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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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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

    Impressions: 944

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    https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage

    Radio Compass
    12 Mar 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Top Pharma Companies & Drugs in 2024: Merck’s Keytruda maintains top spot as Novo’s semaglutide nips at its heels

    Top Pharma Companies & Drugs in 2024: Merck’s Keytruda maintains top spot as Novo’s semaglutide nips at its heels

    In 2024, Big Pharma players consolidated and maintained their dominance, even as innovation continued to reshape the pharmaceutical landscape. The primary change last year was the meteoric rise of glucagon-like peptide-1 (GLP-1) receptor agonists that treat diabetes and help in weight loss.Amongst drugmakers, Pfizer retained its numero uno spot with an impressive US$ 63.6 billion in prescription drug sales (up 7 percent from US$ 59.56 billion reported in 2023), despite ever-shrinking Comirnaty sales, which settled at US$ 5.35 billion in 2024 (from US$ 11.22 billion in 2023).Merck secured the second position with revenues of US$ 57.4 billion, a growth of 7 percent over 2023. This performance was predominantly fueled by Keytruda, which now accounts for more than half of Merck’s total pharmaceutical revenue. Johnson & Johnson came a close third with US$ 57 billion in prescription drug sales (up from US$ 54.76 billion in 2023).AbbVie held the fourth position with US$ 56.33 billion in sales, achieving 3.7 percent growth despite the ongoing erosion of Humira revenue. This flagship immunology drug saw sales plummet 37.6 percent to approximately US$ 9 billion, a US$ 5.4 billion reduction compared to 2023. Humira’s loss was offset by AbbVie’s newer immunology assets, particularly Skyrizi and Rinvoq, both of which demonstrated exceptional growth trajectories. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available)European giants Astra, Roche, Novartis, Sanofi round out top 10 list; Novo, Lilly see astounding growthWhile the top four positions were dominated by American drugmakers, European giants dominated the lower half of the top 10 list.AstraZeneca secured the fifth spot with US$ 54.1 billion in sales, thereby posting impressive growth of 18.1 percent over 2023. Roche claimed the sixth position with US$ 50.9 billion in sales while Novartis ranked seventh — with sales of US$ 50.3 billion. Novartis' impressive 10.8 percent sales growth is attributed to its innovative medicines portfolio. Oncology therapies remained a cornerstone for both these Swiss drugmakers.Bristol Myers Squibb (BMS) secured eighth position with revenues of US$ 48.3 billion, representing 7.3 percent growth over the previous year. At US$ 45 billion, Eli Lilly posted 32 percent revenue growth last year. Its GLP-1 drug Mounjaro helped Lilly move up from the tenth in 2023 to the ninth spot last year.Sanofi landed the tenth position with US$ 42.6 billion in sales, propelled largely by the expanding indications of Dupixent. The French multinational has increasingly focused on this immunology blockbuster, while also garnering more sales from its vaccine and rare disease portfolios.Novo Nordisk merits a mention as it posted an incredible 26 percent year-on-year growth. It retained its eleventh spot with US$ 40.25 billion in sales. Novo’s growth was driven almost exclusively by the extraordinary success of its GLP-1 receptor agonist portfolio. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available)       Merck’s Keytruda retains throne with US$ 29.5 bn in sales, as Novo’s semaglutide nips at its heelsMoving on to drugs, Merck’s Keytruda (pembrolizumab) solidified its position as the world’s top-selling pharmaceutical product with sales exceeding US$ 29.5 billion and year-on-year growth of 17.88 percent (US$ 4.5 billion). This remarkable performance was driven by steady sales growth across more than 40 indications in the US. In 2024 alone, Keytruda secured four new approvals from the US Food and Drug Administration (FDA).However, Novo Nordisk’s semaglutide sales (Ozempic, Wegovy and Rybelsus) gave Keytruda a run for its money. Across the three blockbuster drugs, semaglutide earned the Danish drugmaker around US$ 28 billion — i.e. a year-on-year increase of 38 percent.Novo’s Ozempic (semaglutide) reached over US$ 16.7 billion in sales — a 26 percent increase from 2023. Originally approved in 2017 to improve glycemic control, Ozempic bagged additional approvals in 2020, and in January 2025. It is now approved to reduce the risk of major cardiovascular events, as well as to reduce cardiovascular risk and to lower the likelihood of chronic kidney disease in type 2 diabetes patients.Sales of Wegovy (semaglutide), the other blockbuster GLP-1 drug from Novo, grew by a whopping 85.7 percent to over US$ 8 billion.Sanofi and Regeneron’s Dupixent (dupilumab) secured the number three spot with sales of US$ 13.6 billion, representing an impressive 22.4 percent year-on-year growth. In 2024, Dupixent received three new approvals and one label update. Notably, it became the first-ever biologic medicine approved for patients with chronic obstructive pulmonary disease (COPD). View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) AbbVie’s post-Humira strategy pays off as Skyrizi surges 51%; Lilly’s Mounjaro posts 124% growthGilead Sciences’ HIV treatment Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) showed robust growth of 13.27 percent, touching sales of US$ 13.42 billion in 2024 and emerging as the fourth largest selling drug. Biktarvy now commands over 50 percent of the US HIV treatment market. Unlike many other drugs on this list, Biktarvy faces no immediate patent challenges, with key protections expected to remain intact until 2033.BMS and Pfizer’s anticoagulant Eliquis (apixaban) claimed the fifth position with US$ 13.33 billion in sales, representing a 9.21 percent year-on-year increase. AbbVie’s Skyrizi (risankizumab) emerged as one of the fastest-growing assets with a 50.95 percent year-on-year increase, generating US$ 11.71 billion in 2024 sales, thereby surpassing Humira’s (adalimumab) diminished sales.This impressive performance, combined with Rinvoq’s (upadacitinib) growth, has prompted  AbbVie to raise its long-term outlook for these products. The company now expects combined Skyrizi and Rinvoq revenues to exceed US$ 31 billion by 2027, with Skyrizi alone projected to generate over US$ 20 billion.Johnson & Johnson’s Darzalex (daratumumab) claimed the seventh position with US$ 11.67 billion in sales, representing 19.77 percent growth over 2023.Lilly’s Mounjaro (tirzepatide) demonstrated dramatic growth with sales increasing 123.51 percent to US$ 11.54 billion. This performance was complemented by Zepbound (tirzepatide, for weight loss), which contributed US$ 4.9 billion to Lilly’s revenue. By the end of 2024, Mounjaro received FDA approval for a new indication in obstructive sleep apnea (OSA), becoming the first and only prescription medicine for moderate-to-severe OSA in adults with obesity.Stelara (ustekinumab) ranked ninth, bringing J&J sales of US$ 10.36 billion, showing a modest decline of 4.91 percent from its 2023 sales.Vertex’s triple-combination therapy Trikafta (elexacaftor/tezacaftor/ivacaftor) for treating cystic fibrosis rounded out the top ten list with sales of US$ 10.2 billion, up 14 percent from the previous year. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) Our viewIn 2024, transformative therapies like GLP-1 receptor agonists drove growth in the pharmaceutical industry. This year, we expect GLP-1 drugs to dethrone Keytruda from the number one spot. Along with novel immunology agents, we expect GLP-1 drugs to realign the pharmaceutical market.  
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    Impressions: 1611

    https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-drugs-in-2024-merck-s-keytruda-maintains-top-spot-as-novo-s-semaglutide-nips-at-its-heels

    #PharmaFlow by PHARMACOMPASS
    24 Apr 2025
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    NEWS #PharmaBuzz

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    Mallinckrodt plc to Report Q1 2025 Earnings
    Mallinckrodt plc to Report Q1 2025 Earnings

    10 Apr 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-plc-to-report-earnings-results-for-first-quarter-2025-302424998.html

    PR NEWSWIRE
    10 Apr 2025
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    Mallinckrodt and Endo get a bump from tariffs in $6.7 billion merger
    Mallinckrodt and Endo get a bump from tariffs in $6.7 billion merger

    14 Mar 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/drugmakers-mallinckrodt-endo-merge-nearly-7-billion-deal-2025-03-13/

    REUTERS
    14 Mar 2025
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    Mallinckrodt plc Reports Q4 and FY 2024 Results, 2025 Guidance
    Mallinckrodt plc Reports Q4 and FY 2024 Results, 2025 Guidance

    13 Mar 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-plc-reports-fourth-quarter-and-fiscal-year-2024-financial-results-and-provides-2025-guidance-302400719.html

    PR NEWSWIRE
    13 Mar 2025
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    Mallinckrodt plc Reschedules Q4 & FY 2024 Results to March 13
    Mallinckrodt plc Reschedules Q4 & FY 2024 Results to March 13

    10 Mar 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-plc-reschedules-release-of-fourth-quarter-and-fiscal-year-2024-financial-results-to-thursday-march-13-2025-302397490.html

    PR NEWSWIRE
    10 Mar 2025
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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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    ALL APIs

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    01

    Paracetamol

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

    MAGHREB PHARMA
    Not Confirmed
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    Paracetamol

    Ireland

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

    arrow
    MAGHREB PHARMA
    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 : 0406-0694

    Start Marketing Date : 2023-07-07

    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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    #PipelineProspector

    Market
    Place

    02

    Fentanyl

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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Fentanyl

    Ireland

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

    arrow
    MAGHREB PHARMA
    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 : 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 : 0406-5527

    Start Marketing Date : 2001-12-21

    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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Fentanyl Citrate

    Ireland

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

    arrow
    MAGHREB PHARMA
    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 : 0406-1333

    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
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    04

    Amphetamine

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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Amphetamine

    Ireland

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

    arrow
    MAGHREB PHARMA
    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 : 0406-4942

    Start Marketing Date : 2013-11-22

    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

    05

    Buprenorphine Hydrochloride

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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Buprenorphine Hydrochloride

    Ireland

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

    arrow
    MAGHREB PHARMA
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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
    ✖

    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
    ✖

    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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    Market
    Place

    06

    Fentanyl Citrate

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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Fentanyl Citrate

    Ireland

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

    arrow
    MAGHREB PHARMA
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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 : 0406-1205

    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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    Market
    Place

    07

    Methylphenidate Hydrochloride

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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Methylphenidate Hydrochloride

    Ireland

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

    arrow
    MAGHREB PHARMA
    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 : 0406-1335

    Start Marketing Date : 2014-03-01

    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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Naloxone Hydrochloride

    Ireland

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

    arrow
    MAGHREB PHARMA
    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 : 0406-1493

    Start Marketing Date : 2020-11-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Product
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    Market
    Place

    09

    Pethidine Hydrochloride

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

    World Vaccine Conference
    Not Confirmed
    arrow

    Pethidine Hydrochloride

    Ireland

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

    arrow
    World Vaccine Conference
    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
    blank

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    #PipelineProspector

    Market
    Place

    10

    Sufentanil Citrate

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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Sufentanil Citrate

    Ireland

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

    arrow
    MAGHREB PHARMA
    Not Confirmed
    • fda
    • 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 : 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 : 0406-0678

    Start Marketing Date : 2017-01-27

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    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
    MAGHREB PHARMA
    Not Confirmed
    arrow

    02

    Abx And Cbx Bonded Phase Silica Gels

    Ireland
    MAGHREB PHARMA
    Not Confirmed
    arrow

    03

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

    Ireland
    MAGHREB PHARMA
    Not Confirmed
    arrow

    04

    Acetaminophen

    Ireland
    MAGHREB PHARMA
    Not Confirmed
    arrow

    05

    Acetaminophen Controlled-release Bea...

    Ireland
    Cophex
    Not Confirmed
    arrow

    06

    Acetaminophen Usp

    Ireland
    MAGHREB PHARMA
    Not Confirmed
    arrow

    07

    Acetoxyacetyl Chloride

    Ireland
    MAGHREB PHARMA
    Not Confirmed
    arrow

    08

    Acetoxyacetyl Chloride

    Ireland
    MAGHREB PHARMA
    Not Confirmed
    arrow

    09

    Actifed S.a. Brand Of Pseudoephedrin...

    Ireland
    MAGHREB PHARMA
    Not Confirmed
    arrow

    10

    Acyclovir Usp (micronized), Coded 25...

    Ireland
    MAGHREB PHARMA
    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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    02

    Buprenorphine hydrochloride

    CEP/COS

    MAGHREB PHARMA
    Not Confirmed
    arrow

    03

    Buprenorphine hydrochloride, Process II

    CEP/COS

    MAGHREB PHARMA
    Not Confirmed
    arrow

    04

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

    CEP/COS

    MAGHREB PHARMA
    Not Confirmed
    arrow

    05

    Codeine phosphate hemihydrate

    CEP/COS

    MAGHREB PHARMA
    Not Confirmed
    arrow

    06

    Desmopressin

    CEP/COS

    MAGHREB PHARMA
    Not Confirmed
    arrow

    07

    Dexamfetamine sulfate

    CEP/COS

    MAGHREB PHARMA
    Not Confirmed
    arrow

    08

    Fentanyl

    CEP/COS

    MAGHREB PHARMA
    Not Confirmed
    arrow

    09

    Fentanyl citrate

    CEP/COS

    MAGHREB PHARMA
    Not Confirmed
    arrow

    10

    Leuprorelin

    CEP/COS

    MAGHREB PHARMA
    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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    MAGHREB PHARMA
    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

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    Market
    Place

    02

    Fentanyl

    JDMF

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Fentanyl

    Ireland
    arrow
    MAGHREB PHARMA
    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

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    Market
    Place

    03

    Fentanyl citrate

    JDMF

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Fentanyl citrate

    Ireland
    arrow
    MAGHREB PHARMA
    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

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    Market
    Place

    04

    Fentanyl citrate FP

    JDMF

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Fentanyl citrate FP

    Ireland
    arrow
    MAGHREB PHARMA
    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

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    Market
    Place

    05

    Ioversol

    JDMF

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Ioversol

    Ireland
    arrow
    MAGHREB PHARMA
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Methadone hydrochloride

    Ireland
    arrow
    MAGHREB PHARMA
    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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Pethidine hydrochloride

    Ireland
    arrow
    MAGHREB PHARMA
    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

    MAGHREB PHARMA
    Not Confirmed
    arrow

    Konpappu L

    Ireland
    arrow
    MAGHREB PHARMA
    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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    KDMF

    read-more
    read-more

    01

    Acetaminophen

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    Cophex
    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

    02

    Acetaminophen

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen

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

    Registrant Name : Korea Johnson & Johnson 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

    03

    Acetaminophen

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    Cophex
    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
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    04

    Acetaminophen

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    Cophex
    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

    05

    Acetaminophen

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen

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

    Registrant Name : (주)애거슨바이오

    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
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    06

    Acetaminophen

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    Cophex
    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
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    07

    Acetaminophen

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    Cophex
    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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    08

    Acetaminophen

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    Cophex
    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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    09

    Acetaminophen

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    Cophex
    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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    10

    Acetaminophen

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen

    Ireland
    arrow
    Cophex
    Not Confirmed
    • fda
    • EDQM
    • 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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    NDC API

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    01

    ACETAMINOPHEN

    Ireland
    World Vaccine Conference
    Not Confirmed
    arrow

    ACETAMINOPHEN

    Ireland
    arrow
    World Vaccine Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    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

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    Market
    Place

    02

    ACETAMINOPHEN

    Ireland
    World Vaccine Conference
    Not Confirmed
    arrow

    ACETAMINOPHEN

    Ireland
    arrow
    World Vaccine Conference
    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.

    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-0244

    Start Marketing Date : 2013-02-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    Place

    03

    ACETAMINOPHEN

    Ireland
    World Vaccine Conference
    Not Confirmed
    arrow

    ACETAMINOPHEN

    Ireland
    arrow
    World Vaccine Conference
    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.

    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-0422

    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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    Market
    Place

    04

    ACETAMINOPHEN

    Ireland
    World Vaccine Conference
    Not Confirmed
    arrow

    ACETAMINOPHEN

    Ireland
    arrow
    World Vaccine Conference
    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.

    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-0167

    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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    Market
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    05

    ACETAMINOPHEN

    Ireland
    World Vaccine Conference
    Not Confirmed
    arrow

    ACETAMINOPHEN

    Ireland
    arrow
    World Vaccine Conference
    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.

    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-0090

    Start Marketing Date : 1982-12-20

    End Marketing Date : 2026-12-31

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

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    Market
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    06

    ACETAMINOPHEN

    Ireland
    World Vaccine Conference
    Not Confirmed
    arrow

    ACETAMINOPHEN

    Ireland
    arrow
    World Vaccine Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-0081

    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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    Market
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    07

    ACETAMINOPHEN

    Ireland
    World Vaccine Conference
    Not Confirmed
    arrow

    ACETAMINOPHEN

    Ireland
    arrow
    World Vaccine Conference
    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.

    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-0161

    Start Marketing Date : 1982-12-20

    End Marketing Date : 2026-12-31

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

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    Market
    Place

    08

    ACETAMINOPHEN

    Ireland
    World Vaccine Conference
    Not Confirmed
    arrow

    ACETAMINOPHEN

    Ireland
    arrow
    World Vaccine Conference
    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.

    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-0057

    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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    Market
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    09

    ACETAMINOPHEN

    Ireland
    World Vaccine Conference
    Not Confirmed
    arrow

    ACETAMINOPHEN

    Ireland
    arrow
    World Vaccine Conference
    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.

    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-0114

    Start Marketing Date : 2013-02-08

    End Marketing Date : 2026-12-31

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

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    Market
    Place

    10

    ACETAMINOPHEN

    Ireland
    World Vaccine Conference
    Not Confirmed
    arrow

    ACETAMINOPHEN

    Ireland
    arrow
    World Vaccine Conference
    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.

    Mallinckrodt Pharmaceuticals

    NDC Package Code : 0406-0048

    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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    LISTED APIs

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    Acetaminophen/Paracetamol

    Product
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    Market
    Place

    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 his...
    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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    01

    Acetaminophen/Paracetamol

    Ireland
    Cophex
    Not Confirmed
    arrow

    Acetaminophen/Paracetamol

    Ireland
    arrow
    Cophex
    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.

    Mallinckrodt Pharmaceuticals

    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.

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet pati...

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    • EDQM
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    • EDQM
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    Amphetamine

    Product
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    #PipelineProspector

    Market
    Place

    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 his...
    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.
    blank

    02

    Amphetamine

    Ireland
    Cophex
    Not Confirmed
    arrow

    Amphetamine

    Ireland
    arrow
    Cophex
    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.

    Mallinckrodt Pharmaceuticals

    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.

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet pati...

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    Amphetamine Aspartate

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    #PipelineProspector

    Market
    Place

    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 his...
    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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    03

    Amphetamine Aspartate

    Ireland
    Cophex
    Not Confirmed
    arrow

    Amphetamine Aspartate

    Ireland
    arrow
    Cophex
    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.

    Mallinckrodt Pharmaceuticals

    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.

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet pati...

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    • FDA
    • EDQM
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    Amphetasul

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    Market
    Place

    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 his...
    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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    04

    Amphetasul

    Ireland
    Cophex
    Not Confirmed
    arrow

    Amphetasul

    Ireland
    arrow
    Cophex
    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.

    Mallinckrodt Pharmaceuticals

    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.

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet pati...

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    • FDA
    • EDQM
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    Benzphetamine

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    Market
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    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 his...
    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.
    blank

    05

    Benzphetamine

    Ireland
    Cophex
    Not Confirmed
    arrow

    Benzphetamine

    Ireland
    arrow
    Cophex
    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.

    Mallinckrodt Pharmaceuticals

    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.

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet pati...

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    Buprenorphine

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    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 his...
    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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    06

    Buprenorphine

    Ireland
    Cophex
    Not Confirmed
    arrow

    Buprenorphine

    Ireland
    arrow
    Cophex
    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.

    Mallinckrodt Pharmaceuticals

    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.

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet pati...

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    Buprenorphine Hydrochloride

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    Place

    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 his...
    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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    07

    Buprenorphine Hydrochloride

    Ireland
    Cophex
    Not Confirmed
    arrow

    Buprenorphine Hydrochloride

    Ireland
    arrow
    Cophex
    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.

    Mallinckrodt Pharmaceuticals

    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.

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet pati...

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    COCAINE HYDROCHLORIDE

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    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 his...
    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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    COCAINE HYDROCHLORIDE

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    COCAINE HYDROCHLORIDE

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    Mallinckrodt Pharmaceuticals

    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.

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet pati...

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    Codeine Phosphate

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    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 his...
    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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    Codeine Phosphate

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    Codeine Phosphate

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    Mallinckrodt Pharmaceuticals

    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.

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet pati...

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    Codeine Phosphate

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    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 his...
    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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    Codeine Phosphate

    Ireland
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    Codeine Phosphate

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    Mallinckrodt Pharmaceuticals

    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.

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet pati...

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    Drugs in Development

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    Mallinckrodt Reaches Agreement to Sell Therakos® Business to CVC for $925 Million

    Details:

    Through the acquisition, CVC will leverage the Company's Therakos Uvadex (methoxsalen), a fully integrated ECP delivery system for skin manifestations of Cutaneous T-cell lymphoma.


    Lead Product(s): Methoxsalen

    Therapeutic Area: Oncology Brand Name: Uvadex

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: CVC Capital Partners

    Deal Size: $925.0 million Upfront Cash: Undisclosed

    Deal Type: Acquisition May 08, 2024

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    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : Methoxsalen

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : CVC Capital Partners

    Deal Size : $925.0 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Mallinckrodt Reaches Agreement to Sell Therakos® Business to CVC for $925 Million

    Details : Through the acquisition, CVC will leverage the Company's Therakos Uvadex (methoxsalen), a fully integrated ECP delivery system for skin manifestations of Cutaneous T-cell lymphoma.

    Product Name : Uvadex

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    May 08, 2024

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    Mallinckrodt Gets FDA Approval for Acthar® Gel Single-Dose Pre-filled Injector

    Details:

    SelfJect (repository corticotropin) is an ACTH analogue indicated as monotherapy for infantile spasms in children under 2 and exacerbations of multiple sclerosis in adults.


    Lead Product(s): Corticotropin

    Therapeutic Area: Neurology Brand Name: Acthar

    Study Phase: Approved FDFProduct Type: Hormone

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 03, 2024

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    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Lead Product(s) : Corticotropin

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt Gets FDA Approval for Acthar® Gel Single-Dose Pre-filled Injector

    Details : SelfJect (repository corticotropin) is an ACTH analogue indicated as monotherapy for infantile spasms in children under 2 and exacerbations of multiple sclerosis in adults.

    Product Name : Acthar

    Product Type : Hormone

    Upfront Cash : Inapplicable

    January 03, 2024

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    Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Product Used to Treat Attention-Deficit/Hyperactivity Diso...

    Details:

    Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the FDA's drug shortage list.


    Lead Product(s): Lisdexamfetamine Dimesylate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Vyvanse-Generic

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 31, 2023

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    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Lead Product(s) : Lisdexamfetamine Dimesylate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Prod...

    Details : Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the FDA's drug shortage list.

    Product Name : Vyvanse-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    August 31, 2023

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    Mallinckrodt Announces FDA Clearance of the INOmax® EVOLVE™ DS Delivery System and Approval of the INOmax® (nitric oxide) Mini-Cylinder

    Details:

    INOmax® EVOLVE™ DS delivery system has been cleared by the U.S. Food and Drug Administration for the delivery of INOmax® (nitric oxide) gas, for inhalation, for the treating neonatal patients with hypoxic respiratory failure


    Lead Product(s): Nitric Oxide

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: INOmax

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 12, 2023

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    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Lead Product(s) : Nitric Oxide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt Announces FDA Clearance of the INOmax® EVOLVE™ DS Delivery System and Approval of ...

    Details : INOmax® EVOLVE™ DS delivery system has been cleared by the U.S. Food and Drug Administration for the delivery of INOmax® (nitric oxide) gas, for inhalation, for the treating neonatal patients with hypoxic respiratory failure

    Product Name : INOmax

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 12, 2023

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    Silence Therapeutics to Buyback siRNA Complement Assets

    Details:

    Silence will gain rights back to 2 undisclosed complement targets. SLN501, the C3 targeting program will remain under the agreement. Silence’s proprietary mRNAi GOLD™ platform can be used to create siRNAs that precisely target and silence disease-associated genes in the liver.


    Lead Product(s): Undisclosed

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: IND EnablingProduct Type: Other Large Molecule

    Sponsor: Silence Therapeutics

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement March 28, 2023

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    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : IND Enabling

    Partner/Sponsor/Collaborator : Silence Therapeutics

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Silence Therapeutics to Buyback siRNA Complement Assets

    Details : Silence will gain rights back to 2 undisclosed complement targets. SLN501, the C3 targeting program will remain under the agreement. Silence’s proprietary mRNAi GOLD™ platform can be used to create siRNAs that precisely target and silence disease-ass...

    Product Name : Undisclosed

    Product Type : Other Large Molecule

    Upfront Cash : Undisclosed

    March 28, 2023

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    Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gas...

    Details:

    TERLIVAZ (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.


    Lead Product(s): Terlipressin Acetate

    Therapeutic Area: Nephrology Brand Name: Terlivaz

    Study Phase: Approved FDFProduct Type: Other Large Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 24, 2022

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    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
    Not Confirmed

    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Lead Product(s) : Terlipressin Acetate

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hep...

    Details : TERLIVAZ (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.

    Product Name : Terlivaz

    Product Type : Other Large Molecule

    Upfront Cash : Inapplicable

    October 24, 2022

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    Mallinckrodt Announces Submission of 510(k) to the U.S. FDA for Inhaled Nitric Oxide Delivery System

    Details:

    INOmax® (nitric oxide) gas, for inhalation, is an FDA-approved treatment that is indicated to improve oxygenation and reduce need for extracorporeal membrane oxygenation in term and near-term neonates with hypoxic respiratory failure associated.


    Lead Product(s): Nitric Oxide

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: INOmax

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 28, 2022

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    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    MAGHREB PHARMA
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    Lead Product(s) : Nitric Oxide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt Announces Submission of 510(k) to the U.S. FDA for Inhaled Nitric Oxide Delivery Syst...

    Details : INOmax® (nitric oxide) gas, for inhalation, is an FDA-approved treatment that is indicated to improve oxygenation and reduce need for extracorporeal membrane oxygenation in term and near-term neonates with hypoxic respiratory failure associated.

    Product Name : INOmax

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    September 28, 2022

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    Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (terlipressin) for injection for the Treatment of Hepatorenal Syndrome (HRS)

    Details:

    Terlivaz (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.


    Lead Product(s): Terlipressin Acetate

    Therapeutic Area: Nephrology Brand Name: Terlivaz

    Study Phase: Approved FDFProduct Type: Other Large Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 14, 2022

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    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
    Not Confirmed

    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Lead Product(s) : Terlipressin Acetate

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (terlipressin) for injection for the Treatm...

    Details : Terlivaz (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.

    Product Name : Terlivaz

    Product Type : Other Large Molecule

    Upfront Cash : Inapplicable

    September 14, 2022

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    Mallinckrodt to Present Data on Terlipressin in Adult Patients with Hepatorenal Syndrome (HRS) at the European Association for the Study of the Liver (E...

    Details:

    Teripress (Terlipressin) is an analogue of vasopressin used as a vasoactive drug in the management of hypotension which has been found to be effective when norepinephrine fails.


    Lead Product(s): Terlipressin Acetate

    Therapeutic Area: Nephrology Brand Name: Terlivaz

    Study Phase: Approved FDFProduct Type: Other Large Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 23, 2022

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    09

    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
    Not Confirmed

    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Lead Product(s) : Terlipressin Acetate

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt to Present Data on Terlipressin in Adult Patients with Hepatorenal Syndrome (HRS) at ...

    Details : Teripress (Terlipressin) is an analogue of vasopressin used as a vasoactive drug in the management of hypotension which has been found to be effective when norepinephrine fails.

    Product Name : Terlivaz

    Product Type : Other Large Molecule

    Upfront Cash : Inapplicable

    June 23, 2022

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    Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Syndrome

    Details:

    Teripress (Terlipressin) is an investigational agent, to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function, an acute and life-threatening condition.


    Lead Product(s): Terlipressin Acetate

    Therapeutic Area: Nephrology Brand Name: Terlivaz

    Study Phase: Approved FDFProduct Type: Other Large Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 13, 2022

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    10

    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Mallinckrodt Pharmaceuticals

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    MAGHREB PHARMA
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    Lead Product(s) : Terlipressin Acetate

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Sy...

    Details : Teripress (Terlipressin) is an investigational agent, to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function, an acute and life-threatening condition.

    Product Name : Terlivaz

    Product Type : Other Large Molecule

    Upfront Cash : Inapplicable

    June 13, 2022

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    FDA

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    01

    FDA Audited

    USA
    World Vaccine Conference
    Not Confirmed
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    FDA Audited

    USA
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    World Vaccine Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-07-07

    Mallinckrodt Pharmaceuticals

    City : Cincinnati

    State : OH

    Country/Area : US

    Zip : 45237-1624

    District : CIN

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2015-07-07

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    FDA Audited

    USA
    World Vaccine Conference
    Not Confirmed
    arrow

    FDA Audited

    USA
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    World Vaccine Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-07-07

    Mallinckrodt Pharmaceuticals

    City : Cincinnati

    State : OH

    Country/Area : US

    Zip : 45237-1624

    District : CIN

    Center : CDRH

    Project Area : Postmarket Assurance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2015-07-07

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    FDA Audited

    USA
    World Vaccine Conference
    Not Confirmed
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    FDA Audited

    USA
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    World Vaccine Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-07-25

    Mallinckrodt Pharmaceuticals

    City : Raleigh

    State : NC

    Country/Area : US

    Zip : 27616-3104

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-07-25

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    FDA Audited

    USA
    World Vaccine Conference
    Not Confirmed
    arrow

    FDA Audited

    USA
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    World Vaccine Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-18

    Mallinckrodt Pharmaceuticals

    City : Hazelwood

    State : MO

    Country/Area : US

    Zip : 63042-2513

    District : KAN

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-18

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    FDA Audited

    USA
    World Vaccine Conference
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    FDA Audited

    USA
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    World Vaccine Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-18

    Mallinckrodt Pharmaceuticals

    City : Hazelwood

    State : MO

    Country/Area : US

    Zip : 63042-2513

    District : KAN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-18

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    06

    FDA Audited

    USA
    World Vaccine Conference
    Not Confirmed
    arrow

    FDA Audited

    USA
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    World Vaccine Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-18

    Mallinckrodt Pharmaceuticals

    City : Maryland Heights

    State : MO

    Country/Area : US

    Zip : 63043-3421

    District : KAN

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-18

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    07

    FDA Audited

    USA
    World Vaccine Conference
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    World Vaccine Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-18

    Mallinckrodt Pharmaceuticals

    City : Maryland Heights

    State : MO

    Country/Area : US

    Zip : 63043-3421

    District : KAN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-18

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    08

    FDA Audited

    USA
    World Vaccine Conference
    Not Confirmed
    arrow

    FDA Audited

    USA
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    World Vaccine Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-12

    Mallinckrodt Pharmaceuticals

    City : Saint Louis

    State : MO

    Country/Area : US

    Zip : 63147-3457

    District : KAN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-12

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    09

    FDA Audited

    USA
    World Vaccine Conference
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    FDA Audited

    USA
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    World Vaccine Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-05-24

    Mallinckrodt Pharmaceuticals

    City : Saint Louis

    State : MO

    Country/Area : US

    Zip : 63147-3457

    District : KAN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-05-24

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    10

    FDA Audited

    USA
    World Vaccine Conference
    Not Confirmed
    arrow

    FDA Audited

    USA
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    World Vaccine Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-03-27

    Mallinckrodt Pharmaceuticals

    City : Maryland Heights

    State : MO

    Country/Area : US

    Zip : 63043-3421

    District : KAN

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2013-03-27

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