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

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    01 Acenocoumarol (1)

    02 Acetazolamide (1)

    03 Alendronate Sodium (1)

    04 Aniracetam (1)

    05 Antazoline HCl (1)

    06 Antazoline Mesylate (1)

    07 Antazoline Sulfate (1)

    08 Apixaban (1)

    09 Apremilast (1)

    10 Aripiprazole (2)

    11 Aripiprazole Lauroxil (1)

    12 Avanafil (1)

    13 Azacitidine (1)

    14 Baclofen (1)

    15 Baricitinib (1)

    16 Brexpiprazole (1)

    17 Cabozantinib (1)

    18 Carbamazepine (2)

    19 Carfilzomib (1)

    20 Carvedilol (1)

    21 Carvedilol Phosphate (1)

    22 Chlormidazole (1)

    23 Clemastine (1)

    24 Clopamide (1)

    25 Dapagliflozin (1)

    26 Dapagliflozin Propanediol Monohydrate (1)

    27 Denotivir (1)

    28 Elagolix Sodium (1)

    29 Empagliflozin (1)

    30 Enzalutamide (1)

    31 Etodolac (1)

    32 Fulvestrant (1)

    33 Hydrochlorothiazide (1)

    34 Ibandronate Sodium (2)

    35 Ibrutinib (1)

    36 Iron Dextran (1)

    37 Isavuconazonium Sulfate (1)

    38 Lamotrigine (1)

    39 Linagliptin (1)

    40 Molsidomine (1)

    41 Nefopam (1)

    42 Opipramol (1)

    43 Oxcarbazepine (1)

    44 Ozanimod (1)

    45 Palbociclib (1)

    46 Pentoxifylline (1)

    47 Phenyl Salicylate (1)

    48 Pimavanserin Tartrate (1)

    49 Piracetam (1)

    50 Risedronate Sodium (1)

    51 Rivaroxaban (1)

    52 Sacubitril-Valsartan (1)

    53 Safinamide Mesylate (1)

    54 Salicylamide (1)

    55 Sildenafil Citrate (2)

    56 Sitagliptin Hydrochloride (1)

    57 Sodium Salicylate (1)

    58 Solifenacin Succinate (1)

    59 Sulfiram (1)

    60 Tadalafil (1)

    61 Ticagrelor (1)

    62 Tolterodine Tartrate (1)

    63 Topiramate (1)

    64 Trametinib (1)

    65 Undecylenamide Mea (1)

    66 Vardenafil Hydrochloride (1)

    67 Vismodegib (1)

    68 Xylometazoline Hydrochloride (1)

    69 Zoledronic Acid (1)

    filter

    01 Active (38)

    02 Blank (35)

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    01 Valid (24)

    02 Blank (49)

    filter

    01 218MF11020 (1)

    02 220MF10241 (1)

    03 221MF10220 (1)

    04 222MF10015 (1)

    05 225MF10011 (1)

    06 225MF10034 (1)

    07 225MF10101 (1)

    08 228MF10228 (1)

    09 230MF10014 (1)

    10 231MF10080 (1)

    11 302MF10011 (1)

    12 303MF10116 (1)

    13 305MF10084 (1)

    14 306MF10013 (1)

    15 Blank (59)

    filter

    01 Blank (73)

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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
    See all info for this product

    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

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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

    Alendronate Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF Canada, EU, Brazil
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    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

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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

    Baclofen

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, Brazil
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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 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

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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

    Etodolac

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, Canada, Brazil
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    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

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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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    Hydrochlorothiazide

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

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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

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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

    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

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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

    Lamotrigine

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

    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

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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.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Risedronate Sodium

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

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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 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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    Digital Content Digital Content

    Sildenafil Citrate

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

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    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

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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

    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

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