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    Details of Glatt Systems Pvt. Ltd'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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    01

    FDA Audited

    USA
    Discovery on Target
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Discovery on Target
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-07-30

    Glatt Systems Pvt. Ltd

    City : Binzen

    State :

    Country/Area : DE

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-07-30

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    Product
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    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    02

    FDA Audited

    USA
    Discovery on Target
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Discovery on Target
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-12-04

    Glatt Systems Pvt. Ltd

    City : Binzen

    State :

    Country/Area : DE

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-12-04

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    03

    FDA Audited

    USA
    Discovery on Target
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Discovery on Target
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-09-17

    Glatt Systems Pvt. Ltd

    City : Binzen

    State :

    Country/Area : DE

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-09-17

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow