Seqens Seqens

X
menu

    Market Place

    Market Place

    Post Enquiry

    Post Enquiry
    menu

    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Polpharma to the U.S. FDA. Original Data : FDA Website

    Client Virtual Booth

    POLPHARMA

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

    VIDEO(s)

    DIGITAL CONTENT

    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

    PharmaCompass
    Contact SupplierContact Supplier
    Google MapGoogle Map
    Full View ScreenFull View Screen
    polpharma api
    Polpharma
    Poland Flag
    Country
    Country
    Poland
    Address
    Address
    Pelplińska 19, 83-200 Starogard Gdański
    Telephone
    Telephone
    +48 585631600
    Client Email
    Email
    api@polpharma.com
    Client Website
    Website
    https://www.api.polpharma.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/polpharma-api/
    Twitter
    Twitter
    Contact Info
    Others

    cdmo@polpharma.com 

    left grey arrow
    right gray arrow
    ListList of Products
    Full View ScreenFull Screen View
    refresh Reset Filter
    refresh Reset Filter
    product-page Supplier Virtual Booth
    price-trend Ask Us
    Contact Supplier
    • 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
    ZAKLADY FARMACEUTYCZN...
    Active
    10383
    Complete
    2013-01-30
    2013-01-15
    1993-07-30
    II
    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.

    APIXABAN

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Brazil
    ZAKLADY FARMACEUTYCZN...
    Active
    31166
    Complete
    2017-02-10
    2016-12-20
    2016-11-16
    II
    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.

    APREMILAST

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    31141
    Complete
    2017-04-07
    2016-12-20
    2016-11-09
    II
    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.

    ARIPIPRAZOLE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    23314
    Complete
    2015-02-20
    2013-12-19
    2009-11-27
    II
    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.

    ARIPIPRAZOLE LAUROXIL

    PDF Supplier PDF
    URL Supplier Web Content
    ZAKLADY FARMACEUTYCZN...
    Active
    31531
    Complete
    2018-12-10
    2018-08-21
    2018-08-16
    II
    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.

    ARIPIPRAZOLE MONOHYDRATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    33204
    N/A
    2018-10-30
    II
    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.

    AVANAFIL

    PDF Supplier PDF
    URL Supplier Web Content
    ZAKLADY FARMACEUTYCZN...
    Active
    29689
    N/A
    2015-08-20
    II
    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.

    BACLOFEN

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, Brazil
    ZAKLADY FARMACEUTYCZN...
    Active
    18014
    Complete
    2013-01-08
    2012-12-11
    2005-01-20
    II
    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.

    BREXPIPRAZOLE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    32347
    N/A
    2017-12-21
    II
    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.

    CARBAMAZEPINE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    26266
    Complete
    2015-12-16
    2015-06-25
    2012-07-31
    II
    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.

    CARVEDILOL

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    17060
    N/A
    2003-12-18
    II
    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.

    CARVEDILOL PHOSPHATE HEMIHYDRATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    20633
    Complete
    2017-01-19
    2016-12-07
    2007-06-26
    II
    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
    ZAKLADY FARMACEUTYCZN...
    Active
    30555
    Complete
    2017-05-23
    2016-12-08
    2016-05-12
    II
    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 PROPANEDIOL MONOHYDRA...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    33387
    Complete
    2019-07-16
    2018-12-20
    2018-12-30
    II
    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.

    EMPAGLIFLOZIN

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, China
    ZAKLADY FARMACEUTYCZN...
    Active
    33180
    Complete
    2019-02-15
    2018-10-09
    2018-09-27
    II
    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
    ZAKLADY FARMACEUTYCZN...
    Active
    11405
    Complete
    2014-12-16
    2014-11-28
    1995-03-29
    II
    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...
    ZAKLADY FARMACEUTYCZN...
    Active
    17599
    Complete
    2015-01-06
    2014-12-29
    2004-08-12
    II
    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 MONOHYDRATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, China
    ZAKLADY FARMACEUTYCZN...
    Active
    25638
    Complete
    2016-12-12
    2016-06-21
    2011-12-29
    II
    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.

    ISAVUCONAZONIUM SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    38964
    N/A
    2023-10-04
    II
    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
    ZAKLADY FARMACEUTYCZN...
    Active
    20548
    Complete
    2015-02-25
    2014-06-11
    2007-05-23
    II
    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.

    LINAGLIPTIN

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, China, Canada
    ZAKLADY FARMACEUTYCZN...
    Active
    29844
    Complete
    2018-04-03
    2017-11-15
    2015-09-25
    II
    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.

    OXCARBAZEPINE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    34418
    Complete
    2020-08-04
    2020-02-03
    2019-12-20
    II
    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.

    PENTOXIFYLLINE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF China
    ZAKLADY FARMACEUTYCZN...
    Active
    20976
    Complete
    2014-12-16
    2014-11-28
    2007-10-26
    II
    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.

    PIMAVANSERIN TARTRATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    33385
    Complete
    2019-08-11
    2018-12-03
    2018-12-08
    II
    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.

    RIVAROXABAN

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, China, Brazil
    ZAKLADY FARMACEUTYCZN...
    Active
    27661
    Complete
    2015-01-05
    2014-11-21
    2013-10-21
    II
    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.

    SACUBITRIL/VALSARTAN COMPLEX

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    32337
    Complete
    2018-09-04
    2017-12-20
    2017-12-21
    II
    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.

    SAFINAMIDE METHANESULFONATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    34164
    N/A
    2019-09-30
    II
    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
    ZAKLADY FARMACEUTYCZN...
    Active
    23930
    Complete
    2016-08-11
    2016-06-13
    2010-06-29
    II
    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.

    SITAGLIPTIN HYDROCHLORIDE MONOHYDRA...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    36129
    N/A
    2021-07-19
    II
    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 ALENDRONATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF Canada, EU, Brazil
    ZAKLADY FARMACEUTYCZN...
    Active
    16962
    Complete
    2014-12-16
    2014-11-28
    2003-11-17
    II
    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 HEMI-PENTAHYDRAT...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF Canada, Brazil
    ZAKLADY FARMACEUTYCZN...
    Active
    20384
    Complete
    2013-08-13
    2012-12-11
    2007-03-26
    II
    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
    ZAKLADY FARMACEUTYCZN...
    Active
    26873
    N/A
    2013-02-01
    II
    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.

    SOLIFENACIN SUCCINATE

    PDF Supplier PDF
    URL Supplier Web Content
    ZAKLADY FARMACEUTYCZN...
    Active
    24044
    N/A
    2010-08-05
    II
    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
    ZAKLADY FARMACEUTYCZN...
    Active
    24590
    Complete
    2018-03-07
    2017-11-15
    2011-01-31
    II
    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.

    TICAGRELOR

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF Canada
    ZAKLADY FARMACEUTYCZN...
    Active
    28674
    Complete
    2015-02-23
    2014-11-21
    2014-09-24
    II
    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.

    TOPIRAMATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    ZAKLADY FARMACEUTYCZN...
    Active
    20581
    Complete
    2015-04-03
    2013-05-21
    2007-06-06
    II
    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 TRIHYDRATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, China, Bra...
    ZAKLADY FARMACEUTYCZN...
    Active
    25174
    Complete
    2015-09-15
    2015-08-21
    2011-08-02
    II
    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 MONOHYDRATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, Brazil
    ZAKLADY FARMACEUTYCZN...
    Active
    24306
    Complete
    2016-06-03
    2015-08-27
    2010-10-13
    II
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty

    Access Website

    Contact Supplier

    #SpeakPharma

    polpharma api

    CPhI North America

    Booth # 814

    envelop Contact Supplier

    Post Enquiry
    POST ENQUIRY

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search