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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Tyche Industries Ltd

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    01 Azelaic Acid (1)

    02 Glucosamine Hydrochloride (1)

    03 Glucosamine Sulfate Potassium Chloride (1)

    04 Nevirapine (1)

    05 Nimorazole (1)

    06 Nitrofurantoin (1)

    07 Palonosetron (1)

    08 Phenelzine Sulfate (1)

    09 Pirfenidone (1)

    10 Racecadotril (1)

    11 Rupatadine Fumarate (1)

    12 Sertraline Hydrochloride (2)

    13 Silodosin (1)

    14 Solifenacin Succinate (1)

    15 Tamsulosin (1)

    16 Tenofovir Alafenamide Fumarate (1)

    17 Tenofovir Disoproxil Fumarate (1)

    18 Tolvaptan (1)

    filter

    01 Active (2)

    02 Inactive (2)

    03 Blank (15)

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    01 Valid (6)

    02 Blank (13)

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    01 Blank (19)

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    01 WC-0231 (13)

    02 WC-0231A4 (3)

    03 Blank (3)

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    Palonosetron

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    USDMF

    Found USDMF

    29330
    Active
    PALONOSETRON HYDROCHLORIDE
    2015-05-06
    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Found WC

    Indian CDSCO WC-0231
    Valid
    Palonosetron Hydrochloride USP
    2022-06-30
    Application Number
    29330
    Indian CDSCO WC-0231
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    PALONOSETRON HYDROCHLORIDE
    Palonosetron Hydrochloride USP
    Issue/Submission Date
    2015-05-06
    2022-06-30
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    Racecadotril

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2013-223 - Rev 00
    Valid
    Racecadotril
    2019-11-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0231
    Valid
    Racecadotril EP
    2022-06-30
    Application Number
    R1-CEP 2013-223 - Rev 00
    Indian CDSCO WC-0231
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Racecadotril
    Racecadotril EP
    Issue/Submission Date
    2019-11-04
    2022-06-30
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    Rupatadine Fumarate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2018-213 - Rev 01
    Valid
    Rupatadine fumarate
    2022-10-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0231
    Valid
    Rupatadin Fumarate IH/EP
    2022-06-30
    Application Number
    R0-CEP 2018-213 - Rev 01
    Indian CDSCO WC-0231
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Rupatadine fumarate
    Rupatadin Fumarate IH/EP
    Issue/Submission Date
    2022-10-26
    2022-06-30
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    Sertraline Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2022-313 - Rev 00
    Valid
    Sertraline hydrochloride, Form II
    2022-10-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0231
    Valid
    SERTRALINE HYDROCHLORDE, EP
    2022-06-30
    Application Number
    R0-CEP 2022-313 - Rev 00
    Indian CDSCO WC-0231
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Sertraline hydrochloride, Form II
    SERTRALINE HYDROCHLORDE, EP
    Issue/Submission Date
    2022-10-27
    2022-06-30
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    Solifenacin Succinate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-011 - Rev 00
    Valid
    Solifenacin succinate
    2022-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0231
    Valid
    Solifenacin Succinate IH/EP
    2022-06-30
    Application Number
    R0-CEP 2020-011 - Rev 00
    Indian CDSCO WC-0231
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Solifenacin succinate
    Solifenacin Succinate IH/EP
    Issue/Submission Date
    2022-02-07
    2022-06-30
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    Tamsulosin

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2021-149 - Rev 00
    Valid
    Tamsulosin hydrochloride
    2022-11-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0231
    Valid
    Tamsulosin Hydrochloride IP/USP/EP
    2022-06-30
    Application Number
    R0-CEP 2021-149 - Rev 00
    Indian CDSCO WC-0231
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Tamsulosin hydrochloride
    Tamsulosin Hydrochloride IP/USP/EP
    Issue/Submission Date
    2022-11-07
    2022-06-30
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    Tenofovir Disoproxil Fumarate

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    USDMF

    Caution USDMF

    28146
    Inactive
    TENOFOVIR DISOPROXIL FUMARATE
    2014-04-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0231
    Valid
    Tenofovir Disoproxil Fumarate IH
    2022-06-30
    Application Number
    28146
    Indian CDSCO WC-0231
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    TENOFOVIR DISOPROXIL FUMARATE
    Tenofovir Disoproxil Fumarate IH
    Issue/Submission Date
    2014-04-09
    2022-06-30
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    Azelaic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0231
    Valid
    Azelaic Acid IH
    2022-06-30
    Application Number
    Indian CDSCO WC-0231
    Status
     
    Valid
    2025-07-02
    Filing Details
    Azelaic Acid IH
    Issue/Submission Date
    2022-06-30
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    Glucosamine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0231
    Valid
    Glucosamine Hydrochloride EP/USP
    2022-06-30
    Application Number
    Indian CDSCO WC-0231
    Status
     
    Valid
    2025-07-02
    Filing Details
    Glucosamine Hydrochloride EP/USP
    Issue/Submission Date
    2022-06-30
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    Glucosamine Sulfate Potassium Chloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0231
    Valid
    Glucosamine Sulphate Potassium Chlo...
    2022-06-30
    Application Number
    Indian CDSCO WC-0231
    Status
     
    Valid
    2025-07-02
    Filing Details
    Glucosamine Sulphate Potassium Chlo...
    Issue/Submission Date
    2022-06-30
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