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    Company profile for Sandoz B2B

    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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    Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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    About

    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.

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    CONTACT DETAILS

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    Sandoz B2BSwitzerland Flag
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    Switzerland
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    Forum 1, Novartis Campus, CH-4056 Basel
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    +41 613241111
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    enquiries@pharmacompass.com
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    https://www.sandoz.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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    Sandoz Resolves US Generic Drug Antitrust Litigation
    Sandoz Resolves US Generic Drug Antitrust Litigation

    17 Dec 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/12/17/2997976/0/en/Sandoz-takes-further-steps-to-resolve-legacy-US-Generic-Drug-Antitrust-Class-Action-Litigation.html

    GLOBENEWSWIRE
    17 Dec 2024
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    FDA updates label of 33-year-old cancer drug with dose & warning
    FDA updates label of 33-year-old cancer drug with dose & warning

    21 Nov 2024

    // ENDPTS

    https://endpts.com/fda-updates-label-of-33-year-old-cancer-drug-with-new-dose-and-warning/

    ENDPTS
    21 Nov 2024
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    FDA Updates Label Of 33-Year-Old Cancer Drug With Warning
    FDA Updates Label Of 33-Year-Old Cancer Drug With Warning

    20 Nov 2024

    // ENDPTS

    https://endpts.com/fda-updates-label-of-33-year-old-cancer-drug-with-new-dose-and-warning/

    ENDPTS
    20 Nov 2024
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    Agomab Announces Appointment of Former Sandoz CFO
    Agomab Announces Appointment of Former Sandoz CFO

    18 Nov 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20241118736621/en

    BUSINESSWIRE
    18 Nov 2024
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    EC grants approval to Sandoz’s biosimilar to treat retinal diseases
    EC grants approval to Sandoz’s biosimilar to treat retinal diseases

    16 Nov 2024

    // FINANCIALXPRESS

    https://www.financialexpress.com/business/healthcare-european-commission-grants-approval-to-sandozs-biosimilar-to-treat-retinal-diseases-3666104/

    FINANCIALXPRESS
    16 Nov 2024
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    Sandoz Receives EC Approval for Afqlir® Biosimilar
    Sandoz Receives EC Approval for Afqlir® Biosimilar

    15 Nov 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/11/15/2981760/0/en/Sandoz-receives-European-Commission-approval-for-Afqlir-aflibercept-further-strengthening-leading-biosimilar-portfolio.html

    GLOBENEWSWIRE
    15 Nov 2024
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    ALL APIs

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    01

    Amoxicillin Trihydrate

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

    PharmaVenue
    Not Confirmed
    arrow

    Amoxicillin Trihydrate

    Switzerland

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

    arrow
    PharmaVenue
    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 Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-08-13

    Pay. Date : 2019-08-09

    DMF Number : 13764

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R2-CEP 1995-034 - Rev 06

    Issue Date : 2015-11-12

    Type : Chemical

    Substance Number : 260

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10115

    Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria

    Initial Date of Registration : 2024-08-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55984-0218

    Start Marketing Date : 2022-04-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2024-08-23

    Registration Number : 20240823-30-A-380-25

    Manufacturer Name : Sandoz GmbH

    Manufacturer Address : Biochemiestrasse 10, 6250 Kundl, Tyrol, Austria

     VMF Others AUDIT
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    #PipelineProspector

    Market
    Place

    02

    Ampicillin Sodium

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

    PharmaVenue
    Not Confirmed
    arrow

    Ampicillin Sodium

    Switzerland

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

    arrow
    PharmaVenue
    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 : Reviewed

    Rev. Date : 2023-04-20

    Pay. Date : 2023-04-17

    DMF Number : 13754

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1993-005 - Rev 08

    Issue Date : 2024-02-20

    Type : Chemical

    Substance Number : 578

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10454

    Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria

    Initial Date of Registration : 2005-08-24

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2021-11-05

    Registration Number : 20200603-210-J-404(1)

    Manufacturer Name : Sandoz GmbH@Sandoz Industrial Products S.A.

    Manufacturer Address : Biochemiestraβe 10 6250 Kundl Austria@Ctra. Granollers - Cardedeu C-251, km 4 08520 LES FRANQUESES DEL VALLES BARCELONA Spain

     VMF Others AUDIT
    blank

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    #PipelineProspector

    Market
    Place

    03

    Gentamicin Sulfate

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

    PharmaVenue
    Not Confirmed
    arrow

    Gentamicin Sulfate

    Slovenia

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

    arrow
    PharmaVenue
    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 : 13704

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2005-121 - Rev 02

    Issue Date : 2024-10-21

    Type : Chemical

    Substance Number : 331

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10041

    Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia

    Initial Date of Registration : 2008-02-05

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48866-8256

    Start Marketing Date : 2013-07-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
    blank

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    #PipelineProspector

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    04

    Levothyroxine Sodium

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

    PharmaVenue
    Not Confirmed
    arrow

    Levothyroxine Sodium

    Switzerland

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

    arrow
    PharmaVenue
    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 : Reviewed

    Rev. Date : 2013-01-15

    Pay. Date : 2012-12-21

    DMF Number : 4789

    Submission : 1983-01-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1998-141 - Rev 11

    Issue Date : 2023-09-26

    Type : Chemical

    Substance Number : 401

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10456

    Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria

    Initial Date of Registration : 2005-08-24

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 43858-410

    Start Marketing Date : 2010-02-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Penicillin G Potassium

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

    PharmaVenue
    Not Confirmed
    arrow

    Penicillin G Potassium

    Switzerland

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

    arrow
    PharmaVenue
    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 : 13767

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-395 - Rev 03

    Issue Date : 2019-11-20

    Type : Chemical

    Substance Number : 113

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10072

    Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria

    Initial Date of Registration : 2019-03-12

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
    blank

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    Market
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    06

    Amoxicillin Trihydrate

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

    PharmaVenue
    Not Confirmed
    arrow

    Amoxicillin Trihydrate

    Switzerland

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

    arrow
    PharmaVenue
    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 : Reviewed

    Rev. Date : 2023-06-23

    Pay. Date : 2023-05-22

    DMF Number : 38086

    Submission : 2023-06-02

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2007-018 - Rev 02

    Issue Date : 2013-05-28

    Type : Chemical

    Substance Number : 260

    Status : Withdrawn by Holder

     JDMF arrow-down
    ✖

    Registration Number : 217MF10761

    Registrant's Address : Ctra. Granollers-Cardedeu C-251, Km 4, E-08520, Les Franqueses del Valles (Barcelona), Spain

    Initial Date of Registration : 2005-10-20

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55984-0218

    Start Marketing Date : 2022-04-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2024-08-23

    Registration Number : 20240823-30-A-380-25

    Manufacturer Name : Sandoz GmbH

    Manufacturer Address : Biochemiestrasse 10, 6250 Kundl, Tyrol, Austria

     VMF Others AUDIT
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    Market
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    07

    Cefpodoxime Proxetil

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

    PharmaVenue
    Not Confirmed
    arrow

    Cefpodoxime Proxetil

    Switzerland

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

    arrow
    PharmaVenue
    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 : 16542

    Submission : 2003-04-15

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-283 - Rev 01

    Issue Date : 2017-12-05

    Type : Chemical

    Substance Number : 2341

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10129

    Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria

    Initial Date of Registration : 2013-07-09

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : HKINNOEN Co., Ltd.

    Registration Date : 2014-07-25

    Registration Number : 20140611-25-A-300-07(1)

    Manufacturer Name : Sandoz GmbH

    Manufacturer Address : Biochemiestraβe 10, 6250 Kundl, Austria

     VMF Others AUDIT
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    08

    Penicillin G Potassium

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

    PharmaVenue
    Not Confirmed
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    Penicillin G Potassium

    Switzerland

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

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16847

    Submission : 2003-09-18

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1999-017 - Rev 05

    Issue Date : 2023-09-22

    Type : Chemical

    Substance Number : 115

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10169

    Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria

    Initial Date of Registration : 2017-08-28

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    09

    Rosuvastatin Calcium

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

    PharmaVenue
    Not Confirmed
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    Rosuvastatin Calcium

    Slovenia

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

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    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20765

    Submission : 2007-08-09

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2016-321 - Rev 01

    Issue Date : 2019-04-15

    Type : Chemical

    Substance Number : 2631

    Status : Withdrawn by Holder

     JDMF arrow-down
    ✖

    Registration Number : 228MF10155

    Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia

    Initial Date of Registration : 2016-08-08

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Korea Sandoz Co., Ltd.

    Registration Date : 2021-04-06

    Registration Number : 20210406-209-J-687

    Manufacturer Name : Lek Pharmaceuticals dd

    Manufacturer Address : Kolodvorska cesta 27,1234 Menges, Slovenia

     VMF Others AUDIT
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    10

    Vancomycin Hydrochloride

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

    PharmaVenue
    Not Confirmed
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    Vancomycin Hydrochloride

    Slovenia

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

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    PharmaVenue
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13223

    Submission : 1998-04-30

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-179 - Rev 03

    Issue Date : 2019-12-18

    Type : Chemical

    Substance Number : 1058

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10740

    Registrant's Address : Verovskova 57, SI-1526 Ljubljana, Slovenia

    Initial Date of Registration : 2005-10-07

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    3-desacetyl-7-aminocephalosporanic A...

    Switzerland
    PharmaVenue
    Not Confirmed
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    02

    6-apa (6 Aminopenicillanic Acid)

    Switzerland
    PharmaVenue
    Not Confirmed
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    03

    6-methylergolene-8-carboxylic Acid

    Switzerland
    PharmaVenue
    Not Confirmed
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    04

    6-methylergoline-8b-carboxylic Acid

    Switzerland
    PharmaVenue
    Not Confirmed
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    05

    7-act

    Switzerland
    PharmaVenue
    Not Confirmed
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    06

    7-amca

    Switzerland
    PharmaVenue
    Not Confirmed
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    07

    7-amino-cephalosporanic Acid (7-aca)

    Switzerland
    PharmaVenue
    Not Confirmed
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    08

    7-paca (7-amino-3-propenyl-cephalosp...

    Switzerland
    PharmaVenue
    Not Confirmed
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    09

    Amlodipine Besylate

    Slovenia
    PharmaVenue
    Not Confirmed
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    10

    Amlodipine Besylate (process 2)

    Slovenia
    PharmaVenue
    Not Confirmed
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    KDMF

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    01

    Amlodipine besilate

    Slovenia
    PharmaVenue
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    Amlodipine besilate

    Slovenia
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    Lek Pharmaceuticals

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2010-11-30

    Registration Number : 20101130-130-H-45-06

    Manufacturer Name : Novartis Pharmaceutical Manufa...

    Manufacturer Address : Kolodvorska Cesta 27, Menges, 1234, Slovenia

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    02

    Amoxicillin hydrate

    Switzerland
    PharmaVenue
    Not Confirmed
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    Amoxicillin hydrate

    Switzerland
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    PharmaVenue
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    Sandoz B2B

    Registrant Name : Chong Kun Dang Co., Ltd.

    Registration Date : 2014-08-27

    Registration Number : 20050831-30-A-59-01(8)

    Manufacturer Name : Sandoz Industrial Products SA

    Manufacturer Address : Ctra. Granollers a Cardedeu Km4 E-08520 Les Franques del Barcelona,Spain

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    03

    Amoxicillin hydrate

    Switzerland
    PharmaVenue
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    Amoxicillin hydrate

    Switzerland
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    Sandoz B2B

    Registrant Name : Geonil Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-30-A-59-01

    Manufacturer Name : Sandoz Industrial Products SA

    Manufacturer Address : Ctra.Granollers a Cardedeu Km4 E-08520 Les Franques del Barcelona, ​​Spain

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    04

    Amoxicillin hydrate

    Switzerland
    PharmaVenue
    Not Confirmed
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    Amoxicillin hydrate

    Switzerland
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    PharmaVenue
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    Sandoz B2B

    Registrant Name : Boryeong Co., Ltd.

    Registration Date : 2011-12-15

    Registration Number : 20050831-30-A-59-01(6)

    Manufacturer Name : Sandoz Industrial Products SA

    Manufacturer Address : Ctra.Granollers a Cardedeu Km4 E-08520 Les Franques del Barcelona, ​​Spain

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    05

    Amoxicillin hydrate

    Switzerland
    PharmaVenue
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    Amoxicillin hydrate

    Switzerland
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    Sandoz B2B

    Registrant Name : Shin Poong Pharmaceutical Co., Ltd.

    Registration Date : 2011-12-09

    Registration Number : 20050831-30-A-59-01(5)

    Manufacturer Name : Sandoz Industrial Products, S....

    Manufacturer Address : Ctra. Granollers - Cardedeu C-251 Km, 4E-08520 Les Franqueses del Valles (Barcellona)...

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    06

    Amoxicillin hydrate

    Switzerland
    PharmaVenue
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    Amoxicillin hydrate

    Switzerland
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    Sandoz B2B

    Registrant Name : Penmix Co., Ltd.

    Registration Date : 2011-11-11

    Registration Number : 20050831-30-A-59-01(2)

    Manufacturer Name : Sandoz Industrial Products SA

    Manufacturer Address : Ctra.Granollers a Cardedeu Km4 E-08520 Les Franques del Barcelona, ​​Spain

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    07

    Amoxicillin hydrate

    Switzerland
    PharmaVenue
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    Amoxicillin hydrate

    Switzerland
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    PharmaVenue
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    Sandoz B2B

    Registrant Name : Yuhan Corporation

    Registration Date : 2011-11-11

    Registration Number : 20050831-30-A-59-01(1)

    Manufacturer Name : Sandoz Industrial Products SA

    Manufacturer Address : Ctra. Granollers a Cardedeu Km4 E-08520 Les Franques del Barcelona

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    08

    Amoxicillin hydrate

    Switzerland
    PharmaVenue
    Not Confirmed
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    Amoxicillin hydrate

    Switzerland
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    PharmaVenue
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    Sandoz B2B

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2024-08-23

    Registration Number : 20240823-30-A-380-25

    Manufacturer Name : Sandoz GmbH

    Manufacturer Address : Biochemiestrasse 10, 6250 Kundl, Tyrol, Austria

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    09

    Amoxicillin sodium

    Switzerland
    PharmaVenue
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    Amoxicillin sodium

    Switzerland
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    Sandoz B2B

    Registrant Name : Shin Poong Pharmaceutical Co., Ltd.

    Registration Date : 2012-09-04

    Registration Number : 20101116-30-A-240-15(2)

    Manufacturer Name : Sandoz GmbH

    Manufacturer Address : Biochemiestraße 10, A-6250 Kundl, Austria

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    10

    Amoxicillin sodium

    Switzerland
    PharmaVenue
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    Amoxicillin sodium

    Switzerland
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    Sandoz B2B

    Registrant Name : Ilsung Pharmaceutical Co., Ltd.

    Registration Date : 2012-02-03

    Registration Number : 20101116-30-A-240-15(1)

    Manufacturer Name : Sandoz GmbH

    Manufacturer Address : Biochemiestrasse 10, A-6250 Kun, Tyrol, Austria

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    Drugs in Development

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    European Commission Grants Approval to Sandoz’s Biosimilar to Treat Retinal Diseases

    Details:

    Afqlir (aflibercept-biosimilar) is a VEGF receptors inhibitor recombinant fusion protein. It is indication for the treatment of Neovascular (Wet) AMD.


    Lead Product(s): Aflibercept

    Therapeutic Area: Ophthalmology Brand Name: Afqlir

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 15, 2024

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    Sandoz B2B

    Switzerland
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    Sandoz B2B

    Switzerland
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    Lead Product(s) : Aflibercept

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    European Commission Grants Approval to Sandoz’s Biosimilar to Treat Retinal Diseases

    Details : Afqlir (aflibercept-biosimilar) is a VEGF receptors inhibitor recombinant fusion protein. It is indication for the treatment of Neovascular (Wet) AMD.

    Brand Name : Afqlir

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    November 15, 2024

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    Sandoz EC Approval for Afqlir® (aflibercept) Bolsters Biosimilar Portfolio

    Details:

    Afqlir (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration


    Lead Product(s): Aflibercept

    Therapeutic Area: Ophthalmology Brand Name: Afqlir

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 15, 2024

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    02

    Sandoz B2B

    Switzerland
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    Sandoz B2B

    Switzerland
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    Lead Product(s) : Aflibercept

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz EC Approval for Afqlir® (aflibercept) Bolsters Biosimilar Portfolio

    Details : Afqlir (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration

    Brand Name : Afqlir

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    November 15, 2024

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    Sandoz US Launches Generic Paclitaxel in Single-Dose Vial For Oncology Portfolio

    Details:

    Abraxane-Generic (paclitaxel) is a microtubule inhibitor indicated for metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer & metastatic pancreatic adenocarcinoma.


    Lead Product(s): Paclitaxel

    Therapeutic Area: Oncology Brand Name: Abraxane-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 11, 2024

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    Sandoz B2B

    Switzerland
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    Sandoz B2B

    Switzerland
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    Lead Product(s) : Paclitaxel

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz US Launches Generic Paclitaxel in Single-Dose Vial For Oncology Portfolio

    Details : Abraxane-Generic (paclitaxel) is a microtubule inhibitor indicated for metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer & metastatic pancreatic adenocarcinoma.

    Brand Name : Abraxane-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 11, 2024

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    Sandoz Receives FDA Approval for Enzeevu™, Strengthening US Biosimilar Position

    Details:

    Enzeevu (aflibercept), biosimilar of Eylea, is a recombinant fusion protein which inhibits VEGF A. It is approved by FDA for the treatment of Neovascular (Wet) AMD.


    Lead Product(s): Aflibercept

    Therapeutic Area: Ophthalmology Brand Name: Enzeevu

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 12, 2024

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    Sandoz B2B

    Switzerland
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    Switzerland
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    Lead Product(s) : Aflibercept

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz Receives FDA Approval for Enzeevu™, Strengthening US Biosimilar Position

    Details : Enzeevu (aflibercept), biosimilar of Eylea, is a recombinant fusion protein which inhibits VEGF A. It is approved by FDA for the treatment of Neovascular (Wet) AMD.

    Brand Name : Enzeevu

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    August 12, 2024

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    Sandoz Launches Biosimilar Pyzchiva® (ustekinumab) Across Europe for Inflammatory Diseases

    Details:

    Pyzchiva (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: Pyzchiva

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 25, 2024

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    Sandoz B2B

    Switzerland
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    Sandoz B2B

    Switzerland
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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz Launches Biosimilar Pyzchiva® (ustekinumab) Across Europe for Inflammatory Diseases

    Details : Pyzchiva (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.

    Brand Name : Pyzchiva

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 25, 2024

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    FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by Sandoz in US

    Details:

    Pyzchiva (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: Pyzchiva

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Samsung Bioepis

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 01, 2024

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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Recipient : Samsung Bioepis

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by Sandoz in US

    Details : Pyzchiva (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.

    Brand Name : Pyzchiva

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 01, 2024

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    Sandoz Gets EU Approval for Wyost® and Jubbonti® Denosumab Biosimilars

    Details:

    Wyost (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is approved for patients with bone metastases from solid tumors.


    Lead Product(s): Denosumab

    Therapeutic Area: Oncology Brand Name: Wyost

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 22, 2024

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    Lead Product(s) : Denosumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz Gets EU Approval for Wyost® and Jubbonti® Denosumab Biosimilars

    Details : Wyost (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is approved for patients with bone metastases from solid tumors.

    Brand Name : Wyost

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    May 22, 2024

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    Lupin Launches Rymti Biosimilar Etanercept in Canada

    Details:

    Rymti is an etanercept-biosimilar TNF blocker indicated for treating rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis.


    Lead Product(s): Etanercept

    Therapeutic Area: Immunology Brand Name: Rymti

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Lupin Ltd

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 03, 2024

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    Lead Product(s) : Etanercept

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Recipient : Lupin Ltd

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Launches Rymti Biosimilar Etanercept in Canada

    Details : Rymti is an etanercept-biosimilar TNF blocker indicated for treating rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis.

    Brand Name : Rymti

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    May 03, 2024

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    Samsung Bioepis Gains EC Approval For PYZCHIVA™, a Biosimilar to Stelara (Ustekinumab)

    Details:

    Pyzchiva (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: Pyzchiva

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Samsung Bioepis

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 22, 2024

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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Recipient : Samsung Bioepis

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Samsung Bioepis Gains EC Approval For PYZCHIVA™, a Biosimilar to Stelara (Ustekinumab)

    Details : Pyzchiva (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.

    Brand Name : Pyzchiva

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    April 22, 2024

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    Sandoz Receives FDA Approval for First and Only Denosumab Biosimilars

    Details:

    Wyost (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is approved for patients with bone metastases from solid tumors.


    Lead Product(s): Denosumab

    Therapeutic Area: Oncology Brand Name: Wyost

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 05, 2024

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    Lead Product(s) : Denosumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz Receives FDA Approval for First and Only Denosumab Biosimilars

    Details : Wyost (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is approved for patients with bone metastases from solid tumors.

    Brand Name : Wyost

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    March 05, 2024

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    Brand Name : SANDOZ ABIRATERONE

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    Regulatory Info :

    Registration Country : Canada

    ABIRATERONE ACETATE

    Sandoz B2B

    Dosage Form : TABLET

    Dosage Strength : 500MG

    Packaging :

    Brand Name : SANDOZ ABIRATERONE

    Approval Date :

    Application Number : 2521644

    Regulatory Info :

    Registration Country : Canada

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    Regulatory Info :

    Registration Country : Canada

    ABIRATERONE ACETATE

    Sandoz B2B

    Dosage Form : TABLET

    Dosage Strength : 250MG

    Packaging :

    Brand Name : SANDOZ ABIRATERONE

    Approval Date :

    Application Number : 2486393

    Regulatory Info :

    Registration Country : Canada

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    Brand Name : SANDOZ OXYCODONE/ACE...

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    Regulatory Info :

    Registration Country : Canada

    ACETAMINOPHEN

    Sandoz B2B

    Dosage Form : TABLET

    Dosage Strength : 325MG

    Packaging : 100

    Brand Name : SANDOZ OXYCODONE/ACETAMINOPHE...

    Approval Date :

    Application Number : 2307898

    Regulatory Info :

    Registration Country : Canada

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    Regulatory Info :

    Registration Country : Canada

    ACETYLCYSTEINE

    Sandoz B2B

    Dosage Form : SOLUTION

    Dosage Strength : 200MG/ML

    Packaging : 10/30 ML

    Brand Name : ACETYLCYSTEINE SOLUTION

    Approval Date :

    Application Number : 2243098

    Regulatory Info :

    Registration Country : Canada

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    Regulatory Info :

    Registration Country : Canada

    ADALIMUMAB

    Sandoz B2B

    Dosage Form : SOLUTION

    Dosage Strength : 20MG/0.4ML

    Packaging :

    Brand Name : HYRIMOZ

    Approval Date :

    Application Number : 2505258

    Regulatory Info :

    Registration Country : Canada

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    Regulatory Info :

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    ADALIMUMAB

    Sandoz B2B

    Dosage Form : SOLUTION

    Dosage Strength : 40MG/0.8ML

    Packaging :

    Brand Name : HYRIMOZ

    Approval Date :

    Application Number : 2492156

    Regulatory Info :

    Registration Country : Canada

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    Regulatory Info :

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    ADALIMUMAB

    Sandoz B2B

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    Brand Name : HYRIMOZ

    Approval Date :

    Application Number : 2542323

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    ADALIMUMAB

    Sandoz B2B

    Dosage Form : SOLUTION

    Dosage Strength : 40MG/0.4ML

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    Brand Name : HYRIMOZ

    Approval Date :

    Application Number : 2542331

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    Sandoz B2B

    Dosage Form : SOLUTION

    Dosage Strength : 80MG/0.8ML

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    Brand Name : HYRIMOZ

    Approval Date :

    Application Number : 2542358

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    Sandoz B2B

    Dosage Form : SOLUTION

    Dosage Strength : 80MG/0.8ML

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    Brand Name : HYRIMOZ

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    Application Number : 2542366

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