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

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    01 Atorvastatin Calcium (3)

    02 Atorvastatin calcium hydrate (1)

    03 Dapagliflozin propanediol hydrate (2)

    04 Fexofenadine Hydrochloride (1)

    05 Vonoprazan fumarate (1)

    06 montelukast sodium (3)

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    01 Bahnsen Co., Ltd. (1)

    02 Boryeong Co., Ltd. (1)

    03 Chemipharm Co., Ltd. (3)

    04 Hyundai Bioland Co., Ltd. (1)

    05 Inist Farm Co., Ltd. (1)

    06 Mpeak Korea Co., Ltd. (1)

    07 Samo Pharmaceutical Co., Ltd. (2)

    08 Sandoz Korea Co., Ltd. (1)

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    01 Morepen Laboratories Limited (11)

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    01 India (11)

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    Atorvastatin Calcium

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    Chemipharm Co., Ltd.
    2021-03-25
    20150824-132-H-281-31(3)
    Morepen Laboratories Limi...
    India
    (Morepen Village)Vill. Ma...
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    Atorvastatin Calcium

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    Chemipharm Co., Ltd.
    2015-08-24
    20150824-132-H-281-31
    Morepen Laboratories Limi...
    India
    (Morepen Village) Vill. M...
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    Atorvastatin Calcium

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    Inist Farm Co., Ltd.
    2016-04-04
    20150824-132-H-281-31(1)
    Morepen Laboratories Limi...
    India
    (Morepen Village)Vill. Ma...
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    Atorvastatin calcium hydrate

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    Sandoz Korea Co., Ltd.
    2020-08-27
    20200827-132-H-370-46
    Morepen Laboratories Limi...
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    (Morepen Village)Village ...
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    Dapagliflozin propanediol hydrate

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    Mpeak Korea Co., Ltd.
    2024-05-01
    Number 720-9-ND(1)
    Morepen Laboratories Limi...
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    Dapagliflozin propanediol hydrate

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    Bahnsen Co., Ltd.
    2023-06-20
    Number 720-9-ND
    Morepen Laboratories Limi...
    India
    (Morepen Village)Vill. Ma...
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    Fexofenadine Hydrochloride

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    Samo Pharmaceutical Co., Ltd.
    2024-05-01
    20240501-209-J-1622
    Morepen Laboratories Limi...
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    (Morepen Village)Vill. Ma...
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    montelukast sodium

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    Hyundai Bioland Co., Ltd.
    2023-03-03
    20190226-209-J-182(2)
    Morepen Laboratories Limi...
    India
    Village-Masulkhana, Parwa...
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    montelukast sodium

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    Boryeong Co., Ltd.
    2019-03-14
    20190226-209-J-182(1)
    Morepen Laboratories Limi...
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    Village-Masulkhana, Parwa...
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    montelukast sodium

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    Chemipharm Co., Ltd.
    2019-02-26
    20190226-209-J-182
    Morepen Laboratories Limi...
    India
    Village-Masulkhana, Parwa...
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