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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Synergene Active Ingredients Pvt Ltd

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    SYNERGENE ACTIVE INGREDIENTS PVT LTD

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    Synergene Active Ingredients Pvt Ltd
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    India
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    Plot No.302, Bhanu Enclave, Sunder Nagar, Erragadda, Hyderabad- 500 038 A.P.
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    + 91- 40 - 23700421 / 23813969 /23812317 / 23700994
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    • FDA
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    Terbinafine Hydrochloride

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    USDMF

    Found USDMF

    37701
    Active
    TERBINAFINE HYDROCHLORIDE USP
    2023-02-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-305 - Rev 00
    Valid
    Terbinafine hydrochloride, Unit-II
    2022-11-15
    Japanese DMF

    Found JDMF

    303MF10046
    Terbinafine Hydrochloride at Flat N...
    2021-03-17
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465
    Expired
    Terbinafine Hydrochloride (USP/EP)
    2020-03-09
    Application Number
    37701
    R0-CEP 2022-305 - Rev 00
    303MF10046
    Indian CDSCO WC-0465
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Expired
    2023-03-08
    Filing Details
    TERBINAFINE HYDROCHLORIDE USP
    Terbinafine hydrochloride, Unit-II
    Terbinafine Hydrochloride at Flat N...
    Terbinafine Hydrochloride (USP/EP)
    Issue/Submission Date
    2023-02-24
    2022-11-15
    2021-03-17
    2020-03-09
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    Fluconazole

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    USDMF

    Found USDMF

    37703
    Active
    FLUCONAZOLE USP
    2023-09-07
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-366 - Rev 00
    Valid
    Fluconazole, Unit-II
    2022-02-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465
    Expired
    Fluconazole (USP)
    2020-03-09
    Application Number
    37703
    R0-CEP 2021-366 - Rev 00
    Indian CDSCO WC-0465
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Expired
    2023-03-08
    Filing Details
    FLUCONAZOLE USP
    Fluconazole, Unit-II
    Fluconazole (USP)
    Issue/Submission Date
    2023-09-07
    2022-02-28
    2020-03-09
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    Escitalopram Oxalate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10139
    Escitalopram Oxalate at Flat No. 40...
    2021-08-25
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0284
    Expired
    Escitalopram Oxalate USP/IHS
    2014-06-24
    Application Number
    303MF10139
    Indian CDSCO WC-0284
    Status
     
    Expired
    2017-06-19
    Filing Details
    Escitalopram Oxalate at Flat No. 40...
    Escitalopram Oxalate USP/IHS
    Issue/Submission Date
    2021-08-25
    2014-06-24
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    Voriconazole

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    USDMF

    Found USDMF

    37702
    Active
    VORICONAZOLE USP
    2022-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465
    Expired
    Voriconazole (USP/EP)
    2020-03-09
    Application Number
    37702
    Indian CDSCO WC-0465
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2023-03-08
    Filing Details
    VORICONAZOLE USP
    Voriconazole (USP/EP)
    Issue/Submission Date
    2022-12-29
    2020-03-09
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    Escitalopram Oxalate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10120
    Escitalopram Oxate at Flat No. 402,...
    2021-08-02
    Written Confirmation

    Close WC

    Application Number
    303MF10120
    Status
     
    Filing Details
    Escitalopram Oxate at Flat No. 402,...
    Issue/Submission Date
    2021-08-02
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    • FDA
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    Fluconazole

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2011-338 - Rev 00
    Withdrawn by Holder
    Fluconazole
    2020-07-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465A3
    Expired
    Fluconazole EP
    2022-06-14
    Application Number
    R1-CEP 2011-338 - Rev 00
    Indian CDSCO WC-0465A3
    Status
    Withdrawn by Holder
     
    Expired
    2023-03-08
    Filing Details
    Fluconazole
    Fluconazole EP
    Issue/Submission Date
    2020-07-31
    2022-06-14
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    • FDA
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    Terbinafine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2015-235 - Rev 00
    Withdrawn by Holder
    Terbinafine hydrochloride
    2022-02-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0284
    Expired
    Terbinafine Hyrochloride USP/BP/Ph....
    2014-06-24
    Application Number
    R1-CEP 2015-235 - Rev 00
    Indian CDSCO WC-0284
    Status
    Withdrawn by Holder
     
    Expired
    2017-06-19
    Filing Details
    Terbinafine hydrochloride
    Terbinafine Hyrochloride USP/BP/Ph....
    Issue/Submission Date
    2022-02-23
    2014-06-24
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    • FDA
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    S-(-)-4-[4-(DIMETHYLAMINO)-1-(4- FLUOROPHENYL)-1-HYDROX...

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    See Less

    USDMF

    Found USDMF

    38771
    Active
    S-(-)-4-[4-(DIMETHYLAMINO)-1-(4- FL...
    2023-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38771
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    S-(-)-4-[4-(DIMETHYLAMINO)-1-(4- FL...
    Issue/Submission Date
    2023-09-28
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    • FDA
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    LOSARTAN POTASSIUM USP

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    USDMF

    Found USDMF

    38954
    Active
    LOSARTAN POTASSIUM USP
    2023-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38954
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    LOSARTAN POTASSIUM USP
    Issue/Submission Date
    2023-10-04
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    Dapoxetine Hydrochloride

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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465
    Expired
    Dapoxetine Hydrochloride (IH)
    2020-03-09
    Application Number
    Indian CDSCO WC-0465
    Status
     
    Expired
    2023-03-08
    Filing Details
    Dapoxetine Hydrochloride (IH)
    Issue/Submission Date
    2020-03-09
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    Dapoxetine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0284
    Expired
    Dapoxetine Hydrochloride
    2014-06-24
    Application Number
    Indian CDSCO WC-0284
    Status
     
    Expired
    2017-06-19
    Filing Details
    Dapoxetine Hydrochloride
    Issue/Submission Date
    2014-06-24
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    • FDA
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    Flupirtine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465
    Expired
    FLUPIRTINE MALEATE (IH)
    2020-03-09
    Application Number
    Indian CDSCO WC-0465
    Status
     
    Expired
    2023-03-08
    Filing Details
    FLUPIRTINE MALEATE (IH)
    Issue/Submission Date
    2020-03-09
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    Irbesartan

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465A2
    Expired
    Irbesartan USP
    2020-06-17
    Application Number
    Indian CDSCO WC-0465A2
    Status
     
    Expired
    2023-03-08
    Filing Details
    Irbesartan USP
    Issue/Submission Date
    2020-06-17
    ASK
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    • FDA
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    Losartan Potassium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465A2
    Expired
    Losartan Potassium USP
    2020-06-17
    Application Number
    Indian CDSCO WC-0465A2
    Status
     
    Expired
    2023-03-08
    Filing Details
    Losartan Potassium USP
    Issue/Submission Date
    2020-06-17
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    Losartan Potassium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0284
    Expired
    Losartan Potassium USP/Ph. Eur.
    2014-06-24
    Application Number
    Indian CDSCO WC-0284
    Status
     
    Expired
    2017-06-19
    Filing Details
    Losartan Potassium USP/Ph. Eur.
    Issue/Submission Date
    2014-06-24
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    • FDA
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    Luliconazole

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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465
    Expired
    Luliconazole (IH)
    2020-03-09
    Application Number
    Indian CDSCO WC-0465
    Status
     
    Expired
    2023-03-08
    Filing Details
    Luliconazole (IH)
    Issue/Submission Date
    2020-03-09
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    • FDA
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    Olmesartan Medoxomil

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465A2
    Expired
    Olmesartan medoximil EP
    2020-06-17
    Application Number
    Indian CDSCO WC-0465A2
    Status
     
    Expired
    2023-03-08
    Filing Details
    Olmesartan medoximil EP
    Issue/Submission Date
    2020-06-17
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    Sumatriptan

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0465
    Expired
    Sumatriptan Succinate (USP/EP)
    2020-03-09
    Application Number
    Indian CDSCO WC-0465
    Status
     
    Expired
    2023-03-08
    Filing Details
    Sumatriptan Succinate (USP/EP)
    Issue/Submission Date
    2020-03-09
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    Almotriptan Malate

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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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    • FDA
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    Amlodipine Besylate

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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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    Amlodipine Besylate

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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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    Butenafine Hydrochloride

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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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    Carvedilol

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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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    Chlorpromazine Hydrochloride

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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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    Citalopram Hydrobromide

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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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    Dorzolamide Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
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    Efinaconazole

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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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    Eletriptan Hydrobromide

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
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    Fexofenadine Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
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    Fluconazole

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
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    Fluoxetine Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
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    Ketoconazole

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