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    Company profile for Apotex Pharmachem

    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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    EVENTS

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    About

    Apotex Pharmachem is a global fully integrated API R&D and manufacturing organization with its headquarters located in Brantford, Ontario, Canada and is a member of the Apotex group of companies. Currently employing more than 1600 highly-skilled and motivated professionals globally, Apotex Pharmachem has multiple facilities around the world located in Canada, India, Mexico, and China.

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    Apotex PharmachemCanada Flag
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    Canada
    Address
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    11, 34, 50 Spalding Drive, Brantford, Ontario, Canada N3T 6B8
    Telephone
    Telephone
    +1-519-756-8942
    Client Email
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    enquiries@pharmacompass.com
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    https://www.apotex.com/
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    NEWS #PharmaBuzz

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    Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Inj, USP
    Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Inj, USP

    02 Feb 2021

    // PRNEWSWIRE

    https://www.prnewswire.com/news-releases/apotex-corp-issues-voluntary-nationwide-recall-of-enoxaparin-sodium-injection-usp-due-to-mislabeling-of-syringe-barrel-measurement-markings-301220724.html

    PRNEWSWIRE
    02 Feb 2021
    Share Share
    Biohaven's treatment for Lou Gehrig's disease fails to win FDA nod
    Biohaven's treatment for Lou Gehrig's disease fails to win FDA nod

    20 Jul 2019

    // REUTERS

    https://in.reuters.com/article/us-biohaven-pharma-fda/biohavens-treatment-for-lou-gehrigs-disease-fails-to-win-fda-nod-idINKCN1UE2PQ

    REUTERS
    20 Jul 2019
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    A biosimilar company uses a citizen’s petition in a new way to seek approval
    A biosimilar company uses a citizen’s petition in a new way to seek approval

    12 May 2017

    // Ed Silverman STATNEWS

    https://www.statnews.com/pharmalot/2017/05/11/biosimilar-fda-citizen-petition-apotex/

    Ed Silverman STATNEWS
    12 May 2017
    Share Share
    Fed. Circ. Upholds PTAB's Ax Of Novartis MS Drug Patent
    Fed. Circ. Upholds PTAB's Ax Of Novartis MS Drug Patent

    13 Apr 2017

    // Ryan Davis LAW

    https://www.law360.com/lifesciences/articles/912714

    Ryan Davis LAW
    13 Apr 2017
    Share Share
    (Omeprazole): Dexcel v. Apotex
    (Omeprazole): Dexcel v. Apotex

    07 Apr 2017

    // PATENT LITIGATION

    https://www.pharmacompass.com/pdf/news/omeprazole-dexcel-v-apotex-1494841587.pdf

    PATENT LITIGATION
    07 Apr 2017
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    ALL APIs

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

    01

    Cabergoline

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

    PCC
    Not Confirmed
    arrow

    Cabergoline

    Canada

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

    arrow
    PCC
    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22620

    Submission : 2009-03-13

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-047 - Rev 03

    Issue Date : 2024-06-26

    Type : Chemical

    Substance Number : 1773

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-25

    Valid Till : 2026-07-25

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
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    Market
    Place

    02

    Mycophenolate Mofetil

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

    PCC
    Not Confirmed
    arrow

    Mycophenolate Mofetil

    Canada

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

    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21227

    Submission : 2008-01-11

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-302 - Rev 01

    Issue Date : 2018-11-20

    Type : Chemical

    Substance Number : 1700

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-25

    Valid Till : 2026-07-25

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Rizatriptan Benzoate

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

    PCC
    Not Confirmed
    arrow

    Rizatriptan Benzoate

    Canada

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

    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24061

    Submission : 2010-08-12

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-206 - Rev 01

    Issue Date : 2025-09-12

    Type : Chemical

    Substance Number : 2585

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-25

    Valid Till : 2026-07-25

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
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    #PipelineProspector

    Market
    Place

    04

    Perindopril Arginine

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

    PCC
    Not Confirmed
    arrow

    Perindopril Arginine

    Canada

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

    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-11-18

    Pay. Date : 2016-08-24

    DMF Number : 30810

    Submission : 2016-08-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-25

    Valid Till : 2026-07-25

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Perindopril Erbumine

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

    PCC
    Not Confirmed
    arrow

    Perindopril Erbumine

    Canada

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

    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21393

    Submission : 2008-03-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-196 - Rev 02

    Issue Date : 2024-12-23

    Type : Chemical

    Substance Number : 2019

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Market
    Place

    06

    Pravastatin

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

    PCC
    Not Confirmed
    arrow

    Pravastatin

    Canada

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

    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17023

    Submission : 2003-12-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-101 - Rev 04

    Issue Date : 2019-11-05

    Type : Chemical

    Substance Number : 2059

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Product
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    Market
    Place

    07

    Anastrozole

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

    BPI Europe
    Not Confirmed
    arrow

    Anastrozole

    Canada

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

    arrow
    BPI Europe
    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 : 23326

    Submission : 2009-12-01

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2014-296 - Rev 00

    Issue Date : 2016-01-15

    Type : Chemical

    Substance Number : 2406

    Status : Expired

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    08

    Mycophenolate Mofetil

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

    PCC
    Not Confirmed
    arrow

    Mycophenolate Mofetil

    Canada

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

    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25746

    Submission : 2012-01-31

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-263 - Rev 00

    Issue Date : 2019-02-07

    Type : Chemical

    Substance Number : 1700

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    09

    Pramipexole Dihydrochloride

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

    PCC
    Not Confirmed
    arrow

    Pramipexole Dihydrochloride

    Canada

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

    arrow
    PCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21095

    Submission : 2007-11-30

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-112 - Rev 00

    Issue Date : 2018-02-07

    Type : Chemical

    Substance Number : 2416

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Product
    Web Link

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    Market
    Place

    10

    Raloxifene Hydrochloride

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

    PCC
    Not Confirmed
    arrow

    Raloxifene Hydrochloride

    Canada

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

    arrow
    PCC
    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24589

    Submission : 2011-02-01

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-097 - Rev 01

    Issue Date : 2024-08-22

    Type : Chemical

    Substance Number : 2375

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Product
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    Only 10 entries up to this point, click to access all click full view read-more
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    USDMF

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    01

    Adefovir Dipivoxil

    Canada
    Bioprocess International Europe
    Not Confirmed
    arrow

    Adefovir Dipivoxil

    Canada
    arrow
    Bioprocess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Apotex Pharmachem

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-08-26

    Pay. Date : 2012-12-06

    DMF Number : 26630

    Submission : 2012-12-07

    Status : Active

    Type : II

    blank

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    Market
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    02

    Alfuzosin Hydrochloride Usp

    Canada
    Bioprocess International Europe
    Not Confirmed
    arrow

    03

    Almotriptan Malate

    Canada
    Bioprocess International Europe
    Not Confirmed
    arrow

    04

    Alprazolam Usp

    Canada
    Bioprocess International Europe
    Not Confirmed
    arrow

    05

    Anastrozole Usp

    Canada
    Bioprocess International Europe
    Not Confirmed
    arrow

    06

    Apixaban

    Canada
    Bioprocess International Europe
    Not Confirmed
    arrow

    07

    Aripiprazole Usp

    Canada
    Bioprocess International Europe
    Not Confirmed
    arrow

    08

    Atomoxetine Hydrochloride Usp

    Canada
    Bioprocess International Europe
    Not Confirmed
    arrow

    09

    Atorvastatin Calcium Granulation

    Canada
    Bioprocess International Europe
    Not Confirmed
    arrow

    10

    Bicalutamide Usp

    Canada
    Bioprocess International Europe
    Not Confirmed
    arrow
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    ABOUT THIS PAGE

    Contact Apotex Pharmachem India Pvt. Ltd. and get a quotation

    Apotex Pharmachem India Pvt. Ltd. is a supplier offers 139 products (APIs, Excipients or Intermediates).

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