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    Chunghwa Chemical Synthesis & Biotech-PSE
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    CCSB accomplished an inspection of Münster, Germany.

    10 Apr 2024

    // PRESS RELEASE

    CCSB accomplished Caspofungin audit.

    25 Jan 2024

    // PRESS RELEASE

    CCSB obtained US patent for Tofacitinib Citrate

    11 Jan 2024

    // PRESS RELEASE

    DATA COMPILATION
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    Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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    About

    Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast Asia to receive FDA approval for synthetic and biotech APIs, CCSB has a proven track record of commercializing Statin, Immunosuppressant, Muscle Relaxant, and ACE Inhibitor APIs, all with complete DMF or COS. For years, CCSB has partnered with leading brand and generic drug companies to develop and produce APIs and advanced intermediates, focusing on specialty APIs crafted through a sophisticated fusion of fermentation and synthesis technologies in Taiwan.

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    Chunghwa Chemical Synthesis & BiotechTaiwan Flag
    Country
    Country
    Taiwan
    Address
    Address
    1 Tung-Hsing St., Shu-Lin 23850, New Taipei City
    Telephone
    Telephone
    +886 286843318
    Client Email
    Email
    tina.yang@ccsb.com.tw
    Client Website
    Website
    http://www.ccsb.com.tw/
    Linkedin
    Linkedin
    youtube
    YouTube
    https://www.youtube.com/@user-hx1ew6np2v/videos
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    Twitter
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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    NEWS #PharmaBuzz

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    CCSB accomplished an inspection of Münster, Germany.
    CCSB accomplished an inspection of Münster, Germany.

    10 Apr 2024

    // PRESS RELEASE

    https://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=114

    PRESS RELEASE
    10 Apr 2024
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    CCSB accomplished Caspofungin audit.
    CCSB accomplished Caspofungin audit.

    25 Jan 2024

    // PRESS RELEASE

    https://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=113

    PRESS RELEASE
    25 Jan 2024
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    CCSB obtained US patent for Tofacitinib Citrate
    CCSB obtained US patent for Tofacitinib Citrate

    11 Jan 2024

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=111

    PRESS RELEASE
    11 Jan 2024
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    CCSB obtained US patent for Etelcalcetide
    CCSB obtained US patent for Etelcalcetide

    17 Jan 2023

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=110

    PRESS RELEASE
    17 Jan 2023
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    CCSB accomplished Trandolapril audit.
    CCSB accomplished Trandolapril audit.

    12 Jan 2023

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=109

    PRESS RELEASE
    12 Jan 2023
    Share Share
    CCSB accomplished Methocarbamol remote audit.
    CCSB accomplished Methocarbamol remote audit.

    20 Dec 2022

    // PRESS RELEASE

    http://www.ccsb.com.tw/english/04_news/02_detail.aspx?pid=1&xid=108

    PRESS RELEASE
    20 Dec 2022
    Share Share

    ALL APIs

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

    01

    Pravastatin

    Taiwan

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14235

    Submission : 1999-06-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-168 - Rev 01

    Issue Date : 2021-03-04

    Type : Chemical and TSE

    Substance Number : 2059

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10474

    Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan

    Initial Date of Registration : 2006-04-27

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
    CCSB Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Tacrolimus

    Taiwan

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-04-01

    Pay. Date : 2016-03-09

    DMF Number : 18985

    Submission : 2005-11-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-345 - Rev 00

    Issue Date : 2024-03-28

    Type : Chemical

    Substance Number : 2244

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 224MF10125

    Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan

    Initial Date of Registration : 2012-07-13

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52076-6222

    Start Marketing Date : 2017-05-23

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2014-04-17

    Registration Number : 20140417-204-I-289-08

    Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shanjia Plant

    Manufacturer Address : No.1, Tung-Hsing st., Shu-Lin, New Taipei City, Taiwan

     VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    CCSB Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Everolimus

    Taiwan

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-11

    Pay. Date : 2013-03-14

    DMF Number : 26819

    Submission : 2013-02-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-367 - Rev 01

    Issue Date : 2023-05-16

    Type : Chemical

    Substance Number : 2918

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52076-6234

    Start Marketing Date : 2018-01-11

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    CCSB Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Everolimus

    Taiwan

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-04

    Pay. Date : 2013-08-05

    DMF Number : 27216

    Submission : 2013-07-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-192 - Rev 02

    Issue Date : 2024-02-22

    Type : Chemical

    Substance Number : 2918

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52076-6234

    Start Marketing Date : 2018-01-11

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    CCSB Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Methocarbamol

    Taiwan

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13080

    Submission : 1998-07-17

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10061

    Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan

    Initial Date of Registration : 2006-01-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52076-6206

    Start Marketing Date : 2018-01-10

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2011-09-01

    Registration Number : 20080228-81-D-61-03(2)

    Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co.Ltd

    Manufacturer Address : No.1, Tung-Hsing St., Shu-Lin, New Taipei City 23850, Taiwan

     VMF Others AUDIT
    CCSB Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Mycophenolate Sodium

    Taiwan

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35848

    Submission : 2021-06-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-444 - Rev 00

    Issue Date : 2024-09-20

    Type : Chemical

    Substance Number : 2813

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52076-6236

    Start Marketing Date : 2020-03-26

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    CCSB Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Sirolimus

    Taiwan

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17399

    Submission : 2004-05-20

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 303MF10065

    Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan

    Initial Date of Registration : 2021-04-13

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52076-6216

    Start Marketing Date : 2016-04-29

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Santen Pharmaceutical Co., Ltd.

    Registration Date : 2017-05-16

    Registration Number : 20170516-190-I-542-03

    Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shanjia Plant

    Manufacturer Address : 1, Tung-Hsing St. Shu-Lin, New Taipei City 23850, Taiwan

     VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    CCSB Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Sirolimus

    Taiwan

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-03

    Pay. Date : 2017-01-04

    DMF Number : 31189

    Submission : 2016-12-30

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 224MF10198

    Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan

    Initial Date of Registration : 2012-09-13

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52076-6216

    Start Marketing Date : 2016-04-29

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Santen Pharmaceutical Co., Ltd.

    Registration Date : 2017-05-16

    Registration Number : 20170516-190-I-542-03

    Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shanjia Plant

    Manufacturer Address : 1, Tung-Hsing St. Shu-Lin, New Taipei City 23850, Taiwan

     VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    CCSB Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Tacrolimus

    Taiwan

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23213

    Submission : 2009-10-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2018-241 - Rev 01

    Issue Date : 2023-03-30

    Type : Chemical

    Substance Number : 2244

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52076-6222

    Start Marketing Date : 2017-05-23

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2014-04-17

    Registration Number : 20140417-204-I-289-08

    Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shanjia Plant

    Manufacturer Address : No.1, Tung-Hsing st., Shu-Lin, New Taipei City, Taiwan

     VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    CCSB Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Trandolapril

    Taiwan

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17573

    Submission : 2004-07-27

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 225MF10083

    Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan

    Initial Date of Registration : 2013-04-23

    Latest Date of Registration :

    EU-WC NDC KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    CCSB Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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    API & Drug Product Development

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    ABOUT THIS PAGE

    Contact Chunghwa Chemical Synthesis & Biotech and get a quotation

    Chunghwa Chemical Synthesis & Biotech is a supplier offers 43 products (APIs, Excipients or Intermediates).

    Find a price of Pravastatin bulk with DMF, CEP, JDMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Tacrolimus bulk with DMF, CEP, JDMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Everolimus bulk with DMF, CEP offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Methocarbamol bulk with DMF, JDMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Mycophenolate Sodium bulk with DMF, CEP offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Sirolimus bulk with DMF, JDMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Tacrolimus bulk with DMF, CEP offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Trandolapril bulk with DMF, JDMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Baricitinib bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Carfilzomib bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Caspofungin bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Dexbrompheniramine Maleate bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Difelikefalin bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Eslicarbazepine Acetate bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Everolimus bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Favipiravir bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Fluconazole bulk with JDMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Guaifenesin bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Icosapent Ethyl bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Midostaurin bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Mycophenolate Mofetil bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Mycophenolate Mofetil Hydrochloride bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Ozanimod Hydrochloride bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Palbociclib bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Ribociclib bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Tacrolimus bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Tofacitinib Citrate bulk with DMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Trandolapril bulk with JDMF offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Abaloparatide Acetate bulk offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Brivaracetam bulk offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Dalbavancin bulk offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Edoxaban Tosylate bulk offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Eltrombopag bulk offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Etelcalcetide bulk offered by Chunghwa Chemical Synthesis & Biotech

    Find a price of Lanreotide Acetate bulk offered by Chunghwa Chemical Synthesis & Biotech

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