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    Company profile for Lek Pharmaceuticals

    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    pharmacompass-1-m-2026-01-12

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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.https://marketing.lgmpharma.com/LGM-CDMO

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    Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    INSPECTIONS & REGISTRATIONS

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    About

    Lek is a part of Sandoz, a global generics leader. We save and improve lives by developing, producing and distributing high-quality, affordable pharmaceuticals. Thanks to our global network, Sandoz medicines are now available to 90% of people worldwide. In addition to the direct cost savings to patients, we contribute to the stability of healthcare systems worldwide and free up resources for new and innovative medicines. We m...
    Lek is a part of Sandoz, a global generics leader. We save and improve lives by developing, producing and distributing high-quality, affordable pharmaceuticals. Thanks to our global network, Sandoz medicines are now available to 90% of people worldwide. In addition to the direct cost savings to patients, we contribute to the stability of healthcare systems worldwide and free up resources for new and innovative medicines. We make far more than just traditional off-patent medicines. We stand out from the crowd thanks to our ability to develop and produce a wide range of differentiated products.

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    CONTACT DETAILS

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    Lek PharmaceuticalsSlovenia Flag
    Country
    Country
    Slovenia
    Address
    Address
    Verovkova 57, 1526 Ljubljana
    Telephone
    Telephone
    +386 1 580 21 11
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://lek.si/en/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

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    Events

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    NEWS #PharmaBuzz

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    China’s Porton to set up biotech park in Slovenia’s Menges
    China’s Porton to set up biotech park in Slovenia’s Menges

    10 Jan 2023

    // INTELLINEWS

    https://intellinews.com/china-s-porton-to-set-up-biotech-park-in-slovenia-s-menges-266425/?source=slovenia

    INTELLINEWS
    10 Jan 2023
    Share Share
    Imbruvica® (Ibrutinib) : Pharmacyclics v. Zydus Worldwide DMCC
    Imbruvica® (Ibrutinib) : Pharmacyclics v. Zydus Worldwide DMCC

    16 Feb 2018

    // PATENT LITIGATION

    https://www.pharmacompass.com/pdf/news/imbruvica-ibrutinib-pharmacyclics-v-zydus-worldwide-dmcc-1520247536.pdf

    PATENT LITIGATION
    16 Feb 2018
    Share Share
    Trintellix (Vortioxetine): H. Lundbeck v. Sandoz
    Trintellix (Vortioxetine): H. Lundbeck v. Sandoz

    30 Jan 2018

    // PATENT LITIGATION

    https://www.pharmacompass.com/pdf/news/trintellix-vortioxetineh-lundbeck-v-sandoz-1517811354.pdf

    PATENT LITIGATION
    30 Jan 2018
    Share Share
    Sandoz's Lek Invests in Final Dosage Form Biosimilar Capabilities
    Sandoz's Lek Invests in Final Dosage Form Biosimilar Capabilities

    27 Jan 2016

    // DCAT CONNECT

    http://connect.dcat.org/blogs/pharma-news/2016/01/26/sandozs-lek-invests-in-final-dosage-form-biosimilar-capabilities#.Vqhfipp97IU

    DCAT CONNECT
    27 Jan 2016
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    ALL APIs

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

    01

    Gentamicin Sulfate

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

    ESF Europe
    Not Confirmed
    arrow

    Gentamicin Sulfate

    Slovenia

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

    arrow
    ESF Europe
    Not Confirmed
    • fda
    • 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 : 13704

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2005-121 - Rev 02

    Issue Date : 2024-10-21

    Type : Chemical

    Substance Number : 331

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10041

    Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia

    Initial Date of Registration : 2008-02-05

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48866-8256

    Start Marketing Date : 2013-07-12

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT arrow-down
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    Market
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    02

    Amlodipine Besylate

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

    ESF Europe
    Not Confirmed
    arrow

    Amlodipine Besylate

    Slovenia

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

    arrow
    ESF Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16887

    Submission : 2003-10-02

    Status : Inactive

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2004-210 - Rev 00

    Issue Date : 2011-07-01

    Type : Chemical

    Substance Number : 1491

    Status : Withdrawn by Holder

     JDMF arrow-down
    ✖

    Registration Number : 222MF10151

    Registrant's Address : Verovskova ulica 57, 1000 Ljubljana, Slovenia

    Initial Date of Registration : 2010-05-17

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea Co., Ltd.

    Registration Date : 2010-11-30

    Registration Number : 20101130-130-H-45-06

    Manufacturer Name : Novartis Pharmaceutical Manufacturing LLC

    Manufacturer Address : Kolodvorska Cesta 27, Menges, 1234, Slovenia

     VMF Others AUDIT arrow-down
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    03

    Atorvastatin

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

    ESF Europe
    Not Confirmed
    arrow

    Atorvastatin

    Slovenia

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

    arrow
    ESF Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18082

    Submission : 2005-02-01

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 222MF10232

    Registrant's Address : Verovskova ulica 57, 1000 Ljubljana, Slovenia

    Initial Date of Registration : 2010-09-24

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : IMCD Korea Co., Ltd.

    Registration Date : 2011-11-11

    Registration Number : 20101011-132-H-1-02(1)

    Manufacturer Name : Lek Pharmaceuticals dd

    Manufacturer Address : Kolodvorska cesta 27, 1234 Menges, Slovenia

     VMF Others AUDIT arrow-down
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    Product
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    04

    Clavulanic Acid

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

    ESF Europe
    Not Confirmed
    arrow

    Clavulanic Acid

    Slovenia

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

    arrow
    ESF Europe
    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15211

    Submission : 2000-12-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-258 - Rev 02

    Issue Date : 2021-03-05

    Type : Chemical

    Substance Number : 1653

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48866-9981

    Start Marketing Date : 2022-11-03

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (20kg/20kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2022-04-25

    Registration Number : 20220425-113-F-95-25

    Manufacturer Name : Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava

    Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia

     VMF Others AUDIT arrow-down
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    Market
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    05

    Clavulanic Acid

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

    ESF Europe
    Not Confirmed
    arrow

    Clavulanic Acid

    Slovenia

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

    arrow
    ESF Europe
    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 : 2019-10-24

    Pay. Date : 2018-05-17

    DMF Number : 32777

    Submission : 2018-05-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-259 - Rev 02

    Issue Date : 2021-03-05

    Type : Chemical

    Substance Number : 1653

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48866-9982

    Start Marketing Date : 2022-11-03

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (20kg/20kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2022-04-25

    Registration Number : 20220425-113-F-96-26

    Manufacturer Name : Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava

    Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia

     VMF Others AUDIT arrow-down
    blank

    Product
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    Market
    Place

    06

    Clavulanic Acid

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

    ESF Europe
    Not Confirmed
    arrow

    Clavulanic Acid

    Slovenia

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

    arrow
    ESF Europe
    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 : 2023-03-07

    Pay. Date : 2023-02-02

    DMF Number : 36941

    Submission : 2023-01-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-260 - Rev 02

    Issue Date : 2021-03-08

    Type : Chemical

    Substance Number : 1653

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Yuhan Corporation

    Registration Date : 2018-02-08

    Registration Number : 20081031-113-F-10-03(4)

    Manufacturer Name : lek pharmaceuticals dd

    Manufacturer Address : Perzonali 47, SI-2391 Prevalje

     VMF Others AUDIT arrow-down
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    07

    Clavulanic Acid

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

    ESF Europe
    Not Confirmed
    arrow

    Clavulanic Acid

    Slovenia

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

    arrow
    ESF Europe
    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 : 2023-12-07

    Pay. Date : 2022-11-23

    DMF Number : 37008

    Submission : 2023-09-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-262 - Rev 03

    Issue Date : 2020-06-17

    Type : Chemical

    Substance Number : 1140

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Boryeong Co., Ltd.

    Registration Date : 2015-09-09

    Registration Number : 20081031-113-F-9-04(2)

    Manufacturer Name : Lek Pharmaceuticals dd

    Manufacturer Address : Perzonali 47, SI-2391 Prevalje

     VMF Others AUDIT arrow-down
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    Market
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    08

    Tacrolimus

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

    ESF Europe
    Not Confirmed
    arrow

    Tacrolimus

    Slovenia

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

    arrow
    ESF Europe
    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 : 2015-05-28

    Pay. Date : 2015-05-05

    DMF Number : 19979

    Submission : 2006-11-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-204 - Rev 01

    Issue Date : 2023-08-07

    Type : Chemical

    Substance Number : 2244

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    09

    Mycophenolate Mofetil

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

    ESF Europe
    Not Confirmed
    arrow

    Mycophenolate Mofetil

    Slovenia

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

    arrow
    ESF Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25323

    Submission : 2011-09-27

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2005-222 - Rev 02

    Issue Date : 2016-10-13

    Type : Chemical

    Substance Number : 1700

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    10

    Mycophenolate Mofetil

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

    ESF Europe
    Not Confirmed
    arrow

    Mycophenolate Mofetil

    Slovenia

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

    arrow
    ESF Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18936

    Submission : 2005-11-07

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-317 - Rev 06

    Issue Date : 2024-09-16

    Type : Chemical

    Substance Number : 1700

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    ABOUT THIS PAGE

    Contact Lek Pharmaceuticals and get a quotation

    Lek Pharmaceuticals is a supplier offers 54 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 Atorvastatin bulk with DMF, JDMF offered by Lek Pharmaceuticals

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    Find a price of Dolutegravir Sodium bulk with DMF 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 Culture medium/culture medium additives DM122 0060 bulk with JDMF offered by Lek Pharmaceuticals

    Find a price of Culture medium/culture medium additives COMBL 0053 bulk with JDMF offered by Lek Pharmaceuticals

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