mayne has status lifted by the fda

17/02/2003 09:08:06

Mayne has Status Lifted by the FDA

 


MAYNE GROUP LIMITED 2003-02-17 ASX-SIGNAL-G

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'
status.

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
employees.

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