Leiters Health is an FDA-registered 503B outsourcing provider of high-quality ready-to-use compounded sterile preparations and pharmacy services including pre-filled syringes, IV bags and vials, non-opioid pain solutions, and a pharmacy fill service for the ON-Q* Pain Relief System. We also offer ophthalmic medications and services including, an FDA-Compliant Repackaged Avastin® service.

We combine our team, our robust processes, and our state-of-the-art facilities to ensure the highest-quality medications for you and your patients. Through three key pillars, People, Place and Product, Leiters is elevating the standards in pharmaceutical outsourcing.

People
• Our highly trained multifunctional teams of pharmaceutical experts ensure quality and regulatory compliance for all released products.
• Our team has relevant industry experience with sterile injectable pharmaceutical companies, hospital pharmacies and academia.
• Our customer experience team of regionally based account representatives, account managers and customer service specialists work together to provide you with consistent and reliable service.
Place
• Our state-of-the-art facility was designed to exceed traditional outsourcing facilities and ensures quality, consistency, and compliance with all released products.
• We are licensed to ship to all 50 states (and the District of Columbia).
• State-of-the-art equipment and automation are used throughout our sterile manufacturing process.
Product
• All sterile preparations are produced under 503B of the Food, Drug, & Cosmetic Act (503B Guidance), cGMP and USP Chapter <797>.
• Release, stability, potency and sterility testing is performed on every batch made.
• We provide a Certificate of Analysis (CoA), detailing the testing, with every shipment.

We Don’t Want to Simply Tell You About What We Do, We Want to Show You
We invite you to visit our facilities to better understand the cGMP regulations, sterile manufacturing processes and automation we use to elevate the quality of our products and services. Come join the growing list of organizations that have visited our facilities.

Elevating the Standards in 503B Pharmaceutical Outsourcing
Leiters Health provides medicines and pharmacy services across the continuum of care, including hospitals, surgery centers, clinics and physicians’ offices. We are also strategically partnered with many market–leading, innovative healthcare companies that complement what we do here at Leiters. The products and services offered by these partners—and available through Leiters—may provide additional value to your organization.

As part of our commitment to quality, compliance, and sterile manufacturing excellence, we continue to invest in our state-of-the-art 503B facilities, including two existing facilities in Denver, Colorado, and a new facility in Buena, New Jersey, which will be operational in 2024. We stand ready to support the needs of the healthcare community now and in the future. To learn more about how we can support your pharmacy, please visit leiters.com