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    01 1Alcaftadine

    02 1Aprocitentan

    03 1Bempedoic Acid

    04 1Benfotiamine

    05 1Beta-Aminoisobutyric Acid

    06 1Bilastine

    07 1Brimonidine Tartrate

    08 1Brivaracetam

    09 2Bromfenac Sodium

    10 1Bucillamine

    11 1Butylphthalide

    12 1Calcifediol

    13 1Calcium 2-Oxo-3-Phenylpropionate

    14 1Calcium 3-Methyl-2-Oxobutyrate

    15 1Calcium 3-methyl-2-Oxovalerate

    16 1Calcium 4-Methyl-2-Oxovalerate

    17 1Calcium-DL-2-Hydroxy-4(Methylthio)Butyrate

    18 1Chlorpromazine Hydrochloride

    19 1Choline Fenofibrate

    20 1Ciclopirox

    21 1Citicoline Sodium

    22 1Clonidine

    23 1Desloratadine

    24 1Dimethyl Fumarate

    25 1Dofetilide

    26 1Dronedarone Hydrochloride

    27 1Elafibranor

    28 1Elagolix Sodium

    29 1Empagliflozin

    30 1Escitalopram Oxalate

    31 1Ethacrynate Sodium

    32 1Ethacrynic Acid

    33 1Fampridine

    34 1Febuxostat

    35 1Ferric Carboxymaltose

    36 1Fluphenazine

    37 1Fluralaner

    38 1Gefapixant Citrate

    39 1Gepirone

    40 1Glimepiride

    41 1Hopantenic Acid

    42 1Ifenprodil Tartrate

    43 1Imeglimin Hydrochloride

    44 1Istradefylline

    45 1Linagliptin

    46 1Lobeglitazone

    47 1Lumateperone Tosylate

    48 1Midodrine

    49 2Moxifloxacin Hydrochloride

    50 1Neostigmine Methylsulfate

    51 2Nepafenac

    52 1Oleoylethanolamide

    53 1Oxaloacetic Acid

    54 1Oxcarbazepine

    55 1Palmitoylethanolamide

    56 1Pitavastatin

    57 1Ramelteon

    58 1Remimazolam Besylate

    59 1Resmetirom

    60 1Rosuvastatin Calcium

    61 1Rupatadine Fumarate

    62 1Safinamide Methanesulfonate

    63 1Sitagliptin Phosphate

    64 1Sulforaphane

    65 1Tapinarof

    66 1Tazarotene

    67 1Teriflunomide

    68 2Tetrabenazine

    69 1Timolol Maleate

    70 1Trigonelline

    71 1Trospium Chloride

    72 1Upacicalcet Sodium

    73 1Urolithin A

    74 1Valganciclovir Hydrochloride

    75 1Varenicline Tartrate

    76 2Vitamin K1

    77 1Vonoprazan Fumarate

    78 1Xanomeline

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    01

    Clonidine

    India

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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-03-01

    Pay. Date : 2017-10-27

    DMF Number : 31386

    Submission : 2017-08-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-326 - Rev 00

    Issue Date : 2024-07-08

    Type : Chemical

    Substance Number : 477

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-08-07

    Written Confirmation Number : WC-0424

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42413-0053

    Start Marketing Date : 2018-03-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    02

    Trospium Chloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-12-22

    Pay. Date : 2014-09-04

    DMF Number : 28230

    Submission : 2014-09-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-350 - Rev 00

    Issue Date : 2023-02-16

    Type : Chemical

    Substance Number : 1798

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-08-07

    Written Confirmation Number : WC-0424

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42413-0108

    Start Marketing Date : 2014-07-19

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    03

    Dronedarone Hydrochloride

    India

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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-341 - Rev 00

    Issue Date : 2023-04-11

    Type : Chemical

    Substance Number : 3039

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-08-07

    Written Confirmation Number : WC-0424

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42413-0060

    Start Marketing Date : 2017-12-29

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (36.215kg/36.215kg)

    Marketing Category : BULK INGREDIENT

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    04

    Midodrine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-17

    Pay. Date : 2016-09-26

    DMF Number : 30806

    Submission : 2016-09-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-08-07

    Written Confirmation Number : WC-0424

    Address of the Firm :

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    05

    Neostigmine Methylsulfate

    India

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-04-27

    Pay. Date : 2018-03-15

    DMF Number : 31387

    Submission : 2018-03-05

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-08-07

    Written Confirmation Number : WC-0424

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42413-0153

    Start Marketing Date : 2018-03-30

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    06

    Ramelteon

    India

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-11-12

    Pay. Date : 2020-09-29

    DMF Number : 33601

    Submission : 2019-05-14

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-08-07

    Written Confirmation Number : WC-0424

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42413-0180

    Start Marketing Date : 2019-05-10

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    Varenicline Tartrate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-08-29

    Pay. Date : 2018-07-31

    DMF Number : 32835

    Submission : 2018-06-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-08-07

    Written Confirmation Number : WC-0424

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42413-0179

    Start Marketing Date : 2018-07-03

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    Vitamin K1

    India

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-01-05

    Pay. Date : 2016-09-23

    DMF Number : 30176

    Submission : 2016-09-24

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-08-07

    Written Confirmation Number : WC-0424

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    09

    Moxifloxacin Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-487 - Rev 00

    Issue Date : 2025-04-25

    Type : Chemical

    Substance Number : 2254

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-12-16

    Valid Till : 2025-12-15

    Written Confirmation Number : WC-0544

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Essel Bio Co., Ltd.

    Registration Date : 2023-04-12

    Registration Number : 20221012-209-J-1378(1)

    Manufacturer Name : Enaltec Labs Private Limited

    Manufacturer Address : Plot no. 825, 826 & 827, Sector-III, Industrial Area, Dist-Dhar, Pithampur-454 774, Madhya Pradesh, India

     VMF BR arrow-down
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    Available Reg. Filing : BR
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    10

    Bromfenac Sodium

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-08-07

    Written Confirmation Number : WC-0424

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42413-0007

    Start Marketing Date : 2011-05-27

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Contact Enaltec Labs and get a quotation

    Enaltec Labs is a supplier offers 83 products (APIs, Excipients or Intermediates).

    Find Clonidine bulk with DMF, CEP, WC offered by Enaltec Labs

    Find Trospium Chloride bulk with DMF, CEP, WC offered by Enaltec Labs

    Find Dronedarone Hydrochloride bulk with CEP, WC offered by Enaltec Labs

    Find Midodrine bulk with DMF, WC offered by Enaltec Labs

    Find Neostigmine Methylsulfate bulk with DMF, WC offered by Enaltec Labs

    Find Ramelteon bulk with DMF, WC offered by Enaltec Labs

    Find Varenicline Tartrate bulk with DMF, WC offered by Enaltec Labs

    Find Vitamin K1 bulk with DMF, WC offered by Enaltec Labs

    Find Moxifloxacin Hydrochloride bulk with CEP offered by Enaltec Labs

    Find Bromfenac Sodium bulk with WC offered by Enaltec Labs

    Find Chlorpromazine Hydrochloride bulk with DMF offered by Enaltec Labs

    Find Dofetilide bulk with DMF offered by Enaltec Labs

    Find Ethacrynic Acid bulk with WC offered by Enaltec Labs

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    Find Brimonidine Tartrate bulk offered by Enaltec Labs

    Find Bromfenac Sodium bulk offered by Enaltec Labs

    Find Desloratadine bulk offered by Enaltec Labs

    Find Febuxostat bulk offered by Enaltec Labs

    Find Nepafenac bulk offered by Enaltec Labs

    Find Pitavastatin bulk offered by Enaltec Labs

    Find Rosuvastatin Calcium bulk offered by Enaltec Labs

    Find Rupatadine Fumarate bulk offered by Enaltec Labs

    Find Tazarotene bulk offered by Enaltec Labs

    Find Tetrabenazine bulk offered by Enaltec Labs

    Find Alcaftadine bulk offered by Enaltec Labs

    Find Aprocitentan bulk offered by Enaltec Labs

    Find Bempedoic Acid bulk offered by Enaltec Labs

    Find Benfotiamine bulk offered by Enaltec Labs

    Find Beta-Aminoisobutyric Acid bulk offered by Enaltec Labs

    Find Bilastine bulk offered by Enaltec Labs

    Find Brivaracetam bulk offered by Enaltec Labs

    Find Bucillamine bulk offered by Enaltec Labs

    Find Butylphthalide bulk offered by Enaltec Labs

    Find Calcifediol bulk offered by Enaltec Labs

    Find Calcium 2-Oxo-3-Phenylpropionate bulk offered by Enaltec Labs

    Find Calcium 3-Methyl-2-Oxobutyrate bulk offered by Enaltec Labs

    Find Calcium 3-methyl-2-Oxovalerate bulk offered by Enaltec Labs

    Find Calcium 4-Methyl-2-Oxovalerate bulk offered by Enaltec Labs

    Find Calcium-DL-2-Hydroxy-4(Methylthio)Butyrate bulk offered by Enaltec Labs

    Find Choline Fenofibrate bulk offered by Enaltec Labs

    Find Ciclopirox bulk offered by Enaltec Labs

    Find Citicoline Sodium bulk offered by Enaltec Labs

    Find Dimethyl Fumarate bulk offered by Enaltec Labs

    Find Elafibranor bulk offered by Enaltec Labs

    Find Elagolix Sodium bulk offered by Enaltec Labs

    Find Empagliflozin bulk offered by Enaltec Labs

    Find Escitalopram Oxalate bulk offered by Enaltec Labs

    Find Ethacrynate Sodium bulk offered by Enaltec Labs

    Find Fampridine bulk offered by Enaltec Labs

    Find Ferric Carboxymaltose bulk offered by Enaltec Labs

    Find Fluralaner bulk offered by Enaltec Labs

    Find Gefapixant Citrate bulk offered by Enaltec Labs

    Find Gepirone bulk offered by Enaltec Labs

    Find Glimepiride bulk offered by Enaltec Labs

    Find Hopantenic Acid bulk offered by Enaltec Labs

    Find Ifenprodil Tartrate bulk offered by Enaltec Labs

    Find Imeglimin Hydrochloride bulk offered by Enaltec Labs

    Find Istradefylline bulk offered by Enaltec Labs

    Find Linagliptin bulk offered by Enaltec Labs

    Find Lobeglitazone bulk offered by Enaltec Labs

    Find Lumateperone Tosylate bulk offered by Enaltec Labs

    Find Moxifloxacin Hydrochloride bulk offered by Enaltec Labs

    Find Oleoylethanolamide bulk offered by Enaltec Labs

    Find Oxaloacetic Acid bulk offered by Enaltec Labs

    Find Oxcarbazepine bulk offered by Enaltec Labs

    Find Palmitoylethanolamide bulk offered by Enaltec Labs

    Find Remimazolam Besylate bulk offered by Enaltec Labs

    Find Resmetirom bulk offered by Enaltec Labs

    Find Safinamide Methanesulfonate bulk offered by Enaltec Labs

    Find Sitagliptin Phosphate bulk offered by Enaltec Labs

    Find Sulforaphane bulk offered by Enaltec Labs

    Find Tapinarof bulk offered by Enaltec Labs

    Find Teriflunomide bulk offered by Enaltec Labs

    Find Timolol Maleate bulk offered by Enaltec Labs

    Find Trigonelline bulk offered by Enaltec Labs

    Find Upacicalcet Sodium bulk offered by Enaltec Labs

    Find Urolithin A bulk offered by Enaltec Labs

    Find Valganciclovir Hydrochloride bulk offered by Enaltec Labs

    Find Vonoprazan Fumarate bulk offered by Enaltec Labs

    Find Xanomeline bulk offered by Enaltec Labs

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.