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    01 1Atorvastatin

    02 1Codeine Phosphate

    03 1Dihydrocodeine Hydrogen Tartrate

    04 1Doxazosin Mesylate

    05 1Duloxetine Hydrochloride

    06 1Fentanyl Citrate

    07 1Hydromorphone Hydrochloride

    08 1Losartan Potassium

    09 1Methadone Hydrochloride

    10 1Metoprolol Succinate

    11 1Morphine Sulfate

    12 1Nalbuphine Hydrochloride

    13 1Nalmefene Hydrochloride

    14 1Naloxone Hydrochloride

    15 1Naltrexone

    16 2Naltrexone Hydrochloride

    17 1Oxycodone Hydrochloride

    18 1Pentoxifylline

    19 1Pethidine Hydrochloride

    20 1Pholcodine

    21 2Pimobendan

    22 1Rivastigmine

    23 2Rivastigmine Tartrate

    24 1Sertraline Hydrochloride

    25 1Terbinafine Hydrochloride

    26 1Tramadol Hydrochloride

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    01

    Naltrexone Hydrochloride

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

    DDL Conference
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    Naltrexone Hydrochloride

    Slovakia

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

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    DDL Conference
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-11-17

    Pay. Date : 2025-09-30

    DMF Number : 41264

    Submission : 2025-06-20

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2025-194 - Rev 00

    Issue Date : 2025-06-25

    Type : Chemical

    Substance Number : 1790

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    NDC Package Code : 82105-004

    Start Marketing Date : 2023-08-03

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2025-08-05

    Registration Number : 20250805-209-J-1983

    Manufacturer Name : Saneca Pharmaceuticals as

    Manufacturer Address : Nitrianska 100, 920 27 Hlohovec, Slovak Republic

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    02

    Pethidine Hydrochloride

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

    DDL Conference
    Not Confirmed
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    Pethidine Hydrochloride

    Slovakia

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

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    DDL Conference
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    Certificate Number : R1-CEP 2010-243 - Rev 00

    Issue Date : 2016-11-23

    Type : Chemical

    Substance Number : 420

    Status : Valid

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    ✖

    Registration Number : 223MF10069

    Registrant's Address : Nitrianska 100,920 27 Hlohovec, Slovak Republic

    Initial Date of Registration : 2011-05-25

    Latest Date of Registration :

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    03

    Tramadol Hydrochloride

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

    DDL Conference
    Not Confirmed
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    Tramadol Hydrochloride

    Slovakia

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

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    DDL Conference
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    Certificate Number : R1-CEP 2009-214 - Rev 02

    Issue Date : 2017-09-15

    Type : Chemical

    Substance Number : 1681

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10138

    Registrant's Address : Nitrianska 100,920 27 Hlohovec, Slovak Republic

    Initial Date of Registration : 2017-07-24

    Latest Date of Registration :

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    04

    Codeine Phosphate

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

    DDL Conference
    Not Confirmed
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    Codeine Phosphate

    Slovakia

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

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    DDL Conference
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    Certificate Number : R1-CEP 2007-023 - Rev 05

    Issue Date : 2020-08-19

    Type : Chemical

    Substance Number : 74

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Nosa Chemical Co., Ltd.

    Registration Date : 2019-12-10

    Registration Number : 20191210-209-J-498

    Manufacturer Name : Saneca Pharmaceuticals as

    Manufacturer Address : Nitrianska 100 920 27 Hlohovec, Slovak Republic

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    05

    Dihydrocodeine Hydrogen Tartrate

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

    DDL Conference
    Not Confirmed
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    Dihydrocodeine Hydrogen Tartrate

    Slovakia

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

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    DDL Conference
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    Certificate Number : R1-CEP 2008-018 - Rev 01

    Issue Date : 2021-07-07

    Type : Chemical

    Substance Number : 1776

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Nosa Chemical Co., Ltd.

    Registration Date : 2020-04-21

    Registration Number : 20200421-209-J-609

    Manufacturer Name : Saneca Pharmaceuticals as

    Manufacturer Address : Nitrianska 100, 920 27 Hlohovec, Slovak Republic

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    06

    Doxazosin Mesylate

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

    DDL Conference
    Not Confirmed
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    Doxazosin Mesylate

    Slovakia

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

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    DDL Conference
    Not Confirmed
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    • EDQM
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    Certificate Number : R1-CEP 2011-097 - Rev 02

    Issue Date : 2020-12-17

    Type : Chemical

    Substance Number : 2125

    Status : Valid

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    07

    Duloxetine Hydrochloride

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

    DDL Conference
    Not Confirmed
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    Duloxetine Hydrochloride

    Slovakia

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

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    DDL Conference
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    USDMF CEP/COS arrow-down
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    Certificate Number : R1-CEP 2014-297 - Rev 00

    Issue Date : 2021-08-05

    Type : Chemical

    Substance Number : 2594

    Status : Valid

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    08

    Fentanyl Citrate

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

    DDL Conference
    Not Confirmed
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    Fentanyl Citrate

    Slovakia

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

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    DDL Conference
    Not Confirmed
    • fda
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    USDMF CEP/COS arrow-down
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    Certificate Number : CEP 2009-230 - Rev 01

    Issue Date : 2024-11-07

    Type : Chemical

    Substance Number : 1103

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Nosa Chemical Co., Ltd.

    Registration Date : 2021-04-05

    Registration Number : 20210405-210-J-919

    Manufacturer Name : Saneca Pharmaceuticals as

    Manufacturer Address : Nitrianska 100, 920 27 Hlohovec, Slovak Republic

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    09

    Hydromorphone Hydrochloride

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

    DDL Conference
    Not Confirmed
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    Hydromorphone Hydrochloride

    Slovakia

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

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    DDL Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Certificate Number : CEP 2012-099 - Rev 02

    Issue Date : 2024-03-20

    Type : Chemical

    Substance Number : 2099

    Status : Valid

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    10

    Methadone Hydrochloride

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

    DDL Conference
    Not Confirmed
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    Methadone Hydrochloride

    Slovakia

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

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    DDL Conference
    Not Confirmed
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    Certificate Number : R1-CEP 2007-068 - Rev 01

    Issue Date : 2018-09-07

    Type : Chemical

    Substance Number : 408

    Status : Valid

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