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Pharmaxis facility licensed to produce inhalation powders
By Lisa Kerner
Erie, Pa., April 7 - Pharmaxis Ltd. said that the Therapeutic Goods Administration (TGA) has reissued its Good Manufacturing Practices License for the company's manufacturing facility in Sydney, Australia.
The facility was first licensed by the TGA in May 2003 for the manufacture of inhalation powders for clinical trial purposes, according to a company news release.
Following a TGA audit, the license now authorizes all steps in the manufacture of powders for inhalation for human use, with the exception of microbiological testing, which is conducted under contract in certified laboratories, Pharmaxis said.
"We are now ready to supply for human use our leading inhalation products manufactured under the most controlled of conditions," chief executive officer Alan Robertson said in the release.
"This represents another important step on our quest to build an integrated business. We are looking forward to bringing our products to the international arena."
Pharmaxis is a specialist pharmaceutical company that researches, develops and commercializes therapeutic products for chronic respiratory and autoimmune diseases. The company is located in Sydney, Australia.
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