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    Company profile for Johnson & Johnson Innovative Medicine

    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

    Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including attention deficit hyperactivity disorder (ADHD), general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, a...
    Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including attention deficit hyperactivity disorder (ADHD), general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health.

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    Johnson & Johnson Innovative MedicineUnited_States_of_America Flag
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    U.S.A
    Address
    Address
    1125 Trenton-Harbourton Road, P.O. Box 200, Titusville, NJ 08560
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    +1 8007755514
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    enquiries@pharmacompass.com
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    https://www.janssen.com/us/
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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

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    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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    Treatment with RYBREVANT and Lazertinib Showed Survival in Advanced NSCLC
    Treatment with RYBREVANT and Lazertinib Showed Survival in Advanced NSCLC

    11 Sep 2023

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/treatment-with-rybrevant-amivantamab-vmjw-and-lazertinib-plus-chemotherapy-showed-durable-progression-free-survival-in-patients-with-previously-treated-egfr-mutated-advanced-non-small-cell-lung-cancer-301923248.html

    PR NEWSWIRE
    11 Sep 2023
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    Janssen Submits MAA to the EMA Seeking Approval of Erdafitinib
    Janssen Submits MAA to the EMA Seeking Approval of Erdafitinib

    08 Sep 2023

    // GLOBENEWSWIRE

    https://www.globenewswire.com//news-release/2023/09/08/2739919/0/en/Janssen-Submits-Marketing-Authorisation-Application-to-the-European-Medicines-Agency-Seeking-Approval-of-Erdafitinib-for-the-Treatment-of-Patients-with-Locally-Advanced-or-Metastat.html

    GLOBENEWSWIRE
    08 Sep 2023
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    Janssen Submits sNDA to the USFDA Seeking Full Approval of BALVERSA for MUC
    Janssen Submits sNDA to the USFDA Seeking Full Approval of BALVERSA for MUC

    28 Aug 2023

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/janssen-submits-supplemental-new-drug-application-to-the-us-food-and-drug-administration-seeking-full-approval-of-balversa-erdafitinib-for-the-treatment-of-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-and-301911509.html

    PR NEWSWIRE
    28 Aug 2023
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    Janssen submits sBLA to FDA for NSCLC combination therapy
    Janssen submits sBLA to FDA for NSCLC combination therapy

    28 Aug 2023

    // PHARMACEUTICAL TECHNOLOGY

    https://www.pharmaceutical-technology.com/news/janssen-sbla-fda-nsclc-therapy/

    PHARMACEUTICAL TECHNOLOGY
    28 Aug 2023
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    Janssen Submits sBLA to FDA Seeking Approval of RYBREVANT for NSCLC
    Janssen Submits sBLA to FDA Seeking Approval of RYBREVANT for NSCLC

    25 Aug 2023

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/janssen-submits-supplemental-biologics-license-application-to-the-us-food-and-drug-administration-seeking-approval-of-rybrevant-amivantamab-vmjw-in-combination-with-chemotherapy-for-the-first-line-treatment-of-patients-with-l-301910074.html

    PR NEWSWIRE
    25 Aug 2023
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    J&J's Janssen to close part of its vaccine division
    J&J's Janssen to close part of its vaccine division

    24 Aug 2023

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/jjs-janssen-close-part-its-vaccine-division-2023-08-23/

    REUTERS
    24 Aug 2023
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    ALL APIs

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

    01

    Domperidone

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Domperidone

    U.S.A

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

    arrow
    BIO Partnering at JPM
    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 : 5402

    Submission : 1984-05-17

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1996-069 - Rev 10

    Issue Date : 2019-10-22

    Type : Chemical

    Substance Number : 1009

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10687

    Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium

    Initial Date of Registration : 2006-08-11

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    #PipelineProspector

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    Place

    02

    Levocabastine

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Levocabastine

    U.S.A

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

    arrow
    BIO Partnering at JPM
    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 : 5847

    Submission : 1985-04-19

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-147 - Rev 03

    Issue Date : 2020-12-09

    Type : Chemical

    Substance Number : 1484

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10206

    Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium

    Initial Date of Registration : 2016-11-02

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    #PipelineProspector

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    Place

    03

    Miconazole

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Miconazole

    U.S.A

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

    arrow
    BIO Partnering at JPM
    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 : 10912

    Submission : 1994-05-20

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R2-CEP 1995-007 - Rev 03

    Issue Date : 2014-11-14

    Type : Chemical

    Substance Number : 935

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10165

    Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium

    Initial Date of Registration : 2007-05-21

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    04

    Miconazole Nitrate

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Miconazole Nitrate

    U.S.A

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

    arrow
    BIO Partnering at JPM
    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 : 10913

    Submission : 1994-05-20

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R2-CEP 1995-008 - Rev 04

    Issue Date : 2023-03-01

    Type : Chemical

    Substance Number : 513

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10167

    Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium

    Initial Date of Registration : 2007-05-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12578-488

    Start Marketing Date : 2012-04-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    05

    Haloperidol

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Haloperidol

    U.S.A

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

    arrow
    BIO Partnering at JPM
    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 : 10946

    Submission : 1994-06-13

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-076 - Rev 09

    Issue Date : 2014-06-05

    Type : Chemical

    Substance Number : 616

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12578-617

    Start Marketing Date : 1989-02-08

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Haloperidol Decanoate

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Haloperidol Decanoate

    U.S.A

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

    arrow
    BIO Partnering at JPM
    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 : 10954

    Submission : 1994-06-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-187 - Rev 04

    Issue Date : 2014-06-12

    Type : Chemical

    Substance Number : 1431

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    #PipelineProspector

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    07

    Itraconazole

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Itraconazole

    U.S.A

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

    arrow
    BIO Partnering at JPM
    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 : 10725

    Submission : 1994-02-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-092 - Rev 07

    Issue Date : 2017-02-07

    Type : Chemical

    Substance Number : 1335

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12578-299

    Start Marketing Date : 1996-05-22

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Janssen Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-56-A-103-04

    Manufacturer Name : Janssen Pharmaceutica NV

    Manufacturer Address : Janssen Pharmaceutica NV Janssen Pharmaceuticalaan 3, B-2440 Geel, Belgium

     VMF Others AUDIT
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    Market
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    08

    Ketoconazole

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Ketoconazole

    U.S.A

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10037

    Submission : 1993-01-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R2-CEP 1995-009 - Rev 04

    Issue Date : 2021-03-08

    Type : Chemical

    Substance Number : 921

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Hyons Co., Ltd.

    Registration Date : 2012-08-14

    Registration Number : 20120814-167-I-49-02

    Manufacturer Name : Janssen Pharmaceutica NV

    Manufacturer Address : Janssen Pharmaceuticalaan 3, B-2440 Geel

     VMF Others AUDIT
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    09

    Rilpivirine Hydrochloride

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Rilpivirine Hydrochloride

    U.S.A

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-07

    Pay. Date : 2012-12-26

    DMF Number : 23824

    Submission : 2010-07-19

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 229MF10183

    Registrant's Address : Little Island Industrial Estate, Little Island, Co. Cork, Ireland

    Initial Date of Registration : 2017-10-06

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65267-501

    Start Marketing Date : 2010-07-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Janssen Co., Ltd.

    Registration Date : 2011-10-28

    Registration Number : Su217-14-ND

    Manufacturer Name : Janssen Pharmaceutical Sciences Unlimited Company

    Manufacturer Address : Little Island Industrial EST., Little Island, Co. Cork, Ireland_x000D_

     VMF Others AUDIT
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    10

    Risperidone

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Risperidone

    U.S.A

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11438

    Submission : 1995-04-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-183 - Rev 05

    Issue Date : 2017-01-10

    Type : Chemical

    Substance Number : 1559

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12578-303

    Start Marketing Date : 1999-04-23

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Janssen Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-10-C-81-05

    Manufacturer Name : Janssen Pharmaceutica NV

    Manufacturer Address : Janssen Pharmaceuticalaan 3, B-2440 Geel, Belgium

     VMF Others AUDIT
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    Drugs in Development

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    Protagonist Announces Positive Results for Icotrokinra in Phase 3 Plaque Psoriasis

    Details:

    JNJ-2113 (icotrokinra) is a first and only targeted oral peptide that is designed to selectively block the IL-23R. It is under clinical development for the treatment of moderate-to-severe psoriasis.


    Lead Product(s): Icotrokinra

    Therapeutic Area: Dermatology Brand Name: JNJ-2113

    Study Phase: Phase IIIProduct Type: Peptide

    Sponsor: Protagonist Therapeutics

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 18, 2024

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    01

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Icotrokinra

    Therapeutic Area : Dermatology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Protagonist Therapeutics

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Protagonist Announces Positive Results for Icotrokinra in Phase 3 Plaque Psoriasis

    Details : JNJ-2113 (icotrokinra) is a first and only targeted oral peptide that is designed to selectively block the IL-23R. It is under clinical development for the treatment of moderate-to-severe psoriasis.

    Brand Name : JNJ-2113

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    November 18, 2024

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    CHMP Recommends RYBREVANT® and LAZCLUZE® for EGFR-Mutated Lung Cancer

    Details:

    Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is indicated in combination with Lazertinib for the treatment of Advanced or Metastatic Non-small Cell Lung Cancer.


    Lead Product(s): Amivantamab,Lazertinib,Dexamethasone

    Therapeutic Area: Oncology Brand Name: Rybrevant

    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

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Amivantamab,Lazertinib,Dexamethasone

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    CHMP Recommends RYBREVANT® and LAZCLUZE® for EGFR-Mutated Lung Cancer

    Details : Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is indicated in combination with Lazertinib for the treatment of Advanced or Metastatic Non-small Cell Lung Cancer.

    Brand Name : Rybrevant

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    November 15, 2024

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    TREMFYA® First IL-23 Inhibitor to Show Results in Crohn's Disease

    Details:

    Tremfya (guselkumab) is the first approved fully-human, monoclonal antibody that blocks IL-23. It is being evaluated for the treatment of adults with moderately to severely active crohn's disease.


    Lead Product(s): Guselkumab

    Therapeutic Area: Gastroenterology Brand Name: Tremfya

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 28, 2024

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    03

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Lead Product(s) : Guselkumab

    Therapeutic Area : Gastroenterology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    TREMFYA® First IL-23 Inhibitor to Show Results in Crohn's Disease

    Details : Tremfya (guselkumab) is the first approved fully-human, monoclonal antibody that blocks IL-23. It is being evaluated for the treatment of adults with moderately to severely active crohn's disease.

    Brand Name : Tremfya

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    October 28, 2024

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    J&J’s Subcutaneous Tremfya Shows Promise in Crohn’s Disease Treatment

    Details:

    Tremfya (guselkumab) is the first approved fully-human, monoclonal antibody that blocks IL-23. It is being evaluated for the treatment of adults with moderately to severely active crohn's disease.


    Lead Product(s): Guselkumab

    Therapeutic Area: Gastroenterology Brand Name: Tremfya

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 21, 2024

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    04

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Lead Product(s) : Guselkumab

    Therapeutic Area : Gastroenterology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    J&J’s Subcutaneous Tremfya Shows Promise in Crohn’s Disease Treatment

    Details : Tremfya (guselkumab) is the first approved fully-human, monoclonal antibody that blocks IL-23. It is being evaluated for the treatment of adults with moderately to severely active crohn's disease.

    Brand Name : Tremfya

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    October 21, 2024

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    J&J Discontinues Late-Stage Study for Bladder Cancer Drug

    Details:

    TAR-200 (gemcitabine) is a DNA polymerase inhibitor. It is under phase 2 clinical evaluation in combination with Cetrelimab for the treatment of BCG unresponsive non-muscle-invasive bladder cancer.


    Lead Product(s): Gemcitabine,Cetrelimab

    Therapeutic Area: Oncology Brand Name: TAR-200

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 07, 2024

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    05

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Gemcitabine,Cetrelimab

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    J&J Discontinues Late-Stage Study for Bladder Cancer Drug

    Details : TAR-200 (gemcitabine) is a DNA polymerase inhibitor. It is under phase 2 clinical evaluation in combination with Cetrelimab for the treatment of BCG unresponsive non-muscle-invasive bladder cancer.

    Brand Name : TAR-200

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 07, 2024

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    J&J Drops Phase 2 Dengue Candidate as Part of Ongoing Move Away from Vaccines

    Details:

    JNJ-1802 (mosnodenvir) is an antiviral small molecule drug candidate, which is currently being evaluated for the treatment of patients with dengue infection.


    Lead Product(s): Mosnodenvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: JNJ-1802

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 04, 2024

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    06

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Lead Product(s) : Mosnodenvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    J&J Drops Phase 2 Dengue Candidate as Part of Ongoing Move Away from Vaccines

    Details : JNJ-1802 (mosnodenvir) is an antiviral small molecule drug candidate, which is currently being evaluated for the treatment of patients with dengue infection.

    Brand Name : JNJ-1802

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 04, 2024

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    J&J Files for FDA Approval of DARZALEX FASPRO® Quadruplet Regimen for Myeloma

    Details:

    Darzalex Faspro (daratumumab) is a CD38 inhibitor antibody drug candidate, which is currently being evaluated in combination for the treatment of patients with newly diagnosed multiple myeloma.


    Lead Product(s): Daratumumab,Bortezomib,Lenalidomide

    Therapeutic Area: Oncology Brand Name: Darzalex Faspro

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 30, 2024

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    07

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Pharma, Lab & Chemical Expo
    Not Confirmed

    Johnson & Johnson Innovative Medicine

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    Lead Product(s) : Daratumumab,Bortezomib,Lenalidomide

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    J&J Files for FDA Approval of DARZALEX FASPRO® Quadruplet Regimen for Myeloma

    Details : Darzalex Faspro (daratumumab) is a CD38 inhibitor antibody drug candidate, which is currently being evaluated in combination for the treatment of patients with newly diagnosed multiple myeloma.

    Brand Name : Darzalex Faspro

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 30, 2024

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    European Commission Approves Yuvanci® for Patients with Pulmonary Arterial Hypertension

    Details:

    Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Yuvanci

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 30, 2024

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    Johnson & Johnson Innovative Medicine

    U.S.A
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    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    European Commission Approves Yuvanci® for Patients with Pulmonary Arterial Hypertension

    Details : Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.

    Brand Name : Yuvanci

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 30, 2024

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    TALVEY®▼ and DARZALEX® SC Combination Shows Durable Responses in Myeloma Patients

    Details:

    Talvey (talquetamab) is a CD3 receptor binder in combination with daratumumab antibody drug administered via subcutaneous injection for relapsed or refractory multiple myeloma.


    Lead Product(s): Talquetamab,Daratumumab

    Therapeutic Area: Oncology Brand Name: Talvey

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 27, 2024

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    Johnson & Johnson Innovative Medicine

    U.S.A
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    Johnson & Johnson Innovative Medicine

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    Lead Product(s) : Talquetamab,Daratumumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    TALVEY®▼ and DARZALEX® SC Combination Shows Durable Responses in Myeloma Patients

    Details : Talvey (talquetamab) is a CD3 receptor binder in combination with daratumumab antibody drug administered via subcutaneous injection for relapsed or refractory multiple myeloma.

    Brand Name : Talvey

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 27, 2024

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    TALVEY® And TECVAYLI® Combo Shows High Response in Refractory Myeloma

    Details:

    TALVEY (talquetamab), the first bispecific targeting GPRC5D and TECVAYLI (teclistamab), the first BCMA-directed bispecific therapy are investigated as combination in patients with RRMM.


    Lead Product(s): Talquetamab,Teclistamab

    Therapeutic Area: Oncology Brand Name: Talvey

    Study Phase: Phase I/ Phase IIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 27, 2024

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    Johnson & Johnson Innovative Medicine

    U.S.A
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    Johnson & Johnson Innovative Medicine

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    Lead Product(s) : Talquetamab,Teclistamab

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    TALVEY® And TECVAYLI® Combo Shows High Response in Refractory Myeloma

    Details : TALVEY (talquetamab), the first bispecific targeting GPRC5D and TECVAYLI (teclistamab), the first BCMA-directed bispecific therapy are investigated as combination in patients with RRMM.

    Brand Name : Talvey

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 27, 2024

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    Johnson & Johnson Innovative Medicine is a supplier offers 89 products (APIs, Excipients or Intermediates).

    Find a price of Domperidone bulk with CEP, JDMF offered by Johnson & Johnson Innovative Medicine

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    Find a price of Methylphenidate Hydrochloride bulk with DMF, CEP offered by Johnson & Johnson Innovative Medicine

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    Find a price of Alfentanil Hydrochloride bulk with CEP offered by Johnson & Johnson Innovative Medicine

    Find a price of Domperidone bulk with JDMF offered by Johnson & Johnson Innovative Medicine

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    Find a price of Loperamide Hydrochloride bulk with CEP offered by Johnson & Johnson Innovative Medicine

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    Find a price of Itraconazole bulk with CEP offered by Johnson & Johnson Innovative Medicine

    Find a price of Methylphenidate Hydrochloride bulk with DMF offered by Johnson & Johnson Innovative Medicine

    Find a price of Nebivolol bulk with DMF offered by Johnson & Johnson Innovative Medicine

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    Find a price of Rilpivirine Hydrochloride bulk with JDMF offered by Johnson & Johnson Innovative Medicine

    Find a price of Rivaroxaban bulk with DMF offered by Johnson & Johnson Innovative Medicine

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    Find a price of Dapoxetine Hydrochloride bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of Domperidone Maleate bulk offered by Johnson & Johnson Innovative Medicine

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    Find a price of Galantamine Hydrobromide bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of Haloperidol bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of Isoconazole bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of Isoconazole Nitrate bulk offered by Johnson & Johnson Innovative Medicine

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    Find a price of Ketoconazole bulk offered by Johnson & Johnson Innovative Medicine

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    Find a price of Loperamide Hydrochloride bulk offered by Johnson & Johnson Innovative Medicine

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    Find a price of Miconazole Nitrate bulk offered by Johnson & Johnson Innovative Medicine

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    Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN PHARMACEUTICAL PRODUCTION UNIT, BEERSE, BELGIUM. bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of LIAROZOLE FUMERATE DRUG SUBSTANCE bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BEERSE, BELGIUM. bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of CHEMICAL PRODUCTION & CONTROL OF BPC'S FOR INVESTIGATIONAL USE IN BEERSE, BELGIUM. bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OLEN, BELGIUM. bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES AT GEEL, BELGIUM. bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of FACILS. & CONTROLS FOR PRODUCTION UNIT II AT GEEL, BELGIUM bulk offered by Johnson & Johnson Innovative Medicine

    Find a price of FACILITIES AND OPERATING PROCEDURES IN THE CHEMICAL PILOT PLANT, BEERSE, BELGIUM bulk offered by Johnson & Johnson Innovative Medicine

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