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    Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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    TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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    EVENTS

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    About

    At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better, live longer. Find out how this shapes everything we do, including our R&D, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The...
    At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better, live longer. Find out how this shapes everything we do, including our R&D, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The vaccines, medicines and consumer healthcare products that we research and develop can improve people’s health and well-being, ultimately helping them to live life to its fullest and contribute.

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    980 Great West Road, Brentford, Middlesex TW8 9GS England
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    +44 (0)20 8047 5000
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    NEWS #PharmaBuzz

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    GSK Buys Nuvalent for 10.6B to Rival Roche, Pfizer in Lung Cancer
    GSK Buys Nuvalent for 10.6B to Rival Roche, Pfizer in Lung Cancer

    09 Jun 2026

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/gsk-inks-106b-nuvalent-buyout-challenge-roche-and-pfizer-lung-cancer

    FIERCE BIOTECH
    09 Jun 2026
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    GSK Discusses Acquisition Of Cancer Biotech Nuvalent For Over $9B
    GSK Discusses Acquisition Of Cancer Biotech Nuvalent For Over $9B

    09 Jun 2026

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-talks-buy-cancer-biotech-nuvalent-more-than-9-billion-ft-reports-2026-06-09/

    REUTERS
    09 Jun 2026
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    Engitix Partners with GSK to Advance Liver Fibrosis Regression
    Engitix Partners with GSK to Advance Liver Fibrosis Regression

    08 Jun 2026

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2026/06/08/3307896/0/en/engitix-announces-strategic-collaboration-with-gsk-to-advance-first-in-class-targets-for-liver-fibrosis-regression.html

    GLOBENEWSWIRE
    08 Jun 2026
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    At ASCO 2026, A 'Paradigm Shift' For A Rare Gut Cancer Looms
    At ASCO 2026, A 'Paradigm Shift' For A Rare Gut Cancer Looms

    01 Jun 2026

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/asco-2026-paradigm-shift-rare-gut-cancer-looms

    FIERCE BIOTECH
    01 Jun 2026
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    GSK's Hepatitis B Drug Helps One in Five Achieve Functional Cure
    GSK's Hepatitis B Drug Helps One in Five Achieve Functional Cure

    28 May 2026

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/gsks-chronic-hepatitis-b-drug-helps-one-five-achieve-functional-cure-key-studies-2026-05-28/

    REUTERS
    28 May 2026
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    Abbvie, GSK Race Up Patient Reputation Leaderboard In the UK
    Abbvie, GSK Race Up Patient Reputation Leaderboard In the UK

    22 May 2026

    // FIERCE PHARMA

    https://www.fiercepharma.com/marketing/abbvie-gsk-race-patient-reputation-leaderboard-uk

    FIERCE PHARMA
    22 May 2026
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    ALL APIs

    read-moreClick the button for full data set
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    01

    Fluticasone Propionate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Fluticasone Propionate

    United Kingdom

    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 Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31534

    Submission : 2017-04-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-229 - Rev 03

    Issue Date : 2025-04-25

    Type : Chemical

    Substance Number : 1750

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 63379-001

    Start Marketing Date : 2014-04-18

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Amoxicillin Trihydrate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Amoxicillin Trihydrate

    United Kingdom

    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 : 13201

    Submission : 1998-04-30

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2000-010 - Rev 06

    Issue Date : 2024-11-25

    Type : Chemical

    Substance Number : 260

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Ilsung IS Co., Ltd.

    Registration Date : 2011-10-28

    Registration Number : 20050831-30-A-64-05(1)

    Manufacturer Name : Beecham Pharmaceuticals (Pte) Ltd

    Manufacturer Address : 38 Quality Road Jurong Industrial Estate, Singapore 618809

     VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Amoxicillin Trihydrate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Amoxicillin Trihydrate

    United Kingdom

    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 : 13207

    Submission : 1998-04-30

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-064 - Rev 01

    Issue Date : 2024-10-24

    Type : Chemical

    Substance Number : 260

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : GlaxoSmithKline Inc.

    Registration Date : 2005-08-31

    Registration Number : 20050831-30-A-64-05

    Manufacturer Name : Beecham Pharmaceuticals (Pte) Ltd

    Manufacturer Address : 38 Quality Road Jurong Industrial Estate, Singapore 618809

     VMF Others AUDIT
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    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Betamethasone Valerate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Betamethasone Valerate

    United Kingdom

    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 : 4578

    Submission : 1982-06-09

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2002-219 - Rev 09

    Issue Date : 2024-10-25

    Type : Chemical

    Substance Number : 811

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Cefuroxime Sodium

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefuroxime Sodium

    United Kingdom

    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 : 24411

    Submission : 2011-03-01

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2005-208 - Rev 00

    Issue Date : 2013-07-02

    Type : Chemical

    Substance Number : 992

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Market
    Place

    06

    Clavulanic Acid

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Clavulanic Acid

    United Kingdom

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4349

    Submission : 1981-12-02

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1999-111 - Rev 04

    Issue Date : 2024-11-13

    Type : Chemical

    Substance Number : 1140

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : GlaxoSmithKline Inc.

    Registration Date : 2020-03-10

    Registration Number : 20200310-113-F-91-24

    Manufacturer Name : SmithKline Beecham Pharmaceuticals

    Manufacturer Address : Shewalton Road, Irvine, KA11 5AP United Kingdom

     VMF Others AUDIT
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    Web Link

    Stock Recap
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    Market
    Place

    07

    Clavulanic Acid

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Clavulanic Acid

    United Kingdom

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5701

    Submission : 1985-02-13

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2005-244 - Rev 02

    Issue Date : 2025-11-14

    Type : Chemical

    Substance Number : 1653

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Ilsung IS Co., Ltd.

    Registration Date : 2011-12-09

    Registration Number : 20090227-113-F-18-13(1)

    Manufacturer Name : SmithKline Beecham Pharmaceuticals

    Manufacturer Address : Shewalton Road GB-KA11 5AP Irvine Ayrshire

     VMF Others AUDIT
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    Product
    Web Link

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    Market
    Place

    08

    Clobetasol Propionate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Clobetasol Propionate

    United Kingdom

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25444

    Submission : 2012-12-20

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-034 - Rev 04

    Issue Date : 2024-10-24

    Type : Chemical

    Substance Number : 2127

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : GlaxoSmithKline Inc.

    Registration Date : 2012-03-23

    Registration Number : 20120323-93-E-99-05

    Manufacturer Name : Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)

    Manufacturer Address : Cobden Street, Montrose, Angus, DD10 8EA

     VMF Others AUDIT
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    Market
    Place

    09

    Salbutamol Sulphate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Salbutamol Sulphate

    United Kingdom

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5885

    Submission : 1985-06-14

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-371 - Rev 00

    Issue Date : 2025-03-20

    Type : Chemical

    Substance Number : 687

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 63379-007

    Start Marketing Date : 2014-05-06

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Product
    Web Link

    Stock Recap
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    Market
    Place

    10

    Ceftazidime

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Ceftazidime

    United Kingdom

    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 : 24339

    Submission : 2011-03-01

    Status : Active

    Type : II

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

    Product
    Web Link

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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]

    FDF Dossiers

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    01

    Brand Name : Augmentin ()

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : Augmentin ()

    United Kingdom
    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Amoxicillin Anhydrous; Clavulanic Acid

    GSK

    Dosage Form : Film Coated Tablet

    Brand Name : Augmentin ()

    Dosage Strength : 500mg;125mg

    Packaging :

    Approval Date : 25/11/1983

    Application Number : 45674

    Regulatory Info : Allowed

    Registration Country : Switzerland

    blank

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    Web Link

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    Market
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    02

    Brand Name : Augmentin ()

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : Augmentin ()

    United Kingdom
    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Amoxicillin Anhydrous; Clavulanic Acid

    GSK

    Dosage Form : Film Coated Tablet

    Brand Name : Augmentin ()

    Dosage Strength : 875mg;125mg

    Packaging :

    Approval Date : 15/12/1995

    Application Number : 53692

    Regulatory Info : Allowed

    Registration Country : Switzerland

    blank

    Product
    Web Link

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    Market
    Place

    03

    Brand Name : Augmentin Duo ()

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : Augmentin Duo ()

    United Kingdom
    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Amoxicillin Anhydrous; Clavulanic Acid

    GSK

    Dosage Form : Powder For Oral Suspensi...

    Brand Name : Augmentin Duo ()

    Dosage Strength : 400mg;57mg

    Packaging :

    Approval Date : 25/06/1998

    Application Number : 53974

    Regulatory Info : Allowed

    Registration Country : Switzerland

    blank

    Product
    Web Link

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    Market
    Place

    04

    Brand Name : Malarone

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : Malarone

    United Kingdom
    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Atovaquone; Proguanil Hydrochloride

    GSK

    Dosage Form : Film Coated Tablet

    Brand Name : Malarone

    Dosage Strength :

    Packaging :

    Approval Date : 05/06/1997

    Application Number : 54150

    Regulatory Info : Allowed

    Registration Country : Switzerland

    blank

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    Market
    Place

    05

    Brand Name : Malarone Junior

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : Malarone Junior

    United Kingdom
    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Atovaquone; Proguanil Hydrochloride

    GSK

    Dosage Form : Film Coated Tablet

    Brand Name : Malarone Junior

    Dosage Strength :

    Packaging :

    Approval Date : 05/06/1997

    Application Number : 54150

    Regulatory Info : Allowed

    Registration Country : Switzerland

    blank

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    Market
    Place

    06

    Brand Name : Benlysta

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : Benlysta

    United Kingdom
    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Belimumab

    GSK

    Dosage Form : Solution For Injection

    Brand Name : Benlysta

    Dosage Strength : 120mg

    Packaging :

    Approval Date : 14/06/2012

    Application Number : 61532

    Regulatory Info : Allowed

    Registration Country : Switzerland

    blank

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    Market
    Place

    07

    Brand Name : Benlysta

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : Benlysta

    United Kingdom
    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Belimumab

    GSK

    Dosage Form : Solution For Injection

    Brand Name : Benlysta

    Dosage Strength : 400mg

    Packaging :

    Approval Date : 14/06/2012

    Application Number : 61532

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Market
    Place

    08

    Brand Name : Benlysta

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Benlysta

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
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    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Belimumab

    GSK

    Dosage Form : Solution For Injection

    Brand Name : Benlysta

    Dosage Strength : 200mg/ml

    Packaging :

    Approval Date : 29/06/2018

    Application Number : 66585

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Market
    Place

    09

    Brand Name : Benlysta

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Benlysta

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    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.

    Regulatory Info : Approved

    Registration Country : Sweden

    Belimumab

    GSK

    Dosage Form : Powder For Concentrate F...

    Brand Name : Benlysta

    Dosage Strength : 120mg

    Packaging :

    Approval Date : 13-07-2011

    Application Number : 2.01E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    Market
    Place

    10

    Brand Name : Benlysta

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Benlysta

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    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.

    Regulatory Info : Approved

    Registration Country : Sweden

    Belimumab

    GSK

    Dosage Form : Powder For Concentrate F...

    Brand Name : Benlysta

    Dosage Strength : 400mg

    Packaging :

    Approval Date : 13-07-2011

    Application Number : 2.01E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    FDA Orange Book

    read-more
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    01

    Brand Name : ZIAGEN

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : ZIAGEN

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    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.

    RLD : Yes

    TE Code :

    ABACAVIR SULFATE

    ViiV Healthcare

    Dosage Form : TABLET; ORAL

    Proprietary Name : ZIAGEN

    Dosage Strength : EQ 300MG BASE **Federal ...

    Approval Date : 1998-12-17

    Application Number : 20977

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    Market
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    02

    Brand Name : ZIAGEN

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : ZIAGEN

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    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.

    RLD : Yes

    TE Code : AA

    ABACAVIR SULFATE

    ViiV Healthcare

    Dosage Form : SOLUTION; ORAL

    Proprietary Name : ZIAGEN

    Dosage Strength : EQ 20MG BASE/ML

    Approval Date : 1998-12-17

    Application Number : 20978

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AA

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    Market
    Place

    03

    Brand Name : TRIUMEQ

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : TRIUMEQ

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    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.

    RLD : Yes

    TE Code :

    ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

    ViiV Healthcare

    Dosage Form : TABLET; ORAL

    Proprietary Name : TRIUMEQ

    Dosage Strength : EQ 600MG BASE;EQ 50MG BA...

    Approval Date : 2014-08-22

    Application Number : 205551

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    Market
    Place

    04

    Brand Name : TRIUMEQ PD

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : TRIUMEQ PD

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    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.

    RLD : Yes

    TE Code :

    ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

    ViiV Healthcare

    Dosage Form : TABLET, FOR SUSPENSION; ORAL

    Proprietary Name : TRIUMEQ PD

    Dosage Strength : EQ 60MG BASE;EQ 5MG BASE...

    Approval Date : 2022-03-30

    Application Number : 215413

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    Market
    Place

    05

    Brand Name : EPZICOM

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : EPZICOM

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    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.

    RLD : Yes

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    ViiV Healthcare

    Dosage Form : TABLET; ORAL

    Proprietary Name : EPZICOM

    Dosage Strength : EQ 600MG BASE;300MG **Fe...

    Approval Date : 2004-08-02

    Application Number : 21652

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

    blank

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    Market
    Place

    06

    Brand Name : TRIZIVIR

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : TRIZIVIR

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    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.

    RLD : Yes

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

    ViiV Healthcare

    Dosage Form : TABLET; ORAL

    Proprietary Name : TRIZIVIR

    Dosage Strength : EQ 300MG BASE;150MG;300M...

    Approval Date : 2000-11-14

    Application Number : 21205

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    Market
    Place

    07

    Brand Name : EXCEDRIN (MIGRAINE R...

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : EXCEDRIN (MIGRAINE R...

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    • fda
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    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.

    RLD : Yes

    TE Code :

    ACETAMINOPHEN; ASPIRIN; CAFFEINE

    Haleon

    Dosage Form : TABLET; ORAL

    Proprietary Name : EXCEDRIN (MIGRAINE RELIE...

    Dosage Strength : 250MG;250MG;65MG

    Approval Date : 1998-01-14

    Application Number : 20802

    RX/OTC/DISCN : OTC

    RLD : Yes

    TE Code :

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    Market
    Place

    08

    Brand Name : EMPRACET W/ CODEINE ...

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : EMPRACET W/ CODEINE ...

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    • fda
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    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.

    RLD : No

    TE Code :

    ACETAMINOPHEN; CODEINE PHOSPHATE

    GSK

    Dosage Form : TABLET; ORAL

    Proprietary Name : EMPRACET W/ CODEINE PHOS...

    Dosage Strength : 300MG;30MG

    Approval Date : 1982-01-01

    Application Number : 83951

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Market
    Place

    09

    Brand Name : EMPRACET W/ CODEINE ...

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : EMPRACET W/ CODEINE ...

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    • fda
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    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.

    RLD : No

    TE Code :

    ACETAMINOPHEN; CODEINE PHOSPHATE

    GSK

    Dosage Form : TABLET; ORAL

    Proprietary Name : EMPRACET W/ CODEINE PHOS...

    Dosage Strength : 300MG;60MG

    Approval Date : 1982-01-01

    Application Number : 83951

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Market
    Place

    10

    Brand Name : ADVIL DUAL ACTION WI...

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : ADVIL DUAL ACTION WI...

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    • fda
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    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.

    RLD : Yes

    TE Code :

    ACETAMINOPHEN; IBUPROFEN

    Haleon

    Dosage Form : TABLET; ORAL

    Proprietary Name : ADVIL DUAL ACTION WITH A...

    Dosage Strength : 250MG;125MG

    Approval Date : 2020-02-28

    Application Number : 211733

    RX/OTC/DISCN : OTC

    RLD : Yes

    TE Code :

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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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    Europe

    read-more
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    01

    Brand Name : Augmentin ()

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Augmentin ()

    United Kingdom
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    PEGS Boston Summit
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    • fda
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    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Amoxicillin Anhydrous; Clavulanic Acid

    GSK

    Dosage Form : Film Coated Tablet

    Dosage Strength : 500mg;125mg

    Packaging :

    Brand Name : Augmentin ()

    Approval Date : 25/11/1983

    Application Number : 45674

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Market
    Place

    02

    Brand Name : Augmentin ()

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Augmentin ()

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Amoxicillin Anhydrous; Clavulanic Acid

    GSK

    Dosage Form : Film Coated Tablet

    Dosage Strength : 875mg;125mg

    Packaging :

    Brand Name : Augmentin ()

    Approval Date : 15/12/1995

    Application Number : 53692

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Market
    Place

    03

    Brand Name : Augmentin Duo ()

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Augmentin Duo ()

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    • 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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Amoxicillin Anhydrous; Clavulanic Acid

    GSK

    Dosage Form : Powder For Oral Suspension

    Dosage Strength : 400mg;57mg

    Packaging :

    Brand Name : Augmentin Duo ()

    Approval Date : 25/06/1998

    Application Number : 53974

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Market
    Place

    04

    Brand Name : Malarone

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Malarone

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
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    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Atovaquone; Proguanil Hydrochloride

    GSK

    Dosage Form : Film Coated Tablet

    Dosage Strength :

    Packaging :

    Brand Name : Malarone

    Approval Date : 05/06/1997

    Application Number : 54150

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Market
    Place

    05

    Brand Name : Malarone Junior

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Malarone Junior

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Atovaquone; Proguanil Hydrochloride

    GSK

    Dosage Form : Film Coated Tablet

    Dosage Strength :

    Packaging :

    Brand Name : Malarone Junior

    Approval Date : 05/06/1997

    Application Number : 54150

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Market
    Place

    06

    Brand Name : Benlysta

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Benlysta

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Belimumab

    GSK

    Dosage Form : Solution For Injection

    Dosage Strength : 120mg

    Packaging :

    Brand Name : Benlysta

    Approval Date : 14/06/2012

    Application Number : 61532

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Market
    Place

    07

    Brand Name : Benlysta

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : Benlysta

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Belimumab

    GSK

    Dosage Form : Solution For Injection

    Dosage Strength : 400mg

    Packaging :

    Brand Name : Benlysta

    Approval Date : 14/06/2012

    Application Number : 61532

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Market
    Place

    08

    Brand Name : Benlysta

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : Benlysta

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    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.

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Belimumab

    GSK

    Dosage Form : Solution For Injection

    Dosage Strength : 200mg/ml

    Packaging :

    Brand Name : Benlysta

    Approval Date : 29/06/2018

    Application Number : 66585

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Market
    Place

    09

    Brand Name : Benlysta

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Benlysta

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    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.

    Regulatory Info : Approved

    Registration Country : Sweden

    Belimumab

    GSK

    Dosage Form : Powder For Concentrate For Sol...

    Dosage Strength : 120mg

    Packaging :

    Brand Name : Benlysta

    Approval Date : 13-07-2011

    Application Number : 2.01E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    Market
    Place

    10

    Brand Name : Benlysta

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
    arrow

    Brand Name : Benlysta

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    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.

    Regulatory Info : Approved

    Registration Country : Sweden

    Belimumab

    GSK

    Dosage Form : Powder For Concentrate For Sol...

    Dosage Strength : 400mg

    Packaging :

    Brand Name : Benlysta

    Approval Date : 13-07-2011

    Application Number : 2.01E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    Market
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    South Africa

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    01

    Brand Name : Fluarix Tetra

    United Kingdom
    PEGS Boston Summit
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    Brand Name : Fluarix Tetra

    United Kingdom
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    Regulatory Info : Originator

    Registration Country : South Africa

    A/HongKong/K4801/2014 (H3N2)

    GSK

    Dosage Form : INJ

    Dosage Strength : 15ug

    Packaging : 0.5X1ug

    Brand Name : Fluarix Tetra

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Market
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    02

    Brand Name : Fluarix Tetra

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Fluarix Tetra

    United Kingdom
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    Regulatory Info : Originator

    Registration Country : South Africa

    A/Michigan/45/2015 (H1N1) PDM09

    GSK

    Dosage Form : INJ

    Dosage Strength : 15ug

    Packaging : 0.5X1ug

    Brand Name : Fluarix Tetra

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Market
    Place

    03

    Brand Name : Trizivar

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Trizivar

    United Kingdom
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    Regulatory Info : Originator

    Registration Country : South Africa

    Abacavir

    GSK

    Dosage Form : TAB

    Dosage Strength : 300mg

    Packaging : 60X1mg

    Brand Name : Trizivar

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Market
    Place

    04

    Brand Name : Kivexa

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    Brand Name : Kivexa

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    Regulatory Info : Originator

    Registration Country : South Africa

    Abacavir

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    Dosage Form : TAB

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Brand Name : Kivexa

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    Abacavir

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    Dosage Form : TAB

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    Dosage Form : TAB

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    Abacavir

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    Dosage Form : SYR

    Dosage Strength : 20mg/ml

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    Aciclovir

    GSK

    Dosage Form : OIN

    Dosage Strength : 30mg/g

    Packaging : 4.5X1mg/g

    Brand Name : Zovirax

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    Regulatory Info : Originator

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    Brand Name : Zovirax IV

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    Aciclovir

    GSK

    Dosage Form : INJ

    Dosage Strength : 250mg

    Packaging : 10X5mg

    Brand Name : Zovirax IV

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    Regulatory Info : Originator

    Registration Country : South Africa

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    Aciclovir

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    Dosage Form : SUS

    Dosage Strength : 200mg/5ml

    Packaging : 125X1mg/5ml

    Brand Name : Zovirax Suspension

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    Regulatory Info : Originator

    Registration Country : South Africa

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    EMPTY HARD GELATIN CAPSULES

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    GSK

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5770

    Submission : 1985-04-08

    Status : Inactive

    Type : IV

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2025-01-31

    GSK

    City : Godollo

    State :

    Country/Area : Hungary

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    Center :

    Project Area : Vaccines and Allergenic Products

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2025-01-31

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-12-06

    GSK

    City : Ware

    State :

    Country/Area : United Kingdom

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    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-12-06

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    District Decision : No Action Indicated

    Inspection End Date : 2024-11-22

    Haleon

    City : Warren

    State : New Jersey

    Country/Area : U.S.A

    Zip : 7059

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    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date : 2024-11-22

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    District Decision : No Action Indicated

    Inspection End Date : 2024-11-22

    GSK

    City : Collegeville

    State : Pennsylvania

    Country/Area : U.S.A

    Zip : 19426

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    Center :

    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date : 2024-11-22

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    District Decision : No Action Indicated

    Inspection End Date : 2024-08-16

    GSK

    City : Durham

    State : North Carolina

    Country/Area : U.S.A

    Zip : 27701

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    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date : 2024-08-16

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-04-19

    GSK

    City : Zebulon

    State : North Carolina

    Country/Area : U.S.A

    Zip : 27597

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-04-19

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-03-15

    GSK

    City : Dresden

    State :

    Country/Area : Germany

    Zip :

    District :

    Center :

    Project Area : Vaccines and Allergenic Products

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-03-15

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-03-12

    GSK

    City : Saint-Amand-Les-Eaux

    State :

    Country/Area : France

    Zip :

    District :

    Center :

    Project Area : Vaccines and Allergenic Products

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-03-12

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-01-26

    GSK

    City : Sovicille

    State :

    Country/Area : Italy

    Zip :

    District :

    Center :

    Project Area : Vaccines and Allergenic Products

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-01-26

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-10-26

    GSK

    City : Torrile

    State :

    Country/Area : Italy

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-10-26

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