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

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    01 Acebutolol Hydrochloride (1)

    02 Apixaban (1)

    03 Bupropion Hydrobromide (2)

    04 Bupropion Hydrochloride (2)

    05 Butorphanol (1)

    06 Celecoxib (1)

    07 Cinnarizine (1)

    08 Clofibrate (1)

    09 Dabigatran Etexilate Mesylate (1)

    10 Dapagliflozin (1)

    11 Dapagliflozin Propanediol Monohydrate (1)

    12 Desvenlafaxine Succinate (1)

    13 Donepezil (1)

    14 Empagliflozin (1)

    15 Ertugliflozin (1)

    16 Favipiravir (1)

    17 Flunarizine (1)

    18 Gabapentin (2)

    19 Gemfibrozil (1)

    20 Lacosamide (1)

    21 Levetiracetam (1)

    22 Memantine Hydrochloride (1)

    23 Olmesartan Medoxomil (1)

    24 Ondansetron (1)

    25 Ondansetron Hydrochloride (1)

    26 Pentoxifylline (1)

    27 Piracetam (1)

    28 Pregabalin (2)

    29 Pyrimethamine (1)

    30 Quetiapine Hemifumarate (1)

    31 Rivaroxaban (1)

    32 Sitagliptin Hydrochloride (1)

    33 Sitagliptin Phosphate (2)

    34 Thiabendazole (1)

    35 Triprolidine Hydrochloride (1)

    36 Valacyclovir Hydrochloride (2)

    37 Venlafaxine (1)

    38 Venlafaxine Hydrochloride (3)

    39 Vildagliptin (1)

    40 Blank (1)

    filter

    01 Active (31)

    02 Inactive (5)

    03 Blank (12)

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    01 Valid (15)

    02 Withdrawn by Holder (2)

    03 Blank (31)

    filter

    01 222MF10223 (1)

    02 230MF10093 (1)

    03 304MF10116 (1)

    04 Blank (45)

    filter

    01 WC-0094 (20)

    02 WC-0094A2 (7)

    03 Blank (21)

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    Gabapentin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16060
    Active
    GABAPENTIN USP
    2002-07-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-330 - Rev 04
    Valid
    Gabapentin
    2022-09-07
    Japanese DMF

    Found JDMF

    222MF10223
    Gabapentin at Great Eastern Chamber...
    2010-09-03
    Written Confirmation

    Found WC

    Indian CDSCO WC-0094
    Valid
    Gabapentin (USP/EP)
    2022-06-08
    Application Number
    16060
    R1-CEP 2011-330 - Rev 04
    222MF10223
    Indian CDSCO WC-0094
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    GABAPENTIN USP
    Gabapentin
    Gabapentin at Great Eastern Chamber...
    Gabapentin (USP/EP)
    Issue/Submission Date
    2002-07-24
    2022-09-07
    2010-09-03
    2022-06-08
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    Pregabalin

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    USDMF

    Found USDMF

    28663
    Active
    PREGABALIN USP
    2014-09-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-181 - Rev 02
    Valid
    Pregabalin
    2023-06-28
    Japanese DMF

    Found JDMF

    230MF10093
    Pregabalin at Great Eastern Chamber...
    2018-07-26
    Written Confirmation

    Found WC

    Indian CDSCO WC-0094
    Valid
    Pregabalin (EP)
    2022-06-08
    Application Number
    28663
    R1-CEP 2016-181 - Rev 02
    230MF10093
    Indian CDSCO WC-0094
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PREGABALIN USP
    Pregabalin
    Pregabalin at Great Eastern Chamber...
    Pregabalin (EP)
    Issue/Submission Date
    2014-09-19
    2023-06-28
    2018-07-26
    2022-06-08
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    Celecoxib

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    USDMF

    Found USDMF

    31971
    Active
    CELECOXIB
    2017-07-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-199 - Rev 03
    Valid
    Celecoxib
    2023-07-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0094A2
    Valid
    Celecoxib USP/EP
    2022-06-08
    Application Number
    31971
    R0-CEP 2017-199 - Rev 03
    Indian CDSCO WC-0094A2
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CELECOXIB
    Celecoxib
    Celecoxib USP/EP
    Issue/Submission Date
    2017-07-29
    2023-07-05
    2022-06-08
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    Gemfibrozil

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    USDMF

    Found USDMF

    18815
    Active
    GEIBROZIL API
    2005-09-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-089 - Rev 05
    Valid
    Gemfibrozil
    2022-09-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0094
    Valid
    Gemfibrozil (USP/EP/IH)
    2022-06-08
    Application Number
    18815
    R1-CEP 2007-089 - Rev 05
    Indian CDSCO WC-0094
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    GEIBROZIL API
    Gemfibrozil
    Gemfibrozil (USP/EP/IH)
    Issue/Submission Date
    2005-09-15
    2022-09-07
    2022-06-08
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    Lacosamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30345
    Active
    LACOSAMIDE USP
    2016-02-25
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-107 - Rev 02
    Valid
    Lacosamide
    2022-12-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0094
    Valid
    Lacosamide IH
    2022-06-08
    Application Number
    30345
    R0-CEP 2020-107 - Rev 02
    Indian CDSCO WC-0094
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LACOSAMIDE USP
    Lacosamide
    Lacosamide IH
    Issue/Submission Date
    2016-02-25
    2022-12-13
    2022-06-08
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    Ondansetron Hydrochloride

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    USDMF

    Found USDMF

    16710
    Active
    ONDANSETRON HYDROCHLORIDE USP
    2003-07-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-012 - Rev 05
    Valid
    Ondansetron hydrochloride dihydrate
    2022-09-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0094
    Valid
    Ondansetron Hydrochloride Dihydrate...
    2022-06-08
    Application Number
    16710
    R1-CEP 2005-012 - Rev 05
    Indian CDSCO WC-0094
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ONDANSETRON HYDROCHLORIDE USP
    Ondansetron hydrochloride dihydrate
    Ondansetron Hydrochloride Dihydrate...
    Issue/Submission Date
    2003-07-15
    2022-09-07
    2022-06-08
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    Pentoxifylline

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    USDMF

    Found USDMF

    14182
    Active
    PENTOXIFYLLINE USP
    1999-06-01
    CEP/COS

    Found CEP/COS

    CEP 2005-131 - Rev 04
    Valid
    Pentoxifylline
    2023-11-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0094
    Valid
    Pentoxifylline (USP/EP/BP)
    2022-06-08
    Application Number
    14182
    CEP 2005-131 - Rev 04
    Indian CDSCO WC-0094
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PENTOXIFYLLINE USP
    Pentoxifylline
    Pentoxifylline (USP/EP/BP)
    Issue/Submission Date
    1999-06-01
    2023-11-07
    2022-06-08
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    Quetiapine Hemifumarate

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    USDMF

    Found USDMF

    24087
    Active
    QUETIAPINE FUMARATE (PROCESS-B) USP
    2010-08-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-255 - Rev 00
    Valid
    Quetiapine Fumarate
    2022-10-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0094
    Valid
    Quetiapine Fumarate( IH)
    2022-06-08
    Application Number
    24087
    R1-CEP 2016-255 - Rev 00
    Indian CDSCO WC-0094
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    QUETIAPINE FUMARATE (PROCESS-B) USP
    Quetiapine Fumarate
    Quetiapine Fumarate( IH)
    Issue/Submission Date
    2010-08-18
    2022-10-03
    2022-06-08
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    Valacyclovir Hydrochloride

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    USDMF

    Found USDMF

    30456
    Active
    VALACYCLOVIR HYDROCHLORIDE USP
    2016-03-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-255 - Rev 01
    Valid
    Valaciclovir hydrochloride hydrate
    2022-09-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0094
    Valid
    Valacyclovir HCl USP
    2022-06-08
    Application Number
    30456
    R0-CEP 2017-255 - Rev 01
    Indian CDSCO WC-0094
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VALACYCLOVIR HYDROCHLORIDE USP
    Valaciclovir hydrochloride hydrate
    Valacyclovir HCl USP
    Issue/Submission Date
    2016-03-29
    2022-09-14
    2022-06-08
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    Venlafaxine Hydrochloride

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    USDMF

    Found USDMF

    22956
    Active
    VENLAFAXINE HYDROCHLORIDE USP
    2009-07-18
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-400 - Rev 01
    Valid
    Venlafaxine hydrochloride, Process-...
    2022-09-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0094
    Valid
    Venlafaxine Hydrochloride (USP/EP)
    2022-06-08
    Application Number
    22956
    R0-CEP 2020-400 - Rev 01
    Indian CDSCO WC-0094
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VENLAFAXINE HYDROCHLORIDE USP
    Venlafaxine hydrochloride, Process-...
    Venlafaxine Hydrochloride (USP/EP)
    Issue/Submission Date
    2009-07-18
    2022-09-07
    2022-06-08
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