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

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    Recipharm AB
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    Country
    Sweden
    Address
    Address
    Box 603 SE-101 32 Stockholm
    Telephone
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    +46 8 602 52 00
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    enquiries@pharmacompass.com
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    https://www.recipharm.com/
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    • FDA
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    Dexmedetomidine Hydrochloride

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    USDMF

    Found USDMF

    26984
    Active
    DEXMEDETOMIDINE HCL
    2013-03-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10087
    Dexmedetomidine Hydrochloride at St...
    2018-07-20
    Written Confirmation

    Close WC

    Application Number
    26984
    230MF10087
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXMEDETOMIDINE HCL
    Dexmedetomidine Hydrochloride at St...
    Issue/Submission Date
    2013-03-12
    2018-07-20
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    Norepinephrine Bitartrate

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    USDMF

    Found USDMF

    34008
    Active
    NORADRENALINE BITARTRATE MONOHYDRAT...
    2019-07-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-089 - Rev 00
    Valid
    Noradrenaline tartrate
    2021-06-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34008
    R0-CEP 2020-089 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NORADRENALINE BITARTRATE MONOHYDRAT...
    Noradrenaline tartrate
    Issue/Submission Date
    2019-07-31
    2021-06-08
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    • FDA
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    Ropivacaine Hydrochloride

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    USDMF

    Found USDMF

    35401
    Active
    ROPIVACAINE HYDROCHLORIDE MONOHYDRA...
    2020-12-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-342 - Rev 03
    Valid
    Ropivacaine hydrochloride monohydra...
    2021-07-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35401
    R1-CEP 2007-342 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ROPIVACAINE HYDROCHLORIDE MONOHYDRA...
    Ropivacaine hydrochloride monohydra...
    Issue/Submission Date
    2020-12-21
    2021-07-15
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    • FDA
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    Tulobuterol

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    USDMF

    Found USDMF

    21750
    Active
    TULOBUTEROL BASE
    2008-06-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10871
    Tulobuterol at Strada Statale dei G...
    2006-11-06
    Written Confirmation

    Close WC

    Application Number
    21750
    218MF10871
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TULOBUTEROL BASE
    Tulobuterol at Strada Statale dei G...
    Issue/Submission Date
    2008-06-27
    2006-11-06
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    Cefazolin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10087
    Day stations cefazolin sodium (prod...
    2006-01-27
    Written Confirmation

    Close WC

    Application Number
    218MF10087
    Status
     
    Filing Details
    Day stations cefazolin sodium (prod...
    Issue/Submission Date
    2006-01-27
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    • FDA
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    Chloroprocaine HCl

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    USDMF

    Found USDMF

    35698
    Active
    CHLOROPROCAINE HYDROCHLORIDE
    2021-04-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35698
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CHLOROPROCAINE HYDROCHLORIDE
    Issue/Submission Date
    2021-04-21
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    • FDA
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    Clenbuterol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-073 - Rev 01
    Valid
    Clenbuterol Hydrochloride
    2020-01-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-073 - Rev 01
    Status
    Valid
     
    Filing Details
    Clenbuterol Hydrochloride
    Issue/Submission Date
    2020-01-13
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    Gliclazide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10193
    Gliclazide at Via G. B. Grassi 15-2...
    2009-08-31
    Written Confirmation

    Close WC

    Application Number
    221MF10193
    Status
     
    Filing Details
    Gliclazide at Via G. B. Grassi 15-2...
    Issue/Submission Date
    2009-08-31
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    Glimepiride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-180 - Rev 01
    Valid
    Glimepiride
    2015-04-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-180 - Rev 01
    Status
    Valid
     
    Filing Details
    Glimepiride
    Issue/Submission Date
    2015-04-24
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    Indapamide

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-300 - Rev 04
    Valid
    Indapamide
    2017-01-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-300 - Rev 04
    Status
    Valid
     
    Filing Details
    Indapamide
    Issue/Submission Date
    2017-01-18
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    Isoproterenol Hydrochloride

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    USDMF

    Found USDMF

    31569
    Active
    ISOPROTERENOL HYDROCHLORIDE
    2017-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31569
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ISOPROTERENOL HYDROCHLORIDE
    Issue/Submission Date
    2017-05-15
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    • FDA
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    Lurasidone Hydrochloride

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    USDMF

    Found USDMF

    28723
    Active
    LURASIDONE HYDROCHLORIDE
    2014-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28723
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LURASIDONE HYDROCHLORIDE
    Issue/Submission Date
    2014-09-30
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    Midodrine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10582
    Midodrine hydrochloride at Strada S...
    2005-09-14
    Written Confirmation

    Close WC

    Application Number
    217MF10582
    Status
     
    Filing Details
    Midodrine hydrochloride at Strada S...
    Issue/Submission Date
    2005-09-14
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    • FDA
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    Paracetamol

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-415 - Rev 00
    Valid
    Paracetamol
    2023-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-415 - Rev 00
    Status
    Valid
     
    Filing Details
    Paracetamol
    Issue/Submission Date
    2023-07-20
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    • FDA
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    Procaterol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10948
    Procaterol hydrochloride hydrate at...
    2006-11-24
    Written Confirmation

    Close WC

    Application Number
    218MF10948
    Status
     
    Filing Details
    Procaterol hydrochloride hydrate at...
    Issue/Submission Date
    2006-11-24
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    • FDA
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    Tenoxicam

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1998-057 - Rev 05
    Valid
    Tenoxicam
    2022-01-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1998-057 - Rev 05
    Status
    Valid
     
    Filing Details
    Tenoxicam
    Issue/Submission Date
    2022-01-04
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    Trimebutine Maleate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10141
    TRIMEBUTINE MALEATE at Via G. B. Gr...
    2010-04-20
    Written Confirmation

    Close WC

    Application Number
    222MF10141
    Status
     
    Filing Details
    TRIMEBUTINE MALEATE at Via G. B. Gr...
    Issue/Submission Date
    2010-04-20
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    • FDA
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    Carteolol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2002-228 - Rev 03
    Withdrawn by Holder
    Carteolol hydrochloride
    2015-04-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-228 - Rev 03
    Status
    Withdrawn by Holder
     
    Filing Details
    Carteolol hydrochloride
    Issue/Submission Date
    2015-04-24
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    • FDA
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    Stanozolol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2002-222 - Rev 01
    Withdrawn by Holder
    Stanozolol, Micronised
    2011-05-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-222 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Stanozolol, Micronised
    Issue/Submission Date
    2011-05-19
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    • FDA
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    Terfenadine

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 1997-010 - Rev 01
    Expired
    Terfenadine
    2004-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1997-010 - Rev 01
    Status
    Expired
     
    Filing Details
    Terfenadine
    Issue/Submission Date
    2004-10-28
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