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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Long-Term Data on Fabrazyme® (agalsidase Beta) for People with Fabry Disease

    Details:

    Fabrazyme (agalsidase beta) works by replacing a naturally occurring enzyme (alpha-galactosidase A) to help clear GL-3 build-up in cells, including those lining the blood vessels of the kidneys, heart and skin. It is the only FDA-approved therapy for Fabry disease.


    Lead Product(s): Agalsidase Beta

    Therapeutic Area: Genetic Disease Brand Name: Fabrazyme

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 12, 2020

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Agalsidase Beta

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Long-Term Data on Fabrazyme® (agalsidase Beta) for People with Fabry Disease

    Details : Fabrazyme (agalsidase beta) works by replacing a naturally occurring enzyme (alpha-galactosidase A) to help clear GL-3 build-up in cells, including those lining the blood vessels of the kidneys, heart and skin. It is the only FDA-approved therapy for Fab...

    Brand Name : Fabrazyme

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    March 12, 2020

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    mAbxience and Biosidus Sign CDMO agreement for agalsidase beta in Fabry disease

    Details:

    mAbxience will manufacture the biosimilar of Fabrazyme (agalsidase beta), developed by Biosidus, for Fabry disease treatment under the agreement.


    Lead Product(s): Agalsidase Beta

    Therapeutic Area: Genetic Disease Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Biosidus

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement February 05, 2024

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    Mabxience

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    Mabxience

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    Lead Product(s) : Agalsidase Beta

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Biosidus

    Deal Size : Undisclosed

    Deal Type : Agreement

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    mAbxience and Biosidus Sign CDMO agreement for agalsidase beta in Fabry disease

    Details : mAbxience will manufacture the biosimilar of Fabrazyme (agalsidase beta), developed by Biosidus, for Fabry disease treatment under the agreement.

    Brand Name : Undisclosed

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    February 05, 2024

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    Fabagal® for Fabry Disease Management is Now Available in Russia

    Details:

    Fabagal (agalsidase-beta) is a recombinant analogue of human alpha-galactosidase A and is produced by recombinant DNA technology. It is approved for the treatment of fabry disease in adults and children from 8 years old.


    Lead Product(s): Agalsidase Beta

    Therapeutic Area: Genetic Disease Brand Name: Fabagal

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: ISU ABXIS

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 02, 2023

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    Petrovax

    Russia
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    Petrovax

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    Lead Product(s) : Agalsidase Beta

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : ISU ABXIS

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Fabagal® for Fabry Disease Management is Now Available in Russia

    Details : Fabagal (agalsidase-beta) is a recombinant analogue of human alpha-galactosidase A and is produced by recombinant DNA technology. It is approved for the treatment of fabry disease in adults and children from 8 years old.

    Brand Name : Fabagal

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    October 02, 2023

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    JCR and Sumitomo Dainippon Pharma Enter into Marketing Alliance for Agalsidase Beta BS I.V. Infusion, for Treatment of Fabry Disease in Japan

    Details:

    The agreement includes the marketing alliance for JR-051 (agalsidase beta BS), a biosimilar of Fabrazyme, a therapeutic enzyme, being sold by JCR for the treatment of Fabry disease.


    Lead Product(s): Agalsidase Beta

    Therapeutic Area: Genetic Disease Brand Name: JR-051

    Study Phase: ApprovedProduct Type: Cell and Gene therapy

    Sponsor: Sumitomo Pharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement March 01, 2022

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    JCR Pharmaceuticals

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    JCR Pharmaceuticals

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    Lead Product(s) : Agalsidase Beta

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Sumitomo Pharma

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    JCR and Sumitomo Dainippon Pharma Enter into Marketing Alliance for Agalsidase Beta BS I.V. Infusi...

    Details : The agreement includes the marketing alliance for JR-051 (agalsidase beta BS), a biosimilar of Fabrazyme, a therapeutic enzyme, being sold by JCR for the treatment of Fabry disease.

    Brand Name : JR-051

    Molecule Type : Cell and Gene therapy

    Upfront Cash : Undisclosed

    March 01, 2022

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    ISU ABXIS has Signed a License Agreement for “fabagal” a Therapeutic for Fabry Disease, with NPO Petrovax Pharm Located in Russia

    Details:

    Under the agreement, Petrovax gains access to Fabagal (agalsidase beta), indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).


    Lead Product(s): Agalsidase Beta

    Therapeutic Area: Genetic Disease Brand Name: Fabagal

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Petrovax

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement January 26, 2022

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    ISU ABXIS

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    Lead Product(s) : Agalsidase Beta

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Petrovax

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    ISU ABXIS has Signed a License Agreement for “fabagal” a Therapeutic for Fabry Disease, with N...

    Details : Under the agreement, Petrovax gains access to Fabagal (agalsidase beta), indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).

    Brand Name : Fabagal

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    January 26, 2022

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    Sanofi

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    Regulatory Info :

    Registration Country : USA

    AGALSIDASE BETA

    Brand Name : FABRAZYME

    Dosage Form : VIAL; INTRAVENOUS

    Dosage Strength : 5MG/VIAL

    Packaging :

    Approval Date :

    Application Number : 103979

    Regulatory Info :

    Registration Country : USA

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info :

    Registration Country : USA

    AGALSIDASE BETA

    Brand Name : FABRAZYME

    Dosage Form : VIAL; INTRAVENOUS

    Dosage Strength : 35MG/VIAL

    Packaging :

    Approval Date :

    Application Number : 103979

    Regulatory Info :

    Registration Country : USA

    Sanofi Company Banner

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info :

    Registration Country : Sweden

    agalsidase beta

    Brand Name : Fabrazyme

    Dosage Form : POWDER FOR CONCENTRATE FOR

    Dosage Strength : -

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info :

    Registration Country : Canada

    AGALSIDASE BETA

    Brand Name : FABRAZYME

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 5MG/VIAL

    Packaging : 1.1ML

    Approval Date :

    Application Number : 2248965

    Regulatory Info :

    Registration Country : Canada

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    Sanofi

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info :

    Registration Country : Canada

    AGALSIDASE BETA

    Brand Name : FABRAZYME

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 35MG/VIAL

    Packaging : 7.2ML

    Approval Date :

    Application Number : 2248966

    Regulatory Info :

    Registration Country : Canada

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info : Originator

    Registration Country : South Africa

    Agalsidase beta

    Brand Name : Fabrazyme 35mg

    Dosage Form : POI

    Dosage Strength : 35mg/20ml

    Packaging : 20X1mg/20ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info : Originator

    Registration Country : South Africa

    Agalsidase beta

    Brand Name : Fabrazyme 5mg

    Dosage Form : POI

    Dosage Strength : 5mg/5ml

    Packaging : 5X1mg/5ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Takeda Pharmaceutical

    Japan
    BIO Partnering at JPM
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    Takeda Pharmaceutical

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    Regulatory Info :

    Registration Country : Canada

    AGALSIDASE ALFA

    Brand Name : REPLAGAL

    Dosage Form : SOLUTION

    Dosage Strength : 1MG/ML

    Packaging :

    Approval Date :

    Application Number : 2249057

    Regulatory Info :

    Registration Country : Canada

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    Takeda Pharmaceutical

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    Regulatory Info : Originator

    Registration Country : South Africa

    Agalsidase Alfa

    Brand Name : Replagal

    Dosage Form : INF

    Dosage Strength : 1mg/ml

    Packaging : 3.5X1mg/ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Country
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    Regulatory Info :

    Registration Country : Sweden

    agalsidas alfa

    Brand Name : Replagal

    Dosage Form : KONCENTRAT TILL INFUSIONSVÄTSKA, LÖSNING

    Dosage Strength : 1 MG/ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    RLD :

    TE Code :

    AGALSIDASE BETA

    Brand Name : FABRAZYME

    Dosage Form : VIAL; INTRAVENOUS

    Dosage Strength : 5MG/VIAL

    Approval Date :

    Application Number : 103979

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    RLD :

    TE Code :

    AGALSIDASE BETA

    Brand Name : FABRAZYME

    Dosage Form : VIAL; INTRAVENOUS

    Dosage Strength : 35MG/VIAL

    Approval Date :

    Application Number : 103979

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Genzyme Europe BV

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    Regulatory Info :

    Registration Country : Sweden

    agalsidase beta

    Brand Name : Fabrazyme

    Dosage Form : POWDER FOR CONCENTRATE FOR

    Dosage Strength : -

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

    Sanofi Company Banner

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    Shire Human Genetic Therapies AB

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    Shire Human Genetic Therapies AB

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    Regulatory Info :

    Registration Country : Sweden

    agalsidas alfa

    Brand Name : Replagal

    Dosage Form : KONCENTRAT TILL INFUSIONSVÄTSKA, LÖSNING

    Dosage Strength : 1 MG/ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    Brand Name : Fabrazyme

    France
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    Sanofi

    Agalsidase Beta

    Main Therapeutic Indication : Rare Disorders

    Currency : USD

    2019 Revenue in Millions : 886

    2018 Revenue in Millions : 823

    Growth (%) : 8

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Brand Name : Fabrazyme

    France
    arrow
    Biotech Showcase
    Not Confirmed
    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Sanofi

    Agalsidase Beta

    Main Therapeutic Indication : Rare Disorders

    Currency : USD

    2020 Revenue in Millions : 988

    2019 Revenue in Millions : 983

    Growth (%) : 0

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Brand Name : Fabrazyme

    France
    arrow
    Biotech Showcase
    Not Confirmed
    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Sanofi

    Agalsidase Beta

    Main Therapeutic Indication : Rare Disorders

    Currency : USD

    2021 Revenue in Millions : 929

    2020 Revenue in Millions : 891

    Growth (%) : 3

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    04

    Brand Name : Fabrazyme

    France
    arrow
    Biotech Showcase
    Not Confirmed
    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Sanofi

    Agalsidase beta

    Main Therapeutic Indication : Rare Diseases

    Currency : USD

    2022 Revenue in Millions : 1,029

    2021 Revenue in Millions : 929

    Growth (%) : 11

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    05

    Brand Name : Fabrazyme

    France
    arrow
    Biotech Showcase
    Not Confirmed
    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Sanofi

    Agalsidase Beta

    Main Therapeutic Indication : Rare Diseases

    Currency : USD

    2023 Revenue in Millions : 1,070

    2022 Revenue in Millions : 1,029

    Growth (%) : 6

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    06

    Brand Name : Fabrazyme

    France
    arrow
    Biotech Showcase
    Not Confirmed
    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Sanofi

    Agalsidase beta

    Main Therapeutic Indication : Rare Disease

    Currency : USD

    2014 Revenue in Millions : 20.10%

    2013 Revenue in Millions :

    Growth (%) :

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    07

    Brand Name : Fabrazyme

    France
    arrow
    Biotech Showcase
    Not Confirmed
    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Sanofi

    Agalsidase beta

    Main Therapeutic Indication : Rare Disease

    Currency : USD

    2015 Revenue in Millions : 506

    2014 Revenue in Millions : 651

    Growth (%) : 29%

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    08

    Brand Name : Fabrazyme

    France
    arrow
    Biotech Showcase
    Not Confirmed
    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Sanofi

    Agalsidase Beta

    Main Therapeutic Indication : Rare Diseases

    Currency : USD

    2016 Revenue in Millions : 714

    2015 Revenue in Millions : 628

    Growth (%) : 14

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    09

    Brand Name : Fabrazyme

    France
    arrow
    Biotech Showcase
    Not Confirmed
    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Sanofi

    Agalsidase Beta

    Main Therapeutic Indication : Rare Diseases

    Currency : USD

    2017 Revenue in Millions : 895

    2016 Revenue in Millions : 836

    Growth (%) : 7

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    Brand Name : Fabrazyme

    France
    arrow
    Biotech Showcase
    Not Confirmed
    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Sanofi

    Agalsidase Beta

    Main Therapeutic Indication : Rare Diseases

    Currency : USD

    2018 Revenue in Millions : 853

    2017 Revenue in Millions : 816

    Growth (%) : 5%

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

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