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    Coagulation Factor Ix Recombinant

    ACTIVE PHARMA INGREDIENTS

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    01 1Bio Products Laboratory

    02 3CSL Behring

    03 1Kedrion

    04 5Octapharma

    05 20Pfizer Inc

    06 2Prothya Biosolutions Netherlands Bv

    07 3Stragen Pharma SA

    08 3Takeda Pharmaceutical

    09 3Wyeth Europe Ltd

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    01

    CSL Behring

    U.S.A
    BOS Manchester
    Not Confirmed
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    CSL Behring

    U.S.A
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)

    Brand Name : Confidex

    Dosage Form : Solution For Injection

    Dosage Strength : 1000IE

    Packaging :

    Approval Date : 29/08/2013

    Application Number : 20120705000069

    Regulatory Info : Approved

    Registration Country : Sweden

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    02

    CSL Behring

    U.S.A
    BOS Manchester
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    CSL Behring

    U.S.A
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    BOS Manchester
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)

    Brand Name : Confidex

    Dosage Form : Solution For Injection

    Dosage Strength : 250IE

    Packaging :

    Approval Date : 09/05/2008

    Application Number : 20071006000084

    Regulatory Info : Approved

    Registration Country : Sweden

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    03

    CSL Behring

    U.S.A
    BOS Manchester
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    CSL Behring

    U.S.A
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)

    Brand Name : Confidex

    Dosage Form : Solution For Injection

    Dosage Strength : 500IU

    Packaging :

    Approval Date : 09/05/2008

    Application Number : 20071006000091

    Regulatory Info : Approved

    Registration Country : Sweden

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    04

    Octapharma

    Switzerland
    BOS Manchester
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    Octapharma

    Switzerland
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)

    Brand Name : Ocplex

    Dosage Form : Solution For Infusion

    Dosage Strength : 1000IE

    Packaging :

    Approval Date : 17/09/2015

    Application Number : 20140910000067

    Regulatory Info : Approved

    Registration Country : Sweden

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    05

    Octapharma

    Switzerland
    BOS Manchester
    Not Confirmed
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    Octapharma

    Switzerland
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    BOS Manchester
    Not Confirmed
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    Regulatory Info : Approved

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    Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)

    Brand Name : Ocplex

    Dosage Form : Solution For Infusion

    Dosage Strength : 500IU

    Packaging :

    Approval Date : 23/07/2004

    Application Number : 20040607006917

    Regulatory Info : Approved

    Registration Country : Sweden

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    06

    Pfizer Inc

    U.S.A
    BOS Manchester
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BOS Manchester
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nonacogum Alpha

    Brand Name : BeneFIX

    Dosage Form : Powder For Injection

    Dosage Strength : 250IU

    Packaging :

    Approval Date : 26/02/1998

    Application Number : 54510

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    07

    Pfizer Inc

    U.S.A
    BOS Manchester
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BOS Manchester
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nonacogum Alpha

    Brand Name : BeneFIX

    Dosage Form : Powder For Injection

    Dosage Strength : 500IU

    Packaging :

    Approval Date : 26/02/1998

    Application Number : 54510

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    08

    Pfizer Inc

    U.S.A
    BOS Manchester
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BOS Manchester
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nonacogum Alpha

    Brand Name : BeneFIX

    Dosage Form : Powder For Injection

    Dosage Strength : 000IU

    Packaging :

    Approval Date : 26/02/1998

    Application Number : 54510

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    09

    Pfizer Inc

    U.S.A
    BOS Manchester
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BOS Manchester
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nonacogum Alpha

    Brand Name : BeneFIX

    Dosage Form : Powder For Injection

    Dosage Strength : 000IU

    Packaging :

    Approval Date : 26/02/1998

    Application Number : 54510

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    10

    Pfizer Inc

    U.S.A
    BOS Manchester
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BOS Manchester
    Not Confirmed
    • fda
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    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.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nonacogum Alpha

    Brand Name : BeneFIX

    Dosage Form : Powder For Injection

    Dosage Strength : 3000IU

    Packaging :

    Approval Date : 26/02/1998

    Application Number : 54510

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Digital Content

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    11

    Pfizer Inc

    U.S.A
    BOS Manchester
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BOS Manchester
    Not Confirmed
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    Regulatory Info : Approved

    Registration Country : Sweden

    Nonakog Alfa

    Brand Name : Benefix

    Dosage Form : Solution For Injection

    Dosage Strength : 1000IE

    Packaging :

    Approval Date : 30/07/2007

    Application Number : 20070824000047

    Regulatory Info : Approved

    Registration Country : Sweden

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    12

    Pfizer Inc

    U.S.A
    BOS Manchester
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BOS Manchester
    Not Confirmed
    • fda
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    Regulatory Info : Approved

    Registration Country : Sweden

    Nonakog Alfa

    Brand Name : Benefix

    Dosage Form : Solution For Injection

    Dosage Strength : 1500IU

    Packaging :

    Approval Date : 22/03/2017

    Application Number : 20160916000052

    Regulatory Info : Approved

    Registration Country : Sweden

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    13

    Pfizer Inc

    U.S.A
    BOS Manchester
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BOS Manchester
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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Nonakog Alfa

    Brand Name : Benefix

    Dosage Form : Solution For Injection

    Dosage Strength : 2000IE

    Packaging :

    Approval Date : 30/07/2007

    Application Number : 20060616000034

    Regulatory Info : Approved

    Registration Country : Sweden

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    14

    Pfizer Inc

    U.S.A
    BOS Manchester
    Not Confirmed
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    Pfizer Inc

    U.S.A
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    BOS Manchester
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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Nonakog Alfa

    Brand Name : Benefix

    Dosage Form : Solution For Injection

    Dosage Strength : 250IE

    Packaging :

    Approval Date : 30/07/2007

    Application Number : 20070824000023

    Regulatory Info : Approved

    Registration Country : Sweden

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    15

    Pfizer Inc

    U.S.A
    BOS Manchester
    Not Confirmed
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    Pfizer Inc

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    BOS Manchester
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    Regulatory Info : Approved

    Registration Country : Sweden

    Nonakog Alfa

    Brand Name : Benefix

    Dosage Form : Solution For Injection

    Dosage Strength : 3000IU

    Packaging :

    Approval Date : 23/08/2012

    Application Number : 20110809000249

    Regulatory Info : Approved

    Registration Country : Sweden

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    16

    Stragen Pharma SA

    Switzerland
    BOS Manchester
    Not Confirmed
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    Stragen Pharma SA

    Switzerland
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    BOS Manchester
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    Coagulation Factor IX Recombinant

    Brand Name :

    Dosage Form : Powder and Solvent for Solution for Injection

    Dosage Strength : 250IU

    Packaging : 1 vial of powder + 1 vial of solvent + 1 injection kit

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country :

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    17

    Stragen Pharma SA

    Switzerland
    BOS Manchester
    Not Confirmed
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    Stragen Pharma SA

    Switzerland
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    BOS Manchester
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    Registration Country :

    Coagulation Factor IX Recombinant

    Brand Name :

    Dosage Form : Powder and Solvent for Solution for Injection

    Dosage Strength : 500IU

    Packaging : 1 vial of powder + 1 vial of solvent + 1 injection kit

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country :

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    18

    Stragen Pharma SA

    Switzerland
    BOS Manchester
    Not Confirmed
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    Stragen Pharma SA

    Switzerland
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    Registration Country :

    Coagulation Factor IX Recombinant

    Brand Name :

    Dosage Form : Powder and Solvent for Solution for Injection

    Dosage Strength : 1000IU

    Packaging : 1 vial of powder + 1 vial of solvent + 1 injection kit

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country :

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    19

    Prothya Biosolutions Netherlands Bv

    Country
    BOS Manchester
    Not Confirmed
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    Prothya Biosolutions Netherlands Bv

    Country
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)

    Brand Name : Thyaplex

    Dosage Form : Solution For Injection

    Dosage Strength : 250IE

    Packaging :

    Approval Date : 09/05/2022

    Application Number : 20210720000035

    Regulatory Info : Approved

    Registration Country : Sweden

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    20

    Prothya Biosolutions Netherlands Bv

    Country
    BOS Manchester
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    Prothya Biosolutions Netherlands Bv

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    BOS Manchester
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    Regulatory Info : Approved

    Registration Country : Sweden

    Coagulation Factor II (Prothrombin, Human); Factor IX (Human); Factor VII (Human); Factor X (Human); Protein C (Human); Protein S (Human)

    Brand Name : Thyaplex

    Dosage Form : Solution For Injection

    Dosage Strength : 500IU

    Packaging :

    Approval Date : 09/05/2022

    Application Number : 20210720000042

    Regulatory Info : Approved

    Registration Country : Sweden

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