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    List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Lek Pharmaceuticals by EDQM. Original Data: EDQM Database

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    01 Amlodipine besilate (1)

    02 Gentamicin sulfate (1)

    03 Lisinopril dihydrate (1)

    04 Lovastatin (1)

    05 Mycophenolate mofetil (1)

    06 Mycophenolate mofetil, Process B (1)

    07 Omeprazole (1)

    08 Omeprazole, Process B (1)

    09 Potassium clavulanate (1)

    10 Potassium clavulanate, Code Number 472803 (1)

    11 Potassium clavulanate, diluted, with microcrystalline cellulose in a ratio of 1:1 (1)

    12 Potassium clavulanate, diluted, with microcrystalline cellulose in the ratio 1:1 (1)

    13 Potassium clavulanate, diluted, with microcrystalline cellulose in the ratio 7:3 (1)

    14 Potassium clavulanate, diluted, with silica, colloidal hydrated in the ratio 1:1 (2)

    15 Pravastatin sodium (1)

    16 Rosuvastatin calcium, Process C (1)

    17 Simvastatin (1)

    18 Tacrolimus monohydrate (1)

    19 Vancomycin hydrochloride (1)

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    01 LEK PHARMACEUTICALS D.D. Ljubljana SI (20)

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    01 Slovenia (20)

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    01 Expired (1)

    02 Valid (11)

    03 Withdrawn by Holder (8)

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    Amlodipine besilate

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    LEK PHARMACEUTICALS D.D...
    Withdrawn by Holder
    R1-CEP 2004-210 - Rev 00
    Chemical
    2011-07-01
    2016-01-14
    1491
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    Gentamicin sulfate

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    LEK PHARMACEUTICALS D.D...
    Valid
    R1-CEP 2005-121 - Rev 01
    Chemical
    2016-02-03
    331
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    Lisinopril dihydrate

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    LEK PHARMACEUTICALS D.D...
    Withdrawn by Holder
    R0-CEP 2006-065 - Rev 00
    Chemical
    2008-08-12
    2012-12-13
    1120
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    Lovastatin

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    LEK PHARMACEUTICALS D.D...
    Withdrawn by Holder
    R0-CEP 2005-140 - Rev 00
    Chemical
    2007-12-07
    2010-02-02
    1538
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    Mycophenolate mofetil

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    LEK PHARMACEUTICALS D.D...
    Withdrawn by Holder
    R1-CEP 2005-222 - Rev 02
    Chemical
    2016-10-13
    2018-04-03
    1700
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    Mycophenolate mofetil, Process B

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    LEK PHARMACEUTICALS D.D...
    Valid
    R1-CEP 2011-317 - Rev 05
    Chemical
    2023-08-07
    1700
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    Omeprazole

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    LEK PHARMACEUTICALS D.D...
    Withdrawn by Holder
    R1-CEP 2004-101 - Rev 02
    Chemical
    2013-04-18
    2015-06-09
    942
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    Omeprazole, Process B

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    LEK PHARMACEUTICALS D.D...
    Expired
    R0-CEP 2010-250 - Rev 01
    Chemical
    2013-04-18
    2016-02-11
    942
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    Potassium clavulanate

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    LEK PHARMACEUTICALS D.D...
    Valid
    R1-CEP 2003-262 - Rev 03
    Chemical
    2020-06-17
    1140
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    Potassium clavulanate, Code Number 472803

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    LEK PHARMACEUTICALS D.D...
    Valid
    R1-CEP 1998-001 - Rev 09
    Chemical
    2020-02-25
    1140
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