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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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    01 Acebrophylline (ambroxol acephyllate) (2)

    02 Cetirizine hydrochloride (1)

    03 Levodropropizine (6)

    04 Meloxicam (2)

    05 Metoclopramide (1)

    06 Milnacipran hydrochloride (1)

    07 Tyropramide hydrochloride (1)

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    01 Daewoong Pharmaceutical Co., Ltd. (1)

    02 Dongwha Pharmaceutical Co., Ltd. (1)

    03 Good Pharma Co., Ltd. (2)

    04 Goodwills Co., Ltd. (2)

    05 Hyundai Pharmaceutical Co., Ltd. (3)

    06 IMCD Korea Co., Ltd. (1)

    07 Pharmaking Co., Ltd. (1)

    08 Samil Pharmaceutical Co., Ltd. (1)

    09 Sampoong Finechem Co., Ltd. (1)

    10 Sungjin Exim Co., Ltd. (1)

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    01 AMSA - ANONIMA MATERIE SINTETICHE & AFFINI SPA (2)

    02 AMSA SpA (2)

    03 AMSA SpA, (1)

    04 AMSASpA (1)

    05 COSMA SPA (1)

    06 COSMA SpA (1)

    07 Clarochem Ireland Ltd. (5)

    08 Cosma SpA (1)

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    01 Ireland (5)

    02 Italy (9)

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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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    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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    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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    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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    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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    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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    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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    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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    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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