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    Company profile for Apotex Fermentation Inc.

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    EVENTS

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    About

    Apotex Fermentation carries out R&D, process development, scale up and manufacturing of fermentation based active pharmaceutical ingredients (APIs). Our business is based on the science of microbiology and chemistry, supported by our engineering and quality expertise. We specialize in secondary metabolites from fungal and bacterial fermentations. AFI’s scientific and operations staff have experience in transforming early sta...
    Apotex Fermentation carries out R&D, process development, scale up and manufacturing of fermentation based active pharmaceutical ingredients (APIs). Our business is based on the science of microbiology and chemistry, supported by our engineering and quality expertise. We specialize in secondary metabolites from fungal and bacterial fermentations. AFI’s scientific and operations staff have experience in transforming early stage bench scale processes into economically viable commercial scale processes. We produce APIs in small quantities for clinical trials and development work, as well as larger quantities (to 1000s of kgs) for final dosage forms. We operate under GMP complete with protocols, SOPs and production batch records in full compliance with regulatory requirements.

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    CONTACT DETAILS

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    Apotex Fermentation Inc.Canada Flag
    Country
    Country
    Canada
    Address
    Address
    50 Scurfield BoulevardWinnipeg, ManitobaCanada R3Y 1G4
    Telephone
    Telephone
    +1 (204) 989-6830
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.apoferm.com/
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    Linkedin
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    YouTube
    Twitter
    Twitter

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    NEWS #PharmaBuzz

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    Apotex’s Generics Paliperidone Receives Approval in US
    Apotex’s Generics Paliperidone Receives Approval in US

    26 Jan 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203279

    FDA
    26 Jan 2026
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    Apotex’s Generics Linagliptin Receives Tentative Approval in US
    Apotex’s Generics Linagliptin Receives Tentative Approval in US

    08 Dec 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218552

    FDA
    08 Dec 2025
    Share Share
    Apotex’s Generics Rivaroxaban Receives Approval in US
    Apotex’s Generics Rivaroxaban Receives Approval in US

    14 Nov 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208579

    FDA
    14 Nov 2025
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    Apotex Gets Canada Nod for Loqtorzi in Nasopharyngeal Cancer
    Apotex Gets Canada Nod for Loqtorzi in Nasopharyngeal Cancer

    24 Oct 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/apotex-receives-health-canada-approval-for-loqtorzi--the-first-and-only-immuno-therapy-for-recurrent-unresectable-or-metastatic-nasopharyngeal-cancer-302591943.html

    PR NEWSWIRE
    24 Oct 2025
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    Apotex’s Loqtorzi Approved in Canada
    Apotex’s Loqtorzi Approved in Canada

    17 Oct 2025

    // HEALTH CANADA

    https://pdf.hres.ca/dpd_pm/00082094.PDF

    HEALTH CANADA
    17 Oct 2025
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    Apotex’s Generics Cladribine Receives Tentative Approval in US
    Apotex’s Generics Cladribine Receives Tentative Approval in US

    08 Oct 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218425

    FDA
    08 Oct 2025
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    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Everolimus

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

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    Everolimus

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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-30

    Pay. Date : 2016-10-24

    DMF Number : 31073

    Submission : 2016-10-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Sirolimus

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

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    Sirolimus

    Canada

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-07-09

    Pay. Date : 2013-02-26

    DMF Number : 26904

    Submission : 2013-02-27

    Status : Active

    Type : II

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    03

    Tacrolimus

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

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    Tacrolimus

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-07-14

    Pay. Date : 2014-03-13

    DMF Number : 28065

    Submission : 2014-03-17

    Status : Active

    Type : II

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    04

    Cyclosporine

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

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    Cyclosporine

    Canada

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    USDMF CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2015-367 - Rev 00

    Issue Date : 2017-11-27

    Type : Chemical

    Substance Number : 994

    Status : Withdrawn by Holder

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    ABOUT THIS PAGE

    Contact Apotex Fermentation Inc. and get a quotation

    Apotex Fermentation Inc. is a supplier offers 4 products (APIs, Excipients or Intermediates).

    Find Everolimus bulk with DMF offered by Apotex Fermentation Inc.

    Find Sirolimus bulk with DMF offered by Apotex Fermentation Inc.

    Find Tacrolimus bulk with DMF offered by Apotex Fermentation Inc.

    Find Cyclosporine bulk offered by Apotex Fermentation Inc.

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