QuVa Pharma's Temple, TX Facility Receives Inspection Closeout from FDA
— Establishment Inspection Report is one of the first issued to a registered 503B sterile outsourcing compounder by the FDA —
Sugar Land, TX – December 21, 2015 – QuVa Pharma, Inc., a newly formed national platform for sterile compounding pharmacy services, announced today that Unique Pharmaceuticals Ltd. ("UPI") had received a letter from the FDA concluding its review of the operations at Temple, TX, previously owned by UPI. QuVa Pharma acquired the Temple, TX assets of UPI, including its state-of-the-art 503B manufacturing facility, on October 30, 2015 with support from Bain Capital Private Equity, whose majority equity commitment was instrumental in the company's formation in August of this year.
The FDA letter states that an Establishment Inspection Report ("EIR") is issued when the inspection of the facility is closed. The FDA acknowledged the corrective actions taken in response to the concerns raised by the Agency during previous inspections at the Unique facility. Future FDA audits will evaluate the adequacy and sustainability of those corrective actions. The Temple facility was initially inspected in March 2014, June 2014, and again in January 2015. QuVa Pharma is determined to rectify industry standards in an effort to not only meet, but to exceed FDA standards. The FDA notification is evidence of QuVa Pharma's ongoing commitment to raise the bar regarding outsourcing compounding standards.
QuVa Pharma's modern 503B manufacturing facility in Temple, Texas has recently undergone extensive modification, including installation of closed, restricted access barrier compounding units designed to minimize the risk of product contamination by operators. All products produced at the facility undergo complete USP 71 testing for sterility, as well as additional testing for potency and endotoxins, before delivery to customers. The new implementations represent some of the most stringent patient safety standards in the industry.
QuVa Pharma's management team is led by Stuart Hinchen, co-founder and Chief Executive Officer, and Peter Jenkins, co-founder and Chief Development Officer. Both executives bring deep industry experience and understanding of pharmaceutical cGMP standards built during their tenure at JHP Pharmaceuticals and Mayne Pharma.
"We are delighted that the Temple facility has received an EIR indicating the closeout of the FDA audits dating back to March 2014. Both during the due diligence of the operation, and subsequent to our acquisition, we have been very impressed with the dedication to quality and cGMP standards from the staff at the facility. We understand that in being one of the first to receive an EIR, we have the opportunity to further lead the industry to a higher degree of cGMP compliance and product safety than previously experienced. The EIR supports our view regarding the tremendous capabilities we have within QuVa Pharma to innovate quality standards across the industry," said Hinchen.
About QuVa Pharma, Inc.
QuVa Pharma is a recently formed company with the plan to be a 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 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, visitwww.quvapharma.com.
About Bain Capital Private Equity
Bain Capital, LLC (www.baincapital.com) is one of the world's foremost private investment firms, with more than $75 billion under management across several asset classes including private equity, venture capital, public equity, credit products and absolute return. Founded in 1984, Bain Capital's more than 400 professionals are collectively the single largest investor in all of its funds and are dedicated to investing in and building its portfolio companies. Bain Capital Private Equity has a long history of investing in leading healthcare companies such as HCA, Quintiles, Warner Chilcott, Emcure Pharmaceuticals, Bio Products Laboratory, Beacon Health Options, Physio-Control, CRC Health, Grupo Notre Dame Intermedica, and Air Medical Group Holdings, and across a broad range of sectors including service providers, facilities, life sciences, devices, and distribution.
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For QuVa Pharma:
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