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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Lek Pharmaceuticals

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    FAMAR CDMO- From early development to commercial manufacturing.

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    xyz-pharma-m-2024-09-09

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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    Veranova: A CDMO that manages complexity with confidence.

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    xyz-pharma-m-2024-09-09

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    Lek Pharmaceuticals

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    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

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    01 2Amlodipine Besylate

    02 1Apremilast

    03 1Atorvastatin

    04 1Auranofin

    05 1Bromocriptine Mesylate

    06 1Calcium Gluceptate

    07 1Candesartan Cilexetil

    08 1Caspofungin

    09 1Cimetidine

    10 7Clavulanic Acid

    11 1Dihydroergotamine Mesylate

    12 1Dolutegravir Sodium

    13 1Enalapril Maleate

    14 1Entecavir

    15 1Ferric Carboxymaltose

    16 1Ferumoxytol

    17 1Fesoterodine

    18 1Gentamicin Sulfate

    19 1Lisinopril

    20 2Lithium Carbonate

    21 1Losartan Potassium

    22 2Lovastatin

    23 2Mycophenolate Mofetil

    24 1Nifedipine

    25 1Nitrofurantoin

    26 1Olanzapine

    27 2Omeprazole

    28 2Pravastatin

    29 1Propranolol Hydrochloride

    30 3Rosuvastatin Calcium

    31 1Silver Sulfadiazine

    32 1Simvastatin

    33 1Sirolimus

    34 1Sugammadex Sodium

    35 2Tacrolimus

    36 1Tamsulosin

    37 1Ticagrelor

    38 1Tolterodine Tartrate

    39 2Vancomycin Hydrochloride

    40 1Vortioxetine Hydrobromide

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    01

    Gentamicin Sulfate

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

    BioProcess International
    Not Confirmed
    arrow

    Gentamicin Sulfate

    Slovenia

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

    arrow
    BioProcess International
    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 : R1-CEP 2005-121 - Rev 01

    Issue Date : 2016-02-03

    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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
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    02

    Rosuvastatin Calcium

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

    BioProcess International
    Not Confirmed
    arrow

    Rosuvastatin Calcium

    Slovenia

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

    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20765

    Submission : 2007-08-09

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2016-321 - Rev 01

    Issue Date : 2019-04-15

    Type : Chemical

    Substance Number : 2631

    Status : Withdrawn by Holder

     JDMF arrow-down
    ✖

    Registration Number : 228MF10155

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

    Initial Date of Registration : 2016-08-08

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Sandoz Korea Co., Ltd.

    Registration Date : 2021-04-06

    Registration Number : 20210406-209-J-687

    Manufacturer Name : Lek Pharmaceuticals d.d.

    Manufacturer Address : Kolodvorska cesta 27,1234 Menges, Slovenia

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    03

    Vancomycin Hydrochloride

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

    BioProcess International
    Not Confirmed
    arrow

    Vancomycin Hydrochloride

    Slovenia

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

    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13223

    Submission : 1998-04-30

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-179 - Rev 03

    Issue Date : 2019-12-18

    Type : Chemical

    Substance Number : 1058

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10740

    Registrant's Address : Verovskova 57, SI-1526 Ljubljana, Slovenia

    Initial Date of Registration : 2005-10-07

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    04

    Amlodipine Besylate

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

    BioProcess International
    Not Confirmed
    arrow

    Amlodipine Besylate

    Slovenia

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

    arrow
    BioProcess International
    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 : Lek Pharmaceuticals d.d.

    Manufacturer Address : Kolodvorska cesta 27,1234 Menges, Slovenia

     VMF Others AUDIT
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    05

    Atorvastatin

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

    BioProcess International
    Not Confirmed
    arrow

    Atorvastatin

    Slovenia

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

    arrow
    BioProcess International
    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 d.d.

    Manufacturer Address : Kolodvorska cesta 27, 1234 Menges, Slovenia

     VMF Others AUDIT
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    06

    Bromocriptine Mesylate

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

    BioProcess International
    Not Confirmed
    arrow

    Bromocriptine Mesylate

    Slovenia

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

    arrow
    BioProcess International
    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.
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 6827

    Submission : 1987-02-13

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 221MF10054

    Registrant's Address : Verovskova 57, SI-1526 Ljubljana, Slovenia

    Initial Date of Registration : 2009-03-16

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    07

    Clavulanic Acid

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

    BioProcess International
    Not Confirmed
    arrow

    Clavulanic Acid

    Slovenia

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

    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Leesung 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
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    08

    Clavulanic Acid

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

    BioProcess International
    Not Confirmed
    arrow

    Clavulanic Acid

    Slovenia

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

    arrow
    BioProcess International
    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.
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    Flag Slovenia
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    Digital Content Digital Content
    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 : 48866-9981

    Start Marketing Date : 2022-11-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Leesung 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
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    09

    Clavulanic Acid

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

    BioProcess International
    Not Confirmed
    arrow

    Clavulanic Acid

    Slovenia

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

    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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 arrow-down
    ✖

    NDC Package Code : 48866-9981

    Start Marketing Date : 2022-11-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Leesung 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
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    10

    Clavulanic Acid

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

    BioProcess International
    Not Confirmed
    arrow

    Clavulanic Acid

    Slovenia

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

    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    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 arrow-down
    ✖

    NDC Package Code : 48866-9981

    Start Marketing Date : 2022-11-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Leesung 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
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    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

    Find a price of Rosuvastatin Calcium bulk with DMF, JDMF offered by Lek Pharmaceuticals

    Find a price of Vancomycin Hydrochloride bulk with CEP, JDMF offered by Lek Pharmaceuticals

    Find a price of Amlodipine Besylate bulk with JDMF offered by Lek Pharmaceuticals

    Find a price of Atorvastatin bulk with DMF, JDMF offered by Lek Pharmaceuticals

    Find a price of Bromocriptine Mesylate bulk with DMF, JDMF offered by Lek Pharmaceuticals

    Find a price of Clavulanic Acid bulk with DMF, CEP offered by Lek Pharmaceuticals

    Find a price of Tacrolimus bulk with DMF, CEP offered by Lek Pharmaceuticals

    Find a price of Candesartan Cilexetil bulk with JDMF offered by Lek Pharmaceuticals

    Find a price of Lithium Carbonate bulk with JDMF offered by Lek Pharmaceuticals

    Find a price of Mycophenolate Mofetil bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Mycophenolate Mofetil bulk with CEP offered by Lek Pharmaceuticals

    Find a price of Amlodipine Besylate bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Apremilast bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Clavulanic Acid bulk with CEP offered by Lek Pharmaceuticals

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

    Find a price of Entecavir bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Ferric Carboxymaltose bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Ferumoxytol bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Lisinopril bulk offered by Lek Pharmaceuticals

    Find a price of Lithium Carbonate bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Lovastatin bulk offered by Lek Pharmaceuticals

    Find a price of Omeprazole bulk offered by Lek Pharmaceuticals

    Find a price of Pravastatin bulk offered by Lek Pharmaceuticals

    Find a price of Rosuvastatin Calcium bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Silver Sulfadiazine bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Simvastatin bulk offered by Lek Pharmaceuticals

    Find a price of Sirolimus bulk with DMF offered by Lek Pharmaceuticals

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

    Find a price of Tacrolimus bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Tamsulosin bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Ticagrelor bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Vancomycin Hydrochloride bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Vortioxetine Hydrobromide bulk with DMF offered by Lek Pharmaceuticals

    Find a price of Auranofin bulk offered by Lek Pharmaceuticals

    Find a price of Calcium Gluceptate bulk offered by Lek Pharmaceuticals

    Find a price of Caspofungin bulk offered by Lek Pharmaceuticals

    Find a price of Cimetidine bulk offered by Lek Pharmaceuticals

    Find a price of Dihydroergotamine Mesylate bulk offered by Lek Pharmaceuticals

    Find a price of Enalapril Maleate bulk offered by Lek Pharmaceuticals

    Find a price of Fesoterodine bulk offered by Lek Pharmaceuticals

    Find a price of Losartan Potassium bulk offered by Lek Pharmaceuticals

    Find a price of Nifedipine bulk offered by Lek Pharmaceuticals

    Find a price of Nitrofurantoin bulk offered by Lek Pharmaceuticals

    Find a price of Olanzapine bulk offered by Lek Pharmaceuticals

    Find a price of Propranolol Hydrochloride bulk offered by Lek Pharmaceuticals

    Find a price of Rosuvastatin Calcium bulk offered by Lek Pharmaceuticals

    Find a price of Tolterodine Tartrate bulk offered by Lek Pharmaceuticals