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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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    Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

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

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

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    Feraheme

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    Sandoz`s Generic Ferumoxytol Receives Approval in US
    Sandoz`s Generic Ferumoxytol Receives Approval in US

    20 Jan 2021

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206604

    FDA
    20 Jan 2021
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    Analyzing Data for Earliest Market Entry for Subsequent ANDA Filers
    Analyzing Data for Earliest Market Entry for Subsequent ANDA Filers

    12 Feb 2016

    // TWOFOUR INSIGHT

    http://twofourinsight.com/analyzing-data-earliest-market-entry-subsequent-anda-filers/

    TWOFOUR INSIGHT
    12 Feb 2016
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    FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol)
    FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol)

    31 Mar 2015

    // FDA

    http://www.fda.gov/Drugs/DrugSafety/ucm440138.htm

    FDA
    31 Mar 2015
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    AMAG Pharmaceuticals and Takeda Announce Mutual Termination of Agreement to License, Develop and Commercialize Ferumoxytol in Ex-U.S. Territories, Including Europe
    AMAG Pharmaceuticals and Takeda Announce Mutual Termination of Agreement to License, Develop and Commercialize Ferumoxytol in Ex-U.S. Territories, Including Europe

    29 Dec 2014

    // Press Release AMAG PHARMACEUTICALS

    http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&id=2002105

    Press Release AMAG PHARMACEUTICALS
    29 Dec 2014
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