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mayne has status lifted by the fda

  1. Ousia

    706 Posts.
    17/02/2003 09:08:06

    Mayne has Status Lifted by the FDA



    HOMEX - Melbourne

    Mayne Group Limited advised today that it had received formal
    notification from the United States Food and Drug Administration
    (FDA) confirming that the warning letter received in November 2002
    has been lifted, now placing the Mulgrave facility in 'Acceptable'

    This follows a full investigation and report by Mayne in regard to
    the FDA concerns, culminating in discussions in Washington with the
    FDA. These discussions emphasised Mayne's commitment to sustainable
    compliance with current Good Manufacturing Practice, including the
    establishment of a global quality unit.

    The lifting of the status allows the company to continue with
    programs for new product approvals in the US market.

    Mayne's Group Managing Director and Chief Executive Officer, Stuart
    James, said that he was pleased with the company's ability to
    promptly address the issues raised in the warning letter.

    "Our dialogue with the FDA was very productive and in a little over
    two months we have been able to resolve this matter, allowing our
    business to progress with minimum disruption," Mr James said.

    Mayne has businesses in pharmaceuticals (the manufacture of oral and
    injectable pharmaceuticals for distribution to more than 50
    countries), health-related consumer products, health services
    (pathology, diagnostic imaging, medical centres and pharmacy
    services) and hospitals. Mayne, which is listed on the Australian
    Stock Exchange, has a presence in 50 countries and more than 26,000

    Media enquiries: Investor enquiries:

    Rob Tassie Cameron Fuller
    Ph: 03 9868 0886 Ph: 03 9868 0968
    Mb: 0411 126 455 Mb: 0417 338 953


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