Leiters, an FDA-registered 503B outsourcing provider of hospital and ophthalmology compounded sterile preparations, has completed the purchase of a new manufacturing facility in Buena, NJ.

The 110,000 square foot facility was previously used to manufacture prescription products, including sterile preparations. The former pharmaceutical company owner made 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, 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, CO. 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 increase Leiters’ manufacturing capacity, enable new product capabilities, and provide additional warehousing of sterile compounded preparations for the 503B market.