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    About

    Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. From early discovery and development through manufacturing and commercialization, ou...
    Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. From early discovery and development through manufacturing and commercialization, our suite of custom solutions allows us to tailor every engagement to your precise needs, whether that’s an independent project or an opportunity that cuts across the drug continuum.

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    CuriaUnited_States_of_America Flag
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    U.S.A
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    26 Corporate Circle, Albany, New York 12203
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    +1 518.512.2000
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    enquiries@pharmacompass.com
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    https://curiaglobal.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  

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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: 4591

    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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    Curia Commits to SBTi Net-Zero Standard
    Curia Commits to SBTi Net-Zero Standard

    08 Oct 2024

    // PRESS RELEASE

    https://curiaglobal.com/about-us/news/curia-commits-to-sbti-net-zero-standard/

    PRESS RELEASE
    08 Oct 2024
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    Curia Unveils Brand Refresh at CPHI WW in Milan
    Curia Unveils Brand Refresh at CPHI WW in Milan

    07 Oct 2024

    // PRESS RELEASE

    https://curiaglobal.com/about-us/news/curia-unveils-brand-refresh-at-cphi-ww-in-milan/

    PRESS RELEASE
    07 Oct 2024
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    Curia Unveils Comprehensive mRNA Solution
    Curia Unveils Comprehensive mRNA Solution

    05 Sep 2024

    // PRESS RELEASE

    https://curiaglobal.com/about-us/news/curia-unveils-comprehensive-mrna-solution/

    PRESS RELEASE
    05 Sep 2024
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    AMRI Boosts U.S. Hydroxychloroquine API For COVID-19
    AMRI Boosts U.S. Hydroxychloroquine API For COVID-19

    05 Sep 2024

    // PRESS RELEASE

    https://curiaglobal.com/about-us/news/amri-increases-hydroxychloroquine-sulfate-api-production-in-u-s-to-meet-potential-covid-19-demand/

    PRESS RELEASE
    05 Sep 2024
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    Bio X Cell Appoints Christopher Conway CEO
    Bio X Cell Appoints Christopher Conway CEO

    12 Aug 2024

    // CONTRACT PHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2024-08-12/bio-x-cell-appoints-christopher-conway-ceo/72644

    CONTRACT PHARMA
    12 Aug 2024
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    Siegfried expands US reach with deal for Wisconsin facility
    Siegfried expands US reach with deal for Wisconsin facility

    13 Jun 2024

    // FIERCE PHARMA

    https://www.fiercepharma.com/manufacturing/cdmo-siegfried-expands-us-footprint-acquisition-wisconsin-facility

    FIERCE PHARMA
    13 Jun 2024
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    ALL APIs

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    01

    Betamethasone Dipropionate

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

    Duphat
    Not Confirmed
    arrow

    Betamethasone Dipropionate

    U.S.A

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

    arrow
    Duphat
    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 : 2015-10-05

    Pay. Date : 2015-09-24

    DMF Number : 17046

    Submission : 2003-12-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-031 - Rev 03

    Issue Date : 2021-08-24

    Type : Chemical

    Substance Number : 809

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10367

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2007-12-13

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65089-0009

    Start Marketing Date : 1984-10-10

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
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    02

    Betamethasone Sodium Phosphate

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

    Duphat
    Not Confirmed
    arrow

    Betamethasone Sodium Phosphate

    U.S.A

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

    arrow
    Duphat
    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 : 2023-12-07

    Pay. Date : 2023-09-27

    DMF Number : 38831

    Submission : 2023-09-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2023-167 - Rev 00

    Issue Date : 2023-08-23

    Type : Chemical and TSE

    Substance Number : 810

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10235

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2007-07-06

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65089-0004

    Start Marketing Date : 1965-03-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
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    03

    Clobetasol Propionate

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

    Duphat
    Not Confirmed
    arrow

    Clobetasol Propionate

    U.S.A

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

    arrow
    Duphat
    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 : 26191

    Submission : 2012-06-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-095 - Rev 01

    Issue Date : 2021-08-25

    Type : Chemical

    Substance Number : 2127

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10016

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2010-01-07

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65089-0003

    Start Marketing Date : 1994-02-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : JDW Pharmaceutical Co., Ltd.

    Registration Date : 2011-08-12

    Registration Number : 20080530-93-E-56-03(5)

    Manufacturer Name : Crystal Pharma, SA,

    Manufacturer Address : Parque Tecnologico de Boecillo, Parcela 105, 47151-Boecillo (Valladolid), Spain

     VMF Others AUDIT
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    04

    Cyclosporine

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

    Duphat
    Not Confirmed
    arrow

    Cyclosporine

    U.S.A

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-16

    Pay. Date : 2013-12-02

    DMF Number : 12949

    Submission : 1998-04-13

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-034 - Rev 06

    Issue Date : 2021-08-30

    Type : Chemical

    Substance Number : 994

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10617

    Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy

    Initial Date of Registration : 2006-07-03

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55486-1567

    Start Marketing Date : 2012-06-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : AbbVie Korea Inc.

    Registration Date : 2015-06-18

    Registration Number : 20150618-18-C-338-07

    Manufacturer Name : Curia Italy Srl

    Manufacturer Address : Via Volturno, 41/43 - 20089 ROZZANO (MI), Italy

     VMF Others AUDIT
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    05

    Dorzolamide Hydrochloride

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

    Duphat
    Not Confirmed
    arrow

    Dorzolamide Hydrochloride

    U.S.A

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

    arrow
    Duphat
    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 : 2013-09-21

    Pay. Date : 2013-09-11

    DMF Number : 18385

    Submission : 2005-05-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-115 - Rev 03

    Issue Date : 2021-11-15

    Type : Chemical

    Substance Number : 2359

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10011

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2015-01-05

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65089-0039

    Start Marketing Date : 1994-12-09

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samil Pharmaceutical Co., Ltd.

    Registration Date : 2023-01-06

    Registration Number : 20211115-209-J-1151(B)

    Manufacturer Name : CURIA SPAIN SAU

    Manufacturer Address : Parque Tecnológico de Boecillo, Parcela 105. 47151 Boecillo, Valladolid, Spain

     VMF Others AUDIT
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    06

    Hydrocortisone

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

    Duphat
    Not Confirmed
    arrow

    Hydrocortisone

    U.S.A

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

    arrow
    Duphat
    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 : 2019-01-07

    Pay. Date : 2018-09-18

    DMF Number : 33002

    Submission : 2018-07-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-045 - Rev 02

    Issue Date : 2024-10-21

    Type : Chemical

    Substance Number : 335

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10680

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2005-10-07

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65089-0056

    Start Marketing Date : 1982-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
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    Market
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    07

    Minocycline Hydrochloride

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

    Duphat
    Not Confirmed
    arrow

    Minocycline Hydrochloride

    U.S.A

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-16

    DMF Number : 14802

    Submission : 2000-03-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2000-107 - Rev 10

    Issue Date : 2024-02-27

    Type : Chemical

    Substance Number : 1030

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10699

    Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy

    Initial Date of Registration : 2005-10-07

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44657-0051

    Start Marketing Date : 2010-07-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (30kg/30kg)

    Marketing Category : BULK INGREDIENT

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    08

    Propofol

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

    Duphat
    Not Confirmed
    arrow

    Propofol

    U.S.A

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-07-21

    Pay. Date : 2014-07-11

    DMF Number : 10868

    Submission : 1994-04-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-267 - Rev 04

    Issue Date : 2021-08-11

    Type : Chemical

    Substance Number : 1558

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10529

    Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy

    Initial Date of Registration : 2006-05-18

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 44657-0044

    Start Marketing Date : 2010-10-20

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (5kg/5kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF arrow-down
    ✖

    VMF Number : 5894

    Submission : 2007-06-01

    Status : Active

    Type : II

     Others AUDIT
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    09

    Flutamide

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

    Duphat
    Not Confirmed
    arrow

    Flutamide

    U.S.A

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

    arrow
    Duphat
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12807

    Submission : 1997-12-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2000-049 - Rev 07

    Issue Date : 2024-09-10

    Type : Chemical

    Substance Number : 1423

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44657-0048

    Start Marketing Date : 2012-03-28

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Ribavirin

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

    Duphat
    Not Confirmed
    arrow

    Ribavirin

    U.S.A

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

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    Duphat
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-17

    Pay. Date : 2014-01-14

    DMF Number : 15700

    Submission : 2001-10-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-182 - Rev 03

    Issue Date : 2021-08-11

    Type : Chemical

    Substance Number : 2109

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44657-0076

    Start Marketing Date : 2012-03-15

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Only 10 entries up to this point, click to access all click full view read-more
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    USDMF

    read-more
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    01

    1-lzd

    U.S.A
    Duphat
    Not Confirmed
    arrow

    02

    31/ac Hcl

    U.S.A
    Duphat
    Not Confirmed
    arrow

    03

    5-thiazole Wing

    U.S.A
    Duphat
    Not Confirmed
    arrow

    04

    A-84538.0 (ritonavir)

    U.S.A
    Duphat
    Not Confirmed
    arrow

    05

    Alcaftadine

    U.S.A
    Duphat
    Not Confirmed
    arrow

    06

    Alclometasone Dipropionate

    U.S.A
    Duphat
    Not Confirmed
    arrow

    07

    Altrenogest

    U.S.A
    Duphat
    Not Confirmed
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    08

    Amphetamine Aspartate

    U.S.A
    Duphat
    Not Confirmed
    arrow

    09

    Amphetamine Aspartate, Monohydrate D...

    U.S.A
    Duphat
    Not Confirmed
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    10

    Amphetamine Sulfate Usp

    U.S.A
    Duphat
    Not Confirmed
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    CEP/COS

    read-more
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    01

    Beclometasone dipropionate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    02

    Betamethasone dipropionate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    03

    Betamethasone sodium phosphate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    04

    Betamethasone sodium phosphate, Process ...

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    05

    Betamethasone valerate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    06

    Brimonidine tartrate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    07

    Bromocriptine mesilate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    08

    Budesonide

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    09

    Budesonide, Sterile

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    10

    Carbimazole

    CEP/COS

    Duphat
    Not Confirmed
    arrow
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    01

    cGMP MANUFACTURING OF CONTROLLED...

    cGMP MANUFACTURING OF CONTROLLED SUBSTAN...

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    BIO Partnering at JPM
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    MANUFACTURING OF HIGHLY POTENT C...

    MANUFACTURING OF HIGHLY POTENT COMPOUNDS

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    BIO Partnering at JPM
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    01

    Tyloxapol

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

    Biotech Showcase
    Not Confirmed
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    Tyloxapol

    U.S.A

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

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    Biotech Showcase
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23692

    Submission : 2010-04-06

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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