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    Company profile for Patheon

    Evonik

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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    pharmacompass-1-m-2026-01-12

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    End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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    Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.

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    pharmacompass-2-m-2025-11-03

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    SERVICES

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

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    About

    With a commitment to quality, scientific excellence and exceptional customer experiences, Patheon is a leading global provider of contract drug development and manufacturing services. Our integrated network consists of eight development centres of excellence and thirteen manufacturing facilities across North America and Europe.Patheon provides pharmaceutical and biotechnology companies with direct access to the expertise, qual...
    With a commitment to quality, scientific excellence and exceptional customer experiences, Patheon is a leading global provider of contract drug development and manufacturing services. Our integrated network consists of eight development centres of excellence and thirteen manufacturing facilities across North America and Europe.Patheon provides pharmaceutical and biotechnology companies with direct access to the expertise, quality and full range of solid and sterile dosage forms to bring drug candidates from preclinical stages through production, and launch products anywhere in the world.

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    CONTACT DETAILS

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    PatheonUnited_States_of_America Flag
    Country
    Country
    U.S.A
    Address
    Address
    4815 Emperor Blvd., Suite 300
 Durham, NC 27703-8470
    Telephone
    Telephone
    +1 919 226 3200
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.patheon.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company-beta/165406?pathWildcard=165406
    youtube
    YouTube
    Twitter
    Twitter
    https://x.com/patheon

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    Events

    Webinars & Exhibitions

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    Tides Asia

    Tides Asia

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    Digital content

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    NEWS #PharmaBuzz

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    Nick Buschur takes over as CEO at blow-fill-seal CDMO Woodstock
    Nick Buschur takes over as CEO at blow-fill-seal CDMO Woodstock

    07 Jan 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/manufacturing/new-woodstock-ceo-buschur-plots-growth-strategy-blow-fill-seal-cdmo

    FIERCE PHARMA
    07 Jan 2025
    Share Share
    FDA Issues Form 483 to Patheon Italia S.p.A
    FDA Issues Form 483 to Patheon Italia S.p.A

    27 Nov 2024

    // FDA

    https://www.fda.gov/media/183884/download

    FDA
    27 Nov 2024
    Share Share
    Patheon`s Generic Ibuprofen Receives Approval in the U.S.
    Patheon`s Generic Ibuprofen Receives Approval in the U.S.

    13 Feb 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217236

    FDA
    13 Feb 2024
    Share Share
    Patheon's Generic Naproxen Sodium Receives Approval in the U.S.
    Patheon's Generic Naproxen Sodium Receives Approval in the U.S.

    10 Jan 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214463

    FDA
    10 Jan 2023
    Share Share
    Neuvivo Begins Manufacture of ALS Treatment NP001
    Neuvivo Begins Manufacture of ALS Treatment NP001

    11 May 2022

    // CONTRACTPHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2022-05-11/neuvivo-begins-manufacture-of-als-treatment-np001/?widget=listSection

    CONTRACTPHARMA
    11 May 2022
    Share Share
    Oxcia contracts Patheon for manufacturing & further strengthens the organization
    Oxcia contracts Patheon for manufacturing & further strengthens the organization

    17 Jan 2022

    // CISION

    https://news.cision.com/oxcia-ab--publ-/r/oxcia-contracts-patheon-for-manufacturing-and-further-strengthens-the-organization,c3486875#:~:text=Oxcia%20contracts%20Patheon%20for%20manufacturing%20and%20further%20strengthens%20the%20organization,-Mon%2C%20Jan%2017&text=OXC%2D101%20is%20Oxcia's%20first,solid%20cancers%20or%20blood%20cancers.

    CISION
    17 Jan 2022
    Share Share

    ALL APIs

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

    01

    Pyridostigmine

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

    VMX
    Not Confirmed
    arrow

    Pyridostigmine

    U.S.A

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

    arrow
    VMX
    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 CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-117 - Rev 03

    Issue Date : 2016-12-15

    Type : Chemical

    Substance Number : 1255

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10212

    Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria

    Initial Date of Registration : 2015-08-18

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 45941-3051

    Start Marketing Date : 1993-01-11

    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

    02

    Clodronic Acid Disodium Salt

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

    VMX
    Not Confirmed
    arrow

    Clodronic Acid Disodium Salt

    U.S.A

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-060 - Rev 00

    Issue Date : 2018-06-13

    Type : Chemical

    Substance Number : 1777

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Fostamatinib Disodium Hexahydrate

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

    VMX
    Not Confirmed
    arrow

    Fostamatinib Disodium Hexahydrate

    U.S.A

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 304MF10064

    Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria

    Initial Date of Registration : 2022-04-06

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Neostigmine Bromide

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

    VMX
    Not Confirmed
    arrow

    Neostigmine Bromide

    U.S.A

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 306MF10020

    Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria

    Initial Date of Registration : 2024-01-30

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Neostigmine Methylsulfate

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

    VMX
    Not Confirmed
    arrow

    Neostigmine Methylsulfate

    U.S.A

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-253 - Rev 02

    Issue Date : 2016-12-15

    Type : Chemical

    Substance Number : 626

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 45941-3053

    Start Marketing Date : 2011-07-19

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Neostigmine Methylsulfate

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

    VMX
    Not Confirmed
    arrow

    Neostigmine Methylsulfate

    U.S.A

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-084 - Rev 02

    Issue Date : 2016-12-15

    Type : Chemical

    Substance Number : 46

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Patiromer Sorbitex Calcium

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

    VMX
    Not Confirmed
    arrow

    Patiromer Sorbitex Calcium

    U.S.A

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10083

    Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria

    Initial Date of Registration : 2023-07-19

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Vitamin E

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

    VMX
    Not Confirmed
    arrow

    Vitamin E

    U.S.A

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 222MF10047

    Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria

    Initial Date of Registration : 2010-02-09

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Latanoprost

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

    VMX
    Not Confirmed
    arrow

    Latanoprost

    U.S.A

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-21

    Pay. Date : 2013-09-17

    DMF Number : 25924

    Submission : 2012-03-30

    Status : Inactive

    Type : II

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Methyltyrosine

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

    VMX
    Not Confirmed
    arrow

    Methyltyrosine

    U.S.A

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

    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16099

    Submission : 2002-08-15

    Status : Inactive

    Type : II

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    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]

    USDMF

    read-more
    read-more

    01

    Latanoprost

    U.S.A
    VMX
    Not Confirmed
    arrow

    02

    Metyrosine Usp

    U.S.A
    VMX
    Not Confirmed
    arrow

    03

    Travoprost, Usp

    U.S.A
    VMX
    Not Confirmed
    arrow

    04

    Manufacturing Site, Facilities And P...

    U.S.A
    VMX
    Not Confirmed
    arrow

    Manufacturing Site, Facilities And P...

    U.S.A
    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Patheon

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 9584

    Submission : 1992-03-12

    Status : Inactive

    Type : II

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Manufacturing Site, Facilities, Pers...

    U.S.A
    VMX
    Not Confirmed
    arrow

    Manufacturing Site, Facilities, Pers...

    U.S.A
    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Patheon

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 9689

    Submission : 1992-05-11

    Status : Inactive

    Type : II

    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Manufacturing Site, Facilities, Pers...

    U.S.A
    VMX
    Not Confirmed
    arrow

    Manufacturing Site, Facilities, Pers...

    U.S.A
    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Patheon

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5252

    Submission : 1984-01-24

    Status : Inactive

    Type : II

    blank

    Product
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    Market
    Place

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

    KDMF

    read-more
    read-more

    01

    Capecitabine

    U.S.A
    VMX
    Not Confirmed
    arrow

    Capecitabine

    U.S.A
    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Patheon

    Registrant Name : Boryeong Co., Ltd.

    Registration Date : 2022-04-25

    Registration Number : 20220425-209-J-1277

    Manufacturer Name : Patheon API Inc.

    Manufacturer Address : 6173 East Old Marion Highway, Florence, South Carolina (SC) 29506, United States (USA...

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    Market
    Place

    02

    Opicaphone

    U.S.A
    VMX
    Not Confirmed
    arrow

    Opicaphone

    U.S.A
    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Patheon

    Registrant Name : SK Chemical Co., Ltd.

    Registration Date : 2019-11-26

    Registration Number : Su703-6-ND

    Manufacturer Name : Patheon Austria GmbH & Co. KG@...

    Manufacturer Address : St. Peter Strasse 25, 4020 Linz Austria@[Micronising Manufactory]Via Sottobisio 42a/c...

    blank

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    Market
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    03

    Oseltamivir phosphate

    U.S.A
    VMX
    Not Confirmed
    arrow

    Oseltamivir phosphate

    U.S.A
    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Patheon

    Registrant Name : Roche Korea Co., Ltd.

    Registration Date : 2022-04-26

    Registration Number : 20220426-209-J-1279

    Manufacturer Name : Patheon API Inc.

    Manufacturer Address : 6173 East Old Marion Highway, Florence, South Carolina 29506-9330, United States

    blank

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    Market
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    04

    Phloroglucinol hydrate

    U.S.A
    VMX
    Not Confirmed
    arrow

    Phloroglucinol hydrate

    U.S.A
    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Patheon

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2021-11-30

    Registration Number : 20211130-209-J-1094

    Manufacturer Name : Patheon Austria GmbH & Co. KG

    Manufacturer Address : St. Peter Strasse 25, 4020 Linz Austria

    blank

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    Market
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    05

    Ticagrelor

    U.S.A
    VMX
    Not Confirmed
    arrow

    Ticagrelor

    U.S.A
    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Patheon

    Registrant Name : AstraZeneca Korea Ltd.

    Registration Date : 2011-07-15

    Registration Number : Su661-6-ND

    Manufacturer Name : Patheon Austria GmbH & Co. KG

    Manufacturer Address : St. Peter Strasse 25, 4020 Linz Austria

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    06

    Trimethylphloroglucinol

    U.S.A
    VMX
    Not Confirmed
    arrow

    Trimethylphloroglucinol

    U.S.A
    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Patheon

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2021-12-03

    Registration Number : 20211203-209-J-1169

    Manufacturer Name : Patheon Austria GmbH & Co. KG

    Manufacturer Address : St. Peter Strasse 25, 4020 Linz Austria

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    07

    Ojanimode

    U.S.A
    VMX
    Not Confirmed
    arrow

    Ojanimode

    U.S.A
    arrow
    VMX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Patheon

    Registrant Name : Korea BMS Pharmaceutical Co., Ltd.

    Registration Date : 2023-02-23

    Registration Number : Su342-20-ND

    Manufacturer Name : Patheon API Manufacturing Inc....

    Manufacturer Address : 309 Delaware Street, Greenville, SC 29605, USA@Hauptstrasse 171, 4416 Bubendorf, Swit...

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    FDF Dossiers

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    01

    Brand Name : CHLOROTRIANISENE

    U.S.A
    VMX
    Not Confirmed
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    Brand Name : CHLOROTRIANISENE

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    CHLOROTRIANISENE

    Banner Pharmacap

    Dosage Form : CAPSULE;ORAL

    Brand Name : CHLOROTRIANISENE

    Dosage Strength : 12MG

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 84652

    Regulatory Info : DISCN

    Registration Country : USA

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    02

    Brand Name : CLOFIBRATE

    U.S.A
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    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    CLOFIBRATE

    Banner Pharmacap

    Dosage Form : CAPSULE;ORAL

    Brand Name : CLOFIBRATE

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 1992-03-20

    Application Number : 73396

    Regulatory Info : DISCN

    Registration Country : USA

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    03

    Brand Name : ETHCHLORVYNOL

    U.S.A
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    Brand Name : ETHCHLORVYNOL

    U.S.A
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    Regulatory Info : DISCN

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    ETHCHLORVYNOL

    Banner Pharmacap

    Dosage Form : CAPSULE;ORAL

    Brand Name : ETHCHLORVYNOL

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 84463

    Regulatory Info : DISCN

    Registration Country : USA

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    Brand Name : ETHCHLORVYNOL

    U.S.A
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    Regulatory Info : DISCN

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    ETHCHLORVYNOL

    Banner Pharmacap

    Dosage Form : CAPSULE;ORAL

    Brand Name : ETHCHLORVYNOL

    Dosage Strength : 200MG

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 84463

    Regulatory Info : DISCN

    Registration Country : USA

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    Brand Name : ETHCHLORVYNOL

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    Regulatory Info : DISCN

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    ETHCHLORVYNOL

    Banner Pharmacap

    Dosage Form : CAPSULE;ORAL

    Brand Name : ETHCHLORVYNOL

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 84463

    Regulatory Info : DISCN

    Registration Country : USA

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    Brand Name : ETHCHLORVYNOL

    U.S.A
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    Regulatory Info : DISCN

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    ETHCHLORVYNOL

    Banner Pharmacap

    Dosage Form : CAPSULE;ORAL

    Brand Name : ETHCHLORVYNOL

    Dosage Strength : 750MG

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 84463

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    Brand Name : IBUPROFEN

    U.S.A
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    Regulatory Info : OTC

    Registration Country : USA

    IBUPROFEN

    Patheon

    Dosage Form : CAPSULE;ORAL

    Brand Name : IBUPROFEN

    Dosage Strength : EQ 200MG FREE ACID AND...

    Packaging :

    Approval Date : 2024-02-13

    Application Number : 217236

    Regulatory Info : OTC

    Registration Country : USA

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    Brand Name : Ibuprofen Banner Pha...

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Ibuprofen

    Banner Pharmacap

    Dosage Form : Capsule

    Brand Name : Ibuprofen Banner Pharmaca...

    Dosage Strength : 200mg

    Packaging :

    Approval Date : 02/09/2005

    Application Number : 20040607001899

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    Brand Name : NAPROXEN SODIUM

    U.S.A
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    Brand Name : NAPROXEN SODIUM

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    Regulatory Info : OTC

    Registration Country : USA

    NAPROXEN SODIUM

    Patheon

    Dosage Form : CAPSULE;ORAL

    Brand Name : NAPROXEN SODIUM

    Dosage Strength : EQ 200MG BASE

    Packaging :

    Approval Date : 2023-01-10

    Application Number : 214463

    Regulatory Info : OTC

    Registration Country : USA

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    10

    Brand Name : Naproxen Banner

    U.S.A
    VMX
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Naproxen Sodium

    Patheon

    Dosage Form : Capsule

    Brand Name : Naproxen Banner

    Dosage Strength : 200mg

    Packaging :

    Approval Date : 10/04/2014

    Application Number : 20120901000030

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    01

    FDA Audited

    USA
    VMX
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    FDA Audited

    USA
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    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-08-11

    Patheon

    City : High Point

    State : NC

    Country/Area : U.S.A

    Zip : 27265-8144

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-08-11

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    02

    FDA Audited

    USA
    VMX
    Not Confirmed
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    FDA Audited

    USA
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    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-04-20

    Patheon

    City : Greenville

    State : NC

    Country/Area : U.S.A

    Zip : 27834-8628

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-04-20

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    03

    FDA Audited

    USA
    VMX
    Not Confirmed
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    FDA Audited

    USA
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    VMX
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-02

    Patheon

    City : Cincinnati

    State : OH

    Country/Area : U.S.A

    Zip : 45237-1625

    District : CIN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-02

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    04

    FDA Audited

    USA
    VMX
    Not Confirmed
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    FDA Audited

    USA
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    VMX
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-09-03

    Patheon

    City : Manati

    State : PR

    Country/Area : U.S.A

    Zip : 674

    District : SJN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-09-03

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    05

    FDA Audited

    USA
    VMX
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    FDA Audited

    USA
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    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-02-13

    Patheon

    City : Princeton

    State : NJ

    Country/Area : U.S.A

    Zip : 8540

    District : NWJ

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-02-13

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    06

    FDA Audited

    USA
    VMX
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    FDA Audited

    USA
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    VMX
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-01-30

    Patheon

    City : Mississauga

    State :

    Country/Area : Canada

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-01-30

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    07

    FDA Audited

    USA
    VMX
    Not Confirmed
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    FDA Audited

    USA
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    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-29

    Banner Pharmacap

    City : High Point

    State : NC

    Country/Area : U.S.A

    Zip : 27265-8144

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-29

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    08

    FDA Audited

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    VMX
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    FDA Audited

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    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-28

    Patheon

    City : Capua

    State :

    Country/Area : Italy

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-28

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    09

    FDA Audited

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    VMX
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    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-11-26

    Patheon

    City : Greenville

    State : SC

    Country/Area : U.S.A

    Zip : 29605

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-11-26

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    10

    FDA Audited

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    VMX
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    VMX
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-11-14

    Patheon

    City : Groningen

    State :

    Country/Area : Netherlands

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-11-14

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