DENVER, Feb. 8, 2022 /PRNewswire/ -- Leiters, a trusted FDA-registered 503B outsourcing provider of hospital and ophthalmology compounded sterile preparations announced today that it has completed the purchase of a new manufacturing facility in Buena, New Jersey.
The 110,000 square foot facility was previously used to manufacture prescription products, including sterile preparations. The former pharmaceutical company owner made considerable capital investments to expand and upgrade the facility, including manufacturing capabilities for injectables, R&D, and labs.
"Our continued investment in 503B capacity is a reflection of our steadfast commitment to providing high-quality compounded sterile preparations in an evolving market, as well as our positive outlook for the future," said Robin Smith Hoke, President and CEO of Leiters. "This second facility will ensure that we are well-positioned to respond to the changing landscape of the 503B industry and the increasing demand for our high-quality products and services."
The facility will be cGMP compliant with automated capabilities to provide additional 503B capacity and redundancy to our existing capabilities and portfolio in Englewood, Colorado. While the facility will require further modifications to meet aseptic manufacturing FDA regulations and guidance, the existing facility and current investments in systems, utilities and equipment help to accelerate time to market. This second facility will meaningfully increase Leiters' manufacturing capacity, enable new product capabilities, and provide additional warehousing of sterile compounded preparations for the 503B market.
Nick O'Leary, General Partner at Welsh, Carson, Anderson & Stowe, the majority shareholder of Leiters, said, "Leiters' unwavering commitment to quality and compliance, along with this new facility acquisition and continued investments in state-of-the art facilities, people and processes, allows it to continue to deliver on its vision of providing better medicine to more people. The Company remains committed to providing the healthcare industry with the highest-quality compounded sterile preparations and stands ready to support the needs of the market now and in the future."
Leiters is a trusted FDA-registered 503B outsourcing provider of ready-to-use hospital and ophthalmology compounded sterile preparations and pharmacy services. It is committed to providing healthcare professionals and their patients with critically needed outsourced medications. Its team of experts in sterile pharmaceutical manufacturing, repackaging and compounding provide a sophisticated understanding of what it takes to elevate quality and consistency of supply in pharmaceutical outsourcing. Leiters combines a highly experienced team, with robust automated processes, in a state-of-the-art outsourcing facility, to ensure delivery of the highest quality medicines. All sterile preparations are produced under the Human Drug Outsourcing Facilities under 503B of the FD&C Act (503B Guidance) and follow Current Good Manufacturing Practices (cGMP). To learn more about how Leiters is Compounding Health™ or request a site tour, please visit www.leiters.com.
Kari Cashmore, Leiters