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

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    01 AC - 485 MICROBEADS (1)

    02 BICALUTAMIDE DRUG SUBSTANCE (1)

    03 BMCB(INERMEDIATE) (1)

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    08 DISOPYRAMIDE PHOSPHATE USP (1)

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    16 PBL (A STARTING MATERIAL FOR MANUFACTURING DRUG SUBSTANCES) (2)

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    26 TERAZOSIN HYDROCHLORIDE (1)

    27 TIMOLOL MALEATE (1)

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    BICALUTAMIDE DRUG SUBSTANCE

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    SUMITOMO CHEMICAL CO ...
    Inactive
    19311
    N/A
    2006-03-31
    II
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    CEFPIRAMIDE

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    SUMITOMO CHEMICAL CO ...
    Inactive
    6940
    N/A
    1987-04-23
    II
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    CITALOPRAM HYDROBROMIDE

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    SUMITOMO CHEMICAL CO ...
    Inactive
    15836
    N/A
    2002-01-31
    II
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    DIPIVEFRIN HYDROCHLORIDE

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    SUMITOMO CHEMICAL CO ...
    Inactive
    9552
    N/A
    1992-02-20
    II
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    DISOPYRAMIDE PHOSPHATE USP

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    SUMITOMO CHEMICAL CO ...
    Active
    4687
    N/A
    1982-10-14
    II
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    GLIPIZIDE

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    SUMITOMO CHEMICAL CO ...
    Inactive
    8805
    N/A
    1990-10-31
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    HYDRALAZINE HYDROCHLORIDE

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    SUMITOMO CHEMICAL CO ...
    Active
    2421
    Complete
    2023-09-20
    2023-09-15
    1975-03-14
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    LEVOBUNOLOL HYDROCHLORIDE

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    SUMITOMO CHEMICAL CO ...
    Inactive
    9652
    N/A
    1992-05-11
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    MCC-555

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    SUMITOMO CHEMICAL CO ...
    Inactive
    14647
    N/A
    1999-12-28
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    MIRTAZAPINE

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    SUMITOMO CHEMICAL CO ...
    Inactive
    15300
    N/A
    2001-02-22
    II
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