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news.Commercial release of the Syringe is expected to occur during the fourth quarter of 2009
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Unilife has initiated US production of the Unitract 1ml Insulin Syringe at its FDA-registered manufacturing facility in Pennsylvania.
The company claims, this milestone follows the successful transfer of the automated assembly system for the Unitract 1ml Syringes into its designated clean room, in accordance with previously announced schedules. Unilife expects to manufacture approximately 40 million units per annum.
In parallel to completing the transfer of the 1ml assembly system into the clean room, Unilife has installed and tested other related manufacturing systems including an automated barrel printer and an automated packaging system.
The start of US production will enable Unilife to complete required product ageing studies and build inventory to fulfil current and anticipated orders for its Unitract 1ml Syringes. The Syringe has received key regulatory certifications for use within the US, Canada, Europe and Australia.
Commercial release of the Syringe is expected to occur during the fourth quarter of 2009, once product ageing studies have been completed. Unilife is currently in discussions with a number of interested pharmaceutical and healthcare companies located in the US, Europe and Asia, regarding the
Unitract 1ml Syringes. Unilife will also promote the products at key US and European industry events.
Alan Shortall, CEO of Unilife, said: “I encourage shareholders to visit Unilife’s website to view a video of the production of the Unitract 1ml Syringes inside its designated clean room. This automated assembly system has been fully designed, developed, built and qualified by Unilife using our own internal resources and world-class operational team. The technical challenges Unilife has overcome to commence high volume production of the Unitract 1ml Syringes has turned our in-house operational capabilities into a key commercial strength.
“The lessons we have learned during the successful completion of fully automated production for the Unitract 1ml Syringes is now serving as a gateway to the creation of additional substantial opportunities such as the Unilife Ready-to-Fill Syringe,” he added.