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    Company profile for Mallinckrodt Pharmaceuticals

    NEW Drugs in Dev: 40
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    EVENTS

    DIGITAL CONTENT

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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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    CONTACT DETAILS

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    Mallinckrodt PharmaceuticalsIreland Flag
    Country
    Country
    Ireland
    Address
    Address
    College Business & Technology Park Cruiserath, Blanchardstown Dublin 15
    Telephone
    Telephone
    +353 1 6960000
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.mallinckrodt.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/mallinckrodt/
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    YouTube
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    Twitter
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    NEWS #PharmaBuzz

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    Specgx’s Generics Buprenorphine HCl Receives Approval in US
    Specgx’s Generics Buprenorphine HCl Receives Approval in US

    10 Dec 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218473

    FDA
    10 Dec 2025
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    Mallinckrodt Spins Off Par Health, Launches Keenova Therapeutics
    Mallinckrodt Spins Off Par Health, Launches Keenova Therapeutics

    10 Nov 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-completes-spin-off-of-par-health-introduces-keenova-therapeutics-302610045.html

    PR NEWSWIRE
    10 Nov 2025
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    Par Health Reveals Q3 2025 Financials And Business Update
    Par Health Reveals Q3 2025 Financials And Business Update

    10 Nov 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/par-health-reports-third-quarter-2025-financial-results-and-provides-business-update-302609774.html

    PR NEWSWIRE
    10 Nov 2025
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    Mallinckrodt Reports Third Quarter 2025 Financial Results
    Mallinckrodt Reports Third Quarter 2025 Financial Results

    10 Nov 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-reports-third-quarter-2025-financial-results-302610046.html

    PR NEWSWIRE
    10 Nov 2025
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    Mallinckrodt To Showcase Terlipressin Data At 2025 AASLD Meeting
    Mallinckrodt To Showcase Terlipressin Data At 2025 AASLD Meeting

    31 Oct 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-to-present-data-on-terlipressin-at-the-2025-american-association-for-the-study-of-liver-diseases-aasld-annual-meeting-302600457.html

    PR NEWSWIRE
    31 Oct 2025
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    Mallinckrodt To Showcase Terlipressin Data For HRS-AKI
    Mallinckrodt To Showcase Terlipressin Data For HRS-AKI

    30 Oct 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/mallinckrodt-to-present-data-on-terlipressin-in-patients-with-hepatorenal-syndrome-acute-kidney-injury-hrs-aki-at-kidney-week-2025-302599248.html

    PR NEWSWIRE
    30 Oct 2025
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    ALL APIs

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

    01

    Paracetamol

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Paracetamol

    Ireland

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4203

    Submission : 1981-06-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

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

    Issue Date : 2018-04-25

    Type : Chemical

    Substance Number : 49

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10905

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

    Initial Date of Registration : 2006-11-10

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-0694

    Start Marketing Date : 2023-07-07

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kenview Korea Sales Co., Ltd.

    Registration Date : 2023-01-10

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

    Manufacturer Name : SpecGx LLC

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

     VMF Others AUDIT arrow-down
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    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Fentanyl

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Fentanyl

    Ireland

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 8074

    Submission : 1989-05-11

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2005-260 - Rev 03

    Issue Date : 2024-02-14

    Type : Chemical

    Substance Number : 1210

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10283

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

    Initial Date of Registration : 2009-12-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-5527

    Start Marketing Date : 2001-12-21

    End Marketing Date : 2026-12-31

    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 arrow-down
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    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Fentanyl Citrate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Fentanyl Citrate

    Ireland

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7051

    Submission : 1987-07-02

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Amphetamine Sulfate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Amphetamine Sulfate

    Ireland

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

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

    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 : 0406-9450

    Start Marketing Date : 2025-08-28

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Buprenorphine Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Buprenorphine Hydrochloride

    Ireland

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

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

    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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Fentanyl Citrate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Fentanyl Citrate

    Ireland

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

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

    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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Methylphenidate Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Methylphenidate Hydrochloride

    Ireland

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

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

    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 : 2026-12-31

    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 arrow-down
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    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    08

    Naloxone Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Naloxone Hydrochloride

    Ireland

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

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

    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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Pethidine Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Pethidine Hydrochloride

    Ireland

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-01

    Pay. Date : 2014-07-28

    DMF Number : 11345

    Submission : 1995-02-10

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10904

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

    Initial Date of Registration : 2006-11-10

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0406-1585

    Start Marketing Date : 2013-11-20

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    Market
    Place

    10

    Sufentanil Citrate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Sufentanil Citrate

    Ireland

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

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

    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 : 2026-12-31

    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 arrow-down
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    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Drugs in Development

    read-more
    read-more
    • Development Update
    • fda
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    • WHO-GMP
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    Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Comb...

    Details:

    RN3161 is a oligonucleotide drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Obesity.


    Lead Product(s): RN3161

    Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed

    Study Phase: Phase I/ Phase IIProduct Type: Oligonucleotide

    Sponsor: Rona Therapeutics

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 24, 2025

    blank

    01

    Mallinckrodt Pharmaceuticals

    Ireland
    arrow
    PEGS Boston Summit
    Not Confirmed

    Mallinckrodt Pharmaceuticals

    Ireland
    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : RN3161

    Therapeutic Area : Nutrition and Weight Loss

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Rona Therapeutics

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effe...

    Details : RN3161 is a oligonucleotide drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Obesity.

    Product Name : Undisclosed

    Product Type : Oligonucleotide

    Upfront Cash : Inapplicable

    November 24, 2025

    blank

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    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Deals
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    Mallinckrodt Spins Off Par Health, Introduces Keenova Therapeutics

    Details:

    In a demerger deal, Corticotropin, a hormone targeting Melanocortin receptor 2, will focus on rare conditions.


    Lead Product(s): Corticotropin

    Therapeutic Area: Neurology Brand Name: Acthar Gel

    Study Phase: Approved FDFProduct Type: Hormone

    Recipient: Par Health

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Demerger November 10, 2025

    blank

    02

    Mallinckrodt Pharmaceuticals

    Ireland
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    Lead Product(s) : Corticotropin

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Recipient : Par Health

    Deal Size : Undisclosed

    Deal Type : Demerger

    DEALS_DEV arrow-down

    Mallinckrodt Spins Off Par Health, Introduces Keenova Therapeutics

    Details : In a demerger deal, Corticotropin, a hormone targeting Melanocortin receptor 2, will focus on rare conditions.

    Product Name : Acthar Gel

    Product Type : Hormone

    Upfront Cash : Undisclosed

    November 10, 2025

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    Mallinckrodt, Endo Complete Merger to Create Global, Diversified Therapeutics Leader

    Details:

    Under the merger agreement, the combined generic businesses & Endo's injectables business will form a new standalone entity, which includes Tekturna-Generic (aliskiren hemifumarate) for hypertension.


    Lead Product(s): Aliskiren

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Tekturna-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Endo Pharm

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Merger August 01, 2025

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    Lead Product(s) : Aliskiren

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Endo Pharm

    Deal Size : Undisclosed

    Deal Type : Merger

    DEALS_DEV arrow-down

    Mallinckrodt, Endo Complete Merger to Create Global, Diversified Therapeutics Leader

    Details : Under the merger agreement, the combined generic businesses & Endo's injectables business will form a new standalone entity, which includes Tekturna-Generic (aliskiren hemifumarate) for hypertension.

    Product Name : Tekturna-Generic

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    August 01, 2025

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    Mallinckrodt and Endo Announce Significant Progress in Proposed Merger

    Details:

    Under the merger agreement, the combined generic businesses & Endo's injectables business will form a new standalone entity, which includes Tekturna-Generic (aliskiren hemifumarate) for hypertension.


    Lead Product(s): Aliskiren

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Tekturna-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Recipient: Endo Pharm

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Merger May 13, 2025

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    04

    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : Aliskiren

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Recipient : Endo Pharm

    Deal Size : Undisclosed

    Deal Type : Merger

    DEALS_DEV arrow-down

    Mallinckrodt and Endo Announce Significant Progress in Proposed Merger

    Details : Under the merger agreement, the combined generic businesses & Endo's injectables business will form a new standalone entity, which includes Tekturna-Generic (aliskiren hemifumarate) for hypertension.

    Product Name : Tekturna-Generic

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    May 13, 2025

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    Mallinckrodt and Endo Get a Bump from Tariffs in $6.7 Billion Merger

    Details:

    The companies will merge and integrate their entire pipelines, including Xiaflex (collagenase clostridium histolyticum) for treating adult patients with Dupuytren’s contracture.


    Lead Product(s): Collagenase Clostridium Histolyticum

    Therapeutic Area: Musculoskeletal Brand Name: Xiaflex

    Study Phase: Approved FDFProduct Type: Enzyme

    Recipient: Endo International

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Merger March 13, 2025

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    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : Collagenase Clostridium Histolyticum

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved FDF

    Recipient : Endo International

    Deal Size : Undisclosed

    Deal Type : Merger

    DEALS_DEV arrow-down

    Mallinckrodt and Endo Get a Bump from Tariffs in $6.7 Billion Merger

    Details : The companies will merge and integrate their entire pipelines, including Xiaflex (collagenase clostridium histolyticum) for treating adult patients with Dupuytren’s contracture.

    Product Name : Xiaflex

    Product Type : Enzyme

    Upfront Cash : Undisclosed

    March 13, 2025

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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: Miscellaneous

    Sponsor: CVC Capital Partners

    Deal Size: $925.0 million Upfront Cash: Undisclosed

    Deal Type: Acquisition August 05, 2024

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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 : Miscellaneous

    Upfront Cash : Undisclosed

    August 05, 2024

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    Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

    Details:

    RN0361 is a Oligonucleotide drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Hypertriglyceridemia.


    Lead Product(s): RN0361

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase I/ Phase IIProduct Type: Oligonucleotide

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 24, 2024

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    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : RN0361

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

    Details : RN0361 is a Oligonucleotide drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Hypertriglyceridemia.

    Product Name : Undisclosed

    Product Type : Oligonucleotide

    Upfront Cash : Inapplicable

    June 24, 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: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 01, 2024

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    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : Corticotropin

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    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

    March 01, 2024

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    Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

    Details:

    Nitric Oxide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Respiratory Distress Syndrome.


    Lead Product(s): Nitric Oxide

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Yuri Matusov

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 08, 2024

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    09

    Mallinckrodt Pharmaceuticals

    Ireland
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    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : Nitric Oxide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Yuri Matusov

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

    Details : Nitric Oxide is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Respiratory Distress Syndrome.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    February 08, 2024

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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: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 07, 2023

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    10

    Mallinckrodt Pharmaceuticals

    Ireland
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    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : Nitric Oxide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    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 : Miscellaneous

    Upfront Cash : Inapplicable

    December 07, 2023

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    FDA Orange Book

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    01

    Brand Name : BUCET

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : BUCET

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    RLD : No

    TE Code :

    ACETAMINOPHEN; BUTALBITAL

    Mallinckrodt Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BUCET

    Dosage Strength : 650MG;50MG

    Approval Date : 1985-06-28

    Application Number : 88991

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    Brand Name : TENCON

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : TENCON

    Ireland
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    RLD : No

    TE Code :

    ACETAMINOPHEN; BUTALBITAL

    Mallinckrodt Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : TENCON

    Dosage Strength : 650MG;50MG

    Approval Date : 1990-05-15

    Application Number : 89405

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    Brand Name : BUTALBITAL, ACETAMIN...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : BUTALBITAL, ACETAMIN...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    RLD : No

    TE Code :

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Mallinckrodt Pharmaceuticals

    Dosage Form : TABLET; ORAL

    Proprietary Name : BUTALBITAL, ACETAMINOPHE...

    Dosage Strength : 325MG;50MG;40MG

    Approval Date : 1985-01-24

    Application Number : 87804

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    04

    Brand Name : BUTALBITAL, ACETAMIN...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : BUTALBITAL, ACETAMIN...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    RLD : No

    TE Code :

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Mallinckrodt Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BUTALBITAL, ACETAMINOPHE...

    Dosage Strength : 325MG;50MG;40MG

    Approval Date : 1985-07-18

    Application Number : 88743

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    05

    Brand Name : BUTALBITAL, ACETAMIN...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : BUTALBITAL, ACETAMIN...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    RLD : No

    TE Code :

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Mallinckrodt Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BUTALBITAL, ACETAMINOPHE...

    Dosage Strength : 325MG;50MG;40MG

    Approval Date : 1985-03-27

    Application Number : 88758

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    06

    Brand Name : BUTALBITAL, ACETAMIN...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : BUTALBITAL, ACETAMIN...

    Ireland
    PEGS Boston Summit
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    RLD : No

    TE Code :

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Mallinckrodt Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BUTALBITAL, ACETAMINOPHE...

    Dosage Strength : 325MG;50MG;40MG

    Approval Date : 1985-03-27

    Application Number : 88765

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Market
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    07

    Brand Name : TRIAD

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : TRIAD

    Ireland
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    RLD : No

    TE Code :

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Mallinckrodt Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : TRIAD

    Dosage Strength : 325MG;50MG;40MG

    Approval Date : 1985-06-19

    Application Number : 89023

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Market
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    08

    Brand Name : BUTALBITAL, ACETAMIN...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : BUTALBITAL, ACETAMIN...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    RLD : No

    TE Code :

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Mallinckrodt Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BUTALBITAL, ACETAMINOPHE...

    Dosage Strength : 325MG;50MG;40MG

    Approval Date : 1985-04-19

    Application Number : 89067

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Market
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    09

    Brand Name : FEMCET

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : FEMCET

    Ireland
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    RLD : No

    TE Code :

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Mallinckrodt Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : FEMCET

    Dosage Strength : 325MG;50MG;40MG

    Approval Date : 1985-06-19

    Application Number : 89102

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Market
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    10

    Brand Name : ACETAMINOPHEN AND CO...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    RLD : No

    TE Code : AA

    ACETAMINOPHEN; CODEINE PHOSPHATE

    Mallinckrodt Pharmaceuticals

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAMINOPHEN AND CODEIN...

    Dosage Strength : 300MG;15MG

    Approval Date : 2001-05-31

    Application Number : 40419

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

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    Canada

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    01

    Brand Name : METHADOSE

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : METHADOSE

    Ireland
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    PEGS Boston Summit
    Not Confirmed
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    Regulatory Info : NARCOTICS (CDSA I)

    Registration Country : Canada

    METHADONE HYDROCHLORIDE

    Mallinckrodt Pharmaceuticals

    Dosage Form : SOLUTION

    Dosage Strength : 10MG/ML

    Packaging : 1L

    Brand Name : METHADOSE

    Approval Date :

    Application Number : 2394596

    Regulatory Info : NARCOTICS (CDSA I)

    Registration Country : Canada

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    02

    Brand Name : METHADOSE

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : METHADOSE

    Ireland
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    PEGS Boston Summit
    Not Confirmed
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    Regulatory Info : NARCOTICS (CDSA I)

    Registration Country : Canada

    METHADONE HYDROCHLORIDE

    Mallinckrodt Pharmaceuticals

    Dosage Form : SOLUTION

    Dosage Strength : 10MG/ML

    Packaging : 1L

    Brand Name : METHADOSE

    Approval Date :

    Application Number : 2394618

    Regulatory Info : NARCOTICS (CDSA I)

    Registration Country : Canada

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    Excipients

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    All Excipients

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    01

    Magnesium Stearate

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

    PEGS Boston Summit
    Not Confirmed
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    Magnesium Stearate

    Ireland

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5894

    Submission : 1985-06-13

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Magnesium Stearate API

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Magnesium Stearate API

    Ireland

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20585

    Submission : 2007-06-07

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    Stearic Acid

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Stearic Acid

    Ireland

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

    arrow
    PEGS Boston Summit
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-222 - Rev 00

    Issue Date : 2006-08-01

    Type :

    Substance Number :

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    REF. STANDARDS & IMPURITIES

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    Others

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    01

    Alfentanil HCl ARS

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    02

    Benzphetamine HCl ARS

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    03

    Methamphetamine HCl ARS

    Ireland
    PEGS Boston Summit
    Not Confirmed
    arrow

    04

    Cocaine Alkaloid ARS

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    05

    Cocaine HCl ARS

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    06

    Codeine Alkaloid ARS

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    07

    Codeine Phosphate ARS

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    08

    Codeine Sulfate ARS

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    09

    Norcodeine ARS

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    10

    Dextroamphetamine Sulfate ARS

    Ireland
    PEGS Boston Summit
    Not Confirmed
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    ABOUT THIS PAGE

    Contact Mallinckrodt Plc and get a quotation

    Mallinckrodt Plc is a supplier offers 163 products (APIs, Excipients or Intermediates).

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