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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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    PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

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    Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.

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    Kaken Pharmaceuticals

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    01 1Butenafine Hydrochloride

    02 1Colistin Sulfate

    03 1Dofetilide

    04 4Efinaconazole

    05 1Pralmorelin

    06 1Salinomycin

    07 1Sofpironium Bromide

    08 1Tolazamide

    09 3Blank

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    01

    Butenafine Hydrochloride

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Butenafine Hydrochloride

    Japan

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11296

    Submission : 1995-01-09

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10389

    Registrant's Address : 2-28-8 Honkomagome, Bunkyo-ku, Tokyo

    Initial Date of Registration : 2005-07-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51265-363

    Start Marketing Date : 1996-12-31

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2023-03-23

    Registration Number : 20230323-211-J-1455

    Manufacturer Name : Kaken Pharmaceutical Co., Ltd. Shizuoka Factory

    Manufacturer Address : 301-banchi, Gensuke, Fujieda-City, Shizuoka 426-8646, Japan

     VMF Others AUDIT
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    02

    Dofetilide

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Dofetilide

    Japan

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30794

    Submission : 2018-05-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    Efinaconazole

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Efinaconazole

    Japan

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21870

    Submission : 2008-07-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    Efinaconazole

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Efinaconazole

    Japan

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27081

    Submission : 2013-05-24

    Status : Active

    Type : II

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

    Efinaconazole

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Efinaconazole

    Japan

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37590

    Submission : 2022-12-02

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    Sofpironium Bromide

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Sofpironium Bromide

    Japan

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31310

    Submission : 2017-09-22

    Status : Active

    Type : II

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

    Tolazamide

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Tolazamide

    Japan

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10390

    Registrant's Address : 2-28-8 Honkomagome, Bunkyo-ku, Tokyo

    Initial Date of Registration : 2005-07-27

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    08

    Medium / medium additive · bFGF So...

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Medium / medium additive · bFGF So...

    Japan

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF40013

    Registrant's Address : 2-28-8 Honkomagome, Bunkyo-ku, Tokyo

    Initial Date of Registration : 2016-05-26

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    09

    Colistin Sulfate

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Colistin Sulfate

    Japan

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2004-106 - Rev 00

    Issue Date : 2006-03-20

    Type : Chemical

    Substance Number : 320

    Status : Expired

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Efinaconazole

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Efinaconazole

    Japan

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20533

    Submission : 2007-05-01

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Contact Kaken Pharmaceuticals and get a quotation

    Kaken Pharmaceuticals is a supplier offers 12 products (APIs, Excipients or Intermediates).

    Find Butenafine Hydrochloride bulk with DMF, JDMF offered by Kaken Pharmaceuticals

    Find Dofetilide bulk with DMF offered by Kaken Pharmaceuticals

    Find Efinaconazole bulk with DMF offered by Kaken Pharmaceuticals

    Find Sofpironium Bromide bulk with DMF offered by Kaken Pharmaceuticals

    Find Tolazamide bulk with JDMF offered by Kaken Pharmaceuticals

    Find Medium / medium additive · bFGF Solution, MF bulk with JDMF offered by Kaken Pharmaceuticals

    Find Colistin Sulfate bulk offered by Kaken Pharmaceuticals

    Find Efinaconazole bulk offered by Kaken Pharmaceuticals

    Find Pralmorelin bulk offered by Kaken Pharmaceuticals

    Find KP-413 DRUG SUBMSTANCE bulk offered by Kaken Pharmaceuticals

    Find MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SHIZUOKA PREFECTURE, JAPAN. bulk offered by Kaken Pharmaceuticals

    Find Salinomycin bulk offered by Kaken Pharmaceuticals

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.