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List of All Manufacturers & Suppliers of Hepatitis B Immune Globulin Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 1EUROAPI

02 11Sanofi

03 2Biomed Lublin

04 2Biotest

05 1CANGENE CORPORATION

06 1Crucell

07 6GSK

08 2Grifols International

09 1KI Biopharma

10 2Kedrion

11 2ORIFARM GROUP AS

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

Regulatory Info :

Registration Country : Sweden

hepatit B-virus, ytantigen (HBsAg)

Brand Name : HB-vax

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION

Dosage Strength : 10 MIKROGRAM/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

EUROAPI Compnay 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 : Sweden

Hepatitis A virus inactivated antigen

Brand Name : AVAXIM

Dosage Form : SUSPENSION FOR INJECTION IN PRE-FILLED

Dosage Strength : -

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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

hepatitis B virus surface antigen (HBsAg)

Brand Name : HBVAXPRO

Dosage Form : SUSPENSION FOR INJECTION

Dosage Strength : 5 MCG

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 :

Registration Country : Sweden

hepatitis B virus surface antigen (HBsAg)

Brand Name : HBVAXPRO

Dosage Form : SUSPENSION FOR INJECTION

Dosage Strength : 40 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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 :

Registration Country : Sweden

hepatitis B virus surface antigen (HBsAg)

Brand Name : HBVAXPRO

Dosage Form : SUSPENSION FOR INJECTION IN PRE-FILLED

Dosage Strength : 5 MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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 :

Registration Country : Sweden

hepatitis B virus surface antigen (HBsAg)

Brand Name : HBVAXPRO

Dosage Form : SUSPENSION FOR INJECTION

Dosage Strength : 10 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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 :

Registration Country : Sweden

hepatitis B virus surface antigen (HBsAg)

Brand Name : HBVAXPRO

Dosage Form : SUSPENSION FOR INJECTION IN PRE-FILLED

Dosage Strength : 10 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

08

  • 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

hepatit B-virus, ytantigen (HBsAg)

Brand Name : HBVAXPRO

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION, FÖRFYLLD

Dosage Strength : 40 MIKROGRAM/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

09

  • 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

hepatit A-virus, inaktiverat antigen

Brand Name : Vaqta

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION

Dosage Strength : 25 E

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

10

  • 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

hepatit A-virus, inaktiverat antigen

Brand Name : Vaqta

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION

Dosage Strength : 50 E

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

11

  • 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

hepatit A-virus, inaktiverat antigen

Brand Name : Vaqta

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION, FÖRFYLLD

Dosage Strength : 50 E

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

12

  • 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

hepatit A-virus, inaktiverat antigen

Brand Name : Vaqta

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION, FÖRFYLLD

Dosage Strength : 25 E

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

13

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

hepatit A-virus, stam RG-SB

Brand Name : Epaxal

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION, FÖRFYLLD

Dosage Strength : --

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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14

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

hepatit B-virus, ytantigen (HBsAg)

Brand Name : Engerix-B

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION, FÖRFYLLD

Dosage Strength : 20 MIKROGRAM/1 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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15

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

hepatit B-virus, ytantigen (HBsAg)

Brand Name : Engerix-B

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION, FÖRFYLLD

Dosage Strength : 10 MIKROGRAM/0,5 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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16

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

hepatit B-virus, ytantigen (HBsAg)

Brand Name : Engerix-B

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION

Dosage Strength : 20 MIKROGRAM/1 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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17

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

hepatitis B virus surface antigen (HBsAg)

Brand Name : Fendrix

Dosage Form : SUSPENSION FOR INJECTION

Dosage Strength : 20 MICROGRAMS / 0.5 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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18

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Hepatitis A virus inactivated antigen

Brand Name : Havrix

Dosage Form : SUSPENSION FOR INJECTION

Dosage Strength : 1440 ELISA U / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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19

Discovery on Target
Not Confirmed
arrow
arrow
Discovery on Target
Not Confirmed

hepatit B-virus, ytantigen (HBsAg)

Brand Name : Engerix-B

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION, FÖRFYLLD

Dosage Strength : 10 MIKROGRAM/0,5 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

20

Discovery on Target
Not Confirmed
arrow
arrow
Discovery on Target
Not Confirmed

hepatit A-virus, inaktiverat antigen

Brand Name : Havrix

Dosage Form : INJEKTIONSVÄTSKA, SUSPENSION

Dosage Strength : 1440 ELISA U/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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