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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Polpharma

    Client Virtual Booth

    POLPHARMA

    EVENTS

    • Webinars & Exhibitions

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    VIDEO(s)

    DIGITAL CONTENT

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    DOSSIERs // Finished Dosage Formulations

    Key Products KEY PRODUCTS

    • Alendronate Sodium

    • Apixaban

    • Baclofen

    • Dapagliflozin

    • Dapagliflozin Propanediol Monohydrate

    • Empagliflozin

    • Hydrochlorothiazide

    • Isavuconazonium Sulfate

    • Linagliptin

    • Pentoxifylline

    • Piracetam

    • Rivaroxaban

    • Tadalafil

    • Ticagrelor

    • Zoledronic Acid

    SERVICES

    Key Products KEY SERVICES

    • API Development Services

    • Scale Up

    • Cryogenic Reactions

    INSPECTIONS & REGISTRATIONS

    PharmaCompass
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    polpharma api
    Polpharma
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    Country
    Country
    Poland
    Address
    Address
    Pelplińska 19, 83-200 Starogard Gdański
    Telephone
    Telephone
    +48 585 631 600
    Client Email
    Email
    api@polpharma.com
    Client Website
    Website
    https://www.api.polpharma.com/
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    https://www.linkedin.com/company/polpharma-api/
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    Twitter
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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.

    Alendronate Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16962
    Active
    SODIUM ALENDRONATE
    2003-11-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-273 - Rev 04
    Valid
    Sodium alendronate trihydrate
    2021-05-12
    Japanese DMF

    Found JDMF

    220MF10241
    Alendronate sodium hydrate at 19 Pe...
    2008-12-04
    Written Confirmation

    Close WC

    Application Number
    16962
    R1-CEP 2003-273 - Rev 04
    220MF10241
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SODIUM ALENDRONATE
    Sodium alendronate trihydrate
    Alendronate sodium hydrate at 19 Pe...
    Issue/Submission Date
    2003-11-17
    2021-05-12
    2008-12-04
    Polpharma Company Banner

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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.

    Baclofen

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    USDMF

    Found USDMF

    18014
    Active
    BACLOFEN
    2005-01-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-316 - Rev 04
    Valid
    Baclofen
    2021-03-03
    Japanese DMF

    Found JDMF

    230MF10014
    Baclofen at 19 Pelplinska Str. 83-2...
    2018-01-30
    Written Confirmation

    Close WC

    Application Number
    18014
    R1-CEP 2010-316 - Rev 04
    230MF10014
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BACLOFEN
    Baclofen
    Baclofen at 19 Pelplinska Str. 83-2...
    Issue/Submission Date
    2005-01-20
    2021-03-03
    2018-01-30
    Polpharma Company Banner

    IOPC 2023

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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.

    Etodolac

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    USDMF

    Found USDMF

    11405
    Active
    ETODOLAC
    1995-03-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-134 - Rev 02
    Valid
    Etodolac
    2023-02-07
    Japanese DMF

    Found JDMF

    225MF10101
    Etodolac at 19 Pelplinska Str. 83-2...
    2013-05-10
    Written Confirmation

    Close WC

    Application Number
    11405
    R1-CEP 2013-134 - Rev 02
    225MF10101
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ETODOLAC
    Etodolac
    Etodolac at 19 Pelplinska Str. 83-2...
    Issue/Submission Date
    1995-03-29
    2023-02-07
    2013-05-10
    Polpharma Company Banner

    IOPC 2023

    Attending

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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.

    Hydrochlorothiazide

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    USDMF

    Found USDMF

    17599
    Active
    HYDROCHLOROTHIAZIDE
    2004-08-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-058 - Rev 03
    Valid
    Hydrochlorothiazide
    2022-07-29
    Japanese DMF

    Found JDMF

    218MF11020
    HYDROCHLOROTHIAZIDE at 19 Pelplinsk...
    2006-12-28
    Written Confirmation

    Close WC

    Application Number
    17599
    R1-CEP 2004-058 - Rev 03
    218MF11020
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROCHLOROTHIAZIDE
    Hydrochlorothiazide
    HYDROCHLOROTHIAZIDE at 19 Pelplinsk...
    Issue/Submission Date
    2004-08-12
    2022-07-29
    2006-12-28
    Polpharma Company Banner

    IOPC 2023

    Attending

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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.

    Ibandronate Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25638
    Active
    IBANDRONATE SODIUM MONOHYDRATE
    2011-12-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-073 - Rev 00
    Valid
    Ibandronate sodium monohydrate
    2023-02-20
    Japanese DMF

    Found JDMF

    303MF10116
    Ibandronate Sodium Hydrate at 19 Pe...
    2021-07-20
    Written Confirmation

    Close WC

    Application Number
    25638
    R0-CEP 2022-073 - Rev 00
    303MF10116
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IBANDRONATE SODIUM MONOHYDRATE
    Ibandronate sodium monohydrate
    Ibandronate Sodium Hydrate at 19 Pe...
    Issue/Submission Date
    2011-12-29
    2023-02-20
    2021-07-20
    Polpharma Company Banner

    IOPC 2023

    Attending

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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.

    Lamotrigine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20548
    Active
    LAMOTRIGINE
    2007-05-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-128 - Rev 02
    Valid
    Lamotrigine
    2023-02-16
    Japanese DMF

    Found JDMF

    228MF10228
    Lamotrigine at 19 Pelplinska Str. 8...
    2016-12-14
    Written Confirmation

    Close WC

    Application Number
    20548
    R1-CEP 2010-128 - Rev 02
    228MF10228
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LAMOTRIGINE
    Lamotrigine
    Lamotrigine at 19 Pelplinska Str. 8...
    Issue/Submission Date
    2007-05-23
    2023-02-16
    2016-12-14
    Polpharma Company Banner

    IOPC 2023

    Attending

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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.

    Risedronate Sodium

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    USDMF

    Found USDMF

    20384
    Active
    SODIUM RISEDRONATE HEMI-PENTAHYDRAT...
    2007-03-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-126 - Rev 02
    Valid
    Risedronate sodium 2.5-hydrate
    2022-05-09
    Japanese DMF

    Found JDMF

    222MF10015
    Sodium risedronate hydrate at 19 Pe...
    2010-01-07
    Written Confirmation

    Close WC

    Application Number
    20384
    R1-CEP 2013-126 - Rev 02
    222MF10015
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SODIUM RISEDRONATE HEMI-PENTAHYDRAT...
    Risedronate sodium 2.5-hydrate
    Sodium risedronate hydrate at 19 Pe...
    Issue/Submission Date
    2007-03-26
    2022-05-09
    2010-01-07
    Polpharma Company Banner

    IOPC 2023

    Attending

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

    Sildenafil Citrate

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    USDMF

    Found USDMF

    23930
    Active
    SILDENAFIL CITRATE
    2010-06-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-072 - Rev 02
    Valid
    Sildenafil citrate Process A
    2022-03-14
    Japanese DMF

    Found JDMF

    225MF10011
    Sildenafil citrate at 19 Pelplinska...
    2013-01-30
    Written Confirmation

    Close WC

    Application Number
    23930
    R1-CEP 2013-072 - Rev 02
    225MF10011
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SILDENAFIL CITRATE
    Sildenafil citrate Process A
    Sildenafil citrate at 19 Pelplinska...
    Issue/Submission Date
    2010-06-29
    2022-03-14
    2013-01-30
    Polpharma Company Banner

    IOPC 2023

    Attending

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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.

    Tadalafil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24590
    Active
    TADALAFIL
    2011-01-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-150 - Rev 01
    Valid
    Tadalafil
    2021-12-06
    Japanese DMF

    Found JDMF

    302MF10011
    Tadalafil at 19 Pelplinska Str. 83-...
    2020-01-24
    Written Confirmation

    Close WC

    Application Number
    24590
    R1-CEP 2012-150 - Rev 01
    302MF10011
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TADALAFIL
    Tadalafil
    Tadalafil at 19 Pelplinska Str. 83-...
    Issue/Submission Date
    2011-01-31
    2021-12-06
    2020-01-24
    Polpharma Company Banner

    IOPC 2023

    Attending

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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.

    Vardenafil Hydrochloride

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    USDMF

    Found USDMF

    25174
    Active
    VARDENAFIL HYDROCHLORIDE TRIHYDRATE
    2011-08-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-106 - Rev 01
    Valid
    Vardenafil hydrochloride trihydrate
    2021-10-22
    Japanese DMF

    Found JDMF

    231MF10080
    Vardenafil hydrochloride hydrate at...
    2019-04-03
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