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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Sharp is a leader in commercial packaging, clinical services, and sterile manufacturing.

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    01 1Cefazolin

    02 2Cefazolin Sodium

    03 2Cefixime

    04 1Cefotetan

    05 1Ceftizoxime Sodium

    06 3Cephalosporin

    07 2Famotidine

    08 1Fk-330

    09 1Fk962

    10 1Formoterol Fumarate

    11 1Isavuconazonium Sulfate

    12 1Micafungin

    13 2Mirabegron

    14 2Nilvadipine

    15 1Ramosetron HCl

    16 1Rhizoxin

    17 1Solifenacin Succinate

    18 1Tacrolimus

    19 1Tamoxifen Citrate

    20 2Tamsulosin

    21 1Tiaramide Hydrochloride

    22 1Vancomycin Hydrochloride

    23 1Zotepine

    24 19Blank

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    01

    Tacrolimus

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

    RDD
    Not Confirmed
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    Tacrolimus

    Japan

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

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    RDD
    Not Confirmed
    • fda
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16833

    Submission : 2003-09-12

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF11288

    Registrant's Address : 2-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo

    Initial Date of Registration : 2005-12-22

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Astellas Pharma Korea Co., Ltd.

    Registration Date : 2012-08-07

    Registration Number : 20120807-204-I-74-02

    Manufacturer Name : Astellas Pharma Inc. Toyama Technology Center

    Manufacturer Address : 2-178 Kojin-machi, Toyama city, Toyama 930-0809, Japan

     VMF Others AUDIT
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    02

    Tamsulosin

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

    RDD
    Not Confirmed
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    Tamsulosin

    Japan

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

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11761

    Submission : 1995-12-01

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-253 - Rev 06

    Issue Date : 2026-01-22

    Type : Chemical

    Substance Number : 2131

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12838-2788

    Start Marketing Date : 2010-07-22

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    ✖

    Registrant Name : Astellas Pharma Korea Co., Ltd.

    Registration Date : 2023-07-06

    Registration Number : 20230706-209-J-1474

    Manufacturer Name : Astellas Ireland Co. Limited

    Manufacturer Address : Damastown Road, Damastown Industrial Park, Dublin 15, D15 K851, Ireland

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    03

    Cefixime

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

    RDD
    Not Confirmed
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    Cefixime

    Japan

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

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    RDD
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 9478

    Submission : 1991-12-31

    Status : Inactive

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2001-073 - Rev 00

    Issue Date : 2006-07-13

    Type : TSE

    Substance Number : 1188

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    Famotidine

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

    RDD
    Not Confirmed
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    Famotidine

    Japan

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

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    RDD
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    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7356

    Submission : 1988-02-29

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Micafungin

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

    RDD
    Not Confirmed
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    Micafungin

    Japan

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

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    RDD
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12856

    Submission : 1998-02-11

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Yuhan Corporation

    Registration Date : 2006-05-11

    Registration Number : Su118-1-ND

    Manufacturer Name : Astellas Pharma Inc. Toyama Technology Center

    Manufacturer Address : 2-178 Kojin-machi, Toyama City, Toyama 930-0809, Japan

     VMF Others AUDIT
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    06

    Cefazolin

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

    RDD
    Not Confirmed
    arrow

    Cefazolin

    Japan

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

    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Japan
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10156

    Submission : 1991-10-08

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    Cefazolin Sodium

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

    RDD
    Not Confirmed
    arrow

    Cefazolin Sodium

    Japan

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

    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Japan
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 9480

    Submission : 1991-12-16

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    Cefazolin Sodium

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

    RDD
    Not Confirmed
    arrow

    Cefazolin Sodium

    Japan

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

    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Japan
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13797

    Submission : 1998-09-01

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Cefixime

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

    RDD
    Not Confirmed
    arrow

    Cefixime

    Japan

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

    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Japan
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    Digital Content Digital Content
    USDMF CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 1999-158 - Rev 01

    Issue Date : 2007-04-04

    Type : Chemical

    Substance Number : 1188

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Cefotetan

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

    RDD
    Not Confirmed
    arrow

    Cefotetan

    Japan

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

    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Japan
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5074

    Submission : 1983-09-06

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Market
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    Contact Astellas Pharma and get a quotation

    Astellas Pharma is a supplier offers 44 products (APIs, Excipients or Intermediates).

    Find Tacrolimus bulk with DMF, JDMF offered by Astellas Pharma

    Find Tamsulosin bulk with CEP offered by Astellas Pharma

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    Find Cefazolin bulk offered by Astellas Pharma

    Find Cefazolin Sodium bulk offered by Astellas Pharma

    Find Cefotetan bulk offered by Astellas Pharma

    Find Ceftizoxime Sodium bulk offered by Astellas Pharma

    Find Cephalosporin bulk offered by Astellas Pharma

    Find Famotidine bulk offered by Astellas Pharma

    Find Fk-330 bulk offered by Astellas Pharma

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    Find Formoterol Fumarate bulk offered by Astellas Pharma

    Find Nilvadipine bulk offered by Astellas Pharma

    Find Rhizoxin bulk offered by Astellas Pharma

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