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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Shodhana Laboratories Ltd

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    01 Bilastine (1)

    02 Carbidopa (1)

    03 Carvedilol (1)

    04 Citalopram Hydrobromide (1)

    05 Dapoxetine Hydrochloride (1)

    06 Darifenacin Hydrobromide (1)

    07 Desvenlafaxine Succinate (1)

    08 Di-P-Toluoyl-D-Tartaric Acid (1)

    09 Duloxetine (1)

    10 Escitalopram Oxalate (1)

    11 Fluindione (1)

    12 Lacosamide (1)

    13 Mizolastine (1)

    14 Nebivolol (1)

    15 Ondansetron (2)

    16 Ondansetron Hydrochloride (1)

    17 Raloxifene Hydrochloride (1)

    18 Ranolazine (1)

    19 Rivastigmine (1)

    20 Rivastigmine Tartrate (1)

    21 Rotigotine (1)

    22 Silodosin (1)

    23 Sitagliptin Phosphate (1)

    24 Tolterodine Tartrate (1)

    25 Topiramate (1)

    26 Varenicline Tartrate (1)

    27 Ziprasidone Hydrochloride (1)

    filter

    01 Active (1)

    02 Inactive (1)

    03 Blank (26)

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    01 Valid (7)

    02 Blank (21)

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    01 301MF10057 (1)

    02 302MF10049 (1)

    03 Blank (26)

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    01 WC-0230 (9)

    02 WC-0230A2 (1)

    03 Blank (18)

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    Carvedilol

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2008-259 - Rev 01
    Valid
    Carvedilol
    2022-07-28
    Japanese DMF

    Found JDMF

    302MF10049
    Carvedilol at 6TH FLOOR, 6B, KRISHE...
    2020-04-22
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0230
    Expired
    Carvedilol (IP/BP/USP/Ph.Eur)
    2019-10-10
    Application Number
    R1-CEP 2008-259 - Rev 01
    302MF10049
    Indian CDSCO WC-0230
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Carvedilol
    Carvedilol at 6TH FLOOR, 6B, KRISHE...
    Carvedilol (IP/BP/USP/Ph.Eur)
    Issue/Submission Date
    2022-07-28
    2020-04-22
    2019-10-10
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    Rivastigmine

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2015-236 - Rev 00
    Valid
    Rivastigmine
    2022-08-19
    Japanese DMF

    Found JDMF

    301MF10057
    Rivastigmine (manufacturing only) a...
    2019-08-29
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0230
    Expired
    Rivastigmine (Ph. Eur)
    2019-10-10
    Application Number
    R1-CEP 2015-236 - Rev 00
    301MF10057
    Indian CDSCO WC-0230
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Rivastigmine
    Rivastigmine (manufacturing only) a...
    Rivastigmine (Ph. Eur)
    Issue/Submission Date
    2022-08-19
    2019-08-29
    2019-10-10
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    Duloxetine

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    USDMF

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    28398
    Inactive
    DULOXETINE HYDROCHLORIDE USP
    2014-06-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-340 - Rev 00
    Valid
    Duloxetine hydrochloride
    2020-11-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0230
    Expired
    Duloxetine Hydrochloride (USP/Ph. E...
    2019-10-10
    Application Number
    28398
    R1-CEP 2013-340 - Rev 00
    Indian CDSCO WC-0230
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    DULOXETINE HYDROCHLORIDE USP
    Duloxetine hydrochloride
    Duloxetine Hydrochloride (USP/Ph. E...
    Issue/Submission Date
    2014-06-17
    2020-11-03
    2019-10-10
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    Citalopram Hydrobromide

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    CEP/COS

    Found CEP/COS

    R1-CEP 2010-228 - Rev 02
    Valid
    Citalopram hydrobromide
    2022-10-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0230
    Expired
    Citaiopram Hydrobromide (IP/BP/USP/...
    2019-10-10
    Application Number
    R1-CEP 2010-228 - Rev 02
    Indian CDSCO WC-0230
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Citalopram hydrobromide
    Citaiopram Hydrobromide (IP/BP/USP/...
    Issue/Submission Date
    2022-10-05
    2019-10-10
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    Escitalopram Oxalate

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2018-278 - Rev 01
    Valid
    Escitalopram oxalate
    2024-02-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0230
    Expired
    Escitalopram Oxalate (IP/USP/Ph.Eur...
    2019-10-10
    Application Number
    CEP 2018-278 - Rev 01
    Indian CDSCO WC-0230
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Escitalopram oxalate
    Escitalopram Oxalate (IP/USP/Ph.Eur...
    Issue/Submission Date
    2024-02-08
    2019-10-10
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    Ondansetron Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2009-114 - Rev 01
    Valid
    Ondansetron hydrochloride dihydrate
    2023-05-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0230
    Expired
    Ondansetron Hydrochloride Dihydrate...
    2019-10-10
    Application Number
    R1-CEP 2009-114 - Rev 01
    Indian CDSCO WC-0230
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Ondansetron hydrochloride dihydrate
    Ondansetron Hydrochloride Dihydrate...
    Issue/Submission Date
    2023-05-04
    2019-10-10
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    Rivastigmine Tartrate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2019-066 - Rev 01
    Valid
    Rivastigmine hydrogen tartrate
    2021-03-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0230
    Expired
    Rivastigmine Hydrogen Tartrate (Ph....
    2019-10-10
    Application Number
    R0-CEP 2019-066 - Rev 01
    Indian CDSCO WC-0230
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Rivastigmine hydrogen tartrate
    Rivastigmine Hydrogen Tartrate (Ph....
    Issue/Submission Date
    2021-03-31
    2019-10-10
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    Di-P-Toluoyl-D-Tartaric Acid

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    USDMF

    Found USDMF

    32563
    Active
    CYANODIOL HEMI DPTTA SALT
    2018-02-21
    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    32563
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    CYANODIOL HEMI DPTTA SALT
    Issue/Submission Date
    2018-02-21
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    Mizolastine

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0230
    Expired
    Mizolastine (IH)
    2019-10-10
    Application Number
    Indian CDSCO WC-0230
    Status
     
    Expired
    2022-07-02
    Filing Details
    Mizolastine (IH)
    Issue/Submission Date
    2019-10-10
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    Ondansetron

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0230
    Expired
    Ondansetron IH/IP/USP
    2019-10-10
    Application Number
    Indian CDSCO WC-0230
    Status
     
    Expired
    2022-07-02
    Filing Details
    Ondansetron IH/IP/USP
    Issue/Submission Date
    2019-10-10
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