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    Company profile for Shandong Xinhua Pharmaceutical

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    EVENTS

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    About

    Established in 1943 as one of the national largest manufacturing and exporting bases in the chemical synthetic pharmaceuticals field, Shandong Xinhua Pharmaceutical Company Limited ("Shandong Xinhua") is a leading position in the manufacturing technology and capacity for antipyretics and analgesics in China and is an important manufacturer in China for the drugs for central nervous system, steroids, cardio cerebrovascular syst...
    Established in 1943 as one of the national largest manufacturing and exporting bases in the chemical synthetic pharmaceuticals field, Shandong Xinhua Pharmaceutical Company Limited ("Shandong Xinhua") is a leading position in the manufacturing technology and capacity for antipyretics and analgesics in China and is an important manufacturer in China for the drugs for central nervous system, steroids, cardio cerebrovascular system as well as finished dosage forms and pharmaceutical intermediates.

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    CONTACT DETAILS

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    Shandong Xinhua PharmaceuticalChina Flag
    Country
    Country
    China
    Address
    Address
    No. 1 Lutai Avenue, Zibo High-tech Zone, Shandong Province
    Telephone
    Telephone
    +86-533- 2196803
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://xhzy.com/html/english/default.aspx
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    Linkedin
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    NEWS #PharmaBuzz

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    Shandong Xinhua Pharmaceutical on Health Canada Inspection List
    Shandong Xinhua Pharmaceutical on Health Canada Inspection List

    13 May 2020

    // HEALTH CANADA

    https://www.pharmacompass.com/pdf/news/shandong-xinhua-pharmaceutical-on-health-canada-inspection-list-1589346402.pdf

    HEALTH CANADA
    13 May 2020
    Share Share
    China adds 148 drugs to key insurance list - state media
    China adds 148 drugs to key insurance list - state media

    21 Aug 2019

    // Roxanne Liu CNBC

    https://www.cnbc.com/2019/08/20/reuters-america-china-adds-148-drugs-to-key-insurance-list--state-media.html

    Roxanne Liu CNBC
    21 Aug 2019
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    ALL APIs

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    01

    Caffeine

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Caffeine

    China

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

    arrow
    Bioprocess International Europe
    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 Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-25

    Pay. Date : 2014-02-28

    DMF Number : 13092

    Submission : 1998-07-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-027 - Rev 03

    Issue Date : 2015-08-24

    Type : Chemical

    Substance Number : 267

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10007

    Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

    Initial Date of Registration : 2019-05-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0302

    Start Marketing Date : 1987-01-01

    End Marketing Date : 2026-12-31

    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

    02

    Glimepiride

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Glimepiride

    China

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

    arrow
    Bioprocess International Europe
    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 : 32319

    Submission : 2017-11-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-111 - Rev 00

    Issue Date : 2025-12-22

    Type : Chemical

    Substance Number : 2223

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10169

    Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

    Initial Date of Registration : 2021-11-25

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0708

    Start Marketing Date : 2024-05-09

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
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    Market
    Place

    03

    Levodopa

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Levodopa

    China

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

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-10-02

    Pay. Date : 2018-09-28

    DMF Number : 22598

    Submission : 2009-03-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-174 - Rev 02

    Issue Date : 2022-04-11

    Type : Chemical

    Substance Number : 38

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10029

    Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

    Initial Date of Registration : 2009-02-09

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0234

    Start Marketing Date : 2000-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Roche Korea

    Registration Date : 2023-03-21

    Registration Number : 20210810-209-J-943(1)

    Manufacturer Name : Shandong Xinhua Pharmaceutical Co., Ltd

    Manufacturer Address : East Chemical Zone of Zibo High & New Technology Development Zone, Zibo, Shandong, PRChina 255075

     VMF Others AUDIT arrow-down
    blank

    Product
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    Market
    Place

    04

    Theophylline

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Theophylline

    China

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

    arrow
    Bioprocess International Europe
    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 : 4633

    Submission : 1982-07-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1998-004 - Rev 08

    Issue Date : 2025-03-11

    Type : Chemical

    Substance Number : 299

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10482

    Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

    Initial Date of Registration : 2005-09-06

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0713

    Start Marketing Date : 2026-01-19

    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

    05

    Aspirin

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Aspirin

    China

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

    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
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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.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-02-01

    Pay. Date : 2017-01-03

    DMF Number : 10730

    Submission : 1994-01-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-210 - Rev 05

    Issue Date : 2016-11-14

    Type : Chemical

    Substance Number : 309

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0452

    Start Marketing Date : 1985-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Carbidopa

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Carbidopa

    China

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

    arrow
    Bioprocess International Europe
    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 : Reviewed

    Rev. Date : 2018-04-20

    Pay. Date : 2017-12-04

    DMF Number : 27430

    Submission : 2013-07-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-052 - Rev 00

    Issue Date : 2022-04-20

    Type : Chemical

    Substance Number : 755

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0621

    Start Marketing Date : 1984-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2025-03-05

    Registration Number : 20250305-211-J-1798

    Manufacturer Name : Shandong Xinhua Pharmaceutical Co.,Ltd

    Manufacturer Address : Hutian Chemical Industrial Zone, Zibo, Shandong, PR 255075. China

     VMF Others AUDIT arrow-down
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    Product
    Web Link

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    Market
    Place

    07

    Icosapent Ethyl

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Icosapent Ethyl

    China

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

    arrow
    Bioprocess International Europe
    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 : Reviewed

    Rev. Date : 2021-12-10

    Pay. Date : 2021-05-21

    DMF Number : 34361

    Submission : 2020-03-10

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10044

    Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

    Initial Date of Registration : 2023-04-05

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Poonglim Pharmaceutical Co., Ltd.

    Registration Date : 2025-12-29

    Registration Number : 20250415-211-J-1850(1)

    Manufacturer Name : Shandong Xinhua Pharmaceutical Co.,Ltd

    Manufacturer Address : Hutian Chemical Industrial Zone, Zibo, Shandong, China

     VMF Others AUDIT arrow-down
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    Market
    Place

    08

    Metamizole

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Metamizole

    China

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

    arrow
    Bioprocess International Europe
    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 : 31035

    Submission : 2016-10-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2001-356 - Rev 05

    Issue Date : 2025-08-07

    Type : Chemical

    Substance Number : 1346

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0707

    Start Marketing Date : 2024-03-28

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    Product
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    Stock Recap
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    Market
    Place

    09

    Phenobarbital

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Phenobarbital

    China

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

    arrow
    Bioprocess International Europe
    Not Confirmed
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    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27827

    Submission : 2013-12-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-269 - Rev 01

    Issue Date : 2023-11-03

    Type : Chemical

    Substance Number : 201

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0520

    Start Marketing Date : 1997-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    Market
    Place

    10

    Prednisone

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

    Bioprocess International Europe
    Not Confirmed
    arrow

    Prednisone

    China

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

    arrow
    Bioprocess International Europe
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35461

    Submission : 2020-12-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-349 - Rev 00

    Issue Date : 2024-12-17

    Type : Chemical

    Substance Number : 354

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    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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    THIRD-PARTY AUDIT

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    01

    Eurofins Assurance

    Belgium
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    CPhI Milan
    Exhibiting
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    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Shandong Xinhua Pharmaceutical

    Country : China

    City/Region : Zibo City

    Audit Date : 2025-03-26

    Audit Type : On-Site

    Eurofins Assurance

    02

    Eurofins Assurance

    Belgium
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    CPhI Milan
    Exhibiting
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    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Shandong Xinhua Pharmaceutical

    Country : China

    City/Region : Zibo, Shandong

    Audit Date : 2024-07-01

    Audit Type : On-Site

    Eurofins Assurance

    03

    Eurofins Assurance

    Belgium
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    CPhI Milan
    Exhibiting
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    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Shandong Xinhua Pharmaceutical

    Country : China

    City/Region : Zibo, Shandong

    Audit Date : 2024-06-28

    Audit Type : On-Site

    Eurofins Assurance

    04

    AuditGMP Pharma

    Spain
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    Get Site Audit
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAuditGMP Pharma SL delivers ISO 17020-accredited GMP audits and compliance services with expert, reliable, and tailored solutions.

    Shandong Xinquan Pharmaceutical Co., Ltd.

    Country : China

    City/Region : Yiyuan County, Zibo City

    Audit Date : Sep-26

    Audit Type : On-Site

    Company Banner

    05

    AuditGMP Pharma

    Spain
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    Bioprocess International Europe
    Not Confirmed
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    Virtual BoothAuditGMP Pharma SL delivers ISO 17020-accredited GMP audits and compliance services with expert, reliable, and tailored solutions.

    Shandong Xinquan Pharmaceutical Co., Ltd.

    Country : China

    City/Region : Yiyuan County, Zibo City

    Audit Date : Oct-23

    Audit Type : On-Site

    Company Banner

    06

    AuditGMP Pharma

    Spain
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    Bioprocess International Europe
    Not Confirmed
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    Virtual BoothAuditGMP Pharma SL delivers ISO 17020-accredited GMP audits and compliance services with expert, reliable, and tailored solutions.

    Shandong Xinhua Pharmaceutical Co., Ltd - No.1 East Site

    Country : China

    City/Region : Zibo

    Audit Date : 2026

    Audit Type : On-Site

    Company Banner
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    ABOUT THIS PAGE

    Contact Shandong Xinhua Pharmaceutical Company Limited and get a quotation

    Shandong Xinhua Pharmaceutical Company Limited is a supplier offers 56 products (APIs, Excipients or Intermediates).

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    Find Theophylline bulk with DMF, CEP, JDMF offered by Shandong Xinhua Pharmaceutical Company Limited

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