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    Beijing Mesochem Technology

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
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    Virtual BoothMesochem is focused on incessant innovation along with the R&D of new APIs.

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    02

    Qijian Bio Pharmaceutical Co Ltd

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AAPS National Biotech
    Not Confirmed
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    Qijian Bio Pharmaceutical Co Ltd

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AAPS National Biotech
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33745

    Submission : 2019-03-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    KREITMAN ROBERT J MD

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AAPS National Biotech
    Not Confirmed
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    KREITMAN ROBERT J MD

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AAPS National Biotech
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18630

    Submission : 1994-04-06

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    Bio-Technology General Israel Ltd.

    Israel

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AAPS National Biotech
    Not Confirmed
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    Bio-Technology General Israel Ltd.

    Israel

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AAPS National Biotech
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20147

    Submission : 2006-12-31

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Country

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AAPS National Biotech
    Not Confirmed
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    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AAPS National Biotech
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7037

    Submission : 1987-06-22

    Status : Inactive

    Type : II

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    06

    Sandoz B2B

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AAPS National Biotech
    Not Confirmed
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    Sandoz B2B

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AAPS National Biotech
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17719

    Submission : 2004-10-05

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    Merck Group

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AAPS National Biotech
    Not Confirmed
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    Merck Group

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AAPS National Biotech
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4478

    Submission : 1982-03-10

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    Miltenyi Biotec

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AAPS National Biotech
    Not Confirmed
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    Miltenyi Biotec

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AAPS National Biotech
    Not Confirmed
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 226MF40017

    Registrant's Address : Friedrich-Ebert-Straβe 68 51429 Bergisch Gladbach, Germany

    Initial Date of Registration : 2014-12-05

    Latest Date of Registration :

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    09

    Miltenyi Biotec

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AAPS National Biotech
    Not Confirmed
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    Miltenyi Biotec

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AAPS National Biotech
    Not Confirmed
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 226MF40018

    Registrant's Address : Friedrich-Ebert-Straβe 68 51429 Bergisch Gladbach, Germany

    Initial Date of Registration : 2014-12-05

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    10

    ANHUI ANKE BIOTECHNOLOGY (GROUP) C...

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AAPS National Biotech
    Not Confirmed
    arrow

    ANHUI ANKE BIOTECHNOLOGY (GROUP) C...

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AAPS National Biotech
    Not Confirmed
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    01

    AMWC Asia-TDAC
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    01

    Bio Technology General Israel Ltd

    Israel
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    AMWC Asia-TDAC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20147

    Submission : 2006-12-31

    Status : Active

    Type : II

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    02

    Kreitman Robert J Md

    U.S.A

    USDMF

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    AMWC Asia-TDAC
    Not Confirmed

    02

    Kreitman Robert J Md

    U.S.A
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    AMWC Asia-TDAC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18630

    Submission : 1994-04-06

    Status : Active

    Type : II

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    03

    Laboratoires Serono Sa

    Germany

    USDMF

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    AMWC Asia-TDAC
    Not Confirmed

    03

    Laboratoires Serono Sa

    Germany
    arrow
    AMWC Asia-TDAC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4478

    Submission : 1982-03-10

    Status : Inactive

    Type : II

    blank

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    04

    AMWC Asia-TDAC
    Not Confirmed

    04

    Jilin Qijian Bio-pharmaceutical Co L...

    China
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    AMWC Asia-TDAC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33745

    Submission : 2019-03-30

    Status : Active

    Type : II

    blank

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    05

    Sandoz Gmbh

    Switzerland

    USDMF

    arrow
    AMWC Asia-TDAC
    Not Confirmed

    05

    Sandoz Gmbh

    Switzerland
    arrow
    AMWC Asia-TDAC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17719

    Submission : 2004-10-05

    Status : Inactive

    Type : II

    blank

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    06

    Biotechnology General Corp

    Country

    USDMF

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    AMWC Asia-TDAC
    Not Confirmed

    06

    Biotechnology General Corp

    Country
    arrow
    AMWC Asia-TDAC
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7037

    Submission : 1987-06-22

    Status : Inactive

    Type : II

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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

    China
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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

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    Regulatory Info :

    Registration Country : China

    Recombinant Human Growth Hormone

    Brand Name : ANSOMONE

    Dosage Form : Lyophilized Powder for Injection

    Dosage Strength : 2IU

    Packaging : Vial

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : China

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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

    China
    Arvo
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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

    China
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    Arvo
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    Regulatory Info :

    Registration Country : China

    Recombinant Human Growth Hormone

    Brand Name : ANSOMONE

    Dosage Form : Lyophilized Powder for Injection

    Dosage Strength : 4IU

    Packaging : Vial

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : China

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    03

    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

    China
    Arvo
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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

    China
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    Regulatory Info :

    Registration Country : China

    Recombinant Human Growth Hormone

    Brand Name : ANSOMONE

    Dosage Form : Lyophilized Powder for Injection

    Dosage Strength : 4.5IU

    Packaging : Vial

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : China

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    04

    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

    China
    Arvo
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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

    China
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    Regulatory Info :

    Registration Country : China

    Recombinant Human Growth Hormone

    Brand Name : ANSOMONE

    Dosage Form : Lyophilized Powder for Injection

    Dosage Strength : 6IU

    Packaging : Vial

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : China

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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

    China
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    China
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    Regulatory Info :

    Registration Country : China

    Recombinant Human Growth Hormone

    Brand Name : ANSOMONE

    Dosage Form : Lyophilized Powder for Injection

    Dosage Strength : 10IU

    Packaging : Vial

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : China

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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

    China
    Arvo
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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO...

    China
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    Arvo
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    Regulatory Info :

    Registration Country : China

    Recombinant Human Growth Hormone

    Brand Name : ANSOMONE

    Dosage Form : Lyophilized Powder for Injection

    Dosage Strength : 16IU

    Packaging : Vial

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : China

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    07

    Pfizer Inc

    U.S.A
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    Pfizer Inc

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    Regulatory Info :

    Registration Country : Italy

    Recombinant Human Growth Hormone

    Brand Name : Genotropin

    Dosage Form :

    Dosage Strength : 1 Tubofiala 12 Mg  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

    China
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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

    China
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    Regulatory Info :

    Registration Country : China

    Recombinant Human Growth Hormone

    Brand Name : ANSOMONE

    Dosage Form : Lyophilized Powder for...

    Dosage Strength : 2IU

    Packaging : Vial

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : China

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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

    China
    AACR Annual meeting
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    China
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    AACR Annual meeting
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    Packaging : Vial

    Regulatory Info :

    Recombinant Human Growth Hormone

    Dosage : Lyophilized Powder for...

    Dosage Strength : 2IU

    Brand Name : ANSOMONE

    Approval Date :

    Application Number :

    Registration Country : China

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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

    China
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    AACR Annual meeting
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    Regulatory Info :

    Registration Country : China

    Recombinant Human Growth Hormone

    Brand Name : ANSOMONE

    Dosage Form : Lyophilized Powder for...

    Dosage Strength : 4IU

    Packaging : Vial

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : China

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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

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    Packaging : Vial

    Regulatory Info :

    Recombinant Human Growth Hormone

    Dosage : Lyophilized Powder for...

    Dosage Strength : 4IU

    Brand Name : ANSOMONE

    Approval Date :

    Application Number :

    Registration Country : China

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    ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

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