Pharmaxis granted FDA clearance to produce Aridol locally for US market
ASX-listed pharmaceutical company, Pharmaxis has today been granted FDA clearance to commence Sydney-based production of its asthma diagnostic medication, Aridol for the US.
The approval follows hot-on-the-heels of the FDA’s recent inspection of the Sydney facility which manufactures Aridol for Australia, South Korea and Europe, and Bronchitol for Australia, Europe and Russia respectively.
Following FDA clearance, Pharmaxis will team with distributor, Methaphram, to re-launch Aridol into the States in the ensuing months.
The local Pharmaxis factory, which secured TGA approval in 2012, was built to manufacture, package and export the company’s products.