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

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    01 Amlodipine besilate (1)

    02 Amlodipine besilate, 311302 (1)

    03 Atorvastatin calcium (1)

    04 Atorvastatin calcium, 315313 (1)

    05 Atorvastatin calcium, 317500 (1)

    06 Bacitracin zinc (1)

    07 Candesartan cilexetil (1)

    08 Carvedilol (1)

    09 Clopidogrel hydrochloride (1)

    10 Clopidogrel hydrochloride, 313814 (1)

    11 Clopidogrel hydrogen sulfate (1)

    12 Duloxetine hydrochloride (1)

    13 Enalapril maleate (1)

    14 Esomeprazole magnesium dihydrate (1)

    15 Losartan potassium (1)

    16 Losartan potassium, 318642 (1)

    17 Lovastatin (1)

    18 Norfloxacin (1)

    19 Norfloxacin, Product code 312008 (1)

    20 Norfloxacin, Product code 312025 (1)

    21 Olmesartan medoxomil (1)

    22 Oxytetracycline dihydrate (2)

    23 Pantoprazole sodium sesquihydrate (1)

    24 Perindopril tert-butylamine, Code 301644 (1)

    25 Perindopril tert-butylamine, Code 302281 (1)

    26 Rabeprazole sodium hydrate (1)

    27 Rivaroxaban (2)

    28 Rosuvastatin calcium (1)

    29 Simvastatin (2)

    30 Telmisartan (1)

    31 Telmisartan, 315519 (1)

    32 Telmisartan, 315780 (1)

    33 Ticagrelor, Micronized (1)

    34 Valsartan (1)

    35 Venlafaxine hydrochloride (1)

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    01 KRKA, d.d., Novo mesto Novo mesto SI (38)

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    01 Slovenia (38)

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    01 Valid (31)

    02 Withdrawn by Holder (7)

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    Amlodipine besilate

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    KRKA, d.d., Novo mesto ...
    Valid
    R1-CEP 2014-243 - Rev 01
    Chemical
    2021-05-11
    1491
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    Amlodipine besilate, 311302

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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2022-449 - Rev 00
    Chemical
    2023-01-19
    1491
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    Atorvastatin calcium

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    KRKA, d.d., Novo mesto ...
    Valid
    R1-CEP 2013-024 - Rev 01
    Chemical
    2020-05-28
    2191
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    Atorvastatin calcium, 315313

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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2021-105 - Rev 01
    Chemical
    2022-01-28
    2191
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    Atorvastatin calcium, 317500

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    KRKA, d.d., Novo mesto ...
    Valid
    CEP 2023-270 - Rev 01
    Chemical
    2024-02-06
    2191
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    Bacitracin zinc

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    KRKA, d.d., Novo mesto ...
    Withdrawn by Holder
    R0-CEP 2006-052 - Rev 00
    Chemical
    2008-11-07
    2013-11-19
    466
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    Candesartan cilexetil

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    KRKA, d.d., Novo mesto ...
    Valid
    CEP 2016-132 - Rev 01
    Chemical
    2024-02-19
    2573
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    Carvedilol

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    KRKA, d.d., Novo mesto ...
    Valid
    R1-CEP 2001-294 - Rev 04
    Chemical
    2015-01-28
    1745
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    Clopidogrel hydrochloride

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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2018-251 - Rev 00
    Chemical
    2020-01-10
    2791
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    Clopidogrel hydrochloride, 313814

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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2020-254 - Rev 01
    Chemical
    2022-12-20
    2791
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