QuVa Pharma has received FDA registration as a 503B facility for its Bloomsbury, New Jersey facility. The Bloomsbury facility was purchased in October 2016 and has been undergoing renovations to be QuVa's third manufacturing facility.
This marks completion of an initial phase of the development and commercializing of the 160,000 SF buildings on the site. Subsequent development stages will be completed over 12 months to create one of the largest, state of the art 503B facilities in the USA.
"This is an important milestone for QuVa as we continue to set the benchmark for outsourced sterile compounding facilities. Following on from our exemplary quality record in our two Texas facilities that have both earned Inspection Close out reports from the FDA compliance unit in 2017, the registration of the Bloomsbury facility heralds the start of an important increase in available 503B licensed capacity which has been designed to meet or exceed FDA cGMP standards," said Stuart Hinchen, QuVa Pharma's co-founder and Chief Executive Officer. "We are looking forward to this facility commencing shipments this week, and ramping up quickly to support the growing demand for our services in new key markets east of the Mississippi."