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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Smruthi Organics

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    01 Amlodipine Besylate (2)

    02 Amlodipine Maleate (2)

    03 Apixaban (1)

    04 Carbidopa (1)

    05 Ciprofloxacin (1)

    06 Ciprofloxacin Hydrochloride (2)

    07 Dapagliflozin (1)

    08 Diloxanide Furoate (1)

    09 Empagliflozin (1)

    10 Enrofloxacin (1)

    11 Fenofibrate (1)

    12 Levoamlodipine (1)

    13 Losartan Potassium (1)

    14 Metformin (2)

    15 Norfloxacin (2)

    16 Peflacin (1)

    17 Pefloxacin (1)

    18 Rivaroxaban (1)

    19 Telmisartan (1)

    20 Teneligliptin (1)

    21 Ticagrelor (1)

    22 Valsartan (2)

    23 Vildagliptin (1)

    filter

    01 Inactive (9)

    02 Blank (20)

    filter

    01 Withdrawn by EDQM Failure to CEP procedure (5)

    02 Blank (24)

    filter

    01 Blank (29)

    filter

    01 WC-0153 (4)

    02 WC-0158 (6)

    03 WC-0158A2 (4)

    04 WC-0158A3-A4-A5 (3)

    05 WC-0158A6 (1)

    06 Blank (11)

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    Amlodipine Besylate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20916
    Inactive
    AMLODIPINE BESILATE USP
    2007-10-01
    CEP/COS

    Caution CEP/COS

    R0-CEP 2007-285 - Rev 01
    Withdrawn by EDQM Failure to CEP procedure
    Amlodipine besilate
    2010-06-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0158A2
    Expired
    Amlodipine Besylate BP/EP/USP
    2021-05-10
    Application Number
    20916
    R0-CEP 2007-285 - Rev 01
    Indian CDSCO WC-0158A2
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by EDQM Failure to CEP procedure
     
    Expired
    2024-01-24
    Filing Details
    AMLODIPINE BESILATE USP
    Amlodipine besilate
    Amlodipine Besylate BP/EP/USP
    Issue/Submission Date
    2007-10-01
    2010-06-10
    2021-05-10
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    Ciprofloxacin Hydrochloride

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    USDMF

    Caution USDMF

    24636
    Inactive
    CIPROFLOXACIN HYDROCHLORIDE USP
    2011-02-07
    CEP/COS

    Caution CEP/COS

    R0-CEP 2011-051 - Rev 00
    Withdrawn by EDQM Failure to CEP procedure
    Ciprofloxacin Hydrochloride
    2012-12-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0158A2
    Expired
    Ciprofloxacin Hydrochloride BP/EP/U...
    2021-05-10
    Application Number
    24636
    R0-CEP 2011-051 - Rev 00
    Indian CDSCO WC-0158A2
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by EDQM Failure to CEP procedure
     
    Expired
    2024-01-24
    Filing Details
    CIPROFLOXACIN HYDROCHLORIDE USP
    Ciprofloxacin Hydrochloride
    Ciprofloxacin Hydrochloride BP/EP/U...
    Issue/Submission Date
    2011-02-07
    2012-12-10
    2021-05-10
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    Metformin

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    USDMF

    Caution USDMF

    18330
    Inactive
    METFORMIN HYDROCHLORIDE USP
    2005-05-05
    CEP/COS

    Caution CEP/COS

    R1-CEP 2005-232 - Rev 00
    Withdrawn by EDQM Failure to CEP procedure
    Metformin Hydrochloride
    2013-02-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0158A2
    Expired
    Metformin HCl BP/EP/USP
    2021-05-10
    Application Number
    18330
    R1-CEP 2005-232 - Rev 00
    Indian CDSCO WC-0158A2
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by EDQM Failure to CEP procedure
     
    Expired
    2024-01-24
    Filing Details
    METFORMIN HYDROCHLORIDE USP
    Metformin Hydrochloride
    Metformin HCl BP/EP/USP
    Issue/Submission Date
    2005-05-05
    2013-02-05
    2021-05-10
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    Norfloxacin

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    USDMF

    Caution USDMF

    19021
    Inactive
    NORFLOXACIN USP
    2005-12-05
    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-409 - Rev 02
    Withdrawn by EDQM Failure to CEP procedure
    Norfloxacin
    2010-04-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0158A2
    Expired
    Norfloxacin BP/EP/USP
    2021-05-10
    Application Number
    19021
    R1-CEP 2001-409 - Rev 02
    Indian CDSCO WC-0158A2
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by EDQM Failure to CEP procedure
     
    Expired
    2024-01-24
    Filing Details
    NORFLOXACIN USP
    Norfloxacin
    Norfloxacin BP/EP/USP
    Issue/Submission Date
    2005-12-05
    2010-04-01
    2021-05-10
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    Carbidopa

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    USDMF

    Caution USDMF

    18245
    Inactive
    CARBIDOPA USP
    2005-04-05
    CEP/COS

    Caution CEP/COS

    R0-CEP 2006-138 - Rev 01
    Withdrawn by EDQM Failure to CEP procedure
    Carbidopa
    2009-11-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18245
    R0-CEP 2006-138 - Rev 01
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by EDQM Failure to CEP procedure
     
    Filing Details
    CARBIDOPA USP
    Carbidopa
    Issue/Submission Date
    2005-04-05
    2009-11-26
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    Ciprofloxacin

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    USDMF

    Caution USDMF

    24775
    Inactive
    CIPROFLOXACIN USP
    2011-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0158
    Expired
    Ciprofloxacin USP
    2021-01-25
    Application Number
    24775
    Indian CDSCO WC-0158
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Expired
    2024-01-24
    Filing Details
    CIPROFLOXACIN USP
    Ciprofloxacin USP
    Issue/Submission Date
    2011-03-16
    2021-01-25
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    Fenofibrate

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    USDMF

    Caution USDMF

    23940
    Inactive
    FENOFIBRATE USP
    2010-06-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0158
    Expired
    Fenofibrate  (EP/BP/USP)
    2021-01-25
    Application Number
    23940
    Indian CDSCO WC-0158
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Expired
    2024-01-24
    Filing Details
    FENOFIBRATE USP
    Fenofibrate  (EP/BP/USP)
    Issue/Submission Date
    2010-06-28
    2021-01-25
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    Levoamlodipine

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    USDMF

    Caution USDMF

    24174
    Inactive
    S (-) AMLODIPINE BESILATE USP
    2010-08-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0158
    Expired
    S-Amlodipine Besilate
    2021-01-25
    Application Number
    24174
    Indian CDSCO WC-0158
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Expired
    2024-01-24
    Filing Details
    S (-) AMLODIPINE BESILATE USP
    S-Amlodipine Besilate
    Issue/Submission Date
    2010-08-07
    2021-01-25
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    Amlodipine Besylate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0153
    Expired
    Amlodipine Besilate BP/EP/USP
    2021-05-10
    Application Number
    Indian CDSCO WC-0153
    Status
     
    Expired
    2024-01-24
    Filing Details
    Amlodipine Besilate BP/EP/USP
    Issue/Submission Date
    2021-05-10
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    Amlodipine Maleate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0158
    Expired
    Amlodipine Maleate
    2021-01-25
    Application Number
    Indian CDSCO WC-0158
    Status
     
    Expired
    2024-01-24
    Filing Details
    Amlodipine Maleate
    Issue/Submission Date
    2021-01-25
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