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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Roquette to the U.S. FDA. Original Data : FDA Website

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    01 DEXTROSE MONOHYDRATE USP GRADE (LYCADEX® PF) (1)

    02 DEXTROSE MONOHYDRATE, USP GRADE (1)

    03 HYDROXYPROPYL BETADEX (1)

    04 MANNITOL (1)

    05 MANNITOL GRANULAR G.G. (1)

    06 MANNITOL USP GRADE (PEARLITOL PF) (1)

    07 MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN LESTREM,FRANCE. (1)

    08 ROQUETTE® POLYDEXTRIN (Icodextrin) (1)

    09 SODIUM GLUCONATE (1)

    10 SODIUM STARCH GLYOLATE LOW PH (1)

    11 SORBITOL POWDER PYROGEN FREE (1)

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    01 ROQUETTE AMERICA INC (1)

    02 ROQUETTE FRERES (10)

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    DEXTROSE MONOHYDRATE USP GRADE (LYC...

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    ROQUETTE FRERES
    Active
    4697
    Complete
    2014-05-01
    2014-04-29
    1982-10-27
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    DEXTROSE MONOHYDRATE, USP GRADE

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    ROQUETTE AMERICA INC
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    11059
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    2015-11-23
    2015-01-05
    1994-09-01
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    HYDROXYPROPYL BETADEX

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    ROQUETTE FRERES
    Active
    30897
    N/A
    2016-08-29
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    MANNITOL

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    ROQUETTE FRERES
    Inactive
    5443
    N/A
    1984-06-29
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    MANNITOL GRANULAR G.G.

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    ROQUETTE FRERES
    Inactive
    6650
    N/A
    1986-10-29
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    MANNITOL USP GRADE (PEARLITOL PF)

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    ROQUETTE FRERES
    Active
    12879
    Complete
    2013-07-31
    2013-07-22
    1998-02-26
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    ROQUETTE® POLYDEXTRIN (Icodextrin)

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    ROQUETTE FRERES
    Active
    37662
    N/A
    2022-12-20
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    SODIUM GLUCONATE

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    ROQUETTE FRERES
    Active
    34499
    N/A
    2020-01-15
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    SODIUM STARCH GLYOLATE LOW PH

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    ROQUETTE FRERES
    Inactive
    5448
    N/A
    1984-02-08
    II
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    SORBITOL POWDER PYROGEN FREE

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    ROQUETTE FRERES
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    34930
    N/A
    2020-06-09
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