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

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    01 Abiraterone Acetate (1)

    02 Benfotiamine (1)

    03 Bicalutamide (1)

    04 Bortezomib (1)

    05 Busulfan (1)

    06 Capecitabine (1)

    07 Celecoxib (1)

    08 Chlorambucil (1)

    09 Citalopram Hydrobromide (1)

    10 Cyclophosphamide (1)

    11 Cytarabine (1)

    12 Dacarbazine (1)

    13 Docetaxel (1)

    14 Eletriptan Hydrobromide (1)

    15 Escitalopram Oxalate (1)

    16 Etoricoxib (1)

    17 Famotidine (1)

    18 Gefitinib (1)

    19 Gemcitabine (1)

    20 Ifosfamide (1)

    21 Imatinib Mesylate (1)

    22 Irinotecan Hydrochloride (1)

    23 Lapatinib Ditosylate (1)

    24 Melphalan (1)

    25 Nilutamide (1)

    26 Pantoprazole Sodium (1)

    27 Pazopanib Hydrochloride (1)

    28 Pemetrexed (1)

    29 Quetiapine Hemifumarate (1)

    30 Telmisartan (1)

    31 Temozolomide (1)

    32 Tofacitinib Citrate (1)

    33 Zoledronic Acid (1)

    filter

    01 Active (2)

    02 Inactive (1)

    03 Blank (30)

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    01 Valid (1)

    02 Blank (32)

    filter

    01 221MF10073 (1)

    02 Blank (32)

    filter

    01 WC-0194 (1)

    02 WC-0194A1 (5)

    03 WC-0194A2 (1)

    04 Blank (26)

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    • FDA
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    Bicalutamide

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20785
    Inactive
    BICALUTAMIDE
    2007-08-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-413 - Rev 00
    Valid
    Bicalutamide
    2019-07-10
    Japanese DMF

    Found JDMF

    221MF10073
    Bicalutamide at A-4, Madhura Nagar,...
    2009-04-14
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0194A1
    Expired
    Bicalutamide EP
    2020-06-18
    Application Number
    20785
    R1-CEP 2012-413 - Rev 00
    221MF10073
    Indian CDSCO WC-0194A1
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    BICALUTAMIDE
    Bicalutamide
    Bicalutamide at A-4, Madhura Nagar,...
    Bicalutamide EP
    Issue/Submission Date
    2007-08-01
    2019-07-10
    2009-04-14
    2020-06-18
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    Nilutamide

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    USDMF

    Found USDMF

    25465
    Active
    NILUTAMIDE
    2011-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0194A1
    Expired
    Nilutamide EP
    2020-06-18
    Application Number
    25465
    Indian CDSCO WC-0194A1
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    NILUTAMIDE
    Nilutamide EP
    Issue/Submission Date
    2011-09-29
    2020-06-18
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    Pazopanib Hydrochloride

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    USDMF

    Found USDMF

    35813
    Active
    N-(2-CHLOROPYRIMIDIN-4-YL)-2,3-DIME...
    2021-04-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35813
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    N-(2-CHLOROPYRIMIDIN-4-YL)-2,3-DIME...
    Issue/Submission Date
    2021-04-14
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    Benfotiamine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0194A2
    Expired
    Benfotiamine IH
    2020-08-10
    Application Number
    Indian CDSCO WC-0194A2
    Status
     
    Expired
    2022-07-02
    Filing Details
    Benfotiamine IH
    Issue/Submission Date
    2020-08-10
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    Celecoxib

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0194A1
    Expired
    Celecoxib EP
    2020-06-18
    Application Number
    Indian CDSCO WC-0194A1
    Status
     
    Expired
    2022-07-02
    Filing Details
    Celecoxib EP
    Issue/Submission Date
    2020-06-18
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    Etoricoxib

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0194
    Expired
    Etoricoxib IH
    2020-05-12
    Application Number
    Indian CDSCO WC-0194
    Status
     
    Expired
    2022-07-02
    Filing Details
    Etoricoxib IH
    Issue/Submission Date
    2020-05-12
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    Famotidine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0194A1
    Expired
    Famotidine EP
    2020-06-18
    Application Number
    Indian CDSCO WC-0194A1
    Status
     
    Expired
    2022-07-02
    Filing Details
    Famotidine EP
    Issue/Submission Date
    2020-06-18
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    Pantoprazole Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0194A1
    Expired
    Pantoprazole Sodium Sesquihydrate E...
    2020-06-18
    Application Number
    Indian CDSCO WC-0194A1
    Status
     
    Expired
    2022-07-02
    Filing Details
    Pantoprazole Sodium Sesquihydrate E...
    Issue/Submission Date
    2020-06-18
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    Abiraterone Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Bortezomib

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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