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

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    Roquette
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    France
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    1 rue de la Haute Loge, 62136 Lestrem
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    + 33 (0) 3 21 63 36 00
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    enquiries@pharmacompass.com
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    Hydroxypropyl-Beta Cyclodextrin

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    USDMF

    Found USDMF

    30897
    Active
    HYDROXYPROPYL BETADEX
    2016-08-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-264 - Rev 00
    Valid
    Hydroxypropylbetadex, MS 0.58-0.68,...
    2022-04-04
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    30897
    R1-CEP 2015-264 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    HYDROXYPROPYL BETADEX
    Hydroxypropylbetadex, MS 0.58-0.68,...
    Issue/Submission Date
    2016-08-29
    2022-04-04
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    Polydextrose

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    USDMF

    Found USDMF

    37662
    Active
    ROQUETTE® POLYDEXTRIN (Icodextrin)
    2022-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10097
    POLYDEXTRIN at La Haute Loge LESTRE...
    2013-05-08
    Written Confirmation

    Close WC

    Application Number
    37662
    225MF10097
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ROQUETTE® POLYDEXTRIN (Icodextrin)
    POLYDEXTRIN at La Haute Loge LESTRE...
    Issue/Submission Date
    2022-12-20
    2013-05-08
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    Dextrose Monohydrate API

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    USDMF

    Found USDMF

    4697
    Active
    DEXTROSE MONOHYDRATE USP GRADE (LYC...
    1982-10-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    4697
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXTROSE MONOHYDRATE USP GRADE (LYC...
    Issue/Submission Date
    1982-10-27
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    Glucose

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    USDMF

    Found USDMF

    11059
    Active
    DEXTROSE MONOHYDRATE, USP GRADE
    1994-09-01
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    11059
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXTROSE MONOHYDRATE, USP GRADE
    Issue/Submission Date
    1994-09-01
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    Isosorbide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10543
    ISOSORBIDE C PHARMA at La Haute Log...
    2006-06-01
    Written Confirmation

    Close WC

    Application Number
    218MF10543
    Status
     
    Filing Details
    ISOSORBIDE C PHARMA at La Haute Log...
    Issue/Submission Date
    2006-06-01
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    Mannitol API

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    USDMF

    Found USDMF

    12879
    Active
    MANNITOL USP GRADE (PEARLITOL PF)
    1998-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    12879
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MANNITOL USP GRADE (PEARLITOL PF)
    Issue/Submission Date
    1998-02-26
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    Sodium Gluconate

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    USDMF

    Found USDMF

    34499
    Active
    SODIUM GLUCONATE
    2020-01-15
    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    34499
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SODIUM GLUCONATE
    Issue/Submission Date
    2020-01-15
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    Sorbitol API

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    USDMF

    Found USDMF

    34930
    Active
    SORBITOL POWDER PYROGEN FREE
    2020-06-09
    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34930
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SORBITOL POWDER PYROGEN FREE
    Issue/Submission Date
    2020-06-09
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    • FDA
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    Mannitol API

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    USDMF

    Caution USDMF

    5443
    Inactive
    MANNITOL
    1984-06-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5443
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANNITOL
    Issue/Submission Date
    1984-06-29
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    Mannitol API

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    USDMF

    Caution USDMF

    6650
    Inactive
    MANNITOL GRANULAR G.G.
    1986-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6650
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANNITOL GRANULAR G.G.
    Issue/Submission Date
    1986-10-29
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    Sodium Lactate

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2006-048 - Rev 00
    Withdrawn by Holder
    Sodium (S)-lactate solution
    2007-06-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2006-048 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Sodium (S)-lactate solution
    Issue/Submission Date
    2007-06-08
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    SODIUM STARCH GLYOLATE

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    USDMF

    Caution USDMF

    5448
    Inactive
    SODIUM STARCH GLYOLATE LOW PH
    1984-02-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5448
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SODIUM STARCH GLYOLATE LOW PH
    Issue/Submission Date
    1984-02-08
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    MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPE...

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    USDMF

    Caution USDMF

    11223
    Inactive
    MANUFACTURING SITE,FACILITIES,PERSO...
    1994-12-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11223
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE,FACILITIES,PERSO...
    Issue/Submission Date
    1994-12-05
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