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Pharmaxis Secures Licence for Dry Powder Manufacture
06 / 04 / 2006
Specialist pharmaceutical company Pharmaxis Ltd (ASX:PXS, NASDAQ:PXSL) announced today that the Therapeutic Goods Administration (TGA) has reissued its Good Manufacturing Practices (GMP) Licence.
The Pharmaxis manufacturing facility in Sydney, Australia was first licensed by the TGA in May 2003 for the manufacture of inhalation powders for clinical trial purposes. Subsequent to an audit by the TGA earlier this year, the licence now authorises all steps in the manufacture of powders for inhalation for human use, with the exception of microbiological testing.
Microbiological testing of Pharmaxis products is conducted under contract in certified laboratories.
Dr Alan Robertson, Chief Executive Officer said: "We are now ready to supply for human use our leading inhalation products manufactured under the most controlled of conditions. 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."
The Pharmaxis manufacturing facility in Sydney, Australia was first licensed by the TGA in May 2003 for the manufacture of inhalation powders for clinical trial purposes. Subsequent to an audit by the TGA earlier this year, the licence now authorises all steps in the manufacture of powders for inhalation for human use, with the exception of microbiological testing.
Microbiological testing of Pharmaxis products is conducted under contract in certified laboratories.
Dr Alan Robertson, Chief Executive Officer said: "We are now ready to supply for human use our leading inhalation products manufactured under the most controlled of conditions. 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."