QuVa Pharma, Inc. has announced it has signed an agreement to acquire an FDA approved biotech pharmaceutical facility in New Jersey. QuVa Pharma currently operates two Texas-based 503B registered manufacturing facilities. Financial terms of the private transaction were not disclosed. In August 2015, the company received a majority equity commitment from Bain Capital Private Equity to support creation and expansion plans.
The 160,000 square-foot pharmaceutical facility will enable QuVa Pharma to significantly extend its production capability and capacity to deliver high-quality, ready-to-use compounded sterile drug preparations to hospitals in key markets in the eastern half of the US. Located near Route 78 in western New Jersey, and in close proximity to the I-95 corridor and Newark Liberty International Airport, the strategically located facility is a gateway to major distribution hubs and opens significant expansion opportunities for QuVa Pharma with access to Pennsylvania and Ohio to the West, New York to the East, New England to the North, in addition to DC and key Southeastern markets.
“When we complete modifications, this facility will be the country’s premier outsourced sterile compounding site, purpose-constructed to comply with FDA regulations and meet the most stringent state and regulatory requirements,” said Stuart Hinchen, QuVa Pharma’s co-founder and Chief Executive Officer. “By deliberately establishing our presence at the confluence of robust interstate commerce, we are ensuring that major hospitals and health systems have access to a high-quality alternative for compounded drugs. The purchase allows QuVa to continue setting a new standard for safety, in addition to ensuring a reliable supply.”
Once the facility is operational, QuVa Pharma expects to hire more than 100 new employees. Comprising two interconnected buildings, QuVa Pharma anticipates the 503B manufacturing facility will commence operations in mid-2017. The buildings will be modified to meet or exceed the FDA’s requirements for sterile manufacturing in the 503B setting. The site will include complete in-house product and environmental testing capabilities, both of which support a major industry quality initiative that QuVa Pharma is leading.
“QuVa leads the industry in only releasing product that is fully tested to USP standards for sterility, potency, and endotoxins,” said Peter Jenkins, co-founder and Chief Development Officer of QuVa Pharma. “With the added capability of in-house laboratories, we can ensure timely delivery of product at competitive prices. We believe this will be a significant advantage relative to our competitors.”
QuVa Pharma will continue to leverage the healthcare investment experience and deep resources of Bain Capital Private Equity to actively expand its current operations and open additional locations. “This large facility is a key component of the QuVa expansion strategy,” said Chris Gordon, a Managing Director of Bain Capital Private Equity. “We are pleased to support the QuVa Pharma management team as they continue to acquire, build and operate quality-focused compounding facilities. We are encouraged by the strong market demand for their innovative, safety-oriented approach and will continue to commit significant resources in backing this industry-pioneering venture.”