QuVa Pharma Announces FDA 503B Registration of its New Jersey Facility
Initial Phase of 160,000SF building redevelopment complete and facility to commence shipping product in September 2017
Sugar Land, TX – September 26th, 2017 – QuVa Pharma, Inc. a national supplier of sterile compounding services driving new quality standards in the industry, today announced it 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.”
QuVa is the market leader in quality compliance with both existing Texas facilities in excellent standing with the FDA, having received the Inspection Close out report in March 2017 for the main Sugar Land, Texas campus and in September 2017 for the Temple, Texas facility. With deep aseptic pharmaceutical manufacturing experience, QuVa specializes in critical drug shortage products.
For product ordering enquiries please contact QuVa Customer Service at 888.339.0874 or via email
About QuVa Pharma, Inc.
QuVa Pharma is a nationally recognized company emerging as the leading industry 503B platform and partner of choice for compliance-oriented healthcare facilities looking to ensure a quality, safe and consistent supply of medications. The Company offers a broad portfolio of products across Pain Management, Anti-infective, OR Syringes, Labor and Delivery therapeutic areas amongst others, all of which are released only once sterility and potency testing is successfully complete, and with validation supporting appropriate BUD. The company is committed to having a patient-first orientation, as well as a robust product portfolio, leading safety standards, and collaborative, partnership-oriented customer service. For more information, visit www.quvapharma.com.