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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Enaltec Labs Private Limited

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    01 Agomelatine (1)

    02 Albendazole (1)

    03 Alcaftadine (2)

    04 Arformoterol Tartrate (1)

    05 Atorvastatin (1)

    06 Brimonidine Tartrate (2)

    07 Bromfenac Sodium (3)

    08 Chlorpromazine Hydrochloride (1)

    09 Cinacalcet Hydrochloride (1)

    10 Clonidine (4)

    11 Clopidogrel (1)

    12 Dapoxetine Hydrochloride (1)

    13 Darifenacin Hydrobromide (1)

    14 Deferasirox (1)

    15 Desloratadine (1)

    16 Dexketoprofen Trometamol (1)

    17 Dimethyl Fumarate (2)

    18 Dronedarone Hydrochloride (2)

    19 Eletriptan Hydrobromide (1)

    20 Escitalopram Oxalate (1)

    21 Ethacrynate Sodium (1)

    22 Ethacrynic Acid (3)

    23 Everolimus (1)

    24 Fampridine (2)

    25 Febuxostat (2)

    26 Felbamate (2)

    27 Fingolimod Hydrochloride (1)

    28 Fluphenazine (1)

    29 Fluvoxamine (1)

    30 Glimepiride (1)

    31 Ketoprofen (1)

    32 Lacosamide (1)

    33 Losartan Potassium (1)

    34 Lurasidone Hydrochloride (1)

    35 Lymecycline (1)

    36 Midodrine (1)

    37 Montelukast Sodium (1)

    38 Moxifloxacin Hydrochloride (1)

    39 Neostigmine Methylsulfate (2)

    40 Nepafenac (3)

    41 Nitazoxanide (1)

    42 Olanzapine (1)

    43 Olmesartan Medoxomil (1)

    44 Olopatadine Hydrochloride (2)

    45 Pitavastatin (1)

    46 Pramipexole Dihydrochloride (1)

    47 Prasugrel Hydrochloride (1)

    48 Pregabalin (1)

    49 Ramelteon (1)

    50 Risperidone (1)

    51 Rosuvastatin Calcium (1)

    52 Rupatadine Fumarate (2)

    53 Solifenacin Succinate (1)

    54 Tazarotene (1)

    55 Terazosin HCl (1)

    56 Teriflunomide (1)

    57 Tetrabenazine (3)

    58 Timolol Maleate (1)

    59 Tolperisone (1)

    60 Tolvaptan (2)

    61 Topiramate (1)

    62 Trospium Chloride (3)

    63 Varenicline Tartrate (2)

    64 Vitamin K1 (2)

    filter

    01 Active (11)

    02 Inactive (5)

    03 Blank (74)

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    01 Valid (2)

    02 Blank (88)

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    01 Blank (90)

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    01 WC-0424 (11)

    02 WC-0424A4 (2)

    03 WC-0544 (16)

    04 Blank (61)

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    Trospium Chloride

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    USDMF

    Caution USDMF

    21652
    Inactive
    TROSPIUM CHLORIDE
    2008-05-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-350 - Rev 00
    Valid
    Trospium chloride
    2023-02-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0424
    Expired
    Trospium Chloride USP/EP
    2018-12-03
    Application Number
    21652
    R0-CEP 2020-350 - Rev 00
    Indian CDSCO WC-0424
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2021-07-09
    Filing Details
    TROSPIUM CHLORIDE
    Trospium chloride
    Trospium Chloride USP/EP
    Issue/Submission Date
    2008-05-23
    2023-02-16
    2018-12-03
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    Chlorpromazine Hydrochloride

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    USDMF

    Found USDMF

    32014
    Active
    CHLORPROMAZINE HYDROCHLORIDE USP
    2018-05-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0424
    Expired
    Chlorpromazine Hcl USP
    2018-12-03
    Application Number
    32014
    Indian CDSCO WC-0424
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2021-07-09
    Filing Details
    CHLORPROMAZINE HYDROCHLORIDE USP
    Chlorpromazine Hcl USP
    Issue/Submission Date
    2018-05-25
    2018-12-03
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    Clonidine

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    USDMF

    Found USDMF

    31386
    Active
    CLONIDINE HYDROCHLORIDE USP
    2017-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0424
    Expired
    Clonidine Hydrochloride USP
    2018-12-03
    Application Number
    31386
    Indian CDSCO WC-0424
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2021-07-09
    Filing Details
    CLONIDINE HYDROCHLORIDE USP
    Clonidine Hydrochloride USP
    Issue/Submission Date
    2017-08-28
    2018-12-03
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    Dronedarone Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-341 - Rev 00
    Valid
    Dronedarone hydrochloride
    2023-04-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0424
    Expired
    Dronedarone HCl IH
    2018-12-03
    Application Number
    R0-CEP 2019-341 - Rev 00
    Indian CDSCO WC-0424
    Status
    Valid
     
    Expired
    2021-07-09
    Filing Details
    Dronedarone hydrochloride
    Dronedarone HCl IH
    Issue/Submission Date
    2023-04-11
    2018-12-03
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    Midodrine

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    USDMF

    Found USDMF

    30806
    Active
    MIDODRINE HYDROCHLORIDE USP
    2016-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0424
    Expired
    Midodrine HCl USP
    2018-12-03
    Application Number
    30806
    Indian CDSCO WC-0424
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2021-07-09
    Filing Details
    MIDODRINE HYDROCHLORIDE USP
    Midodrine HCl USP
    Issue/Submission Date
    2016-09-27
    2018-12-03
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    Neostigmine Methylsulfate

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    USDMF

    Found USDMF

    31387
    Active
    NEOSTIGMINE METHYLSULFATE USP
    2018-03-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0424A4
    Expired
    Neostigmine Methyl Sulfate USP
    2019-12-17
    Application Number
    31387
    Indian CDSCO WC-0424A4
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2021-07-09
    Filing Details
    NEOSTIGMINE METHYLSULFATE USP
    Neostigmine Methyl Sulfate USP
    Issue/Submission Date
    2018-03-05
    2019-12-17
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    Varenicline Tartrate

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    USDMF

    Found USDMF

    32835
    Active
    VARENICLINE TARTRATE
    2018-06-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0424
    Expired
    Varenicline Tartrate IH
    2018-12-03
    Application Number
    32835
    Indian CDSCO WC-0424
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2021-07-09
    Filing Details
    VARENICLINE TARTRATE
    Varenicline Tartrate IH
    Issue/Submission Date
    2018-06-19
    2018-12-03
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    Atorvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0544
    Valid
    Atorvastatin Calcium BP / USP / IH
    2022-12-16
    Application Number
    Indian CDSCO WC-0544
    Status
     
    Valid
    2025-12-15
    Filing Details
    Atorvastatin Calcium BP / USP / IH
    Issue/Submission Date
    2022-12-16
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    Brimonidine Tartrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0544
    Valid
    Brimonidine Tartrate IH
    2022-12-16
    Application Number
    Indian CDSCO WC-0544
    Status
     
    Valid
    2025-12-15
    Filing Details
    Brimonidine Tartrate IH
    Issue/Submission Date
    2022-12-16
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    Bromfenac Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0544
    Valid
    Bromfenac Sodium IH
    2022-12-16
    Application Number
    Indian CDSCO WC-0544
    Status
     
    Valid
    2025-12-15
    Filing Details
    Bromfenac Sodium IH
    Issue/Submission Date
    2022-12-16
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