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Addresses supply shortages by providing manufactured sterile preparations in FDA-registered 503B facility
November 10, 2015
By: Tim Wright
Editor-in-Chief, Contract Pharma
QuVa Pharma Inc., a newly formed national platform for sterile compounding pharmacy services, has acquired the assets of Unique Pharmaceuticals Ltd., including its state-of-the-art 503B manufacturing facility. With the acquisition, QuVa Pharma is addressing supply shortage issues that routinely and adversely impact the industry, and securing significant, immediately-available capacity in a second location. QuVa Pharma received a majority equity commitment from Bain Capital Private Equity as part of its formation in August. Financial terms were not disclosed. Unique Pharmaceuticals’ modern 503B manufacturing facility in Temple, TX 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, potency and endotoxins before delivery to customers. QuVa Pharma expects to retain all current employees at the Unique Pharmaceuticals facility, and to integrate the operations with its existing 503B manufacturing facility located in Sugar Land, TX. 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. “According to the FDA, more than 70% of drug shortages are related to sterile injectable drugs. Our acquisition of Unique Pharmaceuticals’ 503B operation will allow us help hospitals and healthcare systems across the country to address the challenges they often face with inadequate supply and inconsistent quality,” said Mr. Hinchen. “We have been extremely impressed with the quality commitment demonstrated by the Unique Pharmaceuticals ownership and staff, evident in the recent modifications at the facility, training, and the insistence on USP 71 product testing prior to release.” “This acquisition broadens our catalog of available compounded products, and gives us the capability to compound preparations from API to meet supply shortages,” said Mr. Jenkins. “Our deep experience in pharmaceutical manufacturing puts us in a favorable position to provide hospitals and healthcare facilities with a tangible improvement in service, reliability and quality.” “We are very impressed with the cGMP knowledge demonstrated by the QuVa Pharma management team, and the company’s plans to meaningfully enhance the quality of compounded sterile products in the market,” said Travis Leeah, president, Unique Pharmaceuticals, who will join the QuVa Pharma management team.
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