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

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    POLPHARMA

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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

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    INSPECTIONS & REGISTRATIONS

    PharmaCompass
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    polpharma api
    Polpharma
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    Country
    Poland
    Address
    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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    • 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
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    See Less

    USDMF

    Found USDMF

    10383
    Active
    ACETAZOLAMIDE
    1993-07-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-371 - Rev 02
    Valid
    Acetazolamide
    2020-08-04
    Japanese DMF

    Found JDMF

    306MF10013
    Acetazolamide at 19 Pellinska Str. ...
    2024-01-24
    Written Confirmation

    Close WC

    Application Number
    10383
    R1-CEP 2010-371 - Rev 02
    306MF10013
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ACETAZOLAMIDE
    Acetazolamide
    Acetazolamide at 19 Pellinska Str. ...
    Issue/Submission Date
    1993-07-30
    2020-08-04
    2024-01-24
    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.

    Alendronate Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF Canada, EU, Brazil
    See all info for this product

    See Less

    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 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
    See all info for this product

    See Less

    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 Pellinska Str. 83-20...
    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 Pellinska Str. 83-20...
    Issue/Submission Date
    2005-01-20
    2021-03-03
    2018-01-30
    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
    See all info for this product

    See Less

    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 Pellinska Str. 83-20...
    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 Pellinska Str. 83-20...
    Issue/Submission Date
    1995-03-29
    2023-02-07
    2013-05-10
    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...
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    USDMF

    Found USDMF

    17599
    Active
    HYDROCHLOROTHIAZIDE
    2004-08-12
    CEP/COS

    Found CEP/COS

    CEP 2004-058 - Rev 05
    Valid
    Hydrochlorothiazide
    2024-01-19
    Japanese DMF

    Found JDMF

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

    Close WC

    Application Number
    17599
    CEP 2004-058 - Rev 05
    218MF11020
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROCHLOROTHIAZIDE
    Hydrochlorothiazide
    HYDROCHLOROTHIAZIDE at 19 Pellinska...
    Issue/Submission Date
    2004-08-12
    2024-01-19
    2006-12-28
    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

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, China
    See all info for this product

    See Less

    USDMF

    Found USDMF

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

    Found CEP/COS

    R0-CEP 2023-077 - Rev 00
    Valid
    Ibandronate sodium monohydrate, Typ...
    2023-06-30
    Japanese DMF

    Found JDMF

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

    Close WC

    Application Number
    25638
    R0-CEP 2023-077 - Rev 00
    303MF10116
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IBANDRONATE SODIUM MONOHYDRATE
    Ibandronate sodium monohydrate, Typ...
    Ibandronate Sodium Hydrate at 19 Pe...
    Issue/Submission Date
    2011-12-29
    2023-06-30
    2021-07-20
    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
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    See Less

    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 Pellinska Str. 83...
    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 Pellinska Str. 83...
    Issue/Submission Date
    2007-05-23
    2023-02-16
    2016-12-14
    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.

    Risedronate Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF Canada, Brazil
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    See Less

    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 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
    See all info for this product

    See Less

    USDMF

    Found USDMF

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

    Found CEP/COS

    R1-CEP 2013-073 - Rev 03
    Valid
    Sildenafil citrate, Process B
    2023-04-03
    Japanese DMF

    Found JDMF

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

    Close WC

    Application Number
    23930
    R1-CEP 2013-073 - Rev 03
    225MF10011
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SILDENAFIL CITRATE
    Sildenafil citrate, Process B
    Sildenafil citrate at 19 Pellinska ...
    Issue/Submission Date
    2010-06-29
    2023-04-03
    2013-01-30
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    24590
    Active
    TADALAFIL
    2011-01-31
    CEP/COS

    Found CEP/COS

    CEP 2012-150 - Rev 02
    Valid
    Tadalafil
    2023-10-24
    Japanese DMF

    Found JDMF

    302MF10011
    Tadalafil at 19 Pellinska Str. 83-2...
    2020-01-24
    Written Confirmation

    Close WC

    Application Number
    24590
    CEP 2012-150 - Rev 02
    302MF10011
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TADALAFIL
    Tadalafil
    Tadalafil at 19 Pellinska Str. 83-2...
    Issue/Submission Date
    2011-01-31
    2023-10-24
    2020-01-24
    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

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, China, Bra...
    See all info for this product

    See Less

    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
    Written Confirmation

    Close WC

    Application Number
    25174
    R1-CEP 2014-106 - Rev 01
    231MF10080
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VARDENAFIL HYDROCHLORIDE TRIHYDRATE
    Vardenafil hydrochloride trihydrate
    Vardenafil hydrochloride hydrate at...
    Issue/Submission Date
    2011-08-02
    2021-10-22
    2019-04-03
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    24306
    Active
    ZOLEDRONIC ACID MONOHYDRATE
    2010-10-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-191 - Rev 02
    Valid
    Zoledronic acid monohydrate
    2023-03-08
    Japanese DMF

    Found JDMF

    225MF10034
    Zoledronic acid at 19 Pellinska Str...
    2013-02-20
    Written Confirmation

    Close WC

    Application Number
    24306
    R0-CEP 2018-191 - Rev 02
    225MF10034
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ZOLEDRONIC ACID MONOHYDRATE
    Zoledronic acid monohydrate
    Zoledronic acid at 19 Pellinska Str...
    Issue/Submission Date
    2010-10-13
    2023-03-08
    2013-02-20
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    23314
    Active
    ARIPIPRAZOLE
    2009-11-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-230 - Rev 02
    Valid
    Aripiprazole
    2023-03-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23314
    R1-CEP 2013-230 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ARIPIPRAZOLE
    Aripiprazole
    Issue/Submission Date
    2009-11-27
    2023-03-17
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    26266
    Active
    CARBAMAZEPINE
    2012-07-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-353 - Rev 01
    Valid
    Carbamazepine, Crystallised in etha...
    2021-01-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26266
    R1-CEP 2012-353 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CARBAMAZEPINE
    Carbamazepine, Crystallised in etha...
    Issue/Submission Date
    2012-07-31
    2021-01-21
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    17060
    Active
    CARVEDILOL
    2003-12-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-258 - Rev 08
    Valid
    Carvedilol
    2021-10-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17060
    R1-CEP 2002-258 - Rev 08
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CARVEDILOL
    Carvedilol
    Issue/Submission Date
    2003-12-18
    2021-10-22
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    30555
    Active
    DAPAGLIFLOZIN
    2016-05-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10084
    Dapagliflozin at 19 Pellinska Str. ...
    2023-07-19
    Written Confirmation

    Close WC

    Application Number
    30555
    305MF10084
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DAPAGLIFLOZIN
    Dapagliflozin at 19 Pellinska Str. ...
    Issue/Submission Date
    2016-05-12
    2023-07-19
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    20976
    Active
    PENTOXIFYLLINE
    2007-10-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-246 - Rev 05
    Valid
    Pentoxifylline
    2023-01-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20976
    R1-CEP 2004-246 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PENTOXIFYLLINE
    Pentoxifylline
    Issue/Submission Date
    2007-10-26
    2023-01-27
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    27661
    Active
    RIVAROXABAN
    2013-10-21
    CEP/COS

    Found CEP/COS

    CEP 2021-270 - Rev 02
    Valid
    Rivaroxaban, Micronised
    2023-10-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27661
    CEP 2021-270 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RIVAROXABAN
    Rivaroxaban, Micronised
    Issue/Submission Date
    2013-10-21
    2023-10-13
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    26873
    Active
    SODIUM SALICYLATE
    2013-02-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10220
    Sodium salicylate at 19 Pellinska S...
    2009-10-08
    Written Confirmation

    Close WC

    Application Number
    26873
    221MF10220
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SODIUM SALICYLATE
    Sodium salicylate at 19 Pellinska S...
    Issue/Submission Date
    2013-02-01
    2009-10-08
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    24044
    Active
    SOLIFENACIN SUCCINATE
    2010-08-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-079 - Rev 00
    Valid
    Solifenacin succinate
    2021-10-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24044
    R0-CEP 2020-079 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin succinate
    Issue/Submission Date
    2010-08-05
    2021-10-19
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    28674
    Active
    TICAGRELOR
    2014-09-24
    CEP/COS

    Found CEP/COS

    CEP 2020-338 - Rev 01
    Valid
    Ticagrelor
    2024-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28674
    CEP 2020-338 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TICAGRELOR
    Ticagrelor
    Issue/Submission Date
    2014-09-24
    2024-01-17
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    31166
    Active
    APIXABAN
    2016-11-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31166
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APIXABAN
    Issue/Submission Date
    2016-11-16
    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
    See all info for this product

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    USDMF

    Found USDMF

    31141
    Active
    APREMILAST
    2016-11-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31141
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2016-11-09
    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.

    Aripiprazole

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

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    USDMF

    Found USDMF

    33204
    Active
    ARIPIPRAZOLE MONOHYDRATE
    2018-10-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33204
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ARIPIPRAZOLE MONOHYDRATE
    Issue/Submission Date
    2018-10-30
    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
    See all info for this product

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    USDMF

    Found USDMF

    31531
    Active
    ARIPIPRAZOLE LAUROXIL
    2018-08-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31531
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARIPIPRAZOLE LAUROXIL
    Issue/Submission Date
    2018-08-16
    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.

    Avanafil

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

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    USDMF

    Found USDMF

    29689
    Active
    AVANAFIL
    2015-08-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29689
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AVANAFIL
    Issue/Submission Date
    2015-08-20
    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.

    Brexpiprazole

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

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    USDMF

    Found USDMF

    32347
    Active
    BREXPIPRAZOLE
    2017-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32347
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BREXPIPRAZOLE
    Issue/Submission Date
    2017-12-21
    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
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-141 - Rev 03
    Valid
    Carbamazepine
    2022-04-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-141 - Rev 03
    Status
    Valid
     
    Filing Details
    Carbamazepine
    Issue/Submission Date
    2022-04-25
    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

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

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    USDMF

    Found USDMF

    20633
    Active
    CARVEDILOL PHOSPHATE HEMIHYDRATE
    2007-06-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20633
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CARVEDILOL PHOSPHATE HEMIHYDRATE
    Issue/Submission Date
    2007-06-26
    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 Monohydrate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    See Less

    USDMF

    Found USDMF

    33387
    Active
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    2018-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33387
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    Issue/Submission Date
    2018-12-30
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    33180
    Active
    EMPAGLIFLOZIN
    2018-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33180
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EMPAGLIFLOZIN
    Issue/Submission Date
    2018-09-27
    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

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, China
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

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

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-073 - Rev 00
    Status
    Valid
     
    Filing Details
    Ibandronate sodium monohydrate
    Issue/Submission Date
    2023-02-20
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    38964
    Active
    ISAVUCONAZONIUM SULFATE
    2023-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38964
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ISAVUCONAZONIUM SULFATE
    Issue/Submission Date
    2023-10-04
    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
    See all info for this product

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    USDMF

    Found USDMF

    29844
    Active
    LINAGLIPTIN
    2015-09-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29844
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LINAGLIPTIN
    Issue/Submission Date
    2015-09-25
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    34418
    Active
    OXCARBAZEPINE
    2019-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34418
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OXCARBAZEPINE
    Issue/Submission Date
    2019-12-20
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    33385
    Active
    PIMAVANSERIN TARTRATE
    2018-12-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33385
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PIMAVANSERIN TARTRATE
    Issue/Submission Date
    2018-12-08
    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.

    Piracetam

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF Brazil
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-069 - Rev 04
    Valid
    Piracetam
    2021-05-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-069 - Rev 04
    Status
    Valid
     
    Filing Details
    Piracetam
    Issue/Submission Date
    2021-05-06
    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

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

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    USDMF

    Found USDMF

    32337
    Active
    SACUBITRIL/VALSARTAN COMPLEX
    2017-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32337
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SACUBITRIL/VALSARTAN COMPLEX
    Issue/Submission Date
    2017-12-21
    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 Mesylate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

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    USDMF

    Found USDMF

    34164
    Active
    SAFINAMIDE METHANESULFONATE
    2019-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34164
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SAFINAMIDE METHANESULFONATE
    Issue/Submission Date
    2019-09-30
    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
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

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

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-072 - Rev 02
    Status
    Valid
     
    Filing Details
    Sildenafil citrate, Process A
    Issue/Submission Date
    2022-03-14
    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

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

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    USDMF

    Found USDMF

    36129
    Active
    SITAGLIPTIN HYDROCHLORIDE MONOHYDRA...
    2021-07-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36129
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SITAGLIPTIN HYDROCHLORIDE MONOHYDRA...
    Issue/Submission Date
    2021-07-19
    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.

    Tolterodine Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF Canada
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-192 - Rev 00
    Valid
    Tolterodine tartrate
    2021-08-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-192 - Rev 00
    Status
    Valid
     
    Filing Details
    Tolterodine tartrate
    Issue/Submission Date
    2021-08-30
    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
    See all info for this product

    See Less

    USDMF

    Found USDMF

    20581
    Active
    TOPIRAMATE
    2007-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20581
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TOPIRAMATE
    Issue/Submission Date
    2007-06-06
    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.

    Antazoline HCl

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    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.

    Antazoline Mesylate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    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.

    Antazoline Sulfate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    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.

    Chlormidazole

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    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.

    Denotivir

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    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.

    Trametinib

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    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.

    Undecylenamide Mea

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    Polpharma CB

    CPhI North America

    Booth # 814

    envelop Contact Supplier

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