New & Noteworthy

March 2022

503B Facility Acquisition

Leiters

Leiters, an FDA-registered 503B outsourcing provider, announces the purchase of a manufacturing facility in Buena, New Jersey. The 110,000 square foot facility was previously used to manufacture prescription products, including sterile preparations. The facility will be cGMP compliant with automated capabilities to provide additional 503B capacity and redundancy to Leiters’ existing capabilities and portfolio. While the facility will require further modifications to meet aseptic manufacturing FDA regulations and guidance, this facility will increase manufacturing capacity, enable new product capabilities, and provide additional warehousing of sterile compounded preparations for the 503B market.

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