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

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    01 Almotriptan Malate (1)

    02 Amlodipine Besylate (2)

    03 Bilastine (1)

    04 Butenafine Hydrochloride (1)

    05 Carvedilol (1)

    06 Chlorpromazine Hydrochloride (1)

    07 Citalopram Hydrobromide (1)

    08 Daclatasvir (1)

    09 Dapoxetine Hydrochloride (2)

    10 Dorzolamide Hydrochloride (1)

    11 Doxapram Hydrochloride (1)

    12 Doxazosin Mesylate (1)

    13 Efinaconazole (1)

    14 Eletriptan Hydrobromide (1)

    15 Epalrestat (1)

    16 Escitalopram Oxalate (2)

    17 Fexofenadine Hydrochloride (1)

    18 Fluconazole (3)

    19 Fluoxetine Hydrochloride (1)

    20 Flupirtine (1)

    21 Gabapentin (1)

    22 Gliclazide (1)

    23 Glipizide (1)

    24 Glycopyrronium Bromide (1)

    25 Imatinib Mesylate (1)

    26 Irbesartan (1)

    27 Ketoconazole (1)

    28 Lacosamide (1)

    29 Ledipasvir (1)

    30 Levetiracetam (1)

    31 Lomitapide (1)

    32 Losartan Potassium (2)

    33 Luliconazole (1)

    34 Methylphenidate Hydrochloride (1)

    35 NAFTIFINE HCL (1)

    36 Naratriptan Hydrochloride (1)

    37 Olmesartan Medoxomil (1)

    38 Oxaceprol (1)

    39 Phenylephrine Hydrochloride (1)

    40 Pregabalin (1)

    41 Ravuconazole (1)

    42 Repaglinide (1)

    43 Rivaroxaban (1)

    44 Rivastigmine (1)

    45 Rivastigmine Tartrate (1)

    46 Rizatriptan Benzoate (1)

    47 Rupatadine Fumarate (1)

    48 Seratrodast (1)

    49 Sertaconazole Nitrate (1)

    50 Simeprevir (1)

    51 Sparfloxacin (1)

    52 Sumatriptan (2)

    53 Tapentadol (1)

    54 Terbinafine Hydrochloride (2)

    55 Ticagrelor (1)

    56 Tioconazole (1)

    57 Tizanidine HCl (1)

    58 Trazodone Hydrochloride (1)

    59 Udenafil (1)

    60 Vilazodone Hydrochloride (1)

    61 Voglibose (1)

    62 Voriconazole (1)

    63 Vortioxetine Hydrobromide (1)

    64 Zafirlukast (1)

    65 Ziprasidone Hydrochloride (1)

    66 Zolmitriptan (1)

    67 Zonisamide (1)

    68 Blank (2)

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    01 Active (5)

    02 Blank (72)

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    01 Valid (2)

    02 Withdrawn by Holder (2)

    03 Blank (73)

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    01 303MF10046 (1)

    02 303MF10120 (1)

    03 303MF10139 (1)

    04 Blank (74)

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    01 WC-0284 (4)

    02 WC-0465 (7)

    03 WC-0465A2 (3)

    04 WC-0465A3 (1)

    05 Blank (62)

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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

    PDF Supplier PDF
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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

    PDF Supplier PDF
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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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    Fluconazole

    PDF Supplier PDF
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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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    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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    S-(-)-4-[4-(DIMETHYLAMINO)-1-(4- FLUOROPHENYL)-1-HYDROX...

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    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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    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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    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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