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

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    Fleming Laboratories
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    India
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    Plot No 131, Green Park Avenue, Ground Floor Behind Hotel Surabhi Pride, Jeedimetla, Hyderabad- 500067
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    91-40-27235851
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    enquiries@pharmacompass.com
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    Etodolac

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    USDMF

    Caution USDMF

    31967
    Inactive
    ETODOLAC USP
    2017-11-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-180 - Rev 00
    Valid
    Etodolac
    2023-05-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229
    Expired
    Etodolac USP
    2019-08-13
    Application Number
    31967
    R1-CEP 2015-180 - Rev 00
    Indian CDSCO WC-0229
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-12
    Filing Details
    ETODOLAC USP
    Etodolac
    Etodolac USP
    Issue/Submission Date
    2017-11-11
    2023-05-02
    2019-08-13
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    Meclizine Hydrochloride

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    USDMF

    Caution USDMF

    20470
    Inactive
    MECLIZINE HCL USP
    2007-04-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-031 - Rev 00
    Valid
    Meclozine dihydrochloride
    2020-09-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Meclizine / Meclozine Hydrochloride...
    2020-06-18
    Application Number
    20470
    R0-CEP 2017-031 - Rev 00
    Indian CDSCO WC-0229A2
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-13
    Filing Details
    MECLIZINE HCL USP
    Meclozine dihydrochloride
    Meclizine / Meclozine Hydrochloride...
    Issue/Submission Date
    2007-04-23
    2020-09-21
    2020-06-18
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    Cinnarizine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-019 - Rev 00
    Valid
    Cinnarizine
    2022-05-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229
    Expired
    Cinnarazine BP/EP
    2019-08-13
    Application Number
    R1-CEP 2015-019 - Rev 00
    Indian CDSCO WC-0229
    Status
    Valid
     
    Expired
    2022-08-12
    Filing Details
    Cinnarizine
    Cinnarazine BP/EP
    Issue/Submission Date
    2022-05-09
    2019-08-13
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    Diltiazem Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-181 - Rev 00
    Valid
    Diltiazem hydrochloride
    2023-01-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A3
    Expired
    Diltiazem Hydrochloride EP/USP
    2021-01-22
    Application Number
    R0-CEP 2020-181 - Rev 00
    Indian CDSCO WC-0229A3
    Status
    Valid
     
    Expired
    2022-08-13
    Filing Details
    Diltiazem hydrochloride
    Diltiazem Hydrochloride EP/USP
    Issue/Submission Date
    2023-01-11
    2021-01-22
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    Flunarizine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2016-231 - Rev 01
    Valid
    Flunarizine dihydrochloride
    2023-09-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Flunarizine Dihydrochloride BP/EP
    2020-06-18
    Application Number
    CEP 2016-231 - Rev 01
    Indian CDSCO WC-0229A2
    Status
    Valid
     
    Expired
    2022-08-13
    Filing Details
    Flunarizine dihydrochloride
    Flunarizine Dihydrochloride BP/EP
    Issue/Submission Date
    2023-09-27
    2020-06-18
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    Hydroxyzine Dihydrochloride

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    USDMF

    Found USDMF

    38273
    Active
    HYDROXYZINE HYDROCHLORIDE USP
    2023-08-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A3
    Expired
    Hydroxyzine HCl USP
    2021-01-22
    Application Number
    38273
    Indian CDSCO WC-0229A3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-08-13
    Filing Details
    HYDROXYZINE HYDROCHLORIDE USP
    Hydroxyzine HCl USP
    Issue/Submission Date
    2023-08-10
    2021-01-22
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    Loperamide Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2016-168 - Rev 02
    Valid
    Loperamide hydrochloride
    2022-05-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Loperamide Hydrochloride BP/EP/USP
    2020-06-18
    Application Number
    R0-CEP 2016-168 - Rev 02
    Indian CDSCO WC-0229A2
    Status
    Valid
     
    Expired
    2022-08-13
    Filing Details
    Loperamide hydrochloride
    Loperamide Hydrochloride BP/EP/USP
    Issue/Submission Date
    2022-05-05
    2020-06-18
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    Carisoprodol

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    USDMF

    Caution USDMF

    31965
    Inactive
    CARISOPRODOL USP
    2017-08-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Carisoprodol USP/EP
    2020-06-18
    Application Number
    31965
    Indian CDSCO WC-0229A2
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-08-13
    Filing Details
    CARISOPRODOL USP
    Carisoprodol USP/EP
    Issue/Submission Date
    2017-08-09
    2020-06-18
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    Buclizine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Buclizine Hydrochloride BP
    2020-06-18
    Application Number
    Indian CDSCO WC-0229A2
    Status
     
    Expired
    2022-08-13
    Filing Details
    Buclizine Hydrochloride BP
    Issue/Submission Date
    2020-06-18
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    Cyclizine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A3
    Expired
    Cyclizine Hydrochloride EP
    2021-01-22
    Application Number
    Indian CDSCO WC-0229A3
    Status
     
    Expired
    2022-08-13
    Filing Details
    Cyclizine Hydrochloride EP
    Issue/Submission Date
    2021-01-22
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    Cyclobenzaprine

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    USDMF

    Caution USDMF

    23063
    Inactive
    CYCLOBENZAPRINE HYDROCHLORIDE USP B...
    2009-08-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23063
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CYCLOBENZAPRINE HYDROCHLORIDE USP B...
    Issue/Submission Date
    2009-08-19
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    Cyproheptadine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A2
    Expired
    Cyproheptadiene hydrochloride EP/BP...
    2020-06-18
    Application Number
    Indian CDSCO WC-0229A2
    Status
     
    Expired
    2022-08-13
    Filing Details
    Cyproheptadiene hydrochloride EP/BP...
    Issue/Submission Date
    2020-06-18
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    Ibandronate Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0491
    Expired
    Ibandronate Sodium IH
    2021-02-05
    Application Number
    Indian CDSCO WC-0491
    Status
     
    Expired
    2024-02-04
    Filing Details
    Ibandronate Sodium IH
    Issue/Submission Date
    2021-02-05
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    Ketotifen Fumarate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0491
    Expired
    Ketotifen hydrogen fumarate EP/BP
    2021-02-05
    Application Number
    Indian CDSCO WC-0491
    Status
     
    Expired
    2024-02-04
    Filing Details
    Ketotifen hydrogen fumarate EP/BP
    Issue/Submission Date
    2021-02-05
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    Penicillamine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0491
    Expired
    Penicillamine USP
    2021-02-05
    Application Number
    Indian CDSCO WC-0491
    Status
     
    Expired
    2024-02-04
    Filing Details
    Penicillamine USP
    Issue/Submission Date
    2021-02-05
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    Penicillamine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0491A3
    Expired
    D-Penicillamine EP
    2022-09-30
    Application Number
    Indian CDSCO WC-0491A3
    Status
     
    Expired
    2024-02-04
    Filing Details
    D-Penicillamine EP
    Issue/Submission Date
    2022-09-30
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    Pentoxifylline

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0229A3
    Expired
    Pentoxiphylline USP/EP
    2021-01-22
    Application Number
    Indian CDSCO WC-0229A3
    Status
     
    Expired
    2022-08-13
    Filing Details
    Pentoxiphylline USP/EP
    Issue/Submission Date
    2021-01-22
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    Risedronate Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0491
    Expired
    Risedronate Sodium USP
    2021-02-05
    Application Number
    Indian CDSCO WC-0491
    Status
     
    Expired
    2024-02-04
    Filing Details
    Risedronate Sodium USP
    Issue/Submission Date
    2021-02-05
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    Tolterodine Tartrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0491
    Expired
    TOLTERODINE TARTARATE IH
    2021-02-05
    Application Number
    Indian CDSCO WC-0491
    Status
     
    Expired
    2024-02-04
    Filing Details
    TOLTERODINE TARTARATE IH
    Issue/Submission Date
    2021-02-05
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    Bimatoprost

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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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    Cilostazol

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
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    Filing Details
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    Dapsone

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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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    Hydroxyzine Pamoate

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
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    Latanoprost

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

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    Latanoprostene Bunod

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Lurasidone Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Close WC

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    Misoprostol

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Oxatomide

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    USDMF

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