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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Medichem S.A

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    MEDICHEM S.A

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    Medichem
    Medichem S.A
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    Country
    Country
    Spain
    Address
    Address
    Carrer de Fructuós Gelabert, 608970 Sant Joan Despí, Barcelona
    Telephone
    Telephone
    +34 934776440
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.medichem.es/
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    • FDA
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Clozapine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    10534
    Active
    CLOZAPINE
    1993-10-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-151 - Rev 00
    Valid
    Clozapine
    2015-07-13
    Japanese DMF

    Found JDMF

    301MF10021
    Clozapine at 6-8, Fructo(´)s Gelab...
    2019-06-25
    Written Confirmation

    Close WC

    Application Number
    10534
    R1-CEP 2008-151 - Rev 00
    301MF10021
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLOZAPINE
    Clozapine
    Clozapine at 6-8, Fructo(´)s Gelab...
    Issue/Submission Date
    1993-10-21
    2015-07-13
    2019-06-25
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Brimonidine Tartrate

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    USDMF

    Found USDMF

    15601
    Active
    BRIMONIDINE TARTRATE
    2001-08-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-353 - Rev 00
    Valid
    Brimonidine tartrate
    2019-04-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15601
    R1-CEP 2013-353 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BRIMONIDINE TARTRATE
    Brimonidine tartrate
    Issue/Submission Date
    2001-08-27
    2019-04-24
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Chlorhexidine Acetate

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    USDMF

    Found USDMF

    9573
    Active
    CHLORHEXIDINE ACETATE
    1992-03-10
    CEP/COS

    Found CEP/COS

    CEP 2018-123 - Rev 02
    Valid
    Chlorhexidine diacetate
    2024-02-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9573
    CEP 2018-123 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CHLORHEXIDINE ACETATE
    Chlorhexidine diacetate
    Issue/Submission Date
    1992-03-10
    2024-02-19
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Chlorhexidine Gluconate

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    USDMF

    Found USDMF

    9701
    Active
    CHLORHEXIDINE GLUCONATE
    1992-05-27
    CEP/COS

    Found CEP/COS

    R1-CEP 1993-009 - Rev 04
    Valid
    Chlorhexidine digluconate solution
    2009-02-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9701
    R1-CEP 1993-009 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CHLORHEXIDINE GLUCONATE
    Chlorhexidine digluconate solution
    Issue/Submission Date
    1992-05-27
    2009-02-16
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Chlorhexidine Gluconate

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    USDMF

    Found USDMF

    25149
    Active
    CHLORHEXIDINE GLUCONATE SOLUTION (D...
    2011-07-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-128 - Rev 00
    Valid
    Chlorhexidine digluconate solution,...
    2022-07-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25149
    R1-CEP 2017-128 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CHLORHEXIDINE GLUCONATE SOLUTION (D...
    Chlorhexidine digluconate solution,...
    Issue/Submission Date
    2011-07-25
    2022-07-18
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Chlorhexidine Hydrochloride

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    USDMF

    Found USDMF

    17143
    Active
    CHLORHEXIDINE DIHYDROCHLORIDE
    2004-02-04
    CEP/COS

    Found CEP/COS

    CEP 2018-081 - Rev 02
    Valid
    Chlorhexidine dihydrochloride
    2024-02-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17143
    CEP 2018-081 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CHLORHEXIDINE DIHYDROCHLORIDE
    Chlorhexidine dihydrochloride
    Issue/Submission Date
    2004-02-04
    2024-02-19
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Felodipine

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    USDMF

    Found USDMF

    14099
    Active
    FELODIPINE
    1999-05-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-213 - Rev 01
    Valid
    Felodipine
    2012-05-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14099
    R1-CEP 2004-213 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FELODIPINE
    Felodipine
    Issue/Submission Date
    1999-05-03
    2012-05-18
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Mirtazapine

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    USDMF

    Found USDMF

    15749
    Active
    MIRTAZAPINE
    2001-12-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-178 - Rev 00
    Valid
    Mirtazapine
    2013-09-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15749
    R1-CEP 2007-178 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MIRTAZAPINE
    Mirtazapine
    Issue/Submission Date
    2001-12-05
    2013-09-05
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Paroxetine Hydrochloride

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    USDMF

    Found USDMF

    18052
    Active
    PAROXETINE HYDROCHLORIDE HEMIHYDRAT...
    2005-02-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-200 - Rev 00
    Valid
    Paroxetine hydrochloride hemihydrat...
    2018-03-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18052
    R1-CEP 2011-200 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PAROXETINE HYDROCHLORIDE HEMIHYDRAT...
    Paroxetine hydrochloride hemihydrat...
    Issue/Submission Date
    2005-02-01
    2018-03-05
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Quetiapine Hemifumarate

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    USDMF

    Found USDMF

    28833
    Active
    QUETIAPINE FUMARATE
    2014-12-05
    CEP/COS

    Found CEP/COS

    CEP 2014-081 - Rev 01
    Valid
    Quetiapine Fumarate
    2023-12-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28833
    CEP 2014-081 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    QUETIAPINE FUMARATE
    Quetiapine Fumarate
    Issue/Submission Date
    2014-12-05
    2023-12-12
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Rivaroxaban

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    USDMF

    Found USDMF

    28916
    Active
    RIVAROXABAN
    2014-12-23
    CEP/COS

    Found CEP/COS

    CEP 2021-005 - Rev 01
    Valid
    Rivaroxaban
    2024-01-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28916
    CEP 2021-005 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RIVAROXABAN
    Rivaroxaban
    Issue/Submission Date
    2014-12-23
    2024-01-04
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Sugammadex Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33874
    Active
    SUGAMMADEX SODIUM
    2019-06-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10019
    Sugammadex Sodium at HF61, Hal Far ...
    2023-02-02
    Written Confirmation

    Close WC

    Application Number
    33874
    305MF10019
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUGAMMADEX SODIUM
    Sugammadex Sodium at HF61, Hal Far ...
    Issue/Submission Date
    2019-06-17
    2023-02-02
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Voriconazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21443
    Active
    MED-201950/E (VORICONAZOLE)
    2008-03-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-377 - Rev 00
    Valid
    Voriconazole
    2018-03-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21443
    R1-CEP 2011-377 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MED-201950/E (VORICONAZOLE)
    Voriconazole
    Issue/Submission Date
    2008-03-18
    2018-03-13
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Adapalene

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    21480
    Active
    ADAPALENE (MED-200025/E)
    2008-03-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21480
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ADAPALENE (MED-200025/E)
    Issue/Submission Date
    2008-03-26
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Alendronate Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-273 - Rev 00
    Valid
    Sodium alendronate trihydrate
    2016-10-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-273 - Rev 00
    Status
    Valid
     
    Filing Details
    Sodium alendronate trihydrate
    Issue/Submission Date
    2016-10-13
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Ambrisentan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28781
    Active
    AMBRISENTAN (MED-200028/M)
    2014-11-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28781
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMBRISENTAN (MED-200028/M)
    Issue/Submission Date
    2014-11-18
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Amoxapine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    6887
    Active
    AMOXAPINE
    1987-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6887
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMOXAPINE
    Issue/Submission Date
    1987-03-16
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Apixaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30646
    Active
    APIXABAN
    2016-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30646
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APIXABAN
    Issue/Submission Date
    2016-06-30
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Asenapine Maleate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26923
    Active
    MED-200056/E
    2013-05-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26923
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MED-200056/E
    Issue/Submission Date
    2013-05-16
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Captopril

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32247
    Active
    CAPTOPRIL
    2017-12-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32247
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CAPTOPRIL
    Issue/Submission Date
    2017-12-04
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Chlorhexidine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    6711
    Active
    CHLORHEXIDINE BASE
    1986-12-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6711
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHLORHEXIDINE BASE
    Issue/Submission Date
    1986-12-02
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Cinacalcet Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    21405
    Active
    CINACALCET HYDROCHLORIDE (MED-20014...
    2008-03-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21405
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CINACALCET HYDROCHLORIDE (MED-20014...
    Issue/Submission Date
    2008-03-06
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Cyclobenzaprine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    5827
    Active
    CYCLOBENZAPRINE HCL
    1985-05-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5827
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CYCLOBENZAPRINE HCL
    Issue/Submission Date
    1985-05-10
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Desvenlafaxine Succinate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    25612
    Active
    MED-200400/M (Desvenlafaxine Succin...
    2011-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25612
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MED-200400/M (Desvenlafaxine Succin...
    Issue/Submission Date
    2011-12-22
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Edaravone

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    35211
    Active
    EDARAVONE
    2020-10-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35211
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EDARAVONE
    Issue/Submission Date
    2020-10-26
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Enalapril Maleate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    13055
    Active
    ENALAPRIL MALEATE
    1998-06-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13055
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ENALAPRIL MALEATE
    Issue/Submission Date
    1998-06-29
    Medichem

    CPhI North America

    Booth #644

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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Fluvoxamine

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    USDMF

    Found USDMF

    14511
    Active
    FLUVOXAMINE MALEATE
    1999-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14511
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FLUVOXAMINE MALEATE
    Issue/Submission Date
    1999-10-29
    Medichem

    CPhI North America

    Booth #644

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    • FDA
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Gabapentin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-225 - Rev 00
    Valid
    Gabapentin
    2017-07-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-225 - Rev 00
    Status
    Valid
     
    Filing Details
    Gabapentin
    Issue/Submission Date
    2017-07-04
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Guanfacine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    8590
    Active
    GUANFACINE HYDROCHLORIDE
    1990-06-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8590
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GUANFACINE HYDROCHLORIDE
    Issue/Submission Date
    1990-06-12
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Lamotrigine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    17231
    Active
    LAMOTRIGINE
    2004-03-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17231
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LAMOTRIGINE
    Issue/Submission Date
    2004-03-12
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Lofexidine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    37978
    Active
    LOFEXIDINE HYDROCHLORIDE
    2023-07-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37978
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LOFEXIDINE HYDROCHLORIDE
    Issue/Submission Date
    2023-07-17
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Loxapine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23144
    Active
    LOXAPINE BASE
    2009-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23144
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LOXAPINE BASE
    Issue/Submission Date
    2009-09-30
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Loxapine Succinate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    6767
    Active
    LOXAPINE SUCCINATE
    1986-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6767
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LOXAPINE SUCCINATE
    Issue/Submission Date
    1986-12-29
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Mexiletine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    9257
    Active
    MEXILETINE HYDROCHLORIDE
    1991-07-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9257
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MEXILETINE HYDROCHLORIDE
    Issue/Submission Date
    1991-07-26
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Micafungin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30558
    Active
    MICAFUNGIN SODIUM
    2016-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30558
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MICAFUNGIN SODIUM
    Issue/Submission Date
    2016-06-06
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Nepafenac

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    28432
    Active
    NEPAFENAC
    2014-07-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28432
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NEPAFENAC
    Issue/Submission Date
    2014-07-22
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Olopatadine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    22532
    Active
    MED-201345/E
    2009-02-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22532
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MED-201345/E
    Issue/Submission Date
    2009-02-12
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Pantoprazole Sodium

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-336 - Rev 00
    Valid
    Pantoprazole sodium sesquihydrate, ...
    2017-05-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-336 - Rev 00
    Status
    Valid
     
    Filing Details
    Pantoprazole sodium sesquihydrate, ...
    Issue/Submission Date
    2017-05-30
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Pazopanib Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    36192
    Active
    PAZOPANIB HYDROCHLORIDE
    2021-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36192
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PAZOPANIB HYDROCHLORIDE
    Issue/Submission Date
    2021-10-04
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Pimecrolimus

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29481
    Active
    PIMECROLIMUS (MED 201445/E)
    2015-07-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29481
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PIMECROLIMUS (MED 201445/E)
    Issue/Submission Date
    2015-07-15
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Prucalopride Succinate

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

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    USDMF

    Found USDMF

    37181
    Active
    PRUCALOPRIDE SUCCINATE
    2022-06-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37181
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PRUCALOPRIDE SUCCINATE
    Issue/Submission Date
    2022-06-13
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Revefenacin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    36861
    Active
    REVEFENACIN
    2022-04-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36861
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    REVEFENACIN
    Issue/Submission Date
    2022-04-19
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Risperidone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-105 - Rev 00
    Valid
    Risperidone
    2013-04-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-105 - Rev 00
    Status
    Valid
     
    Filing Details
    Risperidone
    Issue/Submission Date
    2013-04-30
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Solifenacin Succinate

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-240 - Rev 00
    Valid
    Solifenacin succinate
    2022-04-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-240 - Rev 00
    Status
    Valid
     
    Filing Details
    Solifenacin succinate
    Issue/Submission Date
    2022-04-28
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Sunitinib

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30559
    Active
    SUNITINIB MALATE
    2016-06-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30559
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUNITINIB MALATE
    Issue/Submission Date
    2016-06-03
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
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    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Tamsulosin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    23145
    Active
    TAMSULOSIN HYDROCHLORIDE (MED-20175...
    2009-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23145
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TAMSULOSIN HYDROCHLORIDE (MED-20175...
    Issue/Submission Date
    2009-09-30
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Venlafaxine Hydrochloride

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-277 - Rev 00
    Valid
    Venlafaxine hydrochloride
    2012-11-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-277 - Rev 00
    Status
    Valid
     
    Filing Details
    Venlafaxine hydrochloride
    Issue/Submission Date
    2012-11-23
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    MED-201890/E

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

    See Less

    USDMF

    Found USDMF

    23728
    Active
    MED-201890/E
    2010-04-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23728
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MED-201890/E
    Issue/Submission Date
    2010-04-19
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    MED-300006/E (INTERMEDIATE)

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

    See Less

    USDMF

    Found USDMF

    28676
    Active
    MED-300006/E (INTERMEDIATE)
    2014-10-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28676
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MED-300006/E (INTERMEDIATE)
    Issue/Submission Date
    2014-10-08
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

    Octenidine Hydrochloride

    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
    Medichem

    CPhI North America

    Booth #644

    envelop Contact Supplier

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