Imprimis Pharmaceuticals has filed for registration of its recently-constructed New Jersey facility with the U.S. Food and Drug Administration (FDA) as a 503B outsourcing facility. The state-of-the-art facility is expected to begin manufacturing as an outsourcing facility in December 2016 and dispensing medications in early first quarter 2017.
The NJ based outsourcing facility will initially make and distribute Imprimis' proprietary sterile Dropless Therapy® injectable and LessDrops® topical formulations in accordance with current good manufacturing practices (cGMP). Imprimis designed the facility for the production of its core ophthalmology formulations, outfitting it with automated filling, labeling and other state-of-the-art equipment that should allow for improved production efficiencies. The ease of customer ordering for office use and stocking inventory should also increase administration and dispensing efficiencies. The company also believes ophthalmologists, surgery centers and other healthcare providers will benefit greatly by having the ability to simply order the quantities of Dropless Therapy and LessDrops formulations they require for inventory and office use without having to provide patient specific prescriptions.
Mark L. Baum, CEO of Imprimis, stated, "This is an important milestone for our company. We believe transitioning the production of our proprietary Dropless Therapy® injectable and LessDrops® formulations to an outsourcing facility environment should create additional revenue opportunities by simplifying the ordering process with existing and new potential customers, including hospitals, group purchasing organizations and surgery centers, that desire, or in some cases, require purchasing from an FDA-registered outsourcing facility. Based on our internal research and an April 2015 third party market research report, we expect that adoption of our core ophthalmology formulations will increase as a result of moving to an outsourcing facility environment, once customers are no longer required to provide patient-specific prescriptions. This is an exciting time for Imprimis and I am confident that with the investments in infrastructure, improvements in operating efficiencies and strengthening of our senior leadership team, we are well positioned to meet our existing and anticipated increase in demand for our innovative ophthalmic formulations."