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List of All Manufacturers & Suppliers of Agalsidase Beta Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 7Sanofi

02 1Shire Human Genetic Therapies AB

03 2Takeda Pharmaceutical

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

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

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

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

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

03

  • fda
  • EDQM
  • WHO-GMP

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

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

04

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Prescription

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 : Prescription

Registration Country : Canada

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Prescription

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 : Prescription

Registration Country : Canada

Sanofi Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

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

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

Sanofi Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

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

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

Sanofi Company Banner

08

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

AGALSIDASE ALFA

Brand Name : REPLAGAL

Dosage Form : SOLUTION

Dosage Strength : 1MG/ML

Packaging :

Approval Date :

Application Number : 2249057

Regulatory Info : Prescription

Registration Country : Canada

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09

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

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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10

Shire Human Genetic Therapies AB

Country
Luxepack
Not Confirmed
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Shire Human Genetic Therapies AB

Country
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Luxepack
Not Confirmed

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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