpA@Microchem Srl
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    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
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    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
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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
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    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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    Sungjin Exim Co., Ltd.
    2011-12-09
    20111209-71-B-322-06
    NEWCHEM SpA@Henan Lihua P...
    Italy
    Via Roveggia, 47 Verona (...
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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...
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    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...
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    Via Roveggia, 47 Verona (...
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    Tibolone

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    Sungjin Exim Co., Ltd.
    2021-07-15
    20210715-140-H-391-05
    Newchem SPA
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    Via Roveggia, 47-37136 VE...
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    triamcinolone

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    Chodang Pharmaceutical Industry Co., Ltd.
    2013-03-08
    20080829-65-B-249-04(4)
    NewChem SpA
    Italy
    Via Roveggia, 47 Verona
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    triamcinolone

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    Sungjin Exim Co., Ltd.
    2008-08-29
    20080829-65-B-249-04
    NewChem SpA
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    Via Roveggia, 47 Verona I...
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    triamcinolone

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    Hwail Pharmaceutical Co., Ltd.
    2011-06-15
    20080829-65-B-249-04(3)
    NewChem SpA
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    Via Roveggia, 47 Verona I...
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    triamcinolone

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    Daesin Pharmaceutical Co., Ltd.
    2011-05-16
    20080829-65-B-249-04(2)
    NEWCHEM SpA
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    Via Roveggia, 47 Verona I...
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    triamcinolone

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    IMCD Korea Co., Ltd.
    2011-05-16
    20080829-65-B-249-04(1)
    NEWCHEM SpA
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    Via Roveggia, 47 Verona I...
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    Triamcinolone acetonide

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    Sungjin Exim Co., Ltd.
    2011-03-15
    20110315-65-B-311-05
    NEWCHEM SpA
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    Via Roveggia, 47 Verona, ...
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    Triamcinolone acetonide

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    Dongkwang Pharmaceutical Co., Ltd.
    2011-06-15
    20110315-65-B-311-05(6)
    NEWCHEM SpA
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    Via Roveggia, 47 Verona, ...
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    Triamcinolone acetonide

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    Hwail Pharmaceutical Co., Ltd.
    2011-06-15
    20110315-65-B-311-05(5)
    NewChem SpA
    Italy
    Via Roveggia, 47 Verona
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    Triamcinolone acetonide

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    Daesin Pharmaceutical Co., Ltd.
    2011-05-16
    20110315-65-B-311-05(4)
    NEWCHEM SpA
    Italy
    Via Roveggia 47 Verona It...
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    Triamcinolone acetonide

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    Sungwoo Chemical Co., Ltd.
    2011-05-16
    20110315-65-B-311-05(1)
    NewChem SpA
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    Via Roveggia, 47 Verona, ...
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    Triamcinolone acetonide

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    IMCD Korea Co., Ltd.
    2011-05-16
    20110315-65-B-311-05(2)
    NEWCHEM SpA
    Italy
    Via Roveggia, 47 Verona, ...
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    Triamcinolone acetonide

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    Pharmapia Co., Ltd.
    2011-05-16
    20110315-65-B-311-05(3)
    NEWCHEM SpA
    Italy
    Via Roveggia, 47 Verona, ...
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    Triamcinolone acetonide

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    Ace Biopharm Co., Ltd.
    2021-03-23
    20110315-65-B-311-05(7)
    NEWCHEM SpA
    Italy
    Via Roveggia, 47 Verona, ...
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    Valerian acid Prednisolone acetic acid

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    IMCD Korea Co., Ltd.
    2012-02-03
    20111209-71-B-322-06(3)
    NEWCHEM SpA@Henan Lihua P...
    Italy
    Via Roveggia, 47 Verona (...
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    Valerian acid Prednisolone acetic acid

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    Anguk Pharmaceutical Co., Ltd.
    2012-01-20
    20111209-71-B-322-06(2)
    NEWCHEM SpA
    Italy
    Via Roveggia, 47 Verona (...
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    Veraprost Sodium

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    Sungjin Exim Co., Ltd.
    2022-03-28
    20220328-209-J-1255
    NEWCHEM SPA
    Italy
    Via Parco del Ticino, 10-...
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    Veraprost Sodium

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    Unimed Pharmaceutical Co., Ltd.
    2022-05-17
    20220328-209-J-1255(1)
    NEWCHEM SPA
    Italy
    Via Parco del Ticino, 10-...
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