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    Product List of all Excipients 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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    https://www.roquette.com/
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    • FDA
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    Dextrose Monohydrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1996-030 - Rev 04
    Valid
    Glucose monohydrate for use in the ...
    2015-12-21
    Japanese DMF

    Found JDMF

    222MF10150
    LYCADEX PF at La Haute Loge LESTREM...
    2010-05-17
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1996-030 - Rev 04
    222MF10150
    Status
    Valid
     
    Filing Details
    Glucose monohydrate for use in the ...
    LYCADEX PF at La Haute Loge LESTREM...
    Issue/Submission Date
    2015-12-21
    2010-05-17
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    • FDA
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    Mannitol

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    USDMF

    Found USDMF

    14891
    Active
    MANNITOL, SPRAY DRIED
    2000-05-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-039 - Rev 01
    Valid
    Mannitol
    2019-09-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14891
    R1-CEP 2000-039 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MANNITOL, SPRAY DRIED
    Mannitol
    Issue/Submission Date
    2000-05-16
    2019-09-12
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    Mannitol

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    USDMF

    Found USDMF

    18143
    Active
    MANNITOL USP POWDER PEARLITOL ®
    2005-03-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-040 - Rev 02
    Valid
    Mannitol Spray dried
    2019-09-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18143
    R1-CEP 2000-040 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MANNITOL USP POWDER PEARLITOL ®
    Mannitol Spray dried
    Issue/Submission Date
    2005-03-08
    2019-09-12
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    • FDA
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    Sorbitol

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    USDMF

    Found USDMF

    6244
    Active
    POLYSORB 85/70/00 (SORBITOL SORBITA...
    1986-04-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-113 - Rev 02
    Valid
    Sorbitol
    2019-12-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6244
    R1-CEP 2001-113 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    POLYSORB 85/70/00 (SORBITOL SORBITA...
    Sorbitol
    Issue/Submission Date
    1986-04-03
    2019-12-05
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    • FDA
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    Beta-Cyclodextrin

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2009-307 - Rev 00
    Valid
    Betadex
    2017-02-13
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2009-307 - Rev 00
    Status
    Valid
     
    Filing Details
    Betadex
    Issue/Submission Date
    2017-02-13
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    Beta-Cyclodextrin API

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    USDMF

    Found USDMF

    9155
    Active
    BETA CYCLODEXTRIN
    1991-06-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    9155
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BETA CYCLODEXTRIN
    Issue/Submission Date
    1991-06-10
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    • FDA
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    Carboxymethyl Cellulose Sodium

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    USDMF

    Found USDMF

    7651
    Active
    GLYCOLYS@SODIUM STARCH GLYCOLATE NF
    1988-08-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    7651
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GLYCOLYS@SODIUM STARCH GLYCOLATE NF
    Issue/Submission Date
    1988-08-22
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    • FDA
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    Carboxymethyl Ether

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    USDMF

    Found USDMF

    16854
    Active
    GLYCOLYS® SODIUM STARCH GLYCOLATE ...
    2003-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    16854
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GLYCOLYS® SODIUM STARCH GLYCOLATE ...
    Issue/Submission Date
    2003-09-23
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    • FDA
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    Corn Starch

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    USDMF

    Found USDMF

    30976
    Active
    PREGELATINIZED MAIZE STARCH (GELMAC...
    2016-09-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    30976
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PREGELATINIZED MAIZE STARCH (GELMAC...
    Issue/Submission Date
    2016-09-20
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    • FDA
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    Croscarmellose Sodium

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    USDMF

    Found USDMF

    9362
    Active
    SOLUTAB CROSCARMELLOSE SODIUM
    1991-08-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9362
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SOLUTAB CROSCARMELLOSE SODIUM
    Issue/Submission Date
    1991-08-27
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    • FDA
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    Dibasic Calcium Phosphate

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    USDMF

    Found USDMF

    31776
    Active
    DIBASIC CALCIUM PHOSPHATE (CRESTADD...
    2017-05-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31776
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DIBASIC CALCIUM PHOSPHATE (CRESTADD...
    Issue/Submission Date
    2017-05-19
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    • FDA
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    Hydroxypropyl Betacyclodextrin

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    USDMF

    Found USDMF

    9420
    Active
    HYDROXY-PROPYL BETA-CYCLODEXTRIN
    1991-11-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF