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    List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Polpharma to the Review Authority in Japan (PMDA). Original Data : PMDA

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    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • Alendronate Sodium

    • Apixaban

    • Baclofen

    • Dapagliflozin

    • Dapagliflozin Propanediol Monohydrate

    • Empagliflozin

    • Enzalutamide

    • Hydrochlorothiazide

    • Isavuconazonium Sulfate

    • Linagliptin

    • Palbociclib

    • Pentoxifylline

    • Piracetam

    • Rivaroxaban

    • Tadalafil

    • Ticagrelor

    • Trametinib

    • Zoledronic Acid

    INTERMEDIATES

    SERVICES

    Key Products KEY SERVICES

    • Cryogenic Reactions

    • API Scale-Up

    • API Development Services

    • API Scale-Up Capabilities

    INSPECTIONS & REGISTRATIONS

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    Polpharma
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    Country
    Poland
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    Address
    Pelplińska 19, 83-200 Starogard Gdański
    Telephone
    Telephone
    +48 585631600
    Client Email
    Email
    api@polpharma.com
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    https://www.api.polpharma.com/
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    https://www.linkedin.com/company/polpharma-api/
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    Others

    cdmo@polpharma.com 

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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.

    Acetazolamide

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    Pharmaceutical Works POLP...
    2024-01-24
    2024-01-24
    306MF10013
    19 Pellinska Str. 83-200 ...
    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.

    Alendronate sodium hydrate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF Canada, EU, Brazil
    Pharmaceutical Works POLP...
    2018-01-15
    2008-12-04
    220MF10241
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

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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.

    Baclofen

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, Brazil
    Pharmaceutical Works POLP...
    2019-03-19
    2018-01-30
    230MF10014
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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

    Dapagliflozin

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada
    Pharmaceutical Works POLP...
    2023-07-19
    2023-07-19
    305MF10084
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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

    Etodolac

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, Brazil
    Pharmaceutical Works POLP...
    2023-07-26
    2013-05-10
    225MF10101
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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

    HYDROCHLOROTHIAZIDE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, China, Canada, Bra...
    Pharmaceutical Works POLP...
    2023-09-26
    2006-12-28
    218MF11020
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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

    Ibandronate Sodium Hydrate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, China
    Pharmaceutical Works POLP...
    2021-07-20
    2021-07-20
    303MF10116
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

    Contact Supplier
    • 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
    URL Supplier Web Content
    Other DMF EU, China
    Pharmaceutical Works POLP...
    2016-12-14
    2016-12-14
    228MF10228
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

    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

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF China, Canada
    Pharmaceutical Works POLP...
    2020-12-23
    2013-01-30
    225MF10011
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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

    Sodium risedronate hydrate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF Canada, Brazil
    Pharmaceutical Works POLP...
    2018-10-01
    2010-01-07
    222MF10015
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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

    Sodium salicylate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    Pharmaceutical Works POLP...
    2022-11-16
    2009-10-08
    221MF10220
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

    Contact Supplier
    • 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
    URL Supplier Web Content
    Other DMF China
    Pharmaceutical Works POLP...
    2020-01-24
    2020-01-24
    302MF10011
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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

    Vardenafil hydrochloride hydrate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, China, Bra...
    Pharmaceutical Works POLP...
    2019-04-03
    2019-04-03
    231MF10080
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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

    Zoledronic acid

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, Brazil
    Pharmaceutical Works POLP...
    2017-06-15
    2013-02-20
    225MF10034
    19 Pellinska Str. 83-200 ...
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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