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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
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    11, 34, 50 Spalding Drive, Brantford, Ontario, Canada N3T 6B8
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    Telephone
    +1-519-756-8942
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    enquiries@pharmacompass.com
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    https://www.apotex.com/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

    Impressions: 4916

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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

    Radio Compass
    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities.  North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent.  Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.  
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    Impressions: 4560

    https://www.pharmacompass.com/radio-compass-blog/bms-j-j-bayer-lead-25-000-pharma-layoffs-in-2024-amylyx-fibrogen-kronos-bio-hit-by-trial-failures-cash-crunch

    #PharmaFlow by PHARMACOMPASS
    16 Jan 2025
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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
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    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
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    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
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    (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

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    01

    Perindopril Erbumine

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Perindopril Erbumine

    Canada

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

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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    • EDQM
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    USDMF arrow-down Click Us! 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-WCInactive-api
    ✖

    Date of Issue : 2014-03-06

    Valid Till : 2016-07-02

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    Product
    Web Link

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    #PipelineProspector

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    02

    Cabergoline

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Cabergoline

    Canada

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

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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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-WCInactive-api
    ✖

    Date of Issue : 2014-03-06

    Valid Till : 2016-07-02

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    Product
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    Place

    03

    Mycophenolate Mofetil

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Mycophenolate Mofetil

    Canada

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

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    Pharma, Lab & Chemical Expo
    Not Confirmed
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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-WCInactive-api
    ✖

    Date of Issue : 2014-03-06

    Valid Till : 2016-07-02

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    blank

    Product
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    Market
    Place

    04

    Pramipexole Dihydrochloride

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Pramipexole Dihydrochloride

    Canada

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

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    Pharma, Lab & Chemical Expo
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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-WCInactive-api
    ✖

    Date of Issue : 2014-03-06

    Valid Till : 2016-07-02

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    Product
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    05

    Pravastatin

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Pravastatin

    Canada

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

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    Pharma, Lab & Chemical Expo
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    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
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    06

    Raloxifene Hydrochloride

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Raloxifene Hydrochloride

    Canada

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

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    Pharma, Lab & Chemical Expo
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    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-WCInactive-api
    ✖

    Date of Issue : 2014-03-06

    Valid Till : 2016-07-02

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    Market
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    07

    Rizatriptan Benzoate

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Rizatriptan Benzoate

    Canada

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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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 : R1-CEP 2013-206 - Rev 00

    Issue Date : 2020-11-30

    Type : Chemical

    Substance Number : 2585

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2014-03-06

    Valid Till : 2016-07-02

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    08

    Anastrozole

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Anastrozole

    Canada

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

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    Pharma, Lab & Chemical Expo
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    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
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    09

    Dabigatran Etexilate Mesylate

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Dabigatran Etexilate Mesylate

    Canada

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

    arrow
    Pharma, Lab & Chemical Expo
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-25

    Pay. Date : 2014-03-28

    DMF Number : 28029

    Submission : 2014-03-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2014-03-06

    Valid Till : 2016-07-02

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Saehan Pharmaceutical Co., Ltd.

    Registration Date : 2016-09-12

    Registration Number : Su4098-4-ND

    Manufacturer Name : Apotex Pharmachem India Pvt. Ltd.

    Manufacturer Address : Plot No. 1A, Bommasandra Industrial Area, 4th Phase, Bommasandra Industrial Estate (Post office) Bangalore, 560 099, India

     VMF Others AUDIT
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    10

    Gatifloxacin

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Gatifloxacin

    Canada

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20685

    Submission : 2007-07-13

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2014-03-06

    Valid Till : 2016-07-02

    Written Confirmation Number : WC-0128

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    USDMF

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    01

    Adefovir Dipivoxil

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Adefovir Dipivoxil

    Canada
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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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

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    Market
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    02

    Alfuzosin Hydrochloride Usp

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    03

    Almotriptan Malate

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    04

    Alprazolam Usp

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    05

    Anastrozole Usp

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    06

    Apixaban

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    07

    Aripiprazole Usp

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    08

    Atomoxetine Hydrochloride Usp

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    09

    Atorvastatin Calcium Granulation

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    10

    Bicalutamide Usp

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow
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    CEP/COS

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    01

    Anastrozole

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    02

    Cabergoline

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    03

    Letrozole

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    04

    Mycophenolate mofetil

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    05

    Mycophenolate mofetil, MYM

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    06

    Olmesartan medoxomil

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    07

    Perindopril tert-butylamine

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    08

    Perindopril tert-butylamine, PER55LP

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    09

    Pramipexole dihydrochloride monohydrate

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    10

    Pravastatin sodium

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow
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    NDC API

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    01

    OLANZAPINE

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    OLANZAPINE

    Canada
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Apotex Pharmachem

    NDC Package Code : 49867-0073

    Start Marketing Date : 2022-07-28

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    02

    OLANZAPINE

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    OLANZAPINE

    Canada
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Apotex Pharmachem

    NDC Package Code : 49867-0056

    Start Marketing Date : 2010-11-24

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    LISTED APIs

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    Aciclovir

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    Market
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    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 locate...
    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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    01

    Aciclovir

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Aciclovir

    Canada
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Apotex Pharmachem

    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.

    About the Company : 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...

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    Allopurinol

    Product
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    Market
    Place

    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 locate...
    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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    02

    Allopurinol

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Allopurinol

    Canada
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Apotex Pharmachem

    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.

    About the Company : 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...

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    Atorvastatin Calcium

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    Market
    Place

    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 locate...
    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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    03

    Atorvastatin Calcium

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Atorvastatin Calcium

    Canada
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    • WHO-GMP
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    Apotex Pharmachem

    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.

    About the Company : 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...

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    Balsalazide

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    Market
    Place

    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 locate...
    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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    04

    Balsalazide

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Balsalazide

    Canada
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Apotex Pharmachem

    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.

    About the Company : 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...

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    Brexpiprazole

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    Market
    Place

    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 locate...
    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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    05

    Brexpiprazole

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Brexpiprazole

    Canada
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Apotex Pharmachem

    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.

    About the Company : 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...

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    Cabergoline

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    Market
    Place

    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 locate...
    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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    06

    Cabergoline

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Cabergoline

    Canada
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Apotex Pharmachem

    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.

    About the Company : 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...

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    Clopidogrel Bisulfate

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    Market
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    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 locate...
    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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    07

    Clopidogrel Bisulfate

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Clopidogrel Bisulfate

    Canada
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Apotex Pharmachem

    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.

    About the Company : 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...

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    Dabigatran Etexilate Mesylate

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    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 locate...
    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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    Dabigatran Etexilate Mesylate

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Dabigatran Etexilate Mesylate

    Canada
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    Pharma, Lab & Chemical Expo
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    Apotex Pharmachem

    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.

    About the Company : 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...

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    Dasatinib

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    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 locate...
    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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    Dasatinib

    Canada
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Dasatinib

    Canada
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    Apotex Pharmachem

    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.

    About the Company : 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...

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    Desvenlafaxine

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    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 locate...
    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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    Desvenlafaxine

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    Desvenlafaxine

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    Apotex Pharmachem

    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.

    About the Company : 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...

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    Excipients

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    Inspections and registrations

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    FDA

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-12-01

    Apotex Pharmachem

    City : Bangalore

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-12-01

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    District Decision : No Action Indicated

    Inspection End Date : 2012-02-03

    Apotex Pharmachem

    City : Brantford

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-02-03

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    District Decision : Official Action Indicated

    Inspection End Date : 2014-01-31

    Apotex Pharmachem

    City : Bangalore

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Official Action Indicated

    Inspection End Date : 2014-01-31

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-11-21

    Apotex Pharmachem

    City : Brantford

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-11-21

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    Paid in : 2019

    Apotex Pharmachem

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Apotex Pharmachem Inc.

    Business Address : 34 Spalding Dr. Brantford On...

    FEI Number : 3000114091

    Country : Canada

    Paid in : 2019

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    Apotex Pharmachem

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Apotex Pharmachem India Pvt. L...

    Business Address : Plot No. 1A, Bommasandra Ind...

    FEI Number : 3005466325

    Country : Canada

    Paid in : 2019

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    ABOUT THIS PAGE

    Contact Apotex Pharmachem and get a quotation

    Apotex Pharmachem is a supplier offers 137 products (APIs, Excipients or Intermediates).

    Find a price of Perindopril Erbumine bulk with DMF, CEP offered by Apotex Pharmachem

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    Find a price of Methylcellulose API bulk offered by Apotex Pharmachem

    Find a price of Olopatadine Hydrochloride bulk offered by Apotex Pharmachem

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    Find a price of Rosuvastatin bulk offered by Apotex Pharmachem

    Find a price of Topiramate bulk offered by Apotex Pharmachem

    Find a price of Valbenazine Tosylate bulk offered by Apotex Pharmachem

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