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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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    Krka
    Slovenia Flag
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    Slovenia
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    Smarjeska cesta 6, 8501 Novo mesto
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    +386 7 331 21 11
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    enquiries@pharmacompass.com
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    https://www.krka.si/sl/
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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

    PDF Supplier PDF
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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    Withdrawn by Holder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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    Clopidogrel hydrogen sulfate

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    KRKA, d.d., Novo mesto ...
    Valid
    CEP 2014-027 - Rev 03
    Chemical
    2023-12-12
    2531
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    Duloxetine hydrochloride

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    KRKA, d.d., Novo mesto ...
    Valid
    R1-CEP 2015-246 - Rev 00
    Chemical
    2022-03-01
    2594
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    Enalapril maleate

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R1-CEP 2000-212 - Rev 02
    Chemical
    2010-09-10
    1420
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    Esomeprazole magnesium dihydrate

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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2018-035 - Rev 02
    Chemical
    2023-01-05
    2787
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    Losartan potassium

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2019-275 - Rev 00
    Chemical
    2022-03-17
    2232
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    Losartan potassium, 318642

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    KRKA, d.d., Novo mesto ...
    Valid
    CEP 2023-323 - Rev 00
    Chemical
    2024-02-16
    2232
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    Lovastatin

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Withdrawn by Holder
    R1-CEP 2004-191 - Rev 01
    Chemical
    2010-12-02
    2016-12-02
    1538
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    Norfloxacin

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    KRKA, d.d., Novo mesto ...
    Withdrawn by Holder
    R1-CEP 2000-270 - Rev 04
    Chemical
    2013-03-14
    2021-01-26
    1248
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    Norfloxacin, Product code 312008

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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2021-140 - Rev 00
    Chemical
    2022-12-20
    1248
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    Norfloxacin, Product code 312025

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    KRKA, d.d., Novo mesto ...
    Valid
    CEP 2021-141 - Rev 01
    Chemical
    2024-02-06
    1248
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    Olmesartan medoxomil

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R1-CEP 2015-259 - Rev 00
    Chemical
    2021-09-15
    2600
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    Oxytetracycline dihydrate

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Withdrawn by Holder
    R1-CEP 1999-133 - Rev 01
    Chemical
    2007-07-31
    2007-10-25
    199
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    Oxytetracycline dihydrate

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    KRKA, d.d., Novo mesto ...
    Withdrawn by Holder
    R0-CEP 2003-274 - Rev 00
    Chemical
    2005-09-30
    2007-10-25
    199
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    Pantoprazole sodium sesquihydrate

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R1-CEP 2013-227 - Rev 01
    Chemical
    2023-07-13
    2296
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    Perindopril tert-butylamine, Code 301644

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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2019-245 - Rev 01
    Chemical
    2022-03-07
    2019
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    Perindopril tert-butylamine, Code 302281

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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2019-235 - Rev 00
    Chemical
    2021-09-22
    2019
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    Rabeprazole sodium hydrate

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2018-140 - Rev 01
    Chemical
    2022-10-17
    2331
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    Rivaroxaban

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    CEP 2021-231 - Rev 01
    Chemical
    2023-11-07
    2932
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    Rivaroxaban

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2021-232 - Rev 01
    Chemical
    2023-05-11
    2932
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    Rosuvastatin calcium

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2018-077 - Rev 02
    Chemical
    2023-02-10
    2631
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    Simvastatin

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Withdrawn by Holder
    R1-CEP 2006-298 - Rev 00
    Chemical
    2012-10-08
    2017-09-13
    1563
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    Simvastatin

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Withdrawn by Holder
    R1-CEP 2001-212 - Rev 00
    Chemical
    2007-04-10
    2009-06-01
    1563
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    Telmisartan

    PDF Supplier PDF
    URL Supplier Web Content
    KRKA, d.d., Novo mesto ...
    Valid
    R1-CEP 2015-307 - Rev 01
    Chemical
    2023-05-30
    2154
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    Telmisartan, 315519

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2021-254 - Rev 00
    Chemical
    2021-12-08
    2154
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    Telmisartan, 315780

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R0-CEP 2021-280 - Rev 00
    Chemical
    2021-11-30
    2154
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    Valsartan

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R1-CEP 2011-148 - Rev 04
    Chemical
    2023-01-27
    2423
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    Venlafaxine hydrochloride

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    R1-CEP 2005-264 - Rev 03
    Chemical
    2018-09-20
    2119
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    Ticagrelor, Micronized

    PDF Supplier PDF
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    KRKA, d.d., Novo mesto ...
    Valid
    CEP 2022-437 - Rev 00
    Chemical
    2024-03-01
    3087
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