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

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    01 Aciclovir (1)

    02 Atazanavir Sulfate (1)

    03 Atorvastatin (1)

    04 Clopidogrel (1)

    05 Cycloserine (1)

    06 Entecavir (1)

    07 Evogliptin (1)

    08 Formoterol Fumarate (1)

    09 Gadobutrol (1)

    10 Gadolinium Ethoxybenzyl Dtpa (1)

    11 Gadoteridol (1)

    12 Lacosamide (1)

    13 Rosuvastatin Calcium (1)

    14 Sitagliptin Phosphate (1)

    15 Stavudine (1)

    16 Terizidone (1)

    17 Udenafil (1)

    18 Valsartan (1)

    19 Voriconazole (2)

    20 Zidovudine (1)

    21 Blank (1)

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    01 Active (1)

    02 Inactive (4)

    03 Blank (17)

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    01 Valid (1)

    02 Withdrawn by EDQM Failure to CEP procedure (1)

    03 Blank (20)

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    01 227MF10040 (1)

    02 302MF10132 (1)

    03 Blank (20)

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    01 Blank (22)

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    Gadobutrol

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    USDMF

    Found USDMF

    35662
    Active
    GADOBUTROL MONOHYDRATE
    2021-02-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-015 - Rev 01
    Valid
    Gadobutrol monohydrate
    2022-11-28
    Japanese DMF

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    Application Number
    35662
    R0-CEP 2020-015 - Rev 01
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    GADOBUTROL MONOHYDRATE
    Gadobutrol monohydrate
    Issue/Submission Date
    2021-02-26
    2022-11-28
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    Voriconazole

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    302MF10132
    Voriconazole at 231, Hyeomnyeok-ro,...
    2020-10-29
    Written Confirmation

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    Application Number
    302MF10132
    Status
     
    Filing Details
    Voriconazole at 231, Hyeomnyeok-ro,...
    Issue/Submission Date
    2020-10-29
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    Voriconazole

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    USDMF

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    CEP/COS

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    Japanese DMF

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    227MF10040
    Voriconazole at 231, Hyeomnyeok-ro,...
    2015-02-09
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    Application Number
    227MF10040
    Status
     
    Filing Details
    Voriconazole at 231, Hyeomnyeok-ro,...
    Issue/Submission Date
    2015-02-09
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    Zidovudine

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    USDMF

    Caution USDMF

    13181
    Inactive
    ZIDOVUDINE DRUG SUBSTANCE
    1998-09-10
    CEP/COS

    Caution CEP/COS

    R1-CEP 1998-117 - Rev 03
    Withdrawn by EDQM Failure to CEP procedure
    Zidovudine
    2012-01-23
    Japanese DMF

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    Application Number
    13181
    R1-CEP 1998-117 - Rev 03
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by EDQM Failure to CEP procedure
     
    Filing Details
    ZIDOVUDINE DRUG SUBSTANCE
    Zidovudine
    Issue/Submission Date
    1998-09-10
    2012-01-23
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    Aciclovir

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    USDMF

    Caution USDMF

    14865
    Inactive
    ACYCLOVIR DRUG SUBSTANCE
    2000-06-12
    CEP/COS

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    Japanese DMF

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    Application Number
    14865
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ACYCLOVIR DRUG SUBSTANCE
    Issue/Submission Date
    2000-06-12
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    Stavudine

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    USDMF

    Caution USDMF

    26529
    Inactive
    STAVUDINE DRUG SUBSTANCE
    2012-10-08
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    26529
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    STAVUDINE DRUG SUBSTANCE
    Issue/Submission Date
    2012-10-08
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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    USDMF

    Caution USDMF

    10734
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1994-02-17
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    10734
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1994-02-17
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    Atazanavir Sulfate

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Atorvastatin

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Filing Details
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    Clopidogrel

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    USDMF

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    CEP/COS

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    Japanese DMF

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