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    Company profile for Concord Biotech

    Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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    Global Pharma Healthcare: Setting the global benchmark in quality, innovation, and care

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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    pharmacompass-2-m-2025-11-03

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    SERVICES

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

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    About

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known fo...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

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    CONTACT DETAILS

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    Concord Biotechindia-flag Flag
    Country
    Country
    India
    Address
    Address
    1482 - 1486, Trasad Road, Dholka - 387810, Ahmedabad, Gujarat
    Telephone
    Telephone
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.concordbiotech.com/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

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    Digital content

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    NEWS #PharmaBuzz

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    FDA Issues Form 483 to Corcord Biotech
    FDA Issues Form 483 to Corcord Biotech

    30 Oct 2025

    // FDA

    https://www.fda.gov/media/189398/download

    FDA
    30 Oct 2025
    Share Share
    Concord Biotech Passes Russian GMP Inspection at API Facility
    Concord Biotech Passes Russian GMP Inspection at API Facility

    27 Jul 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/drug-approval/concord-biotech-successfully-completes-russian-gmp-inspection-at-its-api-facility-17483

    INDPHARMAPOST
    27 Jul 2025
    Share Share
    Concord Biotech completes successful EU GMP inspection at API
    Concord Biotech completes successful EU GMP inspection at API

    18 Jul 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/concord-biotech-announces-successful-completion-eu-gmp-inspection-at-its-api-facility-17440

    INDPHARMAPOST
    18 Jul 2025
    Share Share
    Concord Biotech's API facility completes USFDA inspection
    Concord Biotech's API facility completes USFDA inspection

    24 Jun 2025

    // CAPTICALMRKT

    https://www.capitalmarket.com/markets/news/live-news/concord-biotechs-api-facility-completes-usfda-inspection/1613344

    CAPTICALMRKT
    24 Jun 2025
    Share Share
    USFDA inspection at Concord Biotechs API facility at Dholka
    USFDA inspection at Concord Biotechs API facility at Dholka

    03 May 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/drug-approval/usfda-inspection-at-concord-biotechs-api-facility-at-dholka-17109

    INDPHARMAPOST
    03 May 2025
    Share Share
    Concord Biotech approved by US FDA to market Teriflunomide
    Concord Biotech approved by US FDA to market Teriflunomide

    07 Apr 2025

    // BUSINESS STD

    https://www.business-standard.com/markets/capital-market-news/concord-biotech-gets-us-fda-nod-for-marketing-multiple-sclerosis-drug-teriflunomide-125040900207_1.html

    BUSINESS STD
    07 Apr 2025
    Share Share

    ALL APIs

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

    01

    Cyclosporine

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Cyclosporine

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2013-09-05

    Pay. Date : 2013-04-08

    DMF Number : 23962

    Submission : 2010-07-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-214 - Rev 03

    Issue Date : 2022-10-17

    Type : Chemical

    Substance Number : 994

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10056

    Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA

    Initial Date of Registration : 2014-03-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68254-0008

    Start Marketing Date : 2010-02-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea Co., Ltd.

    Registration Date : 2024-07-30

    Registration Number : 20120806-18-C-299-06(2)

    Manufacturer Name : CONCORD BIOTECH LIMITED

    Manufacturer Address : 1482-1486, Trasad Road, Dholka, District - Ahmedabad Pin Code - 387810, India

     VMF Others AUDIT arrow-down
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    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Mycophenolate Mofetil

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Mycophenolate Mofetil

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2014-02-18

    Pay. Date : 2014-02-07

    DMF Number : 19231

    Submission : 2006-03-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-361 - Rev 06

    Issue Date : 2024-03-18

    Type : Chemical

    Substance Number : 1700

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 224MF10054

    Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA

    Initial Date of Registration : 2012-03-12

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68254-2508

    Start Marketing Date : 2023-11-09

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2020-06-01

    Registration Number : 20200601-209-J-643

    Manufacturer Name : Concord Biotech Limited

    Manufacturer Address : Plot No.1482-1486, Trasad Road, Dholka, District-Ahmedabad India

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Tacrolimus

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Tacrolimus

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2013-08-28

    Pay. Date : 2013-08-16

    DMF Number : 18908

    Submission : 2005-10-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-216 - Rev 01

    Issue Date : 2025-04-25

    Type : Chemical

    Substance Number : 2244

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10197

    Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA　

    Initial Date of Registration : 2010-07-13

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68254-0020

    Start Marketing Date : 2019-10-16

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Leo Pharma Co., Ltd.

    Registration Date : 2025-10-29

    Registration Number : 20120302-204-I-23-01(3)

    Manufacturer Name : Concord Biotech Limited

    Manufacturer Address : 1482-1486, Trasad Road, Dholka Dist, Ahmedabad Gujarat, 382225, India

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Everolimus

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Everolimus

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2013-10-01

    Pay. Date : 2013-06-13

    DMF Number : 26350

    Submission : 2013-06-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-106 - Rev 01

    Issue Date : 2025-09-04

    Type : Chemical

    Substance Number : 2918

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68254-6234

    Start Marketing Date : 2011-08-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2020-07-21

    Registration Number : Su259-9-ND

    Manufacturer Name : Concord Biotech Limited

    Manufacturer Address : Plot No. 1482-1486, Trasad Road, Dholka, District-Ahmedabad, India

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Mitomycin

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Mitomycin

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2019-10-21

    Pay. Date : 2019-04-24

    DMF Number : 33662

    Submission : 2019-04-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-308 - Rev 01

    Issue Date : 2025-12-02

    Type : Chemical

    Substance Number : 1655

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68254-0016

    Start Marketing Date : 2016-05-16

    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

    Mupirocin

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Mupirocin

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2014-10-28

    Pay. Date : 2014-10-08

    DMF Number : 28618

    Submission : 2014-10-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-041 - Rev 01

    Issue Date : 2024-03-07

    Type : Chemical

    Substance Number : 1450

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68254-2504

    Start Marketing Date : 2012-08-01

    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

    07

    Mupirocin Calcium

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Mupirocin Calcium

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2015-04-03

    Pay. Date : 2015-01-07

    DMF Number : 28907

    Submission : 2015-01-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-119 - Rev 01

    Issue Date : 2025-10-10

    Type : Chemical

    Substance Number : 1451

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68254-0011

    Start Marketing Date : 2013-04-27

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Mycophenolate Sodium

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Mycophenolate Sodium

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2013-04-30

    Pay. Date : 2013-04-22

    DMF Number : 21907

    Submission : 2008-08-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-132 - Rev 02

    Issue Date : 2024-10-28

    Type : Chemical

    Substance Number : 2813

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68254-0007

    Start Marketing Date : 2007-09-01

    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

    09

    Sirolimus

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Sirolimus

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2017-08-18

    Pay. Date : 2017-07-17

    DMF Number : 24468

    Submission : 2011-02-24

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 302MF10039

    Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA

    Initial Date of Registration : 2020-04-02

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68254-1006

    Start Marketing Date : 2011-02-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2014-02-06

    Registration Number : 20140206-190-I-347-02

    Manufacturer Name : Concord Biotech Ltd.

    Manufacturer Address : Plot No. 1482-1486, Trasad Road, Dholka, Dist-Ahmedabad, India

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Tacrolimus

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Tacrolimus

    India

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

    arrow
    BIO Partnering at JPM
    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 : 2020-02-11

    Pay. Date : 2020-01-13

    DMF Number : 34491

    Submission : 2020-01-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2020-227 - Rev 02

    Issue Date : 2025-07-29

    Type : Chemical

    Substance Number : 2244

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68254-0019

    Start Marketing Date : 2007-11-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2012-03-02

    Registration Number : 20120302-204-I-23-01

    Manufacturer Name : CONCORD BIOTECH LIMITED

    Manufacturer Address : 1482-1486, Trasad Road, Dholka, District - Ahmedabad,382225

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
    click full view
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    USDMF

    read-more
    read-more

    01

    Cyclosporine Usp

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    02

    Dactinomycin Usp

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    03

    Everolimus Usp (with 2% Bht)

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    04

    Lovastatin Usp

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    05

    Midostaurin

    India
    BIO Partnering at JPM
    Not Confirmed
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    Midostaurin

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
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    Concord Biotech

    GDUFA

    DMF Review : Complete

    Rev. Date : 2020-12-04

    Pay. Date : 2020-07-03

    DMF Number : 34976

    Submission : 2020-10-27

    Status : Active

    Type : II

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    06

    Mitomycin Usp

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    07

    Mupirocin Calcium Usp

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    08

    Mupirocin Usp

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    09

    Mycophenolate Mofetil Usp

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    10

    Mycophenolate Mofetil Usp (by Azeotr...

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow
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    CEP/COS

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    01

    Ciclosporin

    CEP/COS

    BIO Partnering at JPM
    Not Confirmed
    arrow

    02

    Everolimus, with 2% BHT

    CEP/COS

    BIO Partnering at JPM
    Not Confirmed
    arrow

    03

    Lovastatin

    CEP/COS

    BIO Partnering at JPM
    Not Confirmed
    arrow

    04

    Mitomycin

    CEP/COS

    BIO Partnering at JPM
    Not Confirmed
    arrow

    05

    Mupirocin

    CEP/COS

    BIO Partnering at JPM
    Not Confirmed
    arrow

    06

    Mupirocin calcium

    CEP/COS

    BIO Partnering at JPM
    Not Confirmed
    arrow

    07

    Mycophenolate mofetil

    CEP/COS

    BIO Partnering at JPM
    Not Confirmed
    arrow

    08

    Mycophenolate mofetil, By azeotropic dis...

    CEP/COS

    BIO Partnering at JPM
    Not Confirmed
    arrow

    09

    Mycophenolate mofetil, Source II

    CEP/COS

    BIO Partnering at JPM
    Not Confirmed
    arrow

    10

    Mycophenolate sodium

    CEP/COS

    BIO Partnering at JPM
    Not Confirmed
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    JDMF

    read-more
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    01

    Ciclosporin JP

    JDMF

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Ciclosporin JP

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    Registration Number : 226MF10056

    Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA

    Initial Date of Registration : 2014-03-06

    Latest Date of Registration : 2021-08-16

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    02

    Mycophenolate mofetil (production only)

    JDMF

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Mycophenolate mofetil (production only)

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
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    Concord Biotech

    Registration Number : 224MF10054

    Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA

    Initial Date of Registration : 2012-03-12

    Latest Date of Registration : 2018-12-11

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    03

    Sirolimus (for manufacturing only)

    JDMF

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Sirolimus (for manufacturing only)

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    • WHO-GMP
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    Concord Biotech

    Registration Number : 302MF10039

    Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA

    Initial Date of Registration : 2020-04-02

    Latest Date of Registration : 2020-04-02

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    04

    Tacrolimus hydrate (production only)

    JDMF

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Tacrolimus hydrate (production only)

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    Registration Number : 222MF10197

    Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA　

    Initial Date of Registration : 2010-07-13

    Latest Date of Registration : 2010-07-13

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    EU WC

    read-more
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    01

    Amphotericin B USP

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    02

    Anidulafungin IH

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    03

    Cyclosporine IP/USP/EP

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    04

    Ciclosporin EP

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    05

    Cyclosporine USP/IP/JP

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    06

    Dactinomycin USP

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    07

    Doxorubicin Hydrochloride EP

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    08

    Everolimus Premix 2%, Everol...

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    09

    Everolimus IH/USP/EP

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    10

    Midostaurin IH

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow
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    KDMF

    read-more
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    01

    cyclosporine

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    cyclosporine

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2012-08-06

    Registration Number : 20120806-18-C-299-06

    Manufacturer Name : CONCORD BIOTECH LIMITED

    Manufacturer Address : 1482-1486, Trasad Road, Dholka,District ? Ahmedabad Pin Code - 387810

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    02

    cyclosporine

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    cyclosporine

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    Registrant Name : Novartis Korea Co., Ltd.

    Registration Date : 2024-07-30

    Registration Number : 20120806-18-C-299-06(2)

    Manufacturer Name : CONCORD BIOTECH LIMITED

    Manufacturer Address : 1482-1486, Trasad Road, Dholka, District - Ahmedabad Pin Code - 387810, India

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    03

    everolimus

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    everolimus

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Concord Biotech

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2020-07-21

    Registration Number : Su259-9-ND

    Manufacturer Name : Concord Biotech Limited

    Manufacturer Address : Plot No. 1482-1486, Trasad Road, Dholka, District-Ahmedabad, India

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    04

    Mycophenolate mofetil

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    Mycophenolate mofetil

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Concord Biotech

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2020-06-01

    Registration Number : 20200601-209-J-643

    Manufacturer Name : Concord Biotech Limited

    Manufacturer Address : Plot No.1482-1486, Trasad Road, Dholka, District-Ahmedabad India

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    Place

    05

    sirolimus

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    sirolimus

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Concord Biotech

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2014-02-06

    Registration Number : 20140206-190-I-347-02

    Manufacturer Name : Concord Biotech Ltd.

    Manufacturer Address : Plot No. 1482-1486, Trasad Road, Dholka, Dist-Ahmedabad, India

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    Place

    06

    Tacrolimus hydrate

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    Tacrolimus hydrate

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
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    • WHO-GMP
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    Concord Biotech

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2012-03-02

    Registration Number : 20120302-204-I-23-01

    Manufacturer Name : CONCORD BIOTECH LIMITED

    Manufacturer Address : 1482-1486, Trasad Road, Dholka, District - Ahmedabad,382225

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    Market
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    07

    Tacrolimus hydrate

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    Tacrolimus hydrate

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Concord Biotech

    Registrant Name : Leo Pharma Co., Ltd.

    Registration Date : 2025-10-29

    Registration Number : 20120302-204-I-23-01(3)

    Manufacturer Name : Concord Biotech Limited

    Manufacturer Address : 1482-1486, Trasad Road, Dholka Dist, Ahmedabad Gujarat, 382225, India

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    NDC API

    read-more
    read-more

    01

    1-(2-(4-MORPHOLINYL)ETHOXY) MYCOPHENOLATE MOFETIL

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    1-(2-(4-MORPHOLINYL)ETHOXY) MYCOPHENOLATE MOFETIL

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    • WHO-GMP
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    Concord Biotech

    NDC Package Code : 68254-2508

    Start Marketing Date : 2023-11-09

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    02

    ANIDULAFUNGIN

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    ANIDULAFUNGIN

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Concord Biotech

    NDC Package Code : 68254-0014

    Start Marketing Date : 2014-08-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    ANIDULAFUNGIN

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    ANIDULAFUNGIN

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Concord Biotech

    NDC Package Code : 68254-0013

    Start Marketing Date : 2014-07-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    CYCLOSPORINE

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    CYCLOSPORINE

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    NDC Package Code : 68254-2501

    Start Marketing Date : 2010-02-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    CYCLOSPORINE

    India
    BIO Partnering at JPM
    Not Confirmed
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    CYCLOSPORINE

    India
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    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    NDC Package Code : 68254-0008

    Start Marketing Date : 2010-02-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    DACTINOMYCIN

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    DACTINOMYCIN

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    NDC Package Code : 68254-0017

    Start Marketing Date : 2016-05-16

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    EVEROLIMUS

    India
    BIO Partnering at JPM
    Not Confirmed
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    EVEROLIMUS

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    NDC Package Code : 68254-6234

    Start Marketing Date : 2011-08-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    FIDAXOMICIN

    India
    BIO Partnering at JPM
    Not Confirmed
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    FIDAXOMICIN

    India
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    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    NDC Package Code : 68254-0022

    Start Marketing Date : 2023-12-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    MICAFUNGIN SODIUM

    India
    BIO Partnering at JPM
    Not Confirmed
    arrow

    MICAFUNGIN SODIUM

    India
    arrow
    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    NDC Package Code : 68254-0012

    Start Marketing Date : 2014-05-13

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    MIDOSTAURIN

    India
    BIO Partnering at JPM
    Not Confirmed
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    MIDOSTAURIN

    India
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    BIO Partnering at JPM
    Not Confirmed
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    Concord Biotech

    NDC Package Code : 68254-0021

    Start Marketing Date : 2019-11-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    LISTED APIs

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    Amphotericin B

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    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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    Amphotericin B

    India
    Biotech Showcase
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    Amphotericin B

    India
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    Biotech Showcase
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    Concord Biotech

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

    About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic proce...

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    • FDA
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    Anidulafungin

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    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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    02

    Anidulafungin

    India
    Biotech Showcase
    Not Confirmed
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    Anidulafungin

    India
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    Concord Biotech

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

    About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic proce...

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    Bleomycin Sulphate

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    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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    03

    Bleomycin Sulphate

    India
    Biotech Showcase
    Not Confirmed
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    Bleomycin Sulphate

    India
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    Concord Biotech

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

    About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic proce...

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    Caspofungin

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    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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    04

    Caspofungin

    India
    Biotech Showcase
    Not Confirmed
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    Caspofungin

    India
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    Concord Biotech

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

    About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic proce...

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    Clindamycin Hydrochloride

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    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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    05

    Clindamycin Hydrochloride

    India
    Biotech Showcase
    Not Confirmed
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    Clindamycin Hydrochloride

    India
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    Concord Biotech

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

    About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic proce...

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    Cyclosporine

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    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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    06

    Cyclosporine

    India
    Biotech Showcase
    Not Confirmed
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    Cyclosporine

    India
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    Concord Biotech

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

    About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic proce...

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    Dactinomycin

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    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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    07

    Dactinomycin

    India
    Biotech Showcase
    Not Confirmed
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    Dactinomycin

    India
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    Concord Biotech

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

    About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic proce...

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    Dalbavancin

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    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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    08

    Dalbavancin

    India
    Biotech Showcase
    Not Confirmed
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    Dalbavancin

    India
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    Concord Biotech

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

    About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic proce...

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    Daptomycin

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    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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    09

    Daptomycin

    India
    Biotech Showcase
    Not Confirmed
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    Daptomycin

    India
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    Concord Biotech

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

    About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic proce...

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    Doxorubicin Hydrochloride

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    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering...
    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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    10

    Doxorubicin Hydrochloride

    India
    Biotech Showcase
    Not Confirmed
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    Doxorubicin Hydrochloride

    India
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    Concord Biotech

    Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.

    About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic proce...

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    Drugs in Development

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    Concord Biotech gets US FDA Nod for Marketing Multiple Sclerosis Drug Teriflunomide

    Details:

    Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease.


    Lead Product(s): Teriflunomide

    Therapeutic Area: Neurology Brand Name: Teriflunomide-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 07, 2025

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    01

    Concord Biotech

    India
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    BIO Partnering at JPM
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    Concord Biotech

    India
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    Lead Product(s) : Teriflunomide

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Concord Biotech gets US FDA Nod for Marketing Multiple Sclerosis Drug Teriflunomide

    Details : Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease.

    Product Name : Teriflunomide-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 07, 2025

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    Lupin, Concord, Receive US FDA Approval for Mycophenolate Mofetil Tablets USP

    Details:

    Mycophenolate Mofetil Tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.


    Lead Product(s): Mycophenolate Mofetil,Corticosteroids,Cyclosporine

    Therapeutic Area: Immunology Brand Name: Mofecon

    Study Phase: Approved FDFProduct Type: Antibiotic

    Sponsor: Lupin Ltd

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 06, 2020

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    02

    Concord Biotech

    India
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    BIO Partnering at JPM
    Not Confirmed

    Concord Biotech

    India
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    Lead Product(s) : Mycophenolate Mofetil,Corticosteroids,Cyclosporine

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Lupin Ltd

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lupin, Concord, Receive US FDA Approval for Mycophenolate Mofetil Tablets USP

    Details : Mycophenolate Mofetil Tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.

    Product Name : Mofecon

    Product Type : Antibiotic

    Upfront Cash : Inapplicable

    August 06, 2020

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    FDF Dossiers

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    01

    Brand Name : MYCOPHENOLATE MOFETI...

    India
    BIO Partnering at JPM
    Not Confirmed
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    Brand Name : MYCOPHENOLATE MOFETI...

    India
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    BIO Partnering at JPM
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    Regulatory Info : RX

    Registration Country : USA

    MYCOPHENOLATE MOFETIL

    Concord Biotech

    Dosage Form : CAPSULE;ORAL

    Brand Name : MYCOPHENOLATE MOFETIL

    Dosage Strength : 250MG

    Packaging :

    Approval Date : 2019-01-08

    Application Number : 210181

    Regulatory Info : RX

    Registration Country : USA

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    02

    Brand Name : MYCOPHENOLATE MOFETI...

    India
    BIO Partnering at JPM
    Not Confirmed
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    Brand Name : MYCOPHENOLATE MOFETI...

    India
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    BIO Partnering at JPM
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    MYCOPHENOLATE MOFETIL

    Concord Biotech

    Dosage Form : TABLET;ORAL

    Brand Name : MYCOPHENOLATE MOFETIL

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 2020-07-31

    Application Number : 212087

    Regulatory Info : RX

    Registration Country : USA

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    03

    Brand Name : MYCOPHENOLATE SODIUM

    India
    BIO Partnering at JPM
    Not Confirmed
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    Brand Name : MYCOPHENOLATE SODIUM

    India
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    BIO Partnering at JPM
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    MYCOPHENOLATE SODIUM

    Concord Biotech

    Dosage Form : TABLET, DELAYED RELEASE;...

    Brand Name : MYCOPHENOLATE SODIUM

    Dosage Strength : EQ 180MG BASE

    Packaging :

    Approval Date : 2019-12-13

    Application Number : 211173

    Regulatory Info : RX

    Registration Country : USA

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    04

    Brand Name : MYCOPHENOLATE SODIUM

    India
    BIO Partnering at JPM
    Not Confirmed
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    Brand Name : MYCOPHENOLATE SODIUM

    India
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    BIO Partnering at JPM
    Not Confirmed
    • fda
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    Regulatory Info : RX

    Registration Country : USA

    MYCOPHENOLATE SODIUM

    Concord Biotech

    Dosage Form : TABLET, DELAYED RELEASE;...

    Brand Name : MYCOPHENOLATE SODIUM

    Dosage Strength : EQ 360MG BASE

    Packaging :

    Approval Date : 2019-12-13

    Application Number : 211173

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info : RX

    Registration Country : USA

    TACROLIMUS

    Concord Biotech

    Dosage Form : CAPSULE;ORAL

    Brand Name : TACROLIMUS

    Dosage Strength : EQ 0.5MG BASE

    Packaging :

    Approval Date : 2020-11-10

    Application Number : 213112

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info : RX

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    TACROLIMUS

    Concord Biotech

    Dosage Form : CAPSULE;ORAL

    Brand Name : TACROLIMUS

    Dosage Strength : EQ 1MG BASE

    Packaging :

    Approval Date : 2020-11-10

    Application Number : 213112

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info : RX

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    TACROLIMUS

    Concord Biotech

    Dosage Form : CAPSULE;ORAL

    Brand Name : TACROLIMUS

    Dosage Strength : EQ 5MG BASE

    Packaging :

    Approval Date : 2020-11-10

    Application Number : 213112

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : TERIFLUNOMIDE

    India
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    India
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    Regulatory Info : DISCN

    Registration Country : USA

    TERIFLUNOMIDE

    Concord Biotech

    Dosage Form : TABLET;ORAL

    Brand Name : TERIFLUNOMIDE

    Dosage Strength : 7MG

    Packaging :

    Approval Date : 2025-04-07

    Application Number : 218663

    Regulatory Info : DISCN

    Registration Country : USA

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    Regulatory Info : DISCN

    Registration Country : USA

    TERIFLUNOMIDE

    Concord Biotech

    Dosage Form : TABLET;ORAL

    Brand Name : TERIFLUNOMIDE

    Dosage Strength : 14MG

    Packaging :

    Approval Date : 2025-04-07

    Application Number : 218663

    Regulatory Info : DISCN

    Registration Country : USA

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    FDA Orange Book

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    Brand Name : MYCOPHENOLATE MOFETI...

    India
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    India
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    RLD : No

    TE Code : AB

    MYCOPHENOLATE MOFETIL

    Concord Biotech

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : MYCOPHENOLATE MOFETIL

    Dosage Strength : 250MG

    Approval Date : 2019-01-08

    Application Number : 210181

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : MYCOPHENOLATE MOFETI...

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    RLD : No

    TE Code : AB

    MYCOPHENOLATE MOFETIL

    Concord Biotech

    Dosage Form : TABLET; ORAL

    Proprietary Name : MYCOPHENOLATE MOFETIL

    Dosage Strength : 500MG

    Approval Date : 2020-07-31

    Application Number : 212087

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : MYCOPHENOLATE SODIUM

    India
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    RLD : No

    TE Code : AB

    MYCOPHENOLATE SODIUM

    Concord Biotech

    Dosage Form : TABLET, DELAYED RELEASE; ORAL

    Proprietary Name : MYCOPHENOLATE SODIUM

    Dosage Strength : EQ 180MG BASE

    Approval Date : 2019-12-13

    Application Number : 211173

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : MYCOPHENOLATE SODIUM

    India
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    RLD : No

    TE Code : AB

    MYCOPHENOLATE SODIUM

    Concord Biotech

    Dosage Form : TABLET, DELAYED RELEASE; ORAL

    Proprietary Name : MYCOPHENOLATE SODIUM

    Dosage Strength : EQ 360MG BASE

    Approval Date : 2019-12-13

    Application Number : 211173

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : TACROLIMUS

    India
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    RLD : No

    TE Code : AB

    TACROLIMUS

    Concord Biotech

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : TACROLIMUS

    Dosage Strength : EQ 0.5MG BASE

    Approval Date : 2020-11-10

    Application Number : 213112

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    RLD : No

    TE Code : AB

    TACROLIMUS

    Concord Biotech

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : TACROLIMUS

    Dosage Strength : EQ 1MG BASE

    Approval Date : 2020-11-10

    Application Number : 213112

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    RLD : No

    TE Code : AB

    TACROLIMUS

    Concord Biotech

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : TACROLIMUS

    Dosage Strength : EQ 5MG BASE

    Approval Date : 2020-11-10

    Application Number : 213112

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    08

    Brand Name : TERIFLUNOMIDE

    India
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    Brand Name : TERIFLUNOMIDE

    India
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    RLD : No

    TE Code :

    TERIFLUNOMIDE

    Concord Biotech

    Dosage Form : TABLET; ORAL

    Proprietary Name : TERIFLUNOMIDE

    Dosage Strength : 7MG

    Approval Date : 2025-04-07

    Application Number : 218663

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Brand Name : TERIFLUNOMIDE

    India
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    RLD : No

    TE Code :

    TERIFLUNOMIDE

    Concord Biotech

    Dosage Form : TABLET; ORAL

    Proprietary Name : TERIFLUNOMIDE

    Dosage Strength : 14MG

    Approval Date : 2025-04-07

    Application Number : 218663

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    API Manufacturing

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    Scale Up

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    PROCESS DEVELOPMENT & OPTIMIZATION

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    CDMO FOR FERMENTED APIs

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    Inspections and registrations

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-02-20

    Concord Biotech

    City : Ahmedabad, Gujarat State

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-02-20

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-08-10

    Concord Biotech

    City : Ahmedabad, Gujarat State

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-08-10

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    Concord Biotech

    Type : GMP Certificates

    Number : DE_BY_04_GM...

    EudraGMDP Key : 28027

    Country : India

    Issue Date :

    Post Code : Dholka,

    NCA Ref : 21350

    City : Dist. Ahmedabad 387810 ...

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    Paid in : 2019

    Concord Biotech

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : CONCORD BIOTECH LIMITED

    Business Address : 1482-1486, Trasad Road, Dhol...

    FEI Number : 3004126703

    Country : India

    Paid in : 2019

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    ABOUT THIS PAGE

    Contact Concord Biotech and get a quotation

    Concord Biotech is a supplier offers 55 products (APIs, Excipients or Intermediates).

    Find a price of Cyclosporine bulk with DMF, CEP, JDMF, WC offered by Concord Biotech

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    Find a price of Sirolimus bulk with DMF, JDMF, WC offered by Concord Biotech

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    Find a price of Nystatin bulk with DMF, WC offered by Concord Biotech

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    Find a price of Doxorubicin Hydrochloride bulk with WC offered by Concord Biotech

    Find a price of Everolimus bulk with WC offered by Concord Biotech

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