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    Company profile for Seratec SAS

    Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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    Global Pharma Healthcare: Setting the global benchmark in quality, innovation, and care

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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    pharmacompass-2-m-2025-11-03

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    EVENTS

    ACTIVE PHARMA INGREDIENTS

    INSPECTIONS & REGISTRATIONS

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    About

    Seratec registers DMFs of innovative or generic APIs to the US-FDA or EMEA on behalf of pharmaceutical laboratories, mainly US based.Seratec can handle highly potent APIs in accordance with cGMP (regularly inspected by the US-FDA) from the gr to the ton, from complex, even multi-steps, organic synthesis, essentially within the context of niche markets.Successfully, Seratec was appointed as the main orphans manufacturer for the...
    Seratec registers DMFs of innovative or generic APIs to the US-FDA or EMEA on behalf of pharmaceutical laboratories, mainly US based.Seratec can handle highly potent APIs in accordance with cGMP (regularly inspected by the US-FDA) from the gr to the ton, from complex, even multi-steps, organic synthesis, essentially within the context of niche markets.Successfully, Seratec was appointed as the main orphans manufacturer for the biggest hospital organization in Europe.

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    CONTACT DETAILS

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    Seratec SASFrance Flag
    Country
    Country
    France
    Address
    Address
    2 Rue Du Thymerais, F-28190
    Telephone
    Telephone
    +33 237 231 968
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://serateclab.com/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

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    Meeting

    ALL APIs

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    01

    Carbachol

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

    BIO Partnering at JPM
    Not Confirmed
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    Carbachol

    France

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

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    BIO Partnering at JPM
    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 : 34783

    Submission : 2020-05-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-226 - Rev 00

    Issue Date : 2022-02-11

    Type : Chemical

    Substance Number : 1971

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Bethanechol

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

    BIO Partnering at JPM
    Not Confirmed
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    Bethanechol

    France

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

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    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15866

    Submission : 2002-02-18

    Status : Active

    Type : II

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

    Carbachol

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Carbachol

    France

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35574

    Submission : 2021-01-29

    Status : Active

    Type : II

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

    Dithranol

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Dithranol

    France

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

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    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-290 - Rev 00

    Issue Date : 2024-02-08

    Type : Chemical

    Substance Number : 1007

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Fomepizole

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Fomepizole

    France

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

    arrow
    BIO Partnering at JPM
    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.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20305

    Submission : 2007-02-26

    Status : Active

    Type : II

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

    Methyldopate Hydrochloride

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Methyldopate Hydrochloride

    France

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

    arrow
    BIO Partnering at JPM
    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.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24152

    Submission : 2010-08-01

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Inspections and registrations

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    ABOUT THIS PAGE

    Contact Seratec SAS and get a quotation

    Seratec SAS is a supplier offers 6 products (APIs, Excipients or Intermediates).

    Find a price of Carbachol bulk with DMF, CEP offered by Seratec SAS

    Find a price of Bethanechol bulk with DMF offered by Seratec SAS

    Find a price of Carbachol bulk with DMF offered by Seratec SAS

    Find a price of Dithranol bulk with CEP offered by Seratec SAS

    Find a price of Fomepizole bulk with DMF offered by Seratec SAS

    Find a price of Methyldopate Hydrochloride bulk with DMF offered by Seratec SAS

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