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    About

    Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our visio...
    Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.

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    College Business & Technology Park Cruiserath, Blanchardstown Dublin 15
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

    Impressions: 5385

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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]
    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    A watershed moment in the journey of a drug is when it transitions from being a patented, high‐priced innovator product to an affordable generic.Through an inaugural approval, or a “first generic”,  the US Food Drug Administration (FDA) permits a manufacturer to market a generic version of a brand‐name drug — a process that, when successful, grants 180 days of exclusivity to the generic sponsor. This exclusivity is especially valuable when the drug in question is a blockbuster.In FDA’s fiscal year 2024 (i.e. from October 1, 2023 to September 30, 2024), the number of first-time generic drug approvals decreased by 21.3 percent — from 89 in FY 2023 to 70 in FY 2024, the lowest in at least nine years.Lupin emerged as a frontrunner in first generics, increasing its approvals from three in FY 2023 to seven in FY 2024, Apotex and Zydus Lifesciences from four to six, and Dr. Reddy’s from two to four. In contrast, Teva, Amneal, and Sun Pharma experienced a decline.Overall, neurology led the way with 10 approvals, while immunology saw eight, including three approvals in dermatology. Oncology and cardiology/vascular disease saw six approvals each. Ophthalmology saw five while psychiatry, and infectious diseases each contributed four approvals. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Novartis’ top seller Entresto, blockbuster Tasigna among six key drugs hit by generic rivalsIn 2024, the tide turned sharply for Novartis as it lost exclusivity for six of its drugs. Among them was its blockbuster Entresto, that has generated US$ 29.2 billion in revenue so far, including US$ 7.8 billion in 2024.A combination of sacubitril and valsartan, Entresto has transformed heart failure management. Entresto was the primary driver of Novartis’ sales growth last year. It was also one of the 10 drugs selected by the Biden administration in 2023 for Medicare price negotiations. Novartis has been fighting a fierce legal battle to protect Entresto from generic competition. In 2024, Entresto’s generic saga reached a crescendo. Alembic Pharmaceuticals, Laurus Labs, and Crystal Pharmaceutical’s generic versions of Entresto received FDA approval in May last year. But the Swiss drugmaker has noted that as of January 2025, there were no Entresto generics available in the US.Novartis’ Tasigna (nilotinib) has been a cornerstone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Apotex won approvals for generics of 50 mg, 150 mg, and 200 mg of nilotinib formulations, thereby offering a more affordable option for both adult and pediatric patients. Owing to the generics, Tasigna’s sales fell 10 percent in 2024.Novartis’ Mekinist (trametinib), Votrient (pazopanib), Rydapt (midostaurin), and Promacta (eltrombopag) have long been critical treatments in oncology and hematology. With generic competition hitting these key assets, Novartis is now aggressively forging deals to strengthen its pipeline. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  FDA clears first generics for Neurocrine’s Ingrezza, Supernus’s Gocovri, ALS drugsIn psychiatry, Neurocrine Biosciences’ Ingrezza (valbenazine) capsules have carved out a niche for themselves as a first-in-class treatment for tardive dyskinesia, a movement disorder that can develop as a side effect of long-term use of antipsychotic meds. Two generics for Ingrezza from India’s Zydus and Lupin bagged FDA approval, as Ingrezza sales topped US$ 2.3 billion last year.Zydus also won first generic approval for Supernus Pharmaceuticals’ Gocovri (amantadine) extended-release capsules, which is a treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.Four companies received FDA approvals for their first generics of Mitsubishi Tanabe’s patented drug Radicava (edaravone). These are Dr. Reddy’s Laboratories, Gland Pharma (a Fosun Pharmaceutical subsidiary), Hikma and Long Grove. Radicava is a drug that treats amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Another treatment for ALS from Italfarmaco — Tiglutik (riluzole) — received a first generic when FDA okayed Alkem Laboratories riluzole oral suspension. The med helps slow disease progression. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Pfizer’s Ibrance, Gilead’s Descovy, Lilly’s Olumiant treatment come under generic pressureIn oncology, Synthon Pharmaceuticals launched its generic version of Pfizer’s Ibrance (palbociclib) tablets. Generating sales of US$ 4.4 billion in 2024, this groundbreaking CDK4/6 inhibitor is Pfizer’s best-selling cancer drug. It has transformed treatment for hormone receptor-positive, HER2-negative advanced breast cancer by halting cancer cell division and significantly extending progression-free survival when combined with endocrine therapy.Descovy, a combination of emtricitabine and tenofovir alafenamide, stands as one of the most important therapies in the fight against HIV infection and related conditions. Originally developed by Gilead Sciences, Descovy has played a pivotal role in modern antiretroviral therapy, contributing US$ 2.1 billion to Gilead’s revenue in 2024. Apotex’s first generic approval for Descovy marked its second copycat for a blockbuster drug in 2024. The other generic approval it got its hands on was for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), a blood thinner that posted sales of € 845 million (US$ 883 million) in 2023.In immunology, Eli Lilly’s Olumiant (baricitinib) has emerged as an important therapy for treating inflammatory conditions such as rheumatoid arthritis. Aurobindo Pharma bagged FDA approval for generic baricitinib tablets.Ipsen’s Somatuline Depot (lanreotide) injection, a treatment for neuroendocrine tumors and endocrine disorders that generated about € 1.07 billion (US$1.1 billion) in 2023 sales, also has a generic now, with Cipla’s subsidiary InvaGen Pharmaceuticals receiving an FDA approval. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA okays copycats for opioid withdrawal med Lucemyra, weight loss drug Qsymia, contraceptive SlyndFDA also demonstrated a focused commitment to addressing two of the nation’s biggest public health concerns — the opioid crisis and obesity. Lucemyra (lofexidine), originally developed by US WorldMeds, is a non-opioid medication indicated for mitigating symptoms associated with acute opioid withdrawal and facilitating the completion of opioid discontinuation treatment. The introduction of Indoco Remedies’ generic version is poised to expand access to this critical therapy by offering a cost-effective alternative for managing substance use disorders.Vivus’ Qsymia (phentermine/topiramate), a chronic weight management therapy, also received a first generic. Actavis’ generic for Qsymia provides a more accessible option to patients striving to lose weight. Actavis is a subsidiary of Teva.FDA also approved Lupin’s first generic version of Insud Pharma’s Slynd—a progestin‑only contraceptive containing 4 mg drospirenone for use by females of reproductive potential to prevent pregnancy. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Our viewOver the next two years, several blockbusters such as Novo Nordisk’s Ozempic (semaglutide), AstraZeneca’s Farxiga (dapagliflozin), Bristol Myers Squibb’s Revlimid (lenalidomide) and its Pfizer partnered drug Eliquis (apixaban) stand to lose their patent protection. We expect more patent litigations and some exciting innovations in the generics space.
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    Impressions: 626

    https://www.pharmacompass.com/radio-compass-blog/fda-s-first-generic-approvals-slump-21-in-2024-novartis-top-seller-entresto-cancer-blockbuster-tasigna-lead-2024-patent-cliff

    #PharmaFlow by PHARMACOMPASS
    20 Feb 2025
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    NEWS #PharmaBuzz

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    CVC Completes Acquisition of Therakos from Mallinckrodt
    CVC Completes Acquisition of Therakos from Mallinckrodt

    02 Dec 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20241202409570/en

    BUSINESSWIRE
    02 Dec 2024
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    Mallinckrodt Completes Divestiture of Therakos® Business
    Mallinckrodt Completes Divestiture of Therakos® Business

    02 Dec 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-completes-divestiture-of-therakos-business-302319183.html

    PR NEWSWIRE
    02 Dec 2024
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    Mallinckrodt Presents Data on TERLIVAZ® for Hepatorenal Syndrome
    Mallinckrodt Presents Data on TERLIVAZ® for Hepatorenal Syndrome

    18 Nov 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-presents-data-on-terlivaz-terlipressin-for-injection-in-patients-with-hepatorenal-syndrome-hrs-at-the-2024-american-association-for-the-study-of-liver-diseases-aasld-annual-meeting-302308532.html

    PR NEWSWIRE
    18 Nov 2024
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    Mallinckrodt to Present at Jefferies London Healthcare Conference
    Mallinckrodt to Present at Jefferies London Healthcare Conference

    14 Nov 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-to-present-at-jefferies-london-healthcare-conference-302305741.html

    PR NEWSWIRE
    14 Nov 2024
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    Mallinckrodt Reports Q3 2024 Results & Full-Year Guidance
    Mallinckrodt Reports Q3 2024 Results & Full-Year Guidance

    05 Nov 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-plc-reports-third-quarter-2024-financial-results-and-raises-full-year-guidance-302296022.html

    PR NEWSWIRE
    05 Nov 2024
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    Mallinckrodt to Present TERLIVAZ® Data at AASLD Annual Meeting
    Mallinckrodt to Present TERLIVAZ® Data at AASLD Annual Meeting

    30 Oct 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-to-present-data-on-terlivaz-terlipressin-for-injection-at-the-2024-american-association-for-the-study-of-liver-diseases-aasld-annual-meeting-302290775.html

    PR NEWSWIRE
    30 Oct 2024
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    ALL APIs

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    01

    Paracetamol

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

    BioAsia
    Not Confirmed
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    Paracetamol

    Ireland

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

    arrow
    BioAsia
    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4203

    Submission : 1981-06-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1996-039 - Rev 04

    Issue Date : 2018-04-25

    Type : Chemical

    Substance Number : 49

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10905

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2006-11-10

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-0046

    Start Marketing Date : 2013-02-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Johnson & Johnson Sales Co., Ltd.

    Registration Date : 2023-01-10

    Registration Number : 20050831-32-C-126-07(A)

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 8801 Capital Boulevard, Raleigh, North Carolina 27616, USA

     VMF Others AUDIT
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    02

    Fentanyl

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

    PharmScience R&D
    Not Confirmed
    arrow

    Fentanyl

    Ireland

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

    arrow
    PharmScience R&D
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 8074

    Submission : 1989-05-11

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2005-260 - Rev 03

    Issue Date : 2024-02-14

    Type : Chemical

    Substance Number : 1210

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10283

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2009-12-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-0129

    Start Marketing Date : 1994-09-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Nosa Chemical Co., Ltd.

    Registration Date : 2022-11-28

    Registration Number : 20221128-211-J-1415

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 3600 North 2nd Street, St. Louis, MO 63147, USA

     VMF Others AUDIT
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    03

    Fentanyl Citrate

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

    PharmScience R&D
    Not Confirmed
    arrow

    Fentanyl Citrate

    Ireland

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7051

    Submission : 1987-07-02

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-097 - Rev 02

    Issue Date : 2024-01-30

    Type : Chemical

    Substance Number : 1103

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10161

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2017-08-17

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-1130

    Start Marketing Date : 1996-06-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    04

    Amphetamine

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

    PharmScience R&D
    Not Confirmed
    arrow

    Amphetamine

    Ireland

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-17

    Pay. Date : 2013-03-11

    DMF Number : 15385

    Submission : 2001-04-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-076 - Rev 00

    Issue Date : 2021-07-26

    Type : Chemical

    Substance Number : 2752

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-1950

    Start Marketing Date : 2013-04-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Buprenorphine Hydrochloride

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

    PharmScience R&D
    Not Confirmed
    arrow

    Buprenorphine Hydrochloride

    Ireland

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-30

    Pay. Date : 2012-11-30

    DMF Number : 24927

    Submission : 2012-05-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2023-107 - Rev 00

    Issue Date : 2023-08-24

    Type : Chemical

    Substance Number : 1181

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-2910

    Start Marketing Date : 2011-12-17

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Fentanyl Citrate

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

    PharmScience R&D
    Not Confirmed
    arrow

    Fentanyl Citrate

    Ireland

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

    arrow
    PharmScience R&D
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-12

    Pay. Date : 2012-11-27

    DMF Number : 10128

    Submission : 1993-03-15

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10580

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2006-06-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-1130

    Start Marketing Date : 1996-06-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    07

    Methylphenidate Hydrochloride

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

    PharmScience R&D
    Not Confirmed
    arrow

    Methylphenidate Hydrochloride

    Ireland

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

    arrow
    PharmScience R&D
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-08

    Pay. Date : 2012-11-27

    DMF Number : 12769

    Submission : 1997-11-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-140 - Rev 01

    Issue Date : 2018-02-06

    Type : Chemical

    Substance Number : 2235

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-0570

    Start Marketing Date : 2014-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Pharma Co., Ltd.

    Registration Date : 2023-10-26

    Registration Number : 20231012-209-J-1551(A)

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 3600 North Second Street, St, Louis, Missouri 63147, USA

     VMF Others AUDIT
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    Market
    Place

    08

    Naloxone Hydrochloride

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

    PharmScience R&D
    Not Confirmed
    arrow

    Naloxone Hydrochloride

    Ireland

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

    arrow
    PharmScience R&D
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-11

    Pay. Date : 2012-12-07

    DMF Number : 1862

    Submission : 1972-01-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-294 - Rev 01

    Issue Date : 2023-08-08

    Type : Chemical

    Substance Number : 729

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-1492

    Start Marketing Date : 2013-04-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
    Web Link

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    Market
    Place

    09

    Pethidine Hydrochloride

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

    PharmScience R&D
    Not Confirmed
    arrow

    Pethidine Hydrochloride

    Ireland

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

    arrow
    PharmScience R&D
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-01

    Pay. Date : 2014-07-28

    DMF Number : 11345

    Submission : 1995-02-10

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10904

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2006-11-10

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-1585

    Start Marketing Date : 2013-11-20

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    10

    Sufentanil Citrate

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

    PharmScience R&D
    Not Confirmed
    arrow

    Sufentanil Citrate

    Ireland

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

    arrow
    PharmScience R&D
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12183

    Submission : 1996-10-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-095 - Rev 01

    Issue Date : 2024-05-06

    Type : Chemical

    Substance Number : 1269

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-0310

    Start Marketing Date : 2013-04-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Nosa Chemical Co., Ltd.

    Registration Date : 2022-05-18

    Registration Number : 20220518-210-J-1301

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 3600 North 2nd Street, St. Louis, MO 63147, USA

     VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    6-beta-naltrexol Hydrochloride

    Ireland
    The Generic Rx Session
    Not Confirmed
    arrow

    02

    Abx And Cbx Bonded Phase Silica Gels

    Ireland
    The Generic Rx Session
    Not Confirmed
    arrow

    03

    Accurbron, S.r. (controlled Release ...

    Ireland
    The Generic Rx Session
    Not Confirmed
    arrow

    04

    Acetaminophen

    Ireland
    The Generic Rx Session
    Not Confirmed
    arrow

    05

    Acetaminophen Controlled-release Bea...

    Ireland
    The Generic Rx Session
    Not Confirmed
    arrow

    06

    Acetaminophen Usp

    Ireland
    The Generic Rx Session
    Not Confirmed
    arrow

    07

    Acetoxyacetyl Chloride

    Ireland
    The Generic Rx Session
    Not Confirmed
    arrow

    08

    Acetoxyacetyl Chloride

    Ireland
    The Generic Rx Session
    Not Confirmed
    arrow

    09

    Actifed S.a. Brand Of Pseudoephedrin...

    Ireland
    The Generic Rx Session
    Not Confirmed
    arrow

    10

    Acyclovir Usp (micronized), Coded 25...

    Ireland
    The Generic Rx Session
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
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    CEP/COS

    read-more
    read-more

    01

    Buprenorphine

    CEP/COS

    BioAsia
    Not Confirmed
    arrow

    02

    Buprenorphine hydrochloride

    CEP/COS

    BioAsia
    Not Confirmed
    arrow

    03

    Buprenorphine hydrochloride, Process II

    CEP/COS

    BioAsia
    Not Confirmed
    arrow

    04

    Calcium stearate, (Code numbers 2246, 22...

    CEP/COS

    BioAsia
    Not Confirmed
    arrow

    05

    Codeine phosphate hemihydrate

    CEP/COS

    BioAsia
    Not Confirmed
    arrow

    06

    Desmopressin

    CEP/COS

    BioAsia
    Not Confirmed
    arrow

    07

    Dexamfetamine sulfate

    CEP/COS

    BioAsia
    Not Confirmed
    arrow

    08

    Fentanyl

    CEP/COS

    BioAsia
    Not Confirmed
    arrow

    09

    Fentanyl citrate

    CEP/COS

    BioAsia
    Not Confirmed
    arrow

    10

    Leuprorelin

    CEP/COS

    BioAsia
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
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    JDMF

    read-more
    read-more

    01

    Acetaminophen

    JDMF

    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registration Number : 218MF10905

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2006-11-10

    Latest Date of Registration : 2009-12-22

    blank

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    #PipelineProspector

    Market
    Place

    02

    Fentanyl

    JDMF

    BioAsia
    Not Confirmed
    arrow

    Fentanyl

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registration Number : 221MF10283

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2009-12-22

    Latest Date of Registration : 2018-05-31

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Fentanyl citrate

    JDMF

    BioAsia
    Not Confirmed
    arrow

    Fentanyl citrate

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registration Number : 218MF10580

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2006-06-22

    Latest Date of Registration : 2006-06-22

    blank

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    Web Link

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    Market
    Place

    04

    Fentanyl citrate FP

    JDMF

    BioAsia
    Not Confirmed
    arrow

    Fentanyl citrate FP

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registration Number : 229MF10161

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2017-08-17

    Latest Date of Registration : 2017-08-17

    blank

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    #PipelineProspector

    Market
    Place

    05

    Ioversol

    JDMF

    BioAsia
    Not Confirmed
    arrow

    Ioversol

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Ireland
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    Mallinckrodt Pharmaceuticals

    Registration Number : 226MF10059

    Registrant's Address : Damastown, Mulhuddart, Dublin 15 Ireland

    Initial Date of Registration : 2014-03-06

    Latest Date of Registration : 2014-03-06

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    Market
    Place

    06

    Methadone hydrochloride

    JDMF

    BioAsia
    Not Confirmed
    arrow

    Methadone hydrochloride

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registration Number : 223MF10179

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2011-12-27

    Latest Date of Registration : 2012-09-14

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    Market
    Place

    07

    Pethidine hydrochloride

    JDMF

    BioAsia
    Not Confirmed
    arrow

    Pethidine hydrochloride

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registration Number : 218MF10904

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2006-11-10

    Latest Date of Registration : 2007-09-18

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    Market
    Place

    08

    Konpappu L

    JDMF

    BioAsia
    Not Confirmed
    arrow

    Konpappu L

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registration Number : 218MF10631

    Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States

    Initial Date of Registration : 2006-07-20

    Latest Date of Registration : 2016-11-15

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    Market
    Place

    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    KDMF

    read-more
    read-more

    01

    Acetaminophen

    Ireland
    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registrant Name : Wonpung Pharmaceutical Co., Ltd.

    Registration Date : 2011-05-16

    Registration Number : 20050831-32-C-126-07(D)

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 8801 Capital Boulevard, Raleigh, North Carolina 27616, USA

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    #Pipeline Prospector

    Market
    Place

    02

    Acetaminophen

    Ireland
    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registrant Name : Korea Janssen Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-32-C-125-06

    Manufacturer Name : SpecGx LLC@[Granule Process Ma...

    Manufacturer Address : 8801 Capital Boulevard, Raleigh, North Carolina 27616, USA@[Granulation Process Manuf...

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    Market
    Place

    03

    Acetaminophen

    Ireland
    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2020-07-01

    Registration Number : 20050831-32-C-126-07(C)

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 8801 Capital Boulevard, Raleigh, North Carolina 27616, USA

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    Market
    Place

    04

    Acetaminophen

    Ireland
    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registrant Name : Heilion Korea Co., Ltd.

    Registration Date : 2009-12-24

    Registration Number : 20091224-32-C-266-16

    Manufacturer Name : Mallinckrodt Inc.

    Manufacturer Address : Greenville Plant, Covidien, 100 Louis Latzer Drive, Greenville, Illinois 62246

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    Market
    Place

    05

    Acetaminophen

    Ireland
    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registrant Name : Agerson Bio Co., Ltd.

    Registration Date : 2022-06-10

    Registration Number : 20050831-32-C-126-07(B)

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 8801 Capital Boulevard, Raleigh, North Carolina 27616, USA

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    Market
    Place

    06

    Acetaminophen

    Ireland
    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registrant Name : Johnson & Johnson Korea Sales Co., Ltd.

    Registration Date : 2009-06-26

    Registration Number : 20090626-32-C-261-14

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 8801 Capital Boulevard, Raleigh, North Carolina 27616, USA

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    Market
    Place

    07

    Acetaminophen

    Ireland
    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registrant Name : Samyang Pharmaceutical Co., Ltd.

    Registration Date : 2011-10-21

    Registration Number : 20050831-32-C-126-07(3)

    Manufacturer Name : Spec Gx LLC

    Manufacturer Address : 8801 Capital Boulevard Raleigh, North Carolina 27616, USA

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    Market
    Place

    08

    Acetaminophen

    Ireland
    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2011-06-15

    Registration Number : 20050831-32-C-126-07(E)

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 8801 Capital Boulevard, Raleigh, North Carolina 27616, USA

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    Market
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    09

    Acetaminophen

    Ireland
    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registrant Name : Korea Janssen Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-32-C-126-07

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 8801 Capital Boulevard, Raleigh, North Carolina 27616, USA

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    Market
    Place

    10

    Acetaminophen

    Ireland
    BioAsia
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    BioAsia
    Not Confirmed
    • fda
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    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    Registrant Name : Korea Johnson & Johnson Sales Co., Ltd.

    Registration Date : 2023-01-10

    Registration Number : 20050831-32-C-126-07(A)

    Manufacturer Name : SpecGx LLC

    Manufacturer Address : 8801 Capital Boulevard, Raleigh, North Carolina 27616, USA

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    01

    ACETAMINOPHEN

    Ireland
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-4377

    Start Marketing Date : 2013-02-08

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (0.955kg/kg)

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    02

    ACETAMINOPHEN

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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-6135

    Start Marketing Date : 2013-02-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    ACETAMINOPHEN

    Ireland
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    Ireland
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-6375

    Start Marketing Date : 2013-02-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    ACETAMINOPHEN

    Ireland
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-4255

    Start Marketing Date : 2013-02-13

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (0.95kg/kg)

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    05

    ACETAMINOPHEN

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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-6114

    Start Marketing Date : 2013-02-08

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (0.9kg/kg)

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    06

    ACETAMINOPHEN

    Ireland
    The Generic Rx Session
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    ACETAMINOPHEN

    Ireland
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    The Generic Rx Session
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-3975

    Start Marketing Date : 2013-02-08

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (0.96kg/kg)

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    07

    ACETAMINOPHEN

    Ireland
    The Generic Rx Session
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    The Generic Rx Session
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-6056

    Start Marketing Date : 2013-02-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    ACETAMINOPHEN

    Ireland
    The Generic Rx Session
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    The Generic Rx Session
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-5543

    Start Marketing Date : 2013-02-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    ACETAMINOPHEN

    Ireland
    The Generic Rx Session
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    Ireland
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    The Generic Rx Session
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-4864

    Start Marketing Date : 2013-02-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    ACETAMINOPHEN

    Ireland
    The Generic Rx Session
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    Ireland
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    The Generic Rx Session
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-5541

    Start Marketing Date : 2013-02-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Contact Mallinckrodt Pharmaceuticals and get a quotation

    Mallinckrodt Pharmaceuticals is a supplier offers 154 products (APIs, Excipients or Intermediates).

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