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INSTITUTE OF DRUG TECHNOLOGY
AUSTRALIA LIMITED (IDT)
NEWS RELEASE
7 June 2005
FDA APPROVES IDT FACILITY TO MANUFACTURE
THALIDOMIDE FOR CELGENE
Institute of Drug Technology Australia Ltd (IDT) has been granted
approval by the US Food and Drug Administration to supply commercial
quantities of THALOMID ® (thalidomide) to its client, Celgene
Corporation, a U.S. based global biopharmaceutical company. The
approval will allow IDT to supply Celgene from its state-of-the-art
containment facility at its Boronia complex. IDT established a manufacturing
and supply agreement with Celgene in September, 2003.
"Both the FDA and Celgene should be commended for the expertise
and diligence which it took to ensure that the IDT facility would
be licensed to supply product," commented Dr Graeme Blackman,
Chairman and Managing Director of Institute of Drug Technology Australia
Ltd. "The FDA approval was a significant win for the Australian
pharmaceutical industry and confirmed IDT as a 'world class' GMP
manufacturer of highly potent or cytotoxic drugs."
About IDT
Institute of Drug Technology Australia Limited (IDT) is a leading
developer and manufacturer of active pharmaceutical ingredients
and finished pharmaceutical products for local and international
markets. The company also provides a comprehensive range of consultancy,
research and development, and analytical services to the pharmaceutical
and biotechnology sectors.
Established in 1975, IDT is an Australian-owned public company,
listed on the Australian Stock Exchange and employing over 140 highly
qualified scientific and support staff. The company has extensive
modern manufacturing facilities and laboratories in Melbourne and
is licensed by the Australian Therapeutic Goods Administration (TGA)
and the United States Food and Drug Administration (FDA) for production
of active pharmaceutical ingredients and finished pharmaceutical
products. The company has become especially well known internationally
for its dedicated facilities for the development and production
of anticancer drugs requiring containment. In addition, the company
offers early stage clinical trial services from its base at the
Royal Adelaide Hospital through its CMAX division.
For further information, please contact:
Dr Graeme Blackman
Chairman & Managing Director
Institute of Drug Technology Australia Limited
Telephone: 61 3 98018888
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