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    Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.

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    About

    Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, leveraging the India advantage for global generic formulators. The company operates USFDA-approved and WHO-GMP-approved facilities, a DSIR-approved R&D center, GLP-compliant labs, and cGMP-certified plants. Enaltec has developed over 90 products for regulated and semi-regulated markets in just 16 years, driving advanced synthesis and analytical research. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    CONTACT DETAILS

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    Enaltec Labsindia-flag Flag
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    India
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    401, 4th Floor, Kesar Solitaire, Plot No. 5, Sector 19, Sanpada, Navi Mumbai,...
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    +91 2267507000
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    info@enaltec.com
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    https://www.enaltec.com/
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    https://www.linkedin.com/company/enaltec-labs-pvt-ltd/
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    Product List 2025

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    ALL APIs

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    01

    Clonidine

    India

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

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    Virtual BoothEnaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
    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

    KDMF VMF Others AUDIT
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    02

    Trospium Chloride

    India

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

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    Virtual BoothEnaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
    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

    KDMF VMF Others AUDIT
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    03

    Dronedarone Hydrochloride

    India

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

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    Virtual BoothEnaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
    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

    KDMF VMF Others AUDIT
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    04

    Midodrine

    India

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

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    Virtual BoothEnaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
    USDMF arrow-down
    ✖

    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 :

    NDC KDMF VMF Others AUDIT
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    05

    Neostigmine Methylsulfate

    India

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

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    Virtual BoothEnaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
    USDMF arrow-down
    ✖

    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

    KDMF VMF Others AUDIT
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    06

    Ramelteon

    India

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

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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
    ✖

    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

    KDMF VMF Others AUDIT
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    08

    Vitamin K1

    India

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

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    Virtual BoothEnaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
    USDMF arrow-down
    ✖

    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

    Chlorpromazine Hydrochloride

    India

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

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    Virtual BoothEnaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-06-22

    Pay. Date : 2018-05-15

    DMF Number : 32014

    Submission : 2018-05-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 42413-0137

    Start Marketing Date : 2018-05-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    ABOUT THIS PAGE

    Contact Enaltec Labs and get a quotation

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

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