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    Company profile for BIOTIKA a.s.

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    INSPECTIONS & REGISTRATIONS

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    About

    Biotika was founded in 1953 as a new manufacturer of Penicillin on the territory of former Czechoslovakia with the aim to meet domestic demand. From its foundation until 1990, Biotika was a part of the Spofa concern that was a company embracing all pharmaceutical companies in the former Czechoslovakia. Historical milestones of Biotika are connected with the beginning of the Penicillin G production in 1956 and the Penicillin ...
    Biotika was founded in 1953 as a new manufacturer of Penicillin on the territory of former Czechoslovakia with the aim to meet domestic demand. From its foundation until 1990, Biotika was a part of the Spofa concern that was a company embracing all pharmaceutical companies in the former Czechoslovakia. Historical milestones of Biotika are connected with the beginning of the Penicillin G production in 1956 and the Penicillin V production in 1958. Launching its own research-development site which at the end of the 70‘s obtained the statute of the Research-Development Base, is also connected with the beginning of the penicillins production. At the beginning of the 60‘s the biotechnological production was extended by Oxytetracycline production and later by the production of Chlortetracycline and Dextrans for the pharmaceutical application. In 1971 L-Lysine production by biotechnological process was launched and thereby Biotika became the third manufacturer of this essential amino acid in the world. The manufacturing and business activities of the company gradually expanded into the area of final drug form production, the production of medicated and feed additive premixes.

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    CONTACT DETAILS

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    BIOTIKA a.s.Slovakia Flag
    Country
    Country
    Slovakia
    Address
    Address
    976 13 Slovenská Ľupča 566 Slovak Republic
    Telephone
    Telephone
    421 48 4368 111
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.biotika.sk/en/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

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    NEWS #PharmaBuzz

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    FDA Issues Form 483 to Biotika AS
    FDA Issues Form 483 to Biotika AS

    19 Dec 2024

    // FDA

    https://www.fda.gov/media/184607/download

    FDA
    19 Dec 2024
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    ALL APIs

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    01

    Penicillin V Potassium

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

    BIO Partnering at JPM
    Not Confirmed
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    Penicillin V Potassium

    Slovakia

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

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    BIO Partnering at JPM
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13963

    Submission : 1999-01-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1997-043 - Rev 02

    Issue Date : 2008-02-08

    Type : Chemical

    Substance Number : 149

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 54563-002

    Start Marketing Date : 2002-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    02

    Polymyxin B Sulfate

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Polymyxin B Sulfate

    Slovakia

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

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    BIO Partnering at JPM
    Not Confirmed
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    • EDQM
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-09-29

    Pay. Date : 2013-12-11

    DMF Number : 23876

    Submission : 2010-05-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-166 - Rev 00

    Issue Date : 2017-12-20

    Type : Chemical

    Substance Number : 203

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 54563-008

    Start Marketing Date : 2010-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    Penicillin G Potassium

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Penicillin G Potassium

    Slovakia

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16837

    Submission : 2003-09-15

    Status : Inactive

    Type : II

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    04

    Penicillin G Procaine

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Penicillin G Procaine

    Slovakia

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14400

    Submission : 1999-09-10

    Status : Inactive

    Type : II

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    05

    Salinomycin

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Salinomycin

    Slovakia

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Inactive-api
    ✖

    VMF Number : 5737

    Submission : 2002-02-25

    Status : Inactive

    Type : II

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
    Biotech Showcase
    Not Confirmed
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    FDA Audited

    USA
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    Biotech Showcase
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-22

    BIOTIKA a.s.

    City : Slovenska Lupca

    State :

    Country/Area : Slovakia

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-22

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    02

    FDA Audited

    USA
    Biotech Showcase
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    FDA Audited

    USA
    arrow
    Biotech Showcase
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-12-07

    BIOTIKA a.s.

    City : Slovenska Lupca

    State :

    Country/Area : Slovakia

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-12-07

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    ABOUT THIS PAGE

    Contact BIOTIKA a.s and get a quotation

    BIOTIKA a.s is a supplier offers 5 products (APIs, Excipients or Intermediates).

    Find a price of Penicillin V Potassium bulk with DMF, CEP offered by BIOTIKA a.s

    Find a price of Polymyxin B Sulfate bulk with DMF, CEP offered by BIOTIKA a.s

    Find a price of Penicillin G Potassium bulk offered by BIOTIKA a.s

    Find a price of Penicillin G Procaine bulk offered by BIOTIKA a.s

    Find a price of Salinomycin bulk offered by BIOTIKA a.s

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