menu
    • menu

    Company profile for Apotex Inc

    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Virtual Booth

    Contact Supplier

    Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2024-10-07

    Virtual Booth

    Contact Supplier

    With Fermion, start the journey of your innovative API.

    Virtual Booth

    Contact Supplier

    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2024-10-07

    Virtual Booth

    Contact Supplier

    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

    Update your Virtual Booth on PharmaCompass, ask us

    About

    Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 6,500 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies with 5,000 employees now occupy over 3 million square feet in Montreal, Richmond Hill, Toronto, Etobi...
    Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 6,500 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies with 5,000 employees now occupy over 3 million square feet in Montreal, Richmond Hill, Toronto, Etobicoke, Mississauga, Brantford, Windsor, Winnipeg, London, Calgary and Vancouver.

    List your booth number for exhibitions, ask us

    CONTACT DETAILS

    Click the arrow to open the dropdown
    Contact SupplierContact
    Google MapGoogle Map
    Full View ScreenFull View Screen
    Apotex IncCanada Flag
    Country
    Country
    Canada
    Address
    Address
    150 Signet Drive, Toronto, Ontario, M9L 1T9
    Telephone
    Telephone
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.apotex.com/global
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

    Upload your Marketing & Sales content on your company Virtual Booth, click HERE.

    Events

    Webinars & Exhibitions

    Request a meetingRequest a meeting
    Full Screen ViewFull Screen View
    Default Event

    DCAT Week

    Not Confirmed

    envelop Contact Supplier

    DCAT Week

    Post an Enquiry

    Meeting

    Digital content

    Create Content with PharmaCompass, ask us

    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: 303

    subscribeSubscribe

    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
    Share info Share

    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 11518

    https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

    #PharmaFlow by PHARMACOMPASS
    21 Nov 2024
    Share Share

    NEWS #PharmaBuzz

    read-more
    read-more
    Apotex`s Generics Rivaroxaban HCl Receives Approval in US
    Apotex`s Generics Rivaroxaban HCl Receives Approval in US

    07 Nov 2024

    // FDA

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

    FDA
    07 Nov 2024
    Share Share
    Apotex, Heritage fork over $49M to resolve price-fixing claims
    Apotex, Heritage fork over $49M to resolve price-fixing claims

    01 Nov 2024

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/after-prior-settlements-apotex-and-heritage-hand-over-combined-49m-resolve-longstanding

    FIERCE PHARMA
    01 Nov 2024
    Share Share
    Apopharma`s Generics Rivaroxaban Receives Tentative Approval in US
    Apopharma`s Generics Rivaroxaban Receives Tentative Approval in US

    15 Oct 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217810

    FDA
    15 Oct 2024
    Share Share
    Apotex Launches First Generic Dasatinib Tablets in the United States
    Apotex Launches First Generic Dasatinib Tablets in the United States

    04 Sep 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/apotex-corp-is-the-first-generic-manufacturer-to-launch-dasatinib-tablets-in-the-united-states-302237991.html

    PR NEWSWIRE
    04 Sep 2024
    Share Share
    Formosa Pharma Licenses Clobetasol Eye Drug To Apotex
    Formosa Pharma Licenses Clobetasol Eye Drug To Apotex

    05 Aug 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/formosa-pharmaceuticals-announces-licensing-agreement-with-apotex-inc-for-commercialization-of-clobetasol-propionate-ophthalmic-suspension-for-ocular-surgery-relief-and-recovery-302213856.html

    PR NEWSWIRE
    05 Aug 2024
    Share Share
    Apotex's Generic Bromfenac Sodium Receives Approval in US
    Apotex's Generic Bromfenac Sodium Receives Approval in US

    08 Jul 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207334

    FDA
    08 Jul 2024
    Share Share

    Excipients

    Click here to find the perfect excipient manufacturers by their capabilities

    Inspections and registrations

    Upload your audits for free, ask us

    FDA

    read-more
    read-more

    01

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-07-29

    Apotex Inc

    City : Toronto

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date : 2009-07-29

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    02

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Official Action Indicated

    Inspection End Date : 2009-08-14

    Apotex Inc

    City : Toronto

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Official Action Indicated

    Inspection End Date : 2009-08-14

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    03

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-04-17

    Apotex Inc

    City : Bangalore

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-04-17

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    04

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-08-17

    Apotex Inc

    City : Richmond Hill

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-08-17

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    05

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-02-11

    Apotex Inc

    City : Toronto

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-02-11

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    06

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-06-22

    Apotex Inc

    City : Bangalore

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-06-22

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    07

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Official Action Indicated

    Inspection End Date : 2012-08-24

    Apotex Inc

    City : Toronto

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Official Action Indicated

    Inspection End Date : 2012-08-24

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    08

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Official Action Indicated

    Inspection End Date : 2012-10-26

    Apotex Inc

    City : Richmond Hill

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Official Action Indicated

    Inspection End Date : 2012-10-26

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    09

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-03-12

    Apotex Fermentation Inc.

    City : Winnipeg

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-03-12

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    10

    FDA Audited

    USA
    Antibody Engineering
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-06-07

    Apotex Fermentation Inc.

    City : Winnipeg

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-06-07

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Only 10 entries up to this point, click to access all click full view read-more
    click full view
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    ABOUT THIS PAGE

    Contact Apotex Research Private Limited and get a quotation

    Apotex Research Private Limited is a supplier offers 5 products (APIs, Excipients or Intermediates).

    Find a price of Alendronate Sodium bulk with DMF offered by Apotex Research Private Limited

    Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ONTARIO, CANADA. bulk offered by Apotex Research Private Limited

    Find a price of FACILITIES, PERSONNEL AND CONTROLS IN WESTON, ONTARIO bulk offered by Apotex Research Private Limited

    Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. bulk offered by Apotex Research Private Limited

    Find a price of Pirfenidone bulk offered by Apotex Research Private Limited

    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search