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

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    01 Acetazolamide (1)

    02 Aripiprazole (1)

    03 Baclofen (1)

    04 Carbamazepine (1)

    05 Carbamazepine, Crystallised in ethanol (1)

    06 Carvedilol (1)

    07 Etodolac (1)

    08 Hydrochlorothiazide (1)

    09 Ibandronate sodium monohydrate (1)

    10 Ibandronate sodium monohydrate, Type I (1)

    11 Lamotrigine (1)

    12 Pentoxifylline (1)

    13 Piracetam (1)

    14 Risedronate sodium 2.5-hydrate (1)

    15 Rivaroxaban, Micronised (1)

    16 Sildenafil citrate, Process A (1)

    17 Sildenafil citrate, Process B (1)

    18 Sodium alendronate trihydrate (1)

    19 Solifenacin succinate (1)

    20 Tadalafil (1)

    21 Ticagrelor (1)

    22 Tolterodine tartrate (1)

    23 Vardenafil hydrochloride trihydrate (1)

    24 Zoledronic acid monohydrate (1)

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    01 PHARMACEUTICAL WORKS POLPHARMA S.A. Starogard Gdanski PL (20)

    02 ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL (4)

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    01 Gabon (3)

    02 Poland (21)

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    01 Valid (24)

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    • FDA
    • EDQM
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Digital Content Digital Content

    Acetazolamide

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    PHARMACEUTICAL WORKS PO...
    Valid
    R1-CEP 2010-371 - Rev 02
    Chemical
    2020-08-04
    454
    Polpharma CB

    CPhI North America

    Booth # 814

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    • FDA
    • EDQM
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Aripiprazole

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    PHARMACEUTICAL WORKS PO...
    Valid
    R1-CEP 2013-230 - Rev 02
    Chemical
    2023-03-17
    2617
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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    • FDA
    • EDQM
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Flag Poland
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Baclofen

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, Brazil
    PHARMACEUTICAL WORKS PO...
    Valid
    R1-CEP 2010-316 - Rev 04
    Chemical
    2021-03-03
    653
    Polpharma CB

    CPhI North America

    Booth # 814

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    • FDA
    • EDQM
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Carbamazepine

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    PHARMACEUTICAL WORKS PO...
    Valid
    R1-CEP 2004-141 - Rev 03
    Chemical
    2022-04-25
    543
    Polpharma CB

    CPhI North America

    Booth # 814

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    • FDA
    • EDQM
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Carbamazepine, Crystallised in ethanol

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    URL Supplier Web Content
    Other DMF EU
    PHARMACEUTICAL WORKS PO...
    Valid
    R1-CEP 2012-353 - Rev 01
    Chemical
    2021-01-21
    543
    Polpharma CB

    CPhI North America

    Booth # 814

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    • FDA
    • EDQM
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Carvedilol

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    PHARMACEUTICAL WORKS PO...
    Valid
    R1-CEP 2002-258 - Rev 08
    Chemical
    2021-10-22
    1745
    Polpharma CB

    CPhI North America

    Booth # 814

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    • FDA
    • EDQM
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Etodolac

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    URL Supplier Web Content
    Other DMF EU, Canada, Brazil
    PHARMACEUTICAL WORKS PO...
    Valid
    R1-CEP 2013-134 - Rev 02
    Chemical
    2023-02-07
    1422
    Polpharma CB

    CPhI North America

    Booth # 814

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    • FDA
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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Hydrochlorothiazide

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    Other DMF EU, China, Canada, Bra...
    ZAKŁADY FARMACEUTYCZNE...
    Valid
    CEP 2004-058 - Rev 05
    Chemical
    2024-01-19
    394
    Polpharma CB

    CPhI North America

    Booth # 814

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    • FDA
    • EDQM
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Ibandronate sodium monohydrate

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    URL Supplier Web Content
    Other DMF EU, China
    PHARMACEUTICAL WORKS PO...
    Valid
    R0-CEP 2022-073 - Rev 00
    Chemical
    2023-02-20
    2771
    Polpharma CB

    CPhI North America

    Booth # 814

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    • FDA
    • EDQM
    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    Ibandronate sodium monohydrate, Type I

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    Other DMF EU, China
    PHARMACEUTICAL WORKS PO...
    Valid
    R0-CEP 2023-077 - Rev 00
    Chemical
    2023-06-30
    2771
    Polpharma CB

    CPhI North America

    Booth # 814

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