Unilife Corporation announces that it remains on schedule to commence initial production of the Unifill® prefilled syringes later this month, and commence sales to pharmaceutical customers by the end of June 2011.
Last week the company successfully commissioned the cleanrooms at its state-of-the-art production facility in York, Pa. Following the completion of this essential regulatory milestone, Unilife has now moved toward the final steps required to commence production of its Unifill and Unitract® safety syringe products at its new site. This includes the installation and final qualification of production systems utilized in the assembly of the Unifill syringe. As part of its planning to commence production, Unilife has begun to build up its inventory of components and other materials to be utilized in the assembly of the Unifill syringe.
Once initial production has commenced, Unilife will be able to complete final product qualification activities in the second quarter of the 2011 calendar year. Accordingly, the company expects to start filling initial sales orders it has received from existing pharmaceutical customers for the Unifill syringe by late-June 2011.
Unilife has also received requests from a number of other interested pharmaceutical companies for the Unifill syringe as part of ongoing discussions. It is expected that these pharmaceutical companies will purchase the initial production batches to undertake formal evaluations of the device prior to the signing of any commercial agreements with Unilife.
"This is a truly exciting time for everyone associated with Unilife," says Dr. Ramin Mojdeh, chief operating officer. "Having now established the operational capabilities and human expertise necessary to begin to meet projected demand, we are now preparing to enter into the next phase of our expansion. Unilife is deeply committed to delivering upon our key business milestones. As such, I am very proud to report that the industrialization program for the Unifill syringe remains fully on-schedule. Our cleanrooms have now been commissioned and key sections of our assembly line for the Unifill prefilled syringe have already been installed and qualified. By the end of March, initial production of the Unifill syringe will commence. As a result, we expect to be in a position to commence product sales to pharmaceutical customers toward the end of June 2011."
A video of preparations to commence production of the Unifill prefilled syringe at Unilife's York facility is now available online at www.unilife.com.