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    About

    Xellia Pharmaceuticals is a specialty pharmaceutical company focused on providing clinically effective anti-infective treatments against serious and often life-threatening infections. With over 100 years of pharmaceutical industry expertise, we are a leading developer, manufacturer and trusted supplier of fermented and semi-synthetic Active Pharmaceutical Ingredients (APIs) and finished dosage forms (FDF), and the world-leadin...
    Xellia Pharmaceuticals is a specialty pharmaceutical company focused on providing clinically effective anti-infective treatments against serious and often life-threatening infections. With over 100 years of pharmaceutical industry expertise, we are a leading developer, manufacturer and trusted supplier of fermented and semi-synthetic Active Pharmaceutical Ingredients (APIs) and finished dosage forms (FDF), and the world-leading supplier of Vancomycin and Colistimethate Sodium (CMS). Our range of anti-infective treatments combat, most types of bacterial and antibiotic-resistant infections and certain fungal diseases.

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    CONTACT DETAILS

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    Xellia Pharmaceuticals ApSDenmark Flag
    Country
    Country
    Denmark
    Address
    Address
    Dalslandsgade 11, 2300 Copenhagen S
    Telephone
    Telephone
    45 32 64 55 00
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.xellia.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: 4560

    https://www.pharmacompass.com/radio-compass-blog/bms-j-j-bayer-lead-25-000-pharma-layoffs-in-2024-amylyx-fibrogen-kronos-bio-hit-by-trial-failures-cash-crunch

    #PharmaFlow by PHARMACOMPASS
    16 Jan 2025
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    NEWS #PharmaBuzz

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    U.S. Court Vacates Modified Consent Decree Imposed on Xellia’s Clev Facility
    U.S. Court Vacates Modified Consent Decree Imposed on Xellia’s Clev Facility

    29 Apr 2024

    // CONTRACT PHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2024-04-29/us-court-vacates-modified-consent-decree-imposed-on-xellias-cleveland-facility/?widget=listSection

    CONTRACT PHARMA
    29 Apr 2024
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    Xellia to axe 80 positions at the plant it bought from BI
    Xellia to axe 80 positions at the plant it bought from BI

    14 Dec 2023

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/novo-holdings-specialty-drugmaker-xellia-lay-80-workers-former-boehringer-ingelheim-plant

    FIERCE PHARMA
    14 Dec 2023
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    Xellia starts commercial production and distribution of premix bag products
    Xellia starts commercial production and distribution of premix bag products

    29 Nov 2023

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20231129891959/en

    BUSINESSWIRE
    29 Nov 2023
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    Xellia's Generic Cyclophosphamide Receives Approval in the U.S.
    Xellia's Generic Cyclophosphamide Receives Approval in the U.S.

    18 Oct 2022

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211757

    FDA
    18 Oct 2022
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    Enforcement Report - Week of September 1, 2021
    Enforcement Report - Week of September 1, 2021

    01 Sep 2021

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-1-2021-1630499458.pdf

    FDA
    01 Sep 2021
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    Xellia Pharmaceuticals Cleveland, Ohio Manufacturing site is now operational.
    Xellia Pharmaceuticals Cleveland, Ohio Manufacturing site is now operational.

    17 Aug 2021

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20210817005498/en

    BUSINESSWIRE
    17 Aug 2021
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    ALL APIs

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

    01

    Amphotericin B

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

    PharmaVenue
    Not Confirmed
    arrow

    Amphotericin B

    Denmark

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

    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-02-13

    Pay. Date : 2012-11-19

    DMF Number : 13682

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-079 - Rev 09

    Issue Date : 2023-05-12

    Type : Chemical

    Substance Number : 1292

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10154

    Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark

    Initial Date of Registration : 2021-09-28

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 45932-0008

    Start Marketing Date : 1998-09-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : DKS Korea Co., Ltd.

    Registration Date : 2020-10-13

    Registration Number : 20200727-210-J-391(1)

    Manufacturer Name : Xellia Pharmaceuticals ApS

    Manufacturer Address : Dalslandsgade 11, Kobenhavn S, 2300 Denmark

     VMF Others AUDIT
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    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    02

    Bacitracin Zinc

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

    PharmaVenue
    Not Confirmed
    arrow

    Bacitracin Zinc

    Denmark

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

    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-26

    Pay. Date : 2012-10-31

    DMF Number : 13341

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2002-226 - Rev 08

    Issue Date : 2024-08-22

    Type : Chemical

    Substance Number : 465

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10193

    Registrant's Address : 108 Binhai Road, Taizhou, Zhejiang 318000 PRC, China

    Initial Date of Registration : 2013-10-09

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44231-0002

    Start Marketing Date : 2012-12-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Colistimethate Sodium

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

    PharmaVenue
    Not Confirmed
    arrow

    Colistimethate Sodium

    Denmark

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

    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-08

    Pay. Date : 2012-10-31

    DMF Number : 13363

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-209 - Rev 05

    Issue Date : 2017-07-19

    Type : Chemical

    Substance Number : 319

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10198

    Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark

    Initial Date of Registration : 2009-09-14

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 45932-0015

    Start Marketing Date : 1998-09-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samchundang Pharmaceutical Co., Ltd.

    Registration Date : 2020-12-17

    Registration Number : 20200827-210-J-728(1)

    Manufacturer Name : Xellia Pharmaceuticals ApS

    Manufacturer Address : Dalslandsgade 11, 2300 Kobenhavn S, Denmark

     VMF Others AUDIT
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    Market
    Place

    04

    Polymyxin B Sulfate

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

    PharmaVenue
    Not Confirmed
    arrow

    Polymyxin B Sulfate

    Denmark

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

    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-08

    Pay. Date : 2012-10-31

    DMF Number : 13536

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-062 - Rev 06

    Issue Date : 2019-04-05

    Type : Chemical

    Substance Number : 203

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10071

    Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark

    Initial Date of Registration : 2007-03-14

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 45932-0001

    Start Marketing Date : 1998-09-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2023-08-11

    Registration Number : 20210317-211-J-890(A)

    Manufacturer Name : Xellia Pharmaceuticals ApS

    Manufacturer Address : Dalslandsgade 11, 2300 Copenhagen S, Denmark

     VMF Others AUDIT
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    #PipelineProspector

    Market
    Place

    05

    Polymyxin B Sulfate

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

    PharmaVenue
    Not Confirmed
    arrow

    Polymyxin B Sulfate

    Denmark

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

    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-08

    Pay. Date : 2012-10-31

    DMF Number : 14187

    Submission : 1999-06-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-061 - Rev 05

    Issue Date : 2018-11-21

    Type : Chemical

    Substance Number : 203

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10934

    Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark

    Initial Date of Registration : 2006-11-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 45932-0001

    Start Marketing Date : 1998-09-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2023-08-11

    Registration Number : 20210317-211-J-890(A)

    Manufacturer Name : Xellia Pharmaceuticals ApS

    Manufacturer Address : Dalslandsgade 11, 2300 Copenhagen S, Denmark

     VMF Others AUDIT
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    Market
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    06

    Vancomycin Hydrochloride

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

    PharmaVenue
    Not Confirmed
    arrow

    Vancomycin Hydrochloride

    Denmark

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

    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-08

    Pay. Date : 2012-10-31

    DMF Number : 13691

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1996-006 - Rev 10

    Issue Date : 2019-12-03

    Type : Chemical

    Substance Number : 1058

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10091

    Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark

    Initial Date of Registration : 2007-03-14

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44231-0001

    Start Marketing Date : 1998-09-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2023-05-17

    Registration Number : 20130604-159-I-162-02(2)

    Manufacturer Name : Xellia (Taizhou) Pharmaceuticals Co., Ltd

    Manufacturer Address : No.108, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, 318000, China

     VMF Others AUDIT
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    Market
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    07

    Vancomycin Hydrochloride

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

    PharmaVenue
    Not Confirmed
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    Vancomycin Hydrochloride

    Denmark

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

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    PharmaVenue
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-24

    Pay. Date : 2012-11-15

    DMF Number : 13794

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-245 - Rev 02

    Issue Date : 2019-12-03

    Type : Chemical

    Substance Number : 1058

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10171

    Registrant's Address : H-1107 Budapest, Sza(´)lla(´)s utca 1-3 Hungary

    Initial Date of Registration : 2009-07-30

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44231-0001

    Start Marketing Date : 1998-09-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2023-05-17

    Registration Number : 20130604-159-I-162-02(2)

    Manufacturer Name : Xellia (Taizhou) Pharmaceuticals Co., Ltd

    Manufacturer Address : No.108, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, 318000, China

     VMF Others AUDIT
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    Market
    Place

    08

    Vancomycin Hydrochloride

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

    PharmaVenue
    Not Confirmed
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    Vancomycin Hydrochloride

    Denmark

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

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    PharmaVenue
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-08

    Pay. Date : 2012-10-31

    DMF Number : 20614

    Submission : 2007-06-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-195 - Rev 02

    Issue Date : 2019-08-30

    Type : Chemical

    Substance Number : 1058

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10216

    Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark

    Initial Date of Registration : 2007-06-25

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44231-0001

    Start Marketing Date : 1998-09-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2023-05-17

    Registration Number : 20130604-159-I-162-02(2)

    Manufacturer Name : Xellia (Taizhou) Pharmaceuticals Co., Ltd

    Manufacturer Address : No.108, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, 318000, China

     VMF Others AUDIT
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    Market
    Place

    09

    Bacitracin Zinc

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

    PharmaVenue
    Not Confirmed
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    Bacitracin Zinc

    Denmark

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

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    PharmaVenue
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13388

    Submission : 1998-09-01

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-103 - Rev 10

    Issue Date : 2022-08-18

    Type : Chemical

    Substance Number : 466

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10935

    Registrant's Address : Harbitzalle(´)en 3, P. O. Box 158 Skφyen N-0212 Oslo, Norway

    Initial Date of Registration : 2006-11-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44231-0002

    Start Marketing Date : 2012-12-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Gramicidin

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

    PharmaVenue
    Not Confirmed
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    Gramicidin

    Denmark

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

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    PharmaVenue
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13494

    Submission : 1998-09-01

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-132 - Rev 06

    Issue Date : 2018-12-18

    Type : Chemical

    Substance Number : 907

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10936

    Registrant's Address : H-1107 Budapest, Sza(´)lla(´)s u. 3. Hungary

    Initial Date of Registration : 2006-11-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 61046-0003

    Start Marketing Date : 2004-07-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    USDMF

    read-more
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    01

    Amphotericin B

    Denmark
    Pharmatech Expo 2025
    Not Confirmed
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    02

    Bacitracin Sterile Usp

    Denmark
    Pharmatech Expo 2025
    Not Confirmed
    arrow

    03

    Bacitracin Usp Non-sterile

    Denmark
    Pharmatech Expo 2025
    Not Confirmed
    arrow

    04

    Bacitracin Zinc Sterile Usp

    Denmark
    Pharmatech Expo 2025
    Not Confirmed
    arrow

    05

    Bacitracin Zinc Usp Non-sterile

    Denmark
    Pharmatech Expo 2025
    Not Confirmed
    arrow

    06

    Bacitracin Zinc, Sterile

    Denmark
    Pharmatech Expo 2025
    Not Confirmed
    arrow

    07

    Caspofungin (acetate)

    Denmark
    Pharmatech Expo 2025
    Not Confirmed
    arrow

    08

    Colistimethate Sodium Usp

    Denmark
    Pharmatech Expo 2025
    Not Confirmed
    arrow

    09

    Colistin Sulfate

    Denmark
    Pharmatech Expo 2025
    Not Confirmed
    arrow

    10

    Dalbavancin Hydrochloride

    Denmark
    Pharmatech Expo 2025
    Not Confirmed
    arrow
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    Drugs in Development

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    Xellia Pharmaceuticals expands approved doses of VANCO READY™ (Ready-to-use Premixed Vancomycin bags)

    Details:

    Xellia Pharmaceuticals has received approval for 3 additional dosages of VANCO READY™, expanding its range of room-temperature-stable, ready-to-use (RTU) Vancomycin injection premix bags.


    Lead Product(s): Vancomycin Hydrochloride

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Vanco Ready

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 02, 2020

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    01

    Xellia Pharmaceuticals ApS

    Denmark
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    BIO Partnering at JPM
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Denmark
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    Lead Product(s) : Vancomycin Hydrochloride

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Xellia Pharmaceuticals expands approved doses of VANCO READY™ (Ready-to-use Premixed Vancomycin ...

    Details : Xellia Pharmaceuticals has received approval for 3 additional dosages of VANCO READY™, expanding its range of room-temperature-stable, ready-to-use (RTU) Vancomycin injection premix bags.

    Brand Name : Vanco Ready

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 02, 2020

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    Eton Pharmaceuticals and Xellia Pharmaceuticals Announce Biorphen® (phenylephrine HCl) Co-Promotion Agreement

    Details:

    Agreement significantly expands biorphen commercial footprint and provides access to institutions that prefer ready-to-use injectable formulations.


    Lead Product(s): Phenylephrine HCl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Eton Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration January 21, 2020

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    02

    Xellia Pharmaceuticals ApS

    Denmark
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    BIO Partnering at JPM
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Denmark
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    Lead Product(s) : Phenylephrine HCl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Recipient : Eton Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Eton Pharmaceuticals and Xellia Pharmaceuticals Announce Biorphen® (phenylephrine HCl) Co-Promoti...

    Details : Agreement significantly expands biorphen commercial footprint and provides access to institutions that prefer ready-to-use injectable formulations.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    January 21, 2020

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    FDA Orange Book

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    01

    Brand Name : CASPOFUNGIN ACETATE

    Denmark
    PharmaVenue
    Not Confirmed
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    Brand Name : CASPOFUNGIN ACETATE

    Denmark
    PharmaVenue
    Not Confirmed
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    RLD : No

    TE Code :

    CASPOFUNGIN ACETATE

    Xellia Pharmaceuticals ApS

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : CASPOFUNGIN ACETATE

    Dosage Strength : 50MG/VIAL

    Approval Date : 2018-07-02

    Application Number : 205923

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    Brand Name : CASPOFUNGIN ACETATE

    Denmark
    PharmaVenue
    Not Confirmed
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    Brand Name : CASPOFUNGIN ACETATE

    Denmark
    PharmaVenue
    Not Confirmed
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    RLD : No

    TE Code :

    CASPOFUNGIN ACETATE

    Xellia Pharmaceuticals ApS

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : CASPOFUNGIN ACETATE

    Dosage Strength : 70MG/VIAL

    Approval Date : 2018-07-02

    Application Number : 205923

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    Brand Name : COLISTIMETHATE SODIU...

    Denmark
    PharmaVenue
    Not Confirmed
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    Brand Name : COLISTIMETHATE SODIU...

    Denmark
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    RLD : No

    TE Code : AP

    COLISTIMETHATE SODIUM

    Xellia Pharmaceuticals ApS

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : COLISTIMETHATE SODIUM

    Dosage Strength : EQ 150MG BASE/VIAL

    Approval Date : 2015-05-29

    Application Number : 205356

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    Market
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    04

    Brand Name : DAPTOMYCIN

    Denmark
    PharmaVenue
    Not Confirmed
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    Brand Name : DAPTOMYCIN

    Denmark
    PharmaVenue
    Not Confirmed
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    RLD : No

    TE Code : AP

    DAPTOMYCIN

    Xellia Pharmaceuticals ApS

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : DAPTOMYCIN

    Dosage Strength : 500MG/VIAL

    Approval Date : 2016-06-15

    Application Number : 206005

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    Brand Name : DAPTOMYCIN

    Denmark
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    Brand Name : DAPTOMYCIN

    Denmark
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    RLD : Yes

    TE Code :

    DAPTOMYCIN

    Xellia Pharmaceuticals ApS

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : DAPTOMYCIN

    Dosage Strength : 350MG/VIAL

    Approval Date : 2017-10-20

    Application Number : 209949

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    Brand Name : DAPTOMYCIN

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    Brand Name : DAPTOMYCIN

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    RLD : Yes

    TE Code :

    DAPTOMYCIN

    Xellia Pharmaceuticals ApS

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : DAPTOMYCIN

    Dosage Strength : 350MG/VIAL

    Approval Date : 2023-01-30

    Application Number : 217415

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    07

    Brand Name : DAPTOMYCIN

    Denmark
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    Brand Name : DAPTOMYCIN

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    RLD : Yes

    TE Code :

    DAPTOMYCIN

    Xellia Pharmaceuticals ApS

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : DAPTOMYCIN

    Dosage Strength : 500MG/VIAL

    Approval Date : 2023-01-30

    Application Number : 217415

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    08

    Brand Name : MICAFUNGIN SODIUM

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    Brand Name : MICAFUNGIN SODIUM

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    RLD : No

    TE Code : AP

    MICAFUNGIN SODIUM

    Xellia Pharmaceuticals ApS

    Dosage Form : INJECTABLE; INTRAVENOUS

    Proprietary Name : MICAFUNGIN SODIUM

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2021-06-02

    Application Number : 211713

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    09

    Brand Name : MICAFUNGIN SODIUM

    Denmark
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    Brand Name : MICAFUNGIN SODIUM

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    RLD : No

    TE Code : AP

    MICAFUNGIN SODIUM

    Xellia Pharmaceuticals ApS

    Dosage Form : INJECTABLE; INTRAVENOUS

    Proprietary Name : MICAFUNGIN SODIUM

    Dosage Strength : EQ 100MG BASE/VIAL

    Approval Date : 2021-06-02

    Application Number : 211713

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    10

    Brand Name : POLYMYXIN B SULFATE

    Denmark
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    Brand Name : POLYMYXIN B SULFATE

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    RLD : No

    TE Code : AP

    POLYMYXIN B SULFATE

    Xellia Pharmaceuticals ApS

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : POLYMYXIN B SULFATE

    Dosage Strength : EQ 500,000 UNITS BASE/VI...

    Approval Date : 2014-01-15

    Application Number : 202766

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    Excipients

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
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    FDA Audited

    USA
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    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-02-11

    Xellia Pharmaceuticals ApS

    City : Copenhagen S

    State :

    Country/Area : DK

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-02-11

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    FDA Audited

    USA
    BIO Partnering at JPM
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    FDA Audited

    USA
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    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-10-16

    Xellia Pharmaceuticals ApS

    City : Copenhagen S

    State :

    Country/Area : DK

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-10-16

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    FDA Audited

    USA
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    FDA Audited

    USA
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    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-05-06

    Xellia Pharmaceuticals ApS

    City : Copenhagen S

    State :

    Country/Area : DK

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-05-06

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    04

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
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    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-12-10

    Xellia Pharmaceuticals ApS

    City : Raleigh

    State : NC

    Country/Area : US

    Zip : 27616

    District : ATL

    Center : CBER

    Project Area : Blood and Blood Products

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-12-10

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    05

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
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    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-07-30

    Xellia Pharmaceuticals ApS

    City : Raleigh

    State : NC

    Country/Area : US

    Zip : 27616

    District : ATL

    Center : CBER

    Project Area : Blood and Blood Products

    District Decision : No Action Indicated

    Inspection End Date : 2014-07-30

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    06

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-02

    Xellia Pharmaceuticals ApS

    City : Raleigh

    State : NC

    Country/Area : US

    Zip : 27616

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-02

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    07

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-06-14

    Xellia Pharmaceuticals ApS

    City : Raleigh

    State : NC

    Country/Area : US

    Zip : 27616

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-06-14

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    08

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-10-29

    Xellia Pharmaceuticals ApS

    City : Raleigh

    State : NC

    Country/Area : US

    Zip : 27616

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-10-29

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    09

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-02-27

    Xellia Pharmaceuticals ApS

    City : Taizhou City

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-02-27

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    10

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-09-20

    Xellia Pharmaceuticals ApS

    City : Taizhou City

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-09-20

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    EDQM

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    GMP Certified

    EU
    PharmaVenue
    Not Confirmed
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    GMP Certified

    EU
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    PharmaVenue
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Type : GMP Certificates

    Number : UP/I-530-01...

    EudraGMDP Key : 38595

    Country : Croatia

    Issue Date : 2016-01-29

    Post Code : 10000

    NCA Ref : 48056107198A

    City : Zagreb

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    02

    GMP Certified

    EU
    PharmaVenue
    Not Confirmed
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    GMP Certified

    EU
    arrow
    PharmaVenue
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Type : GMP Certificates

    Number : UP/I-530-01...

    EudraGMDP Key : 38595

    Country : Croatia

    Issue Date : 2016-01-29

    Post Code : 10000

    NCA Ref : 48056107198A

    City : Zagreb

    blank

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    03

    GMP Certified

    EU
    PharmaVenue
    Not Confirmed
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    GMP Certified

    EU
    arrow
    PharmaVenue
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Type : GMP Certificates

    Number : DK API-H 00...

    EudraGMDP Key : 9000

    Country : Denmark

    Issue Date : 2015-12-22

    Post Code : 2300

    NCA Ref : 262093

    City : K

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    04

    GMP Certified

    EU
    PharmaVenue
    Not Confirmed
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    GMP Certified

    EU
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    PharmaVenue
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Type : GMP Certificates

    Number : DK IMP 0006...

    EudraGMDP Key : 9000

    Country : Denmark

    Issue Date : 2015-12-04

    Post Code : 2300

    NCA Ref : 262093

    City : K

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    05

    GMP Certified

    EU
    PharmaVenue
    Not Confirmed
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    GMP Certified

    EU
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    PharmaVenue
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Type : GMP Certificates

    Number : DK H 000667...

    EudraGMDP Key : 9000

    Country : Denmark

    Issue Date : 2015-12-04

    Post Code : 2300

    NCA Ref : 262093

    City : K

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    06

    GMP Certified

    EU
    PharmaVenue
    Not Confirmed
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    GMP Certified

    EU
    arrow
    PharmaVenue
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Type : GMP Certificates

    Number : OGYI/31137-...

    EudraGMDP Key : 37245

    Country : Hungary

    Issue Date : 2015-11-20

    Post Code : 1107

    NCA Ref : HU-M-XEL01

    City : Budapest

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    07

    GMP Certified

    EU
    PharmaVenue
    Not Confirmed
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    GMP Certified

    EU
    arrow
    PharmaVenue
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Type : GMP Certificates

    Number : DK H 000385...

    EudraGMDP Key : 9000

    Country : Denmark

    Issue Date : 2014-12-19

    Post Code : 2300

    NCA Ref : 262093

    City : K

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    08

    GMP Certified

    EU
    PharmaVenue
    Not Confirmed
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    GMP Certified

    EU
    arrow
    PharmaVenue
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Type : GMP Certificates

    Number : OGYI/21936-...

    EudraGMDP Key : 23311

    Country : Hungary

    Issue Date : 2014-07-31

    Post Code : 1107

    NCA Ref : HU-A-XELL01

    City : Budapest

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    09

    GMP Certified

    EU
    PharmaVenue
    Not Confirmed
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    GMP Certified

    EU
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    PharmaVenue
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Type : GMP Certificates

    Number : DK IMP 0002...

    EudraGMDP Key : 9000

    Country : Denmark

    Issue Date : 2012-03-13

    Post Code : 2300

    NCA Ref : 262093

    City : K

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    GMP Certified

    EU
    PharmaVenue
    Not Confirmed
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    GMP Certified

    EU
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    PharmaVenue
    Not Confirmed

    Xellia Pharmaceuticals ApS

    Type : GMP Certificates

    Number : DK H 000201...

    EudraGMDP Key : 9000

    Country : Denmark

    Issue Date : 2012-03-13

    Post Code : 2300

    NCA Ref : 262093

    City : K

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    GDUFA

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    01

    GDUFA fees paid

    USA
    PharmaVenue
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    GDUFA fees paid

    USA
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    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Paid in : 2019

    Xellia Pharmaceuticals ApS

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Xellia (Taizhou) Pharmaceutica...

    Business Address : 18 Binhai Jiaojiang District...

    FEI Number : 3007422723

    Country : Denmark

    Paid in : 2019

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    02

    GDUFA fees paid

    USA
    PharmaVenue
    Not Confirmed
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    GDUFA fees paid

    USA
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    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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    Xellia Pharmaceuticals ApS

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Xellia Pharmaceuticals ApS

    Business Address : Dalslandgade 11 Copenhagen S...

    FEI Number : 3002806860

    Country : Denmark

    Paid in : 2019

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    03

    GDUFA fees paid

    USA
    PharmaVenue
    Not Confirmed
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    GDUFA fees paid

    USA
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    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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    Xellia Pharmaceuticals ApS

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Xellia Pharmaceuticals Ltd.

    Business Address : Szallas utca 1-3 Budapest H-...

    FEI Number : 3002808179

    Country : Denmark

    Paid in : 2019

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    04

    GDUFA fees paid

    USA
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    GDUFA fees paid

    USA
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    PharmaVenue
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    • fda
    • EDQM
    • WHO-GMP
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    Xellia Pharmaceuticals ApS

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Xellia Pharmaceuticals USA LLC

    Business Address : 8841 Wadford Drive Raleigh N...

    FEI Number : 3005208599

    Country : Denmark

    Paid in : 2019

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    05

    GDUFA fees paid

    USA
    PharmaVenue
    Not Confirmed
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    GDUFA fees paid

    USA
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Paid in : 2019

    Xellia Pharmaceuticals ApS

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Xellia Pharmaceuticals USA LLC

    Business Address : 200 Northfield Rd Bedford OH...

    FEI Number : 3012279857

    Country : Denmark

    Paid in : 2019

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    ABOUT THIS PAGE

    Contact Xellia Pharmaceuticals ApS and get a quotation

    Xellia Pharmaceuticals ApS is a supplier offers 24 products (APIs, Excipients or Intermediates).

    Find a price of Amphotericin B bulk with DMF, CEP, JDMF offered by Xellia Pharmaceuticals ApS

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    Find a price of Vancomycin Hydrochloride bulk with DMF, CEP offered by Xellia Pharmaceuticals ApS

    Find a price of Tobramycin Sulfate bulk with JDMF offered by Xellia Pharmaceuticals ApS

    Find a price of Amphotericin B bulk with JDMF offered by Xellia Pharmaceuticals ApS

    Find a price of Bacitracin Zinc bulk with DMF offered by Xellia Pharmaceuticals ApS

    Find a price of Dalbavancin bulk with DMF offered by Xellia Pharmaceuticals ApS

    Find a price of Gramicidin bulk with DMF offered by Xellia Pharmaceuticals ApS

    Find a price of Tobramycin bulk with DMF offered by Xellia Pharmaceuticals ApS

    Find a price of Tyrothricin bulk with CEP offered by Xellia Pharmaceuticals ApS

    Find a price of Caspofungin bulk offered by Xellia Pharmaceuticals ApS

    Find a price of Mupirocin bulk offered by Xellia Pharmaceuticals ApS

    Find a price of Bacitracin Zinc bulk offered by Xellia Pharmaceuticals ApS

    Find a price of Fluticasone Propionate bulk offered by Xellia Pharmaceuticals ApS

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