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    List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Lek Pharmaceuticals to the Review Authority in Japan (PMDA). Original Data : PMDA

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    01 Amlodipine besylate "FIA" (1)

    02 Atorvastatin calcium hydrate (1)

    03 Bromocriptine mesylate (1)

    04 Candesartan cilexetil (1)

    05 Gentamicin sulfate (1)

    06 Lithium carbonate (1)

    07 Rosuvastatin calcium (1)

    08 Vancomycin Hydrochloride (1)

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    01 Lek Pharmaceuticals d. d. (4)

    02 Novartis Pharmaceutical Manufacturing LLC (4)

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    01 Slovenia (8)

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    Amlodipine besylate "FIA"

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    Novartis Pharmaceutical M...
    2022-01-20
    2010-05-17
    222MF10151
    Verovskova ulica 57, 1000...
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    Atorvastatin calcium hydrate

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    Novartis Pharmaceutical M...
    2019-11-15
    2010-09-24
    222MF10232
    Verovskova ulica 57, 1000...
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    Bromocriptine mesylate

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    Lek Pharmaceuticals d. d.
    2009-03-16
    2009-03-16
    221MF10054
    Verovskova 57, SI-1526 Lj...
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    Candesartan cilexetil

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    Novartis Pharmaceutical M...
    2022-11-24
    2013-07-25
    225MF10145
    Verovskova ulica 57, 1000...
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    Gentamicin sulfate

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    Lek Pharmaceuticals d. d.
    2017-06-15
    2008-02-05
    220MF10041
    Verovskova ulica 57, 1526...
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    Lithium carbonate

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    Novartis Pharmaceutical M...
    2007-05-15
    2005-09-06
    217MF10493
    Verovskova ulica 57, 1000...
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    Rosuvastatin calcium

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    Lek Pharmaceuticals d. d.
    2016-08-08
    2016-08-08
    228MF10155
    Verovskova ulica 57, 1526...
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    Vancomycin Hydrochloride

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    Lek Pharmaceuticals d. d.
    2007-01-22
    2005-10-07
    217MF10740
    Verovskova 57, SI-1526 Lj...
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