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    Company profile for Qinhuangdao Zizhu Pharmaceutical

    European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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    Guizhou Utide Biotechnology Co., Ltd. - Specialized GMP manufacturing for next-generation GLP-1 peptide APIs.

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    About

    Qinhuangdao Zizhu Pharmaceutical Co., Ltd. (QZP), a subsidiary of China Resources Zizhu Pharmaceutical Co., Ltd. (CRZP), was designed, built and qualified according to the stringent international standards with an investment of over RMB300 million. It occupies an area of 21.3 hectares and has GMP -certified facilities of steroid hormone APIs including progestins, estrogens and androgens. In 2010, it was granted with a CEP for ...
    Qinhuangdao Zizhu Pharmaceutical Co., Ltd. (QZP), a subsidiary of China Resources Zizhu Pharmaceutical Co., Ltd. (CRZP), was designed, built and qualified according to the stringent international standards with an investment of over RMB300 million. It occupies an area of 21.3 hectares and has GMP -certified facilities of steroid hormone APIs including progestins, estrogens and androgens. In 2010, it was granted with a CEP for levonorgestrel.

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    CONTACT DETAILS

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    Qinhuangdao Zizhu PharmaceuticalChina Flag
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    China
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     +86-10-62250847
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    enquiries@pharmacompass.com
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    http://www.zizhu-pharm.com/
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    NEWS #PharmaBuzz

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    FDA Warning Letter for inadequate Batch Record Review
    FDA Warning Letter for inadequate Batch Record Review

    13 Jul 2017

    // GMP

    http://www.gmp-compliance.org/gmp-news/fda-warning-letter-for-inadequate-batch-record-review

    GMP
    13 Jul 2017
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    WHO's Position on the Import Alert for a Chinese API Manufacturer's Products
    WHO's Position on the Import Alert for a Chinese API Manufacturer's Products

    04 Jul 2017

    // GMP

    http://www.gmp-compliance.org/gmp-news/whos-position-on-the-import-alert-for-a-chinese-api-manufacturers-products

    GMP
    04 Jul 2017
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    Qinhuangdao Zizhu Pharmaceutical Co. Ltd On WHO Public Inspection Report
    Qinhuangdao Zizhu Pharmaceutical Co. Ltd On WHO Public Inspection Report

    30 Jun 2017

    // WHO

    https://www.pharmacompass.com/pdf/news/qinhuangdao-zizhu-pharmaceutical-co-ltd-on-who-public-inspection-report-1499234513.pdf

    WHO
    30 Jun 2017
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    Qinhuangdao Zizhu Pharmaceutical Receives FDA Warning Letter
    Qinhuangdao Zizhu Pharmaceutical Receives FDA Warning Letter

    21 Jun 2017

    // FDA

    https://www.pharmacompass.com/pdf/news/qinhuangdao-zizhu-pharmaceutical-receives-fda-warning-letter-1498717322.pdf

    FDA
    21 Jun 2017
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    FDA Warns Chinese API Maker for Data Integrity Issues
    FDA Warns Chinese API Maker for Data Integrity Issues

    21 Jun 2017

    // Michael Mezher RAPS

    http://www.raps.org/Regulatory-Focus/News/2017/06/21/27952/FDA-Warns-Chinese-API-Maker-for-Data-Integrity-Issues/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails

    Michael Mezher RAPS
    21 Jun 2017
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    Qinhuangdao Zizhu Pharmaceutical on Health Canada Inspection List
    Qinhuangdao Zizhu Pharmaceutical on Health Canada Inspection List

    15 Jun 2017

    // HEALTH CANADA

    https://www.pharmacompass.com/pdf/news/qinhuangdao-zizhu-pharmaceutical-on-health-canada-inspection-list-1497504574.pdf

    HEALTH CANADA
    15 Jun 2017
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    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Dienogest

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

    BePharma
    Not Confirmed
    arrow

    Dienogest

    China

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

    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28680

    Submission : 2014-09-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-376 - Rev 00

    Issue Date : 2024-12-17

    Type : Chemical

    Substance Number : 2732

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
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    Market
    Place

    02

    Gestodene

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

    BePharma
    Not Confirmed
    arrow

    Gestodene

    China

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

    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 29345

    Submission : 2015-06-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-160 - Rev 00

    Issue Date : 2022-01-19

    Type : Chemical

    Substance Number : 1726

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Product
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    Market
    Place

    03

    Levonorgestrel

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

    BePharma
    Not Confirmed
    arrow

    Levonorgestrel

    China

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

    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27692

    Submission : 2013-10-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-237 - Rev 00

    Issue Date : 2019-04-30

    Type : Chemical

    Substance Number : 926

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44132-012

    Start Marketing Date : 2014-06-17

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
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    Market
    Place

    04

    Tibolone

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

    BePharma
    Not Confirmed
    arrow

    Tibolone

    China

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

    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 29217

    Submission : 2015-03-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-015 - Rev 00

    Issue Date : 2021-02-11

    Type : Chemical

    Substance Number : 1739

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2014-03-07

    Registration Number : 20140306-140-H-248-03

    Manufacturer Name : Qinhuangdao Zizhu Pharmaceutical Co., Ltd.

    Manufacturer Address : No.10, Longhai Road, Economic & Technological Development Zone, Qinhuangdao, Hebei, PRChina

     VMF Others AUDIT arrow-down
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    Market
    Place

    05

    Desogestrel

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

    BePharma
    Not Confirmed
    arrow

    Desogestrel

    China

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

    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-219 - Rev 00

    Issue Date : 2021-09-08

    Type : Chemical

    Substance Number : 1717

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

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    Market
    Place

    06

    Estriol

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

    BePharma
    Not Confirmed
    arrow

    Estriol

    China

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

    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-014 - Rev 00

    Issue Date : 2021-02-11

    Type : Chemical

    Substance Number : 1203

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44132-014

    Start Marketing Date : 2014-06-17

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
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    Stock Recap
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    Market
    Place

    07

    Estrovarin

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

    BePharma
    Not Confirmed
    arrow

    Estrovarin

    China

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

    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28304

    Submission : 2014-05-13

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Ethinyl Estradiol

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

    BePharma
    Not Confirmed
    arrow

    Ethinyl Estradiol

    China

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

    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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.
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-220 - Rev 02

    Issue Date : 2025-02-28

    Type : Chemical

    Substance Number : 140

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44132-010

    Start Marketing Date : 2014-06-17

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

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    Market
    Place

    09

    Levonorgestrel

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

    BePharma
    Not Confirmed
    arrow

    Levonorgestrel

    China

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

    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-225 - Rev 02

    Issue Date : 2025-10-08

    Type : Chemical

    Substance Number : 926

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44132-004

    Start Marketing Date : 2012-06-08

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
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    Market
    Place

    10

    Mifepristone

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

    BePharma
    Not Confirmed
    arrow

    Mifepristone

    China

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

    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24628

    Submission : 2011-01-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44132-013

    Start Marketing Date : 2014-06-17

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
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    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Inspections and registrations

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    ABOUT THIS PAGE

    Contact Qinhuangdao Zizhu Pharmaceutical and get a quotation

    Qinhuangdao Zizhu Pharmaceutical is a supplier offers 18 products (APIs, Excipients or Intermediates).

    Find a price of Dienogest bulk with DMF, CEP offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Gestodene bulk with DMF, CEP offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Levonorgestrel bulk with DMF, CEP offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Tibolone bulk with DMF, CEP offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Desogestrel bulk with CEP offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Estriol bulk with CEP offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Estrovarin bulk with DMF offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Ethinyl Estradiol bulk with CEP offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Levonorgestrel bulk with CEP offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Mifepristone bulk with DMF offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Testosterone bulk with CEP offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Levonorgestrel bulk offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Estradiol bulk offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Estriol bulk offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Estrone bulk offered by Qinhuangdao Zizhu Pharmaceutical

    Find a price of Ethinyl Estradiol bulk offered by Qinhuangdao Zizhu Pharmaceutical

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