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    Company profile for Mallinckrodt Pharmaceuticals

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    With Fermion, start the journey of your innovative API.

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

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    About

    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: 4520

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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]
    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025. 
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    Impressions: 222

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-bora-polpharma-make-acquisitions-evonik-euroapi-porton-announce-technological-expansions

    #PharmaFlow by PHARMACOMPASS
    19 Dec 2024
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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

    Antibody Engineering
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    Paracetamol

    Ireland

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

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    Antibody Engineering
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    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Johnson & Johnson Korea 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

    Antibody Engineering
    Not Confirmed
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    Fentanyl

    Ireland

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

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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

    Antibody Engineering
    Not Confirmed
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    Fentanyl Citrate

    Ireland

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

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    Antibody Engineering
    Not Confirmed
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    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
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    Certificate Number : CEP 2009-097 - Rev 02

    Issue Date : 2024-01-30

    Type : Chemical

    Substance Number : 1103

    Status : Valid

     JDMF arrow-down
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    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

    Antibody Engineering
    Not Confirmed
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    Amphetamine

    Ireland

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

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    Not Confirmed
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    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
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    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
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    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

    Antibody Engineering
    Not Confirmed
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    Buprenorphine Hydrochloride

    Ireland

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

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    USDMF arrow-down
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    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
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    Certificate Number : R1-CEP 2013-048 - Rev 00

    Issue Date : 2021-05-04

    Type : Chemical

    Substance Number : 1181

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    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
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    06

    Fentanyl Citrate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Fentanyl Citrate

    Ireland

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

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    Antibody Engineering
    Not Confirmed
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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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    07

    Methylphenidate Hydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Methylphenidate Hydrochloride

    Ireland

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

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

    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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    08

    Naloxone Hydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Naloxone Hydrochloride

    Ireland

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

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    Antibody Engineering
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    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
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    09

    Pethidine Hydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Pethidine Hydrochloride

    Ireland

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

    arrow
    Antibody Engineering
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    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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    10

    Sufentanil Citrate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Sufentanil Citrate

    Ireland

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

    arrow
    Antibody Engineering
    Not Confirmed
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    • EDQM
    • WHO-GMP
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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 : R0-CEP 2019-054 - Rev 00

    Issue Date : 2021-01-20

    Type : Chemical

    Substance Number : 1569

    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

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    01

    6-beta-naltrexol Hydrochloride

    Ireland
    Antibody Engineering
    Not Confirmed
    arrow

    02

    Abx And Cbx Bonded Phase Silica Gels

    Ireland
    Antibody Engineering
    Not Confirmed
    arrow

    03

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

    Ireland
    Antibody Engineering
    Not Confirmed
    arrow

    04

    Acetaminophen

    Ireland
    Antibody Engineering
    Not Confirmed
    arrow

    05

    Acetaminophen Controlled-release Bea...

    Ireland
    Antibody Engineering
    Not Confirmed
    arrow

    06

    Acetaminophen Usp

    Ireland
    Antibody Engineering
    Not Confirmed
    arrow

    07

    Acetoxyacetyl Chloride

    Ireland
    Antibody Engineering
    Not Confirmed
    arrow

    08

    Acetoxyacetyl Chloride

    Ireland
    Antibody Engineering
    Not Confirmed
    arrow

    09

    Actifed S.a. Brand Of Pseudoephedrin...

    Ireland
    Antibody Engineering
    Not Confirmed
    arrow

    10

    Acyclovir Usp (micronized), Coded 25...

    Ireland
    Antibody Engineering
    Not Confirmed
    arrow
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    NDC API

    read-more
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    01

    ACETAMINOPHEN

    Ireland
    Antibody Engineering
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
    arrow
    Antibody Engineering
    Not Confirmed
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-7250

    Start Marketing Date : 2013-02-19

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    blank

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    Market
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    02

    ACETAMINOPHEN

    Ireland
    Antibody Engineering
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    Antibody Engineering
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-7375

    Start Marketing Date : 2013-02-19

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    03

    ACETAMINOPHEN

    Ireland
    Antibody Engineering
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    Antibody Engineering
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-4814

    Start Marketing Date : 2013-02-19

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    blank

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    Market
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    04

    ACETAMINOPHEN

    Ireland
    Antibody Engineering
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    Antibody Engineering
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-7233

    Start Marketing Date : 2020-07-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    blank

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    Market
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    05

    ACETAMINOPHEN

    Ireland
    Antibody Engineering
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    Antibody Engineering
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-6056

    Start Marketing Date : 2013-02-19

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    blank

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    Market
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    06

    ACETAMINOPHEN

    Ireland
    Antibody Engineering
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    Antibody Engineering
    Not Confirmed
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    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-6375

    Start Marketing Date : 2013-02-19

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    07

    ACETAMINOPHEN

    Ireland
    Antibody Engineering
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    Antibody Engineering
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-5543

    Start Marketing Date : 2013-02-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
    Place

    08

    ACETAMINOPHEN

    Ireland
    Antibody Engineering
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    Antibody Engineering
    Not Confirmed
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    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-6135

    Start Marketing Date : 2013-02-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    09

    ACETAMINOPHEN

    Ireland
    Antibody Engineering
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    Antibody Engineering
    Not Confirmed
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-5541

    Start Marketing Date : 2013-02-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    ACETAMINOPHEN

    Ireland
    Antibody Engineering
    Not Confirmed
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    ACETAMINOPHEN

    Ireland
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    Antibody Engineering
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-6114

    Start Marketing Date : 2013-02-08

    End Marketing Date : 2024-12-31

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

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    Contact Mallinckrodt Plc and get a quotation

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