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    Company profile for Navinta

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    EVENTS

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    ACTIVE PHARMA INGREDIENTS

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    About

    Navinta, LLC is a privately held generic pharmaceutical company, established in 2003, dedicated to the development and commercialization of pharmaceutical products to treat patients with chronic and life-threatening diseases. Navinta means “novelty” inspiring a culture of transforming ideas into technology and advancing innovation to the marketplace with new medicines. Navinta has focused its research and regulatory activi...
    Navinta, LLC is a privately held generic pharmaceutical company, established in 2003, dedicated to the development and commercialization of pharmaceutical products to treat patients with chronic and life-threatening diseases. Navinta means “novelty” inspiring a culture of transforming ideas into technology and advancing innovation to the marketplace with new medicines. Navinta has focused its research and regulatory activities on developing new formulations, complex products, and unique pharmaceutical delivery systems. Navinta owns 21 process and product patents, 25 active Drug Master Files, and has 14 approved ANDA commercial products.

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    CONTACT DETAILS

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    NavintaUnited_States_of_America Flag
    Country
    Country
    U.S.A
    Address
    Address
    1499 Lower Ferry Road Ewing, NJ 08618
    Telephone
    Telephone
    +1 609.883.1135
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.navinta.com/
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    Linkedin
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    Twitter

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    NEWS #PharmaBuzz

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    Navinta’s Generics Diazepam Receives Approval in US
    Navinta’s Generics Diazepam Receives Approval in US

    14 Nov 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217468

    FDA
    14 Nov 2025
    Share Share
    Navinta’s Generics Sevelamer Carbonate Receives Approval in US
    Navinta’s Generics Sevelamer Carbonate Receives Approval in US

    27 Oct 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219931

    FDA
    27 Oct 2025
    Share Share
    Navinta’s Generics Nicardipine Hydrochloride Approved in US
    Navinta’s Generics Nicardipine Hydrochloride Approved in US

    25 Jun 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218638

    FDA
    25 Jun 2025
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    Navinta`s Generics Sevelamer HCl Receives Approval in US
    Navinta`s Generics Sevelamer HCl Receives Approval in US

    03 Feb 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218966

    FDA
    03 Feb 2025
    Share Share
    Navinta`s Generic Penicillamine Receives Approval in US
    Navinta`s Generic Penicillamine Receives Approval in US

    14 Oct 2021

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214363

    FDA
    14 Oct 2021
    Share Share
    Navinta's Generic Fosaprepitant Dimeglumine Receives Approval In US
    Navinta's Generic Fosaprepitant Dimeglumine Receives Approval In US

    20 Aug 2020

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212957

    FDA
    20 Aug 2020
    Share Share

    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Cisatracurium Besylate

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

    Global ChemShow
    Not Confirmed
    arrow

    Cisatracurium Besylate

    U.S.A

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

    arrow
    Global ChemShow
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41604

    Submission : 2025-06-18

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Colesevelam Hydrochloride

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

    Global ChemShow
    Not Confirmed
    arrow

    Colesevelam Hydrochloride

    U.S.A

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

    arrow
    Global ChemShow
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38605

    Submission : 2023-07-18

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Crizotinib

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

    Global ChemShow
    Not Confirmed
    arrow

    Crizotinib

    U.S.A

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

    arrow
    Global ChemShow
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39325

    Submission : 2024-01-08

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Diazepam

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

    Global ChemShow
    Not Confirmed
    arrow

    Diazepam

    U.S.A

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

    arrow
    Global ChemShow
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-11-14

    Pay. Date : 2023-09-26

    DMF Number : 38844

    Submission : 2023-09-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Glycerol Phenylbutyrate

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

    Global ChemShow
    Not Confirmed
    arrow

    Glycerol Phenylbutyrate

    U.S.A

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

    arrow
    Global ChemShow
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-04-28

    Pay. Date : 2025-04-02

    DMF Number : 40966

    Submission : 2025-04-03

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Sodium Phenylbutyrate

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

    Global ChemShow
    Not Confirmed
    arrow

    Sodium Phenylbutyrate

    U.S.A

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

    arrow
    Global ChemShow
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-03-04

    Pay. Date : 2025-02-20

    DMF Number : 40965

    Submission : 2025-02-24

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Tafamidis Meglumine

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

    Global ChemShow
    Not Confirmed
    arrow

    Tafamidis Meglumine

    U.S.A

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

    arrow
    Global ChemShow
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-08-09

    Pay. Date : 2024-07-26

    DMF Number : 39928

    Submission : 2024-07-29

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Triheptanoin

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

    Global ChemShow
    Not Confirmed
    arrow

    Triheptanoin

    U.S.A

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

    arrow
    Global ChemShow
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-04-16

    Pay. Date : 2024-03-22

    DMF Number : 39441

    Submission : 2024-03-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Remifentanil

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

    Global ChemShow
    Not Confirmed
    arrow

    Remifentanil

    U.S.A

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

    arrow
    Global ChemShow
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 68475-021

    Start Marketing Date : 2020-07-23

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (500g/500g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
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    Market
    Place

    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    USDMF

    read-more
    read-more

    01

    Cisatracurium Besylate Usp

    U.S.A
    Global ChemShow
    Not Confirmed
    arrow

    02

    Colesevelam Hydrochloride

    U.S.A
    Global ChemShow
    Not Confirmed
    arrow

    03

    Crizotinib

    U.S.A
    Global ChemShow
    Not Confirmed
    arrow

    04

    Diazepam Usp

    U.S.A
    Global ChemShow
    Not Confirmed
    arrow

    05

    Glycerol Phenylbutyrate

    U.S.A
    Global ChemShow
    Not Confirmed
    arrow

    06

    Sodium Phenylbutyrate Usp

    U.S.A
    Global ChemShow
    Not Confirmed
    arrow

    07

    Tafamidis Meglumine

    U.S.A
    Global ChemShow
    Not Confirmed
    arrow

    08

    Triheptanoin

    U.S.A
    Global ChemShow
    Not Confirmed
    arrow
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    ABOUT THIS PAGE

    Contact Navinta and get a quotation

    Navinta is a supplier offers 9 products (APIs, Excipients or Intermediates).

    Find a price of Cisatracurium Besylate bulk with DMF offered by Navinta

    Find a price of Colesevelam Hydrochloride bulk with DMF offered by Navinta

    Find a price of Crizotinib bulk with DMF offered by Navinta

    Find a price of Diazepam bulk with DMF offered by Navinta

    Find a price of Glycerol Phenylbutyrate bulk with DMF offered by Navinta

    Find a price of Sodium Phenylbutyrate bulk with DMF offered by Navinta

    Find a price of Tafamidis Meglumine bulk with DMF offered by Navinta

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