Recro Gainesville has added a 24,000-square-foot facility, which includes high-potent material processing space, near its existing 97,000-square-foot contract pharmaceutical development and manufacturing plant.
The company is a wholly owned subsidiary of Recro Pharma, Inc., and a leading provider of solid oral dose development and manufacturing services for the pharmaceutical industry.
The expanded capabilities will allow Recro Gainesville to provide clients with a broader range of contract development and manufacturing organization (CDMO) services, from benchtop through commercialization. Clients can obtain manufacturing services ranging from formulation and development through clinical trial material (CTM) production for Phase I and beyond.
In addition, a specialized area within the new site will be opened by the end of the year to support clients with development through commercialization for high-potency compounds, a rapidly expanding category of pharmaceuticals, which includes many immune modulation and anti-cancer agents.
“The new square footage allows for early feasibility studies, enabling clients to quickly determine the best formulation path forward at laboratory scale, and subsequent scale-up to the GMP manufacture of CTMs,” said Scott Rizzo, general manager of Recro Gainesville. “This added development capability will save our clients both time and resources.”
“Also, by adding high-potency capabilities, we are continuing to provide our clients with the most comprehensive, highest-quality services in the business,” added Heather N. Sugrue, VP sales and marketing.
The existing Recro Gainesville site is a GMP, DEA-licensed CDMO facility that encompasses an oral dosage formulation, process and analytical development space as well as GMP drug product manufacturing facilities for product development, clinical trial materials and commercial finished product.
About Recro Gainesville
Recro Gainesville provides solid dosage form development, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market. Specializing in extended release solid dose and DEA controlled substances, Recro has the experts to deliver clients’ most complex pharmaceutical development and manufacturing projects in its best-in-class, 120,000 square feet of manufacturing space. For more information about Recro’s flexible CDMO solutions, visit www.recrogainesville.com
About Recro Pharma
Recro Gainesville’s parent is Recro Pharma which is a specialty pharmaceutical company that operates through two business divisions, an Acute Care, hospital product division and a CDMO division, Recro Gainesville. The Acute Care division is primarily focused on developing innovative products for hospital and other acute care settings. The Acute Care division’s lead investigational product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor.