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01 2Sanofi

02 2Biomed Lublin

03 1Central Procurement & Supplies Unit

04 3Cherubino Limited

05 11GSK

06 2Grifols International

07 1JV Healthcare Limited

08 1KI Biopharma

09 2LG Life Sciences

10 2Labomed Ltd

11 6Merck & Co

12 3NM Pharma Limited

13 1National Bioproducts Institute

14 2The Biovac Institute

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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 : Originator

Registration Country : South Africa

Hepatitis B surface antigen

Brand Name : Hexaxim ®

Dosage Form : INJ

Dosage Strength : 10µg/0.5ml

Packaging : 0.5X1IU/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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 : Originator

Registration Country : South Africa

Hepatitis B surface antigen

Brand Name : Hexaxim ®

Dosage Form : INJ

Dosage Strength : 10µg/0.5ml

Packaging : 0.5X10IU/0.5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner

03

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Immune Globulin

Brand Name : GAMMA anty-HBs 200

Dosage Form : Solution for Injection

Dosage Strength : 200IU

Packaging : 1 ampoule 1.0 ml cardboard box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Poland

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04

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Immune Globulin

Brand Name : GAMMA anty-HBs 1000

Dosage Form : Solution for Injection

Dosage Strength : 1000IU

Packaging : 1 ampoule 1.5 ml cardboard box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Poland

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05

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

HEPATITIS B IMMUNOGLOBULIN (HUMAN)

Brand Name : HYPERHEP B

Dosage Form : SOLUTION

Dosage Strength : 220UNIT/ML

Packaging :

Approval Date :

Application Number : 2520001

Regulatory Info : Schedule D

Registration Country : Canada

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06

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

HEPATITIS B IMMUNOGLOBULIN (HUMAN)

Brand Name : HYPERHEP B

Dosage Form : SOLUTION

Dosage Strength : 110UNIT/0.5ML

Packaging :

Approval Date :

Application Number : 2520125

Regulatory Info : Schedule D

Registration Country : Canada

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07

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Fendrix, Injectable Suspension

Dosage Form : Injectable Suspension

Dosage Strength :

Packaging :

Approval Date : 2005-02-23

Application Number : 04299003

Regulatory Info : Authorized

Registration Country : Spain

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08

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Engerix- B Junior

Dosage Form : Injectable Suspension

Dosage Strength : 10MCG

Packaging :

Approval Date : 1990-06-01

Application Number : 58866

Regulatory Info : Cancelled

Registration Country : Spain

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09

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Engerix- B

Dosage Form : Injectable Suspension

Dosage Strength : 20MCG

Packaging :

Approval Date : 1987-10-01

Application Number : 57513

Regulatory Info : Cancelled

Registration Country : Spain

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10

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Engerix- B

Dosage Form : Injectable Suspension In Pre-Filled Syringe

Dosage Strength : 20MCG

Packaging :

Approval Date : 1995-11-01

Application Number : 60653

Regulatory Info : Authorized

Registration Country : Spain

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11

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Engerix- B Junior

Dosage Form : Injectable Suspension In Pre-Filled Syringe

Dosage Strength : 10MCG

Packaging :

Approval Date : 1995-11-01

Application Number : 60652

Regulatory Info : Authorized

Registration Country : Spain

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12

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Fendrix, Injectable Suspension

Dosage Form : Injectable Suspension

Dosage Strength :

Packaging :

Approval Date : 2005-02-23

Application Number : 04299001

Regulatory Info : Authorized

Registration Country : Spain

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13

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B antigen

Brand Name : Hiberix

Dosage Form : VAC

Dosage Strength : 10iu/0.5ml

Packaging : 3X1mcg/0.5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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14

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

HEPATITIS B IMMUNOGLOBULIN (HUMAN)

Brand Name : HEPAGAM B

Dosage Form : SOLUTION

Dosage Strength : 312UNIT/ML

Packaging :

Approval Date :

Application Number : 2290979

Regulatory Info : Schedule D

Registration Country : Canada

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15

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Hbvaxpro

Dosage Form : Injectable Suspension

Dosage Strength : 10MCG

Packaging :

Approval Date : 2001-05-22

Application Number : 01183007

Regulatory Info : Authorized

Registration Country : Spain

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16

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Hbvaxpro

Dosage Form : Injectable Suspension

Dosage Strength : 5MCG

Packaging :

Approval Date : 2001-12-12

Application Number : 01183018

Regulatory Info : Authorized

Registration Country : Spain

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17

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Hbvaxpro

Dosage Form : Injectable Suspension

Dosage Strength : 40MCG

Packaging :

Approval Date : 2001-05-22

Application Number : 01183015

Regulatory Info : Authorized

Registration Country : Spain

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18

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Hbvaxpro

Dosage Form : Injectable Suspension In Pre-Filled Syringe

Dosage Strength : 10MCG

Packaging :

Approval Date : 2005-09-22

Application Number : 01183028

Regulatory Info : Authorized

Registration Country : Spain

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19

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Hbvaxpro

Dosage Form : Injectable Suspension In Pre-Filled Syringe

Dosage Strength : 5MCG

Packaging :

Approval Date : 2005-09-22

Application Number : 01183024

Regulatory Info : Authorized

Registration Country : Spain

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20

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Hepatitis B Surface Antigen

Brand Name : Hbvaxpro

Dosage Form : Injectable Suspension

Dosage Strength : 5MCG

Packaging :

Approval Date : 2001-01-22

Application Number : 01183001

Regulatory Info : Authorized

Registration Country : Spain

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