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

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    01 Afatinib dimaleate (1)

    02 Ambroxol hydrochloride (1)

    03 Dabigatran etexilate mesylate (2)

    04 Empagliflozin (2)

    05 Epinastine hydrochloride (1)

    06 Ipratropium bromide (1)

    07 Linagliptin (micronized) (4)

    08 Meloxicam (1)

    09 Nintedanib esylate (2)

    10 Olodaterol hydrochloride (1)

    11 Phenylephrine hydrochloride (1)

    12 Pramipexole hydrochloride monohydrate (1)

    13 repaglinide (1)

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    01 Boehringer Ingelheim Korea Co., Ltd. (16)

    02 GlaxoSmithKline Consumer Healthcare Korea Co., Ltd. (1)

    03 Novo Nordisk Pharmaceutical Co., Ltd. (1)

    04 Opella Healthcare Korea Co., Ltd. (1)

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    01 (Excluding micronization process) Bidachem SpA@ (micronization manufacturing plant 1) Boehringer Ingelheim Pharma GmbH & Co. KG@(micronization manufacturing plant 2) Gesellschaft fur Micronisierung mbH (1)

    02 Bidachem SpA (4)

    03 Bidachem SpA@Boehringer Ingelheim Pharma GmbH & Co KG (1)

    04 Bidachem SpA@Gesellschaft fur Micronisierung mbH (1)

    05 Boehringer Ingelheim GmbH & Co.KG (1)

    06 Boehringer Ingelheim Pharma GmbH & Co KG (1)

    07 Boehringer Ingelheim Pharma GmbH & Co. K.G. (9)

    08 Boehringer Ingelheim Pharma GmbH & Co. KG@Gesellschaft fur Micronisierung mbH (1)

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    01 Germany (12)

    02 Italy (7)

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    Afatinib dimaleate

    PDF Supplier PDF
    URL Supplier Web Content
    Boehringer Ingelheim Korea Co., Ltd.
    2013-09-27
    Wed2807-4-ND
    Boehringer Ingelheim Phar...
    Germany
    Binger Straße 173, D-552...
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    Ambroxol hydrochloride

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    Opella Healthcare Korea Co., Ltd.
    2005-08-31
    20050831-45-B-117-04
    Bidachem SpA
    Italy
    SS 11(Padana Superiore), ...
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    Dabigatran etexilate mesylate

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    Boehringer Ingelheim Korea Co., Ltd.
    2010-10-11
    Number 426-2-ND
    Bidachem SpA
    Italy
    Strada Statale 11 (Padana...
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    Dabigatran etexilate mesylate

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    Boehringer Ingelheim Korea Co., Ltd.
    2010-10-11
    Number 426-1-ND
    Boehringer Ingelheim Phar...
    Germany
    Binger Strasse 173, 55216...
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    Empagliflozin

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    Boehringer Ingelheim Korea Co., Ltd.
    2014-05-21
    Wed2807-5-ND
    Boehringer Ingelheim Phar...
    Germany
    Binger Straβe 173, D-552...
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    Empagliflozin

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    Boehringer Ingelheim Korea Co., Ltd.
    2018-01-15
    Wed 15-8-ND
    (Excluding micronization ...
    Italy
    Strada Statale 11 (Padana...
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    Epinastine hydrochloride

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    Boehringer Ingelheim Korea Co., Ltd.
    2013-01-09
    20130109-194-I-63-01
    Boehringer Ingelheim GmbH...
    Germany
    Binger Strasse 173 55216 ...
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    Ipratropium bromide

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    Boehringer Ingelheim Korea Co., Ltd.
    2012-09-19
    20120919-188-I-64-01
    Boehringer Ingelheim Phar...
    Germany
    Binger Strasse 173, 55216...
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    Linagliptin (micronized)

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    Boehringer Ingelheim Korea Co., Ltd.
    2022-04-06
    Wed 15-9-ND
    Bidachem SpA@Boehringer I...
    Italy
    Strada Statale 11 (Padana...
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    Linagliptin (micronized)

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    URL Supplier Web Content
    Boehringer Ingelheim Korea Co., Ltd.
    2022-04-06
    Wed 15-10-ND
    Bidachem SpA@Gesellschaft...
    Italy
    Strada Statale 11 (Padana...
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