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    Chunghwa Chemical Synthesis & Biotech-PSE
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    2025 Corporate Sustainability Report Award

    12 Nov 2025

    // PRESS RELEASE

    The company accomplished Ethyl Icosapentate, Everolimus audit

    09 Sep 2025

    // PRESS RELEASE

    The company accomplished Everolimus audit

    04 Sep 2025

    // PRESS RELEASE

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    01 1Abaloparatide

    02 1Baricitinib

    03 1Brivaracetam

    04 1Carfilzomib

    05 1Caspofungin

    06 1Dalbavancin

    07 1Dexbrompheniramine Maleate

    08 1Difelikefalin Acetate

    09 1Edoxaban Tosylate

    10 1Eltrombopag

    11 1Eslicarbazepine Acetate

    12 2Etelcalcetide

    13 4Everolimus

    14 1Favipiravir

    15 1Guaifenesin

    16 1Icosapent Ethyl

    17 1Ixazomib Citrate

    18 1LCZ 696

    19 2Lanreotide Acetate

    20 1Metaxalone

    21 5Methocarbamol

    22 1Midostaurin

    23 2Mycophenolate Mofetil

    24 1Mycophenolate Mofetil Hydrochloride

    25 1Mycophenolate Sodium

    26 1Mycophenolic Acid

    27 2Ozanimod

    28 1Palbociclib

    29 1Perindopril

    30 1Plecanatide

    31 1Pravastatin

    32 2Ribociclib

    33 1Ruxolitinib Phosphate

    34 1Sacubitril Sodium

    35 1Selumetinib

    36 1Semaglutide

    37 1Setmelanotide Acetate

    38 2Sirolimus

    39 1Sugammadex Sodium

    40 3Tacrolimus

    41 1Tenapanor Hydrochloride

    42 1Tofacitinib Citrate

    43 2Trandolapril

    44 2Trilaciclib Dihydrochloride

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    01

    Tacrolimus

    Taiwan

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

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    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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    USDMF arrow-down Click Us! arrow-down
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    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
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    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
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    NDC Package Code : 52076-6222

    Start Marketing Date : 2017-05-23

    End Marketing Date : 2026-12-31

    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

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    Available Reg. Filing : ASMF
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    02

    Everolimus

    Taiwan

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

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    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 : 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 : 52076-6270

    Start Marketing Date : 2021-02-02

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
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    03

    Everolimus

    Taiwan

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

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    USDMF arrow-down
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    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 : 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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    Mycophenolate Sodium

    Taiwan

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

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    Digital Content Digital Content
    USDMF arrow-down
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    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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    Sirolimus

    Taiwan

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

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    USDMF arrow-down
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    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 : 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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
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    06

    Sirolimus

    Taiwan

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

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    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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    Digital Content Digital Content
    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 : 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 KDMF VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
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    07

    Pravastatin

    Taiwan

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

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    CPhI China
    Exhibiting
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    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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    Digital Content Digital Content
    USDMF CEP/COS Inactive-api
    ✖

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

    Issue Date : 2021-03-04

    Type : Chemical and TSE

    Substance Number : 2059

    Status : Withdrawn by Holder

     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
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    08

    Baricitinib

    Taiwan

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

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    CPhI China
    Exhibiting
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    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36030

    Submission : 2021-08-04

    Status : Active

    Type : II

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

    Registrant Name : Hiple Co., Ltd.

    Registration Date : 2025-01-14

    Registration Number : Su30-8-ND

    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
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    09

    Brivaracetam

    Taiwan

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

    arrow
    CPhI China
    Exhibiting
    • fda
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    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41491

    Submission : 2025-03-31

    Status : Active

    Type : II

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

    NDC Package Code : 52076-6268

    Start Marketing Date : 2020-12-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Caspofungin

    Taiwan

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

    arrow
    CPhI China
    Exhibiting
    • fda
    • EDQM
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    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27585

    Submission : 2013-11-27

    Status : Active

    Type : II

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

    NDC Package Code : 52076-6230

    Start Marketing Date : 2018-11-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Pharma Co., Ltd.

    Registration Date : 2020-07-07

    Registration Number : 20200707-210-J-324

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

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

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    Contact Chunghwa Chemical Synthesis & Biotech and get a quotation

    Chunghwa Chemical Synthesis & Biotech is a supplier offers 51 products (APIs, Excipients or Intermediates).

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

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

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

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

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    Find Ixazomib Citrate bulk offered by Chunghwa Chemical Synthesis & Biotech

    Find Lanreotide Acetate bulk offered by Chunghwa Chemical Synthesis & Biotech

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    Find Tenapanor Hydrochloride bulk offered by Chunghwa Chemical Synthesis & Biotech

    Find Trilaciclib Dihydrochloride bulk offered by Chunghwa Chemical Synthesis & Biotech

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.