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    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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

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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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    26 Corporate Circle, Albany, New York 12203
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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

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    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

    FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

    In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 
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    Impressions: 2382

    https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies

    #PharmaFlow by PHARMACOMPASS
    30 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

    SCOPE Summit
    Not Confirmed
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    Betamethasone Dipropionate

    U.S.A

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

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    SCOPE Summit
    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

    SCOPE Summit
    Not Confirmed
    arrow

    Betamethasone Sodium Phosphate

    U.S.A

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

    arrow
    SCOPE Summit
    Not Confirmed
    • fda
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    • 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 : R1-CEP 2002-032 - Rev 01

    Issue Date : 2021-08-24

    Type : Chemical

    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

    SCOPE Summit
    Not Confirmed
    arrow

    Clobetasol Propionate

    U.S.A

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

    arrow
    SCOPE Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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

    SCOPE Summit
    Not Confirmed
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    Cyclosporine

    U.S.A

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

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    SCOPE Summit
    Not Confirmed
    • fda
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    USDMF arrow-down
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    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
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    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

    SCOPE Summit
    Not Confirmed
    arrow

    Dorzolamide Hydrochloride

    U.S.A

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

    arrow
    SCOPE Summit
    Not Confirmed
    • fda
    • EDQM
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    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

    SCOPE Summit
    Not Confirmed
    arrow

    Hydrocortisone

    U.S.A

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

    arrow
    SCOPE Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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

    SCOPE Summit
    Not Confirmed
    arrow

    Minocycline Hydrochloride

    U.S.A

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

    arrow
    SCOPE Summit
    Not Confirmed
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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

    KDMF VMF Others AUDIT
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    Market
    Place

    08

    Propofol

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

    SCOPE Summit
    Not Confirmed
    arrow

    Propofol

    U.S.A

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

    arrow
    SCOPE Summit
    Not Confirmed
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    USDMF arrow-down
    ✖

    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
    ✖

    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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    Market
    Place

    09

    Flutamide

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

    SCOPE Summit
    Not Confirmed
    arrow

    Flutamide

    U.S.A

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

    arrow
    SCOPE Summit
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    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

    SCOPE Summit
    Not Confirmed
    arrow

    Ribavirin

    U.S.A

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

    arrow
    SCOPE Summit
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    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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    USDMF

    read-more
    read-more

    01

    1-lzd

    U.S.A
    Arab Health
    Not Confirmed
    arrow

    02

    31/ac Hcl

    U.S.A
    Arab Health
    Not Confirmed
    arrow

    03

    5-thiazole Wing

    U.S.A
    Arab Health
    Not Confirmed
    arrow

    04

    A-84538.0 (ritonavir)

    U.S.A
    Arab Health
    Not Confirmed
    arrow

    05

    Alcaftadine

    U.S.A
    Arab Health
    Not Confirmed
    arrow

    06

    Alclometasone Dipropionate

    U.S.A
    Arab Health
    Not Confirmed
    arrow

    07

    Altrenogest

    U.S.A
    Arab Health
    Not Confirmed
    arrow

    08

    Amphetamine Aspartate

    U.S.A
    Arab Health
    Not Confirmed
    arrow

    09

    Amphetamine Aspartate, Monohydrate D...

    U.S.A
    Arab Health
    Not Confirmed
    arrow

    10

    Amphetamine Sulfate Usp

    U.S.A
    Arab Health
    Not Confirmed
    arrow
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    Drugs in Development

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    Curia Supports Replicate Bioscience's Phase 1 Clinical Trial of Novel Next-Generation RNA Vaccine

    Details:

    RBI-4000, is a self-replicating (srRNA) rabies vaccine, which is investigated in a Phase 1 clinical study utilizing clinical material developed as part of the collaboration with Curia.


    Lead Product(s): RBI-4000

    Therapeutic Area: Infections and Infectious Diseases Brand Name: RBI-4000

    Study Phase: Phase IProduct Type: Vaccine

    Recipient: Replicate Bioscience

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 13, 2023

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    01

    Curia

    U.S.A
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    Arab Health
    Not Confirmed

    Curia

    U.S.A
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    Arab Health
    Not Confirmed
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    Lead Product(s) : RBI-4000

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase I

    Recipient : Replicate Bioscience

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Curia Supports Replicate Bioscience's Phase 1 Clinical Trial of Novel Next-Generation RNA Vaccine

    Details : RBI-4000, is a self-replicating (srRNA) rabies vaccine, which is investigated in a Phase 1 clinical study utilizing clinical material developed as part of the collaboration with Curia.

    Brand Name : RBI-4000

    Molecule Type : Vaccine

    Upfront Cash : Not Applicable

    September 13, 2023

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    Tonix Pharmaceuticals Announces Exclusive License of Potential Therapeutic or Preventative Humanized anti-SARS-CoV-2 Monoclonal Antibodies from Curia Gl...

    Details:

    Murine monoclonal antibodies have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants and to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein.


    Lead Product(s): Murine Monoclonal Antibody

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Large molecule

    Sponsor: Tonix Pharmaceuticals Holding Corp

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement December 12, 2022

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    02

    Curia

    U.S.A
    arrow
    Arab Health
    Not Confirmed

    Curia

    U.S.A
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    Arab Health
    Not Confirmed
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    Lead Product(s) : Murine Monoclonal Antibody

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Tonix Pharmaceuticals Holding Corp

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Tonix Pharmaceuticals Announces Exclusive License of Potential Therapeutic or Preventative Humaniz...

    Details : Murine monoclonal antibodies have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants and to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein.

    Brand Name : Undisclosed

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    December 12, 2022

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    Incannex Engages Curia to Scale-up Manufacture of cGMP IHL-216A

    Details:

    IHL-216A (cannabidiol) has been observed to have a greater neuroprotective effect in a rodent model of sports concussion than CBD, and results indicate restoration of the spatial memory deficit post-concussion with IHL-216A administration.


    Lead Product(s): Cannabidiol,Isoflurane

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: IHL-216A

    Study Phase: PreclinicalProduct Type: Small molecule

    Recipient: Incannex Healthcare

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement August 02, 2022

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    03

    Curia

    U.S.A
    arrow
    Arab Health
    Not Confirmed

    Curia

    U.S.A
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    Arab Health
    Not Confirmed
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    Lead Product(s) : Cannabidiol,Isoflurane

    Therapeutic Area : Trauma (Emergency, Injury, Surgery)

    Highest Development Status : Preclinical

    Recipient : Incannex Healthcare

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Incannex Engages Curia to Scale-up Manufacture of cGMP IHL-216A

    Details : IHL-216A (cannabidiol) has been observed to have a greater neuroprotective effect in a rodent model of sports concussion than CBD, and results indicate restoration of the spatial memory deficit post-concussion with IHL-216A administration.

    Brand Name : IHL-216A

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    August 02, 2022

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    First Patient Dosed in the ENLIGHTEN Biomarker-Guided Global Clinical Trial of DB104 (Liafensine) for Treatment-Resistant Depression

    Details:

    Denovo discovered a novel genetic biomarker for DB104 (liafensine) efficacy using its unique machine learning approach with whole genome sequencing to identify biomarkers that may be predictive of a patient's response to a specific medicine.


    Lead Product(s): Liafensine

    Therapeutic Area: Psychiatry/Psychology Brand Name: DB104

    Study Phase: Phase IIProduct Type: Small molecule

    Recipient: Denovo Biopharma

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 28, 2022

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    04

    Curia

    U.S.A
    arrow
    Arab Health
    Not Confirmed

    Curia

    U.S.A
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    Arab Health
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Liafensine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II

    Recipient : Denovo Biopharma

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    First Patient Dosed in the ENLIGHTEN Biomarker-Guided Global Clinical Trial of DB104 (Liafensine) ...

    Details : Denovo discovered a novel genetic biomarker for DB104 (liafensine) efficacy using its unique machine learning approach with whole genome sequencing to identify biomarkers that may be predictive of a patient's response to a specific medicine.

    Brand Name : DB104

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 28, 2022

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    Curia and Replicate Bioscience Enter Strategic Collaboration to Create Groundbreaking Development Platform for Self-Replicating RNA (srRNA)

    Details:

    As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials.


    Lead Product(s): srRNA Therapeutic

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Large molecule

    Sponsor: Replicate Bioscience

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration June 09, 2022

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    05

    Curia

    U.S.A
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    Arab Health
    Not Confirmed

    Curia

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

    Therapeutic Area : Immunology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Replicate Bioscience

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Curia and Replicate Bioscience Enter Strategic Collaboration to Create Groundbreaking Development ...

    Details : As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials.

    Brand Name : Undisclosed

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    June 09, 2022

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    Curia Named Exclusive API Supplier for Recently Approved Acne Treatment

    Details:

    Curia has been named as the exclusive supplier of the active pharmaceutical ingredient (API) in Cassiopea SpA’s (SIX: SKIN) recently approved acne treatment, Winlevi® (clascoterone) cream 1%.


    Lead Product(s): Clascoterone

    Therapeutic Area: Dermatology Brand Name: Winlevi

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Cassiopea

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement October 30, 2020

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    06

    Curia

    U.S.A
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    Arab Health
    Not Confirmed

    Curia

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

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Cassiopea

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Curia Named Exclusive API Supplier for Recently Approved Acne Treatment

    Details : Curia has been named as the exclusive supplier of the active pharmaceutical ingredient (API) in Cassiopea SpA’s (SIX: SKIN) recently approved acne treatment, Winlevi® (clascoterone) cream 1%.

    Brand Name : Winlevi

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 30, 2020

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    BryoLogyx Announces Completion of World’s First GMP Synthesis of Bryostatin-1

    Details:

    Bryostatin-1 is the company’s lead compound being developed to improve patient outcomes by amplifying the response and increasing the durability of targeted cancer immunotherapies.


    Lead Product(s): Bryostatin-1

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Small molecule

    Recipient: BryoLogyx Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 13, 2020

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    07

    Curia

    U.S.A
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    Arab Health
    Not Confirmed

    Curia

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Bryostatin-1

    Therapeutic Area : Oncology

    Highest Development Status : Preclinical

    Recipient : BryoLogyx Inc

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    BryoLogyx Announces Completion of World’s First GMP Synthesis of Bryostatin-1

    Details : Bryostatin-1 is the company’s lead compound being developed to improve patient outcomes by amplifying the response and increasing the durability of targeted cancer immunotherapies.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 13, 2020

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    Curia Selected to Support AstraZeneca in Delivery of COVID-19 Vaccine

    Details:

    Curia has been chosen to contribute to the supply of the vaccine candidate through sterile fill/finish of AZD1222 at Curia’s drug product manufacturing facility in Albuquerque, New Mexico.


    Lead Product(s): ChAdOx1 nCoV-19

    Therapeutic Area: Infections and Infectious Diseases Brand Name: AZD1222

    Study Phase: Phase IIIProduct Type: Vaccine

    Sponsor: AstraZeneca

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement September 03, 2020

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    08

    Curia

    U.S.A
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    Not Confirmed

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    Lead Product(s) : ChAdOx1 nCoV-19

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : AstraZeneca

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Curia Selected to Support AstraZeneca in Delivery of COVID-19 Vaccine

    Details : Curia has been chosen to contribute to the supply of the vaccine candidate through sterile fill/finish of AZD1222 at Curia’s drug product manufacturing facility in Albuquerque, New Mexico.

    Brand Name : AZD1222

    Molecule Type : Vaccine

    Upfront Cash : Undisclosed

    September 03, 2020

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    Tryp Therapeutics Partners with Curia to Manufacture a Proprietary Psilocybin-based Drug

    Details:

    Curia will provide research, development and cGMP manufacturing of a proprietary psilocybin active pharmaceutical ingredient to support the clinical development of TRP-8802, TRP-8803 and TRP-8804 programs.


    Lead Product(s): Psilocybine

    Therapeutic Area: Psychiatry/Psychology Brand Name: TRP-8802

    Study Phase: UndisclosedProduct Type: Small molecule

    Sponsor: Tryp Therapeutics

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership August 13, 2020

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    Lead Product(s) : Psilocybine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Tryp Therapeutics

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Tryp Therapeutics Partners with Curia to Manufacture a Proprietary Psilocybin-based Drug

    Details : Curia will provide research, development and cGMP manufacturing of a proprietary psilocybin active pharmaceutical ingredient to support the clinical development of TRP-8802, TRP-8803 and TRP-8804 programs.

    Brand Name : TRP-8802

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    August 13, 2020

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    ViralClear, Curia Enter COVID-19 Partnership

    Details:

    The companies together are undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a stand-alone treatment or in combination with other antiviral agents or immune modulators.


    Lead Product(s): Merimepodib,Remdesivir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: VX-497

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: BioSig Technologies

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership July 08, 2020

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    Lead Product(s) : Merimepodib,Remdesivir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : BioSig Technologies

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    ViralClear, Curia Enter COVID-19 Partnership

    Details : The companies together are undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a stand-alone treatment or in combination with other antiviral agents or immune modulators.

    Brand Name : VX-497

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    July 08, 2020

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    01

    FDA Audited

    USA
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    Not Confirmed
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    Arab Health
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-02-05

    Curia

    City : Rozzano

    State :

    Country/Area : IT

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-02-05

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    FDA Audited

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    FDA Audited

    USA
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    Arab Health
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-11-14

    Curia

    City : Flintshire, Wales

    State :

    Country/Area : UK

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-11-14

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    Arab Health
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-01-25

    Curia

    City : Rozzano

    State :

    Country/Area : IT

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-01-25

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    04

    FDA Audited

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    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-05-18

    Curia

    City : Origgio

    State :

    Country/Area : IT

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-05-18

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-03-22

    Curia

    City : Rozzano

    State :

    Country/Area : IT

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-03-22

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-03-28

    Curia

    City : Origgio

    State :

    Country/Area : IT

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-03-28

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-31

    Curia

    City : Rozzano

    State :

    Country/Area : IT

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-31

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    District Decision : No Action Indicated

    Inspection End Date : 2010-05-13

    Curia

    City : Origgio

    State :

    Country/Area : IT

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2010-05-13

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    District Decision : No Action Indicated

    Inspection End Date : 2011-07-22

    Curia

    City : Flintshire, Wales

    State :

    Country/Area : UK

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-22

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    District Decision : No Action Indicated

    Inspection End Date : 2011-09-15

    Curia

    City : Rozzano

    State :

    Country/Area : IT

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-09-15

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    01

    GMP Certified

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    Curia

    Type : GMP Certificates

    Number : 21MPP075HFR...

    EudraGMDP Key : 143415

    Country : France

    Issue Date : 2022-01-11

    Post Code : 47240

    NCA Ref : 490756038000...

    City : BON ENCONTRE

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    02

    GMP Certified

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    Curia

    Type : GMP Certificates

    Number : 21MPP033HFR...

    EudraGMDP Key : 137242

    Country : France

    Issue Date : 2021-09-30

    Post Code : 47240

    NCA Ref : 490 756 038 ...

    City : BON ENCONTRE

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    03

    GMP Certified

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    Curia

    Type : GMP Certificates

    Number : 17MPP054HFR...

    EudraGMDP Key : 43858

    Country : France

    Issue Date : 2017-09-21

    Post Code : 47400

    NCA Ref : 490 756 038 ...

    City : TONNEINS

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    GMP Certified

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    Curia

    Type : GMP Certificates

    Number : 15MPP038HFR...

    EudraGMDP Key : 30043

    Country : France

    Issue Date : 2015-07-06

    Post Code : 47400

    NCA Ref : 490 756 038 ...

    City : TONNEINS

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    05

    GMP Certified

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    Curia

    Type : GMP Certificates

    Number : HMP/FR/146/...

    EudraGMDP Key : 23389

    Country : France

    Issue Date : 2014-04-25

    Post Code : 47240

    NCA Ref : 490 756 038 ...

    City : BON ENCONTRE

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    06

    GMP Certified

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    EU
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    Curia

    Type : GMP Certificates

    Number : HMP/FR/10/2...

    EudraGMDP Key : 16854

    Country : France

    Issue Date : 2013-01-30

    Post Code : 47400

    NCA Ref : 490 756 038 ...

    City : TONNEINS

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    GMP Certified

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    EU
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    Curia

    Type : GMP Certificates

    Number : HMP/FR/15/2...

    EudraGMDP Key : 16869

    Country : France

    Issue Date : 2013-02-20

    Post Code : 47240

    NCA Ref : 490 756 038 ...

    City : BON ENCONTRE

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    Curia

    Type : GMP Certificates

    Number : HMP/FR/22/2...

    EudraGMDP Key : 17874

    Country : France

    Issue Date : 2013-03-12

    Post Code : 47240

    NCA Ref : 490 756 038 ...

    City : BON ENCONTRE

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    09

    GMP Certified

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    EU
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    Curia

    Type : GMP Certificates

    Number : HMP/FR/204/...

    EudraGMDP Key : 28092

    Country : France

    Issue Date : 2014-10-03

    Post Code : 47240

    NCA Ref : 490756038000...

    City : BON ENCONTRE

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    Curia

    Type : GMP Certificates

    Number : NBF/52/2021...

    EudraGMDP Key : 141572

    Country : Italy

    Issue Date : 2021-10-20

    Post Code : 21014

    NCA Ref : 9347

    City : ORIGGIO (Varese)

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    01

    Inspected

    RoW
    Arab Health
    Not Confirmed

    Curia

    Inspection : Health Canada: Inspection Start Date: 06-05-2023; Rating- Compliant; Type of Inspection- GMP Foreign-Regular On-Site Inspection

    About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering pro...

    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.

    Country : U.S.A

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    ABOUT THIS PAGE

    Contact Albany Molecular Research and get a quotation

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