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    List of Drug Master Files (DMF) of Excipients submissions by Mantrose-haeuser to the U.S. FDA. Original Data : FDA Website

    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Mantrose-Haeuser

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    EXCIPIENTS

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    01 125% AMMONIATED SHELLAC SOLUTION

    02 1CERTISEAL A-100

    03 2CERTISEAL FC-300

    04 1CERTISEAL FC-300A

    05 1CERTISEAL SB-1/P

    06 1CRYSTALAC GLAZE FORMULA C

    07 1MANTROCEL E-4000

    08 1MANTROCEL E5, E6, E15 AND E50

    09 1MANTROCEL HP55-HPMCP

    10 1MANTROCEL K-100M

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    01

    25% AMMONIATED SHELLAC SOLUT...

    Discovery on Target
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    02

    CERTISEAL FC-300A

    Discovery on Target
    Not Confirmed
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    03

    MANTROCEL HP55-HPMCP

    Discovery on Target
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    04

    CERTISEAL A-100

    Discovery on Target
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    CERTISEAL A-100

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    Mantrose-Haeuser

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15851

    Submission : 2002-02-06

    Status : Active

    Type : IV

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    05

    CERTISEAL FC-300

    Discovery on Target
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    CERTISEAL FC-300

    U.S.A
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    Discovery on Target
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15880

    Submission : 2002-02-27

    Status : Inactive

    Type : IV

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    06

    CERTISEAL FC-300

    Discovery on Target
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    CERTISEAL FC-300

    U.S.A
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    Mantrose-Haeuser

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15881

    Submission : 2002-02-27

    Status : Inactive

    Type : IV

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    07

    CERTISEAL SB-1/P

    Discovery on Target
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    CERTISEAL SB-1/P

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10221

    Submission : 1993-05-03

    Status : Active

    Type : IV

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    08

    CRYSTALAC GLAZE FORMULA C

    Discovery on Target
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    CRYSTALAC GLAZE FORMULA C

    U.S.A
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    Mantrose-Haeuser

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10138

    Submission : 1993-03-05

    Status : Active

    Type : IV

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    09

    MANTROCEL E-4000

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    MANTROCEL E-4000

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    Mantrose-Haeuser

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20599

    Submission : 2007-05-07

    Status : Active

    Type : IV

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    10

    MANTROCEL E5, E6, E15 AND E5...

    Discovery on Target
    Not Confirmed
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    MANTROCEL E5, E6, E15 AND E5...

    U.S.A
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    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
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    Mantrose-Haeuser

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16663

    Submission : 2003-06-25

    Status : Active

    Type : IV

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