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    Details of Kyowa Hakko Bio's U.S. FDA Inspections. Original Data: FDA Inspection Database

    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Bora Pharmaceuticals- Making success more certain.

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    Axplora- The partner of choice for complex APIs.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Kyowa Hakko Bio

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    01 2Daiichi Fine Chemical Co Ltd

    02 3Kyowa Hakko Bio Co., Ltd.

    03 2Kyowa Pharma Chemical Co Ltd

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    01

    FDA Audited

    USA
    Luxepack
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Luxepack
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-03-03

    Kyowa Pharma Chemical Co Ltd

    City : Takaokashi

    State :

    Country/Area : JP

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-03-03

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    Product
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    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    02

    FDA Audited

    USA
    Luxepack
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Luxepack
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-08-28

    Kyowa Pharma Chemical Co Ltd

    City : Takaokashi

    State :

    Country/Area : JP

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-08-28

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    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    03

    FDA Audited

    USA
    Luxepack
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Luxepack
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-01-20

    Kyowa Pharma Chemical Co Ltd

    City : Takaoka

    State :

    Country/Area : JP

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-01-20

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    04

    FDA Audited

    USA
    Luxepack
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Luxepack
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-01-20

    Kyowa Pharma Chemical Co Ltd

    City : Takaoka

    State :

    Country/Area : JP

    Zip :

    District : ORA

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-01-20

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    Product
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    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    05

    FDA Audited

    USA
    Luxepack
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Luxepack
    Not Confirmed

    District Decision : Official Action Indicated

    Inspection End Date : 2010-06-25

    Kyowa Hakko Bio

    City : Hofu City

    State :

    Country/Area : JP

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Official Action Indicated

    Inspection End Date : 2010-06-25

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    Product
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    Stock Recap
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    06

    FDA Audited

    USA
    Luxepack
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Luxepack
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-10-27

    Kyowa Hakko Bio

    City : Hofu City

    State :

    Country/Area : JP

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-10-27

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    07

    FDA Audited

    USA
    Luxepack
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Luxepack
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-03-20

    Kyowa Hakko Bio

    City : Hofu City

    State :

    Country/Area : JP

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-03-20

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Contact Kyowa Hakko Bio and get a quotation

    Kyowa Hakko Bio is a supplier offers 69 products (APIs, Excipients or Intermediates).

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