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

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    COSMA S.p.A
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    Via Colleoni 15-17, 24040 Ciserano (BG)
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    +39 035 883 055
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    • FDA
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    Acebrophylline (ambroxol acephyllate)

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    Hyundai Pharmaceutical Co., Ltd.
    2011-10-21
    20110729-152-I-15-06(1)
    AMSA SpA
    Italy
    Via G. Di Vittorio, 6 221...
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    Acebrophylline (ambroxol acephyllate)

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    Sungjin Exim Co., Ltd.
    2011-07-29
    20110729-152-I-15-06
    AMSA SpA,
    Italy
    Via G. Di Vittorio, 6 221...
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    • FDA
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    Cetirizine hydrochloride

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    Samil Pharmaceutical Co., Ltd.
    2021-03-25
    20210325-40-C-393-21
    COSMA SPA
    Italy
    Via Colleoni, 15/17 - 240...
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    • FDA
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    Levodropropizine

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    Hyundai Pharmaceutical Co., Ltd.
    2015-09-09
    20131029-137-H-241-10(3)
    Clarochem Ireland Ltd.
    Ireland
    Damastown, Mulhuddart, Du...
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    • FDA
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    Levodropropizine

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    Hyundai Pharmaceutical Co., Ltd.
    2011-01-31
    20110131-137-H-105-07
    AMSA - ANONIMA MATERIE SI...
    Italy
    VIA G. DI VITTORIO. 6, 22...
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    • FDA
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    Levodropropizine

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    Good Pharma Co., Ltd.
    2013-12-30
    20131029-137-H-241-10(1)
    Clarochem Ireland Ltd.
    Ireland
    Damastown, Mulhuddart, Du...
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    • FDA
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    Levodropropizine

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    Sampoong Finechem Co., Ltd.
    2022-11-15
    20131029-137-H-241-10(4)
    Clarochem Ireland Ltd.
    Ireland
    Damastown, Mulhuddart, Du...
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    • FDA
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    Levodropropizine

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    Pharmaking Co., Ltd.
    2015-05-22
    20131029-137-H-241-10(2)
    Clarochem Ireland Ltd.
    Ireland
    Damastown, Mulhuddart, Du...
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    • FDA
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    Levodropropizine

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    Goodwills Co., Ltd.
    2013-10-29
    20131029-137-H-241-10
    Clarochem Ireland Ltd.
    Ireland
    Damastown, Mulhuddart, Du...
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    • FDA
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    Meloxicam

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    IMCD Korea Co., Ltd.
    2012-11-09
    20120106-148-I-39-16(1)
    AMSA SpA
    Italy
    Via G. di Vittorio, 6 221...
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    • FDA
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    Meloxicam

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    Good Pharma Co., Ltd.
    2012-01-06
    20120106-148-I-39-16
    AMSASpA
    Italy
    Via G. di Vittorio, 6 221...
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    • FDA
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    Metoclopramide

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    Dongwha Pharmaceutical Co., Ltd.
    2022-03-17
    20220317-209-J-1251
    AMSA - ANONIMA MATERIE SI...
    Italy
    VIA G. di VITTORIO, 6 - 2...
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    • FDA
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    Milnacipran hydrochloride

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    Goodwills Co., Ltd.
    2020-06-25
    20200625-211-J-545
    Cosma SpA
    Italy
    Via Colleoni 15/17 - 2404...
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    • FDA
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    Tyropramide hydrochloride

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    Daewoong Pharmaceutical Co., Ltd.
    2004-08-31
    20050831-50-C-164-04
    COSMA SpA
    Italy
    COSMA SpA Via Colleoni 15...
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