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    European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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

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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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    Guizhou Utide Biotechnology Co., Ltd. - Specialized GMP manufacturing for next-generation GLP-1 peptide APIs.

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    01

    Bortezomib

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

    PCHi
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    Bortezomib

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-22

    Pay. Date : 2013-09-20

    DMF Number : 22922

    Submission : 2009-06-30

    Status : Active

    Type : II

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    Registration Number : 231MF10057

    Registrant's Address : 49 Napoleon Ct. , Somerset, NJ 08873, USA

    Initial Date of Registration : 2019-02-25

    Latest Date of Registration :

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    NDC Package Code : 42973-140

    Start Marketing Date : 2009-11-15

    End Marketing Date : 2026-12-31

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

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    02

    Busulfan

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

    PCHi
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    Busulfan

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-06-10

    Pay. Date : 2015-05-27

    DMF Number : 23924

    Submission : 2010-08-05

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2016-270 - Rev 00

    Issue Date : 2023-05-17

    Type : Chemical

    Substance Number : 542

    Status : Valid

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    NDC Package Code : 42973-392

    Start Marketing Date : 2024-11-22

    End Marketing Date : 2026-12-31

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    03

    Cevimeline Hydrochloride

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

    PCHi
    Not Confirmed
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    Cevimeline Hydrochloride

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-09-12

    Pay. Date : 2024-08-24

    DMF Number : 40223

    Submission : 2024-07-23

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

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    NDC Package Code : 42973-228

    Start Marketing Date : 2017-08-01

    End Marketing Date : 2026-12-31

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    04

    Miglustat

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

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    Miglustat

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41867

    Submission : 2025-06-09

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

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    NDC Package Code : 42973-166

    Start Marketing Date : 2011-12-01

    End Marketing Date : 2026-12-31

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    05

    Phentolamine Mesylate

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

    PCHi
    Not Confirmed
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    Phentolamine Mesylate

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39948

    Submission : 2024-06-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

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    NDC Package Code : 42973-423

    Start Marketing Date : 2025-03-14

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

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    06

    Plerixafor

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

    PCHi
    Not Confirmed
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    Plerixafor

    India

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

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    PCHi
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40546

    Submission : 2024-10-04

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

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    NDC Package Code : 42973-202

    Start Marketing Date : 2017-12-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    Trabectedin

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

    PCHi
    Not Confirmed
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    Trabectedin

    India

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

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    PCHi
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-07-13

    Pay. Date : 2021-06-07

    DMF Number : 35828

    Submission : 2021-04-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

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    08

    Voriconazole

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

    PCHi
    Not Confirmed
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    Voriconazole

    India

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

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    PCHi
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35114

    Submission : 2020-09-04

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2022-362 - Rev 00

    Issue Date : 2024-08-02

    Type : Chemical

    Substance Number : 2576

    Status : Valid

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    NDC Package Code : 73223-005

    Start Marketing Date : 2019-08-05

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    Alcaftadine

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

    PCHi
    Not Confirmed
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    Alcaftadine

    India

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

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    PCHi
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32382

    Submission : 2018-01-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
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    NDC Package Code : 42973-204

    Start Marketing Date : 2017-12-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Belzutifan

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

    PCHi
    Not Confirmed
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    Belzutifan

    India

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

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    PCHi
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-07-01

    Pay. Date : 2025-05-27

    DMF Number : 41515

    Submission : 2025-05-06

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
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    NDC Package Code : 42973-376

    Start Marketing Date : 2025-08-06

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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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.