The move to a four shift, 24 hour, seven day per week manufacturing cycle is intended to maximise annual production capacity, which is approximately 40m units, and improve cost efficiencies.
Unilife initiated the change in manufacturing cycle immediately after the US Food and Drug Administration (FDA) gave marketing clearance to the company’s Unitract 1ml insulin syringes.
In August 2008 the FDA gave marketing clearance for Unitract 1ml insulin syringes assembled by Unilife’s manufacturing partner at its facility in Shanghai, China but use of the Lewisberry site required submission of an additional 510(k).
Alan Shortall, CEO of Unilife, explained that the majority of its US-based customers want Unitract syringes manufactured in the US. Having gained market clearance Unilife will “accelerate the rollout” of its Unitract 1ml insulin syringes in the US.
The Lewisberry facility is also being used to meet the demands of Unilife’s Asian distribution partner, Stason Pharmaceuticals. Stason is coordinating local regulatory submissions, establishing relationships with local pharmas and has placed an initial order of 1m units.
Unilife added that it is currently negotiating with a number of interested healthcare and pharma companies in the US, Europe and Asia. Furthermore, it is continuing to send shipments to Haiti to support humanitarian efforts.
The company is also filing a 510(k) with the FDA to gain market clearance for its Unitract 1ml tuberculin (TB) syringes. This is a variant of the insulin syringe.