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    Company profile for Novugen

    NEW Drugs in Dev: 1
    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

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    pharmacompass-1-m-2026-04-20

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    Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

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    Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

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    pharmacompass-2-m-2026-04-20

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

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    Novugensaudiarabiapng-1555324364png-1605701218 Flag
    Country
    Country
    U.A.E
    Address
    Address
    Unit 3301, 33rd Floor, Jumeirah Business Center 4, Cluster N, Jumeirah Lakes T...
    Telephone
    Telephone
    +971-4-277-3301
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.novugen.com/index2.html
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    Linkedin
    https://in.linkedin.com/company/novugen
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    NEWS #PharmaBuzz

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    Novugen’s Generics Everolimus Receives Approval in US
    Novugen’s Generics Everolimus Receives Approval in US

    30 Oct 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219955

    FDA
    30 Oct 2025
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    Hikma acquires Novugen's FDA-approved ANDA for trametinib
    Hikma acquires Novugen's FDA-approved ANDA for trametinib

    17 Apr 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/hikma-acquires-novugens-fda-approved-anda-for-trametinib-302431694.html

    PR NEWSWIRE
    17 Apr 2025
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    Novugen's Generic Pazopanib Hydrochloride Receives Approval in the U.S.
    Novugen's Generic Pazopanib Hydrochloride Receives Approval in the U.S.

    24 Apr 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218231

    FDA
    24 Apr 2024
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    Novugen's Generic Sunitinib Malate Receives Approval in the U.S.
    Novugen's Generic Sunitinib Malate Receives Approval in the U.S.

    21 Aug 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218012

    FDA
    21 Aug 2023
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    ALL APIs

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

    01

    Albendazole

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Albendazole

    U.A.E

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-01-24

    Pay. Date : 2017-10-10

    DMF Number : 32013

    Submission : 2017-10-12

    Status : Active

    Type : II

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

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    02

    Fingolimod Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Fingolimod Hydrochloride

    U.A.E

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-05-02

    Pay. Date : 2019-01-28

    DMF Number : 33328

    Submission : 2018-12-24

    Status : Active

    Type : II

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Solifenacin Succinate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Solifenacin Succinate

    U.A.E

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-04-11

    Pay. Date : 2019-03-06

    DMF Number : 33306

    Submission : 2019-02-20

    Status : Active

    Type : II

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

    FDF Dossiers

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    01

    Brand Name : ABIRATERONE ACETATE

    U.A.E
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : ABIRATERONE ACETATE

    U.A.E
    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : RX

    Registration Country : USA

    ABIRATERONE ACETATE

    Novugen

    Dosage Form : TABLET;ORAL

    Brand Name : ABIRATERONE ACETATE

    Dosage Strength : 250MG

    Packaging :

    Approval Date : 2022-01-05

    Application Number : 215947

    Regulatory Info : RX

    Registration Country : USA

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Brand Name : ABIRATERONE ACETATE

    U.A.E
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : ABIRATERONE ACETATE

    U.A.E
    arrow
    PEGS Boston Summit
    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.

    Regulatory Info : RX

    Registration Country : USA

    ABIRATERONE ACETATE

    Novugen

    Dosage Form : TABLET;ORAL

    Brand Name : ABIRATERONE ACETATE

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 2022-01-05

    Application Number : 215947

    Regulatory Info : RX

    Registration Country : USA

    blank

    Product
    Web Link

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    Market
    Place

    03

    Brand Name : EVEROLIMUS

    U.A.E
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : EVEROLIMUS

    U.A.E
    arrow
    PEGS Boston Summit
    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.

    Regulatory Info : RX

    Registration Country : USA

    EVEROLIMUS

    Novugen

    Dosage Form : TABLET;ORAL

    Brand Name : EVEROLIMUS

    Dosage Strength : 2.5MG

    Packaging :

    Approval Date : 2025-10-30

    Application Number : 219955

    Regulatory Info : RX

    Registration Country : USA

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Brand Name : EVEROLIMUS

    U.A.E
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : EVEROLIMUS

    U.A.E
    arrow
    PEGS Boston Summit
    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.

    Regulatory Info : RX

    Registration Country : USA

    EVEROLIMUS

    Novugen

    Dosage Form : TABLET;ORAL

    Brand Name : EVEROLIMUS

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2025-10-30

    Application Number : 219955

    Regulatory Info : RX

    Registration Country : USA

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Brand Name : EVEROLIMUS

    U.A.E
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : EVEROLIMUS

    U.A.E
    arrow
    PEGS Boston Summit
    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.

    Regulatory Info : RX

    Registration Country : USA

    EVEROLIMUS

    Novugen

    Dosage Form : TABLET;ORAL

    Brand Name : EVEROLIMUS

    Dosage Strength : 7.5MG

    Packaging :

    Approval Date : 2025-10-30

    Application Number : 219955

    Regulatory Info : RX

    Registration Country : USA

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Brand Name : EVEROLIMUS

    U.A.E
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : EVEROLIMUS

    U.A.E
    arrow
    PEGS Boston Summit
    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.

    Regulatory Info : RX

    Registration Country : USA

    EVEROLIMUS

    Novugen

    Dosage Form : TABLET;ORAL

    Brand Name : EVEROLIMUS

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2025-10-30

    Application Number : 219955

    Regulatory Info : RX

    Registration Country : USA

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Brand Name : LENALIDOMIDE

    U.A.E
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : LENALIDOMIDE

    U.A.E
    arrow
    PEGS Boston Summit
    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.

    Regulatory Info : RX

    Registration Country : USA

    LENALIDOMIDE

    Novugen

    Dosage Form : CAPSULE;ORAL

    Brand Name : LENALIDOMIDE

    Dosage Strength : 2.5MG

    Packaging :

    Approval Date : 2024-09-11

    Application Number : 217281

    Regulatory Info : RX

    Registration Country : USA

    blank

    Product
    Web Link

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    Market
    Place

    08

    Brand Name : LENALIDOMIDE

    U.A.E
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : LENALIDOMIDE

    U.A.E
    arrow
    PEGS Boston Summit
    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.

    Regulatory Info : RX

    Registration Country : USA

    LENALIDOMIDE

    Novugen

    Dosage Form : CAPSULE;ORAL

    Brand Name : LENALIDOMIDE

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2024-09-11

    Application Number : 217281

    Regulatory Info : RX

    Registration Country : USA

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Brand Name : LENALIDOMIDE

    U.A.E
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : LENALIDOMIDE

    U.A.E
    arrow
    PEGS Boston Summit
    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.

    Regulatory Info : RX

    Registration Country : USA

    LENALIDOMIDE

    Novugen

    Dosage Form : CAPSULE;ORAL

    Brand Name : LENALIDOMIDE

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2024-09-11

    Application Number : 217281

    Regulatory Info : RX

    Registration Country : USA

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Brand Name : LENALIDOMIDE

    U.A.E
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : LENALIDOMIDE

    U.A.E
    arrow
    PEGS Boston Summit
    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.

    Regulatory Info : RX

    Registration Country : USA

    LENALIDOMIDE

    Novugen

    Dosage Form : CAPSULE;ORAL

    Brand Name : LENALIDOMIDE

    Dosage Strength : 15MG

    Packaging :

    Approval Date : 2024-09-11

    Application Number : 217281

    Regulatory Info : RX

    Registration Country : USA

    blank

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    #PipelineProspector

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    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    FDA Orange Book

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    Inspections and registrations

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    ABOUT THIS PAGE

    Contact Novugen and get a quotation

    Novugen is a supplier offers 3 products (APIs, Excipients or Intermediates).

    Find Albendazole bulk with DMF offered by Novugen

    Find Fingolimod Hydrochloride bulk with DMF offered by Novugen

    Find Solifenacin Succinate bulk with DMF offered by Novugen

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