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    Company profile for Actavis Inc

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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

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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    EVENTS

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    About

    Actavis plc (NYSE: ACT) is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world. The Company has global headquarters in Dublin, Ireland and U.S. Administrative Headquarters in Parsippany, New Jersey, USA.

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    Actavis IncIreland Flag
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    Ireland
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    1 Grand Canal Square Docklands Dublin 2 Ireland
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    353 214619040
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    enquiries@pharmacompass.com
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    Website
    http://www.actavis.com/
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    Actavis’s Generics Rifaximin Receives Approval in US
    Actavis’s Generics Rifaximin Receives Approval in US

    19 Mar 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208959

    FDA
    19 Mar 2026
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    Class Action Over Generic Clobetasol And Clomipramine
    Class Action Over Generic Clobetasol And Clomipramine

    06 May 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/fine-kaplan-and-black-rpc-announce-class-action-lawsuits-on-behalf-of-those-who-paid-andor-reimbursed-for-generic-clobetasol-between-september-1-2014-and-december-31-2018-or-generic-clomipramine-between-august-1-2013-and--302446187.html

    PR NEWSWIRE
    06 May 2025
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    Actavis to Slash 200 Workers as Teva’s Consolidation Efforts
    Actavis to Slash 200 Workers as Teva’s Consolidation Efforts

    08 Apr 2025

    // BIOSPACE

    https://www.biospace.com/actavis-to-slash-200-workers-as-part-of-teva-s-consolidation-efforts

    BIOSPACE
    08 Apr 2025
    Share Share
    Actavis`s Generics Methylnaltrexone Br. Receives Approval in US
    Actavis`s Generics Methylnaltrexone Br. Receives Approval in US

    26 Aug 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208112

    FDA
    26 Aug 2024
    Share Share
    Actavis Lab's Generic Phentermine HCL;Topiramate Receives Approval in US
    Actavis Lab's Generic Phentermine HCL;Topiramate Receives Approval in US

    25 Jun 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204982

    FDA
    25 Jun 2024
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    Enforcement Report - Week of February 7, 2024
    Enforcement Report - Week of February 7, 2024

    07 Feb 2024

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-7-2024-67267.pdf

    FDA
    07 Feb 2024
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    ALL APIs

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    01

    Nicotine

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

    Health 2.0 Conference
    Not Confirmed
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    Nicotine

    Ireland

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

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    Health 2.0 Conference
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-24

    Pay. Date : 2013-06-12

    DMF Number : 7884

    Submission : 1989-01-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-101 - Rev 04

    Issue Date : 2024-04-17

    Type : Chemical

    Substance Number : 1452

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 61252-3006

    Start Marketing Date : 1997-07-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    02

    Nicotine

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

    Health 2.0 Conference
    Not Confirmed
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    Nicotine

    Ireland

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

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    Health 2.0 Conference
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-10-25

    Pay. Date : 2012-11-26

    DMF Number : 10739

    Submission : 1994-02-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-477 - Rev 01

    Issue Date : 2025-12-16

    Type : Chemical

    Substance Number : 1792

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 61252-3002

    Start Marketing Date : 1994-02-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    Cefuroxime Axetil

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

    Health 2.0 Conference
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    Cefuroxime Axetil

    Turkey

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

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    Health 2.0 Conference
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14653

    Submission : 2000-01-03

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-398 - Rev 00

    Issue Date : 2007-02-23

    Type : Chemical

    Substance Number : 1300

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    Telmisartan

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

    Health 2.0 Conference
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    Telmisartan

    Ireland

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

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    Health 2.0 Conference
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22123

    Submission : 2008-11-18

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2010-261 - Rev 00

    Issue Date : 2013-01-22

    Type : Chemical

    Substance Number : 2154

    Status : Withdrawn by EDQM F...

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    05

    Imiquimod

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

    Health 2.0 Conference
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    Imiquimod

    Ireland

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

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    Health 2.0 Conference
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18782

    Submission : 2005-09-19

    Status : Active

    Type : II

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    06

    Letrozole

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

    Health 2.0 Conference
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    Letrozole

    Ireland

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20566

    Submission : 2007-05-29

    Status : Active

    Type : II

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    07

    Midodrine

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

    Health 2.0 Conference
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    Midodrine

    Ireland

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

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    Health 2.0 Conference
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16135

    Submission : 2002-09-16

    Status : Active

    Type : II

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    08

    Nitrofurantoin

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

    Health 2.0 Conference
    Not Confirmed
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    Nitrofurantoin

    Ireland

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

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    Health 2.0 Conference
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15504

    Submission : 2001-07-11

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    09

    Nitrofurantoin

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

    Health 2.0 Conference
    Not Confirmed
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    Nitrofurantoin

    Ireland

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

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    Health 2.0 Conference
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16505

    Submission : 2003-04-22

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    10

    Prilocaine

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

    Health 2.0 Conference
    Not Confirmed
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    Prilocaine

    Ireland

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

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    Health 2.0 Conference
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-05-31

    Pay. Date : 2018-04-29

    DMF Number : 15772

    Submission : 2001-12-18

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    01

    Brand Name : Serlin

    Iceland
    IPhEB Russia
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    Brand Name : Serlin

    Iceland
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    IPhEB Russia
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Sertraline Hydrochloride

    Medis ehff

    Dosage Form : Film Coated Tablet

    Dosage Strength : 50mg

    Packaging :

    Brand Name : Serlin

    Approval Date : 11-03-2005

    Application Number : 2.00E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    02

    Brand Name : Serlin

    Iceland
    IPhEB Russia
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    Brand Name : Serlin

    Iceland
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    IPhEB Russia
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Sertraline Hydrochloride

    Medis ehff

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg

    Packaging :

    Brand Name : Serlin

    Approval Date : 11-03-2005

    Application Number : 2.00E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    03

    Brand Name : Sertrasen

    Iceland
    IPhEB Russia
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    Brand Name : Sertrasen

    Iceland
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    IPhEB Russia
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Sertraline Hydrochloride

    Medis ehff

    Dosage Form : Film Coated Tablet

    Dosage Strength : 50mg

    Packaging :

    Brand Name : Sertrasen

    Approval Date : 11-03-2005

    Application Number : 2.00E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    04

    Brand Name : Sertrasen

    Iceland
    IPhEB Russia
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    Brand Name : Sertrasen

    Iceland
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    IPhEB Russia
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Sertraline Hydrochloride

    Medis ehff

    Dosage Form : Film Coated Tablet

    Dosage Strength : 100mg

    Packaging :

    Brand Name : Sertrasen

    Approval Date : 11-03-2005

    Application Number : 2.00E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    05

    Brand Name : Earcalm

    U.S.A
    IPhEB Russia
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    Brand Name : Earcalm

    U.S.A
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    IPhEB Russia
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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Acetic Acid

    Forest Laboratories

    Dosage Form : Ear Spray

    Dosage Strength : 2%W/W

    Packaging :

    Brand Name : Earcalm

    Approval Date : 2013-01-24

    Application Number :

    Regulatory Info : Withdrawn

    Registration Country : Malta

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    06

    Brand Name : Acyclovir

    Ireland
    IPhEB Russia
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    Brand Name : Acyclovir

    Ireland
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    Regulatory Info :

    Registration Country : Italy

    Acyclovir Sodium

    Actavis Inc

    Dosage Form :

    Dosage Strength : Cream Derm 10 G 5% ...

    Packaging :

    Brand Name : Acyclovir

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    07

    Brand Name : Alendronate

    Ireland
    IPhEB Russia
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    Brand Name : Alendronate

    Ireland
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    Regulatory Info :

    Registration Country : Italy

    Alendronate Sodium Trihydrate

    Actavis Inc

    Dosage Form : Alendronic Acid 70Mg 4 Units' ...

    Dosage Strength : 4 CPR 70 mg

    Packaging :

    Brand Name : Alendronate

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    08

    Brand Name : Alendronic Acid

    Ireland
    IPhEB Russia
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    Brand Name : Alendronic Acid

    Ireland
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    IPhEB Russia
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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Alendronic Acid

    Actavis Inc

    Dosage Form : Tablet

    Dosage Strength : 10MG

    Packaging :

    Brand Name : Alendronic Acid

    Approval Date : 2010-03-18

    Application Number :

    Regulatory Info : Withdrawn

    Registration Country : Malta

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    09

    Brand Name : Alprazolam

    Ireland
    Health 2.0 Conference
    Not Confirmed
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    Brand Name : Alprazolam

    Ireland
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    Health 2.0 Conference
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    Regulatory Info :

    Registration Country : Italy

    Alprazolam

    Actavis Inc

    Dosage Form :

    Dosage Strength : 20 Cpr 0.25 Mg ...

    Packaging :

    Brand Name : Alprazolam

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    10

    Brand Name : Alprazolam

    Ireland
    Health 2.0 Conference
    Not Confirmed
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    Brand Name : Alprazolam

    Ireland
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    Health 2.0 Conference
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Alprazolam

    Actavis Inc

    Dosage Form :

    Dosage Strength : 20 Cpr 0.50 Mg ...

    Packaging :

    Brand Name : Alprazolam

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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