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    Details of Lek Pharmaceuticals'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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    Lek Pharmaceuticals

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    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    INSPECTIONS & REGISTRATIONS

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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 : No Action Indicated

    Inspection End Date : 2009-08-12

    Lek Pharmaceuticals

    City : Menges

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-08-12

    blank

    Product
    Web Link

    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 : 2009-08-12

    Lek Pharmaceuticals

    City : Menges

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-08-12

    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 : Voluntary Action Indicated

    Inspection End Date : 2009-10-01

    Lek Pharmaceuticals

    City : Ljubljana

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-10-01

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    04

    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 : 2012-10-12

    Lek Pharmaceuticals

    City : Lendava - Lendva

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-10-12

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    05

    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 : 2009-10-01

    Lek Pharmaceuticals

    City : Ljubljana

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-10-01

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    06

    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 : 2012-10-12

    Lek Pharmaceuticals

    City : Lendava - Lendva

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-10-12

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    07

    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 : 2012-04-06

    Lek Pharmaceuticals

    City : Ljubljana

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-04-06

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    08

    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 : 2012-10-19

    Lek Pharmaceuticals

    City : Menges

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-10-19

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    09

    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 : 2012-04-06

    Lek Pharmaceuticals

    City : Ljubljana

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-04-06

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    10

    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 : 2012-10-19

    Lek Pharmaceuticals

    City : Menges

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-10-19

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    11

    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 : 2014-07-17

    Lek Pharmaceuticals

    City : Prevalje

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-07-17

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    12

    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 : 2013-09-13

    Lek Pharmaceuticals

    City : Ljubljana

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-09-13

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    13

    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 : 2014-07-17

    Lek Pharmaceuticals

    City : Prevalje

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-07-17

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    14

    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 : 2013-09-13

    Lek Pharmaceuticals

    City : Ljubljana

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-09-13

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    15

    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 : 2015-06-30

    Lek Pharmaceuticals

    City : Ljubljana

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-06-30

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    16

    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 : 2012-05-17

    Lek Pharmaceuticals

    City : Prevalje

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-05-17

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    17

    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 : 2008-11-11

    Lek Pharmaceuticals

    City : Lendava - Lendva

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2008-11-11

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    18

    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 : 2008-11-11

    Lek Pharmaceuticals

    City : Lendava - Lendva

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2008-11-11

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    19

    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 : 2015-06-30

    Lek Pharmaceuticals

    City : Ljubljana

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-06-30

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    20

    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 : 2012-05-17

    Lek Pharmaceuticals

    City : Prevalje

    State :

    Country/Area : SI

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-05-17

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Contact Lek Pharmaceuticals and get a quotation

    Lek Pharmaceuticals is a supplier offers 48 products (APIs, Excipients or Intermediates).

    Find a price of Gentamicin Sulfate bulk with DMF, CEP, JDMF offered by Lek Pharmaceuticals

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    Find a price of Sugammadex Sodium bulk with DMF offered by Lek Pharmaceuticals

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    Find a price of Auranofin bulk offered by Lek Pharmaceuticals

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    Find a price of Cimetidine bulk offered by Lek Pharmaceuticals

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    Find a price of Enalapril Maleate bulk offered by Lek Pharmaceuticals

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    Find a price of Losartan Potassium bulk offered by Lek Pharmaceuticals

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    Find a price of Olanzapine bulk offered by Lek Pharmaceuticals

    Find a price of Propranolol Hydrochloride bulk offered by Lek Pharmaceuticals

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    Find a price of Tolterodine Tartrate bulk offered by Lek Pharmaceuticals