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    Axplora announces the appointment of its Scientific Advisory Board

    13 Nov 2023

    // PRESS RELEASE

    Axplora announces the appointment of its Scientific Advisory Board

    13 Nov 2023

    // PRESS RELEASE

    Axplora appoints Dr. Stephan Haitz as President of its Novasep CDMO Business Unit

    18 Oct 2023

    // PRESS RELEASE

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    About

    Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.

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    NovasepGermany Flag
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    Germany
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    Headquarters, HochstraB-Süd 7, 83064 Raubling
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    YouTube : https://www.youtube.com/channel/UCTuVYD8er8sbIdDE9QYksQA 

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    Axplora announces the appointment of its Scientific Advisory Board
    Axplora announces the appointment of its Scientific Advisory Board

    13 Nov 2023

    // PRESS RELEASE

    https://www.axplora.com/scientific-advisory-board/

    PRESS RELEASE
    13 Nov 2023
    Share Share
    Axplora announces the appointment of its Scientific Advisory Board
    Axplora announces the appointment of its Scientific Advisory Board

    13 Nov 2023

    // PRESS RELEASE

    https://www.axplora.com/scientific-advisory-board/

    PRESS RELEASE
    13 Nov 2023
    Share Share
    Axplora appoints Dr. Stephan Haitz as President of its Novasep CDMO Business Unit
    Axplora appoints Dr. Stephan Haitz as President of its Novasep CDMO Business Unit

    18 Oct 2023

    // PRESS RELEASE

    https://www.axplora.com/axplora-appoints-dr-stephan-haitz-as-president-of-its-novasep-cdmo-business-unit/

    PRESS RELEASE
    18 Oct 2023
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    ALL APIs

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    01

    Adapalene

    Germany

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

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    ChemOutsourcing
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    USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Galderma Korea Co., Ltd.

    Registration Date : 2024-03-27

    Registration Number : 20240327-209-J-1630

    Manufacturer Name : FINORGA SAS

    Manufacturer Address : Route de Givors Chasse Sur Rhone,38670, France

     VMF Others AUDIT
    Axplora Novasep

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    02

    Adapalene

    Germany

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

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    ChemOutsourcing
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    USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Galderma Korea Co., Ltd.

    Registration Date : 2023-08-24

    Registration Number : 20230824-209-J-1526

    Manufacturer Name : FINORGA SAS

    Manufacturer Address : route de Givors Chasse Sur Rhone,38670, France

     VMF Others AUDIT
    Axplora Novasep

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    03

    Brinzolamide

    Germany

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

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    ChemOutsourcing
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    USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2023-10-10

    Registration Number : 20231010-209-J-1549

    Manufacturer Name : Finorga SAS

    Manufacturer Address : route de Givors, Chasse Sur Rhone, 38670, France

     VMF Others AUDIT
    Axplora Novasep

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    KDMF

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    01

    Adapalene

    Germany
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    CPHI Shenzhen
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    • EDQM
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    Novasep

    Registrant Name : Galderma Korea Co., Ltd.

    Registration Date : 2024-03-27

    Registration Number : 20240327-209-J-1630

    Manufacturer Name : FINORGA SAS

    Manufacturer Address : Route de Givors Chasse Sur Rhone,38670, France

    Axplora Novasep

    Product
    Web Link

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    #Pipeline Prospector

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    02

    Adapalene

    Germany
    arrow
    CPHI Shenzhen
    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.

    Novasep

    Registrant Name : Galderma Korea Co., Ltd.

    Registration Date : 2023-08-24

    Registration Number : 20230824-209-J-1526

    Manufacturer Name : FINORGA SAS

    Manufacturer Address : route de Givors Chasse Sur Rhone,38670, France

    Axplora Novasep

    Product
    Web Link

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    #Pipeline Prospector

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    03

    Brinzolamide

    Germany
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    CPHI Shenzhen
    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.

    Novasep

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2023-10-10

    Registration Number : 20231010-209-J-1549

    Manufacturer Name : Finorga SAS

    Manufacturer Address : route de Givors, Chasse Sur Rhone, 38670, France

    Axplora Novasep

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    Drugs in Development

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    Novasep Signs €4.7m Biomanufacturing Deal with Biotech

    Details:

    Through the agreement, Novasep will support Celladon’s plans to produce Mydicar, which is being evaluated in the mid-stage clinical trial for the treatment of heart failure.


    Lead Product(s): AAV1/SERCA2a,Inapplicable

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Mydicar

    Study Phase: Phase IIProduct Type: Cell and Gene therapy

    Sponsor: Celladon

    Deal Size: $5.4 million Upfront Cash: Undisclosed

    Deal Type: Agreement December 13, 2023

    Axplora Novasep

    01

    Novasep

    Germany
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    ChemOutsourcing
    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.

    Lead Product(s) : AAV1/SERCA2a,Inapplicable

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Celladon

    Deal Size : $5.4 million

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Novasep Signs €4.7m Biomanufacturing Deal with Biotech

    Details : Through the agreement, Novasep will support Celladon’s plans to produce Mydicar, which is being evaluated in the mid-stage clinical trial for the treatment of heart failure.

    Product Name : Mydicar

    Product Type : Cell and Gene therapy

    Upfront Cash : Undisclosed

    December 13, 2023

    Axplora Novasep

    Stock Recap
    #PipelineProspector

    Data Compilation
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    • Deals
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    • 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.

    McSAF and Novasep Announce Their Successful Collaboration To Produce A Next-generation Antibody-Drug Conjugate (ADC)

    Details:

    Novasep has successfully optimized and scaled-up the process of Adcitmer® (monomethyl auristatin E-conjugated antibody), McSAF Inside® Oncology’s first-in-class proprietary ADC to treat neuroendocrine cancers.


    Lead Product(s): Adcitmer,Inapplicable

    Therapeutic Area: Oncology Brand Name: Adcitmer

    Study Phase: PreclinicalProduct Type: Antibody-drug Conjugate

    Recipient: McSAF

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration November 18, 2021

    Axplora Novasep

    02

    Novasep

    Germany
    arrow
    ChemOutsourcing
    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.

    Lead Product(s) : Adcitmer,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Preclinical

    Recipient : McSAF

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    McSAF and Novasep Announce Their Successful Collaboration To Produce A Next-generation Antibody-Dr...

    Details : Novasep has successfully optimized and scaled-up the process of Adcitmer® (monomethyl auristatin E-conjugated antibody), McSAF Inside® Oncology’s first-in-class proprietary ADC to treat neuroendocrine cancers.

    Product Name : Adcitmer

    Product Type : Antibody-drug Conjugate

    Upfront Cash : Undisclosed

    November 18, 2021

    Axplora Novasep

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Deals
    • 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.

    Sensorion and Novasep Sign Agreement

    Details:

    The agreement aims for the manufacturing of adeno-associated virus (AAV) vectors, covering the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein and aims to restore the expression of Otoferlin.


    Lead Product(s): OTOF-GT,Inapplicable

    Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: OTOF-GT

    Study Phase: PreclinicalProduct Type: Cell and Gene therapy

    Sponsor: Sensorion

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement November 03, 2020

    Axplora Novasep

    03

    Novasep

    Germany
    arrow
    ChemOutsourcing
    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.

    Lead Product(s) : OTOF-GT,Inapplicable

    Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Sensorion

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Sensorion and Novasep Sign Agreement

    Details : The agreement aims for the manufacturing of adeno-associated virus (AAV) vectors, covering the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein and aims to restore the expression of Otoferlin.

    Product Name : OTOF-GT

    Product Type : Cell and Gene therapy

    Upfront Cash : Undisclosed

    November 03, 2020

    Axplora Novasep

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

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    ABOUT THIS PAGE

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