About Leiters
Leiters. Where quality means everything.
Leiters Health is a leading provider of ready-to-administer compounded and repackaged medications, including pre-filled syringes, IV bags, ophthalmic solutions, and other value-added pharmacy services. As an FDA-registered 503B outsourcing facility, we support hospitals and health systems nationwide by helping address medication shortages and streamline pharmacy operations.
Our approach is grounded in uncompromising quality and regulatory compliance. We invest heavily in advanced manufacturing technologies, robust quality systems, and automation to ensure product consistency, sterility, and reliable supply. These capabilities allow us to meet the evolving needs of the healthcare industry while maintaining the highest standards and strengthening the pharmaceutical supply chain.
What sets Leiters Health apart is our collaborative, partnership-driven model. Backed by health system equity investors, we work closely with our healthcare partners to align on long-term supply strategies while providing transparent, responsive support. We understand the critical role reliability plays in patient care and are committed to being a trusted extension of our partners’ pharmacy operations.
Through a shared commitment to quality, collaboration, and dependable supply, Leiters Health helps healthcare providers maintain continuity of care and focus on delivering exceptional patient outcomes.
Quality Assurance
THE WORLD OF HEALTHCARE IS EVOLVING
Leiters provides hospitals, surgery centers, clinics and physician offices access to high-quality compounded sterile preparations. Our 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 outsourcing. We combine our team, our robust processes and our state-of-the-art outsourcing facility to ensure the highest quality products and services.
Through 3 key pillars, People, Place and Product, Leiters is elevating the standards in pharmaceutical outsourcing.
The People
Our multi-disciplinary team of professionals consists of quality assurance experts, microbiologists, chemists, pharmacists, ophthalmology specialists and health system pharmacy experts.
- 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 regional based account representatives, account managers and customer service specialists work together to provide you with trusted, consistent and reliable service.
The Place
This is the place where quality means everything.
Our FDA-registered 503B outsourcing facility is located in Denver, Colorado. With increasing regulatory pressure, there is a growing need for higher standards in pharmaceutical outsourcing. Our state-of-the-art facility was designed to exceed traditional outsourcing facilities and ensures quality, consistency and compliance with all released products.
- FDA-registered cGMP compliant 503B outsourcing provider.
- Licensed to ship to all 50 states (+ the District of Columbia).
- Continuous facility environmental monitoring to maintain product quality standards.
- Inspected by the FDA, State of California Board of Pharmacy, multiple health systems, group purchasing organizations, and other independent accreditation organizations.
- We invite you to visit our facility 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 who have visited our facilities.
Request a Site Visit
The Product
We offer a comprehensive portfolio of high-quality ready to use hospital and ophthalmology compounded sterile preparations.
- All sterile preparations are produced under 503B of the FD&C act (503B Guidance), Current Good Manufacturing Practices (cGMP) and USP <797>.
- Stability testing is performed prior to producing batches.
- Full microbiological and chemistry testing is completed prior to each batch being released. This includes, sterility, endotoxin, potency, identification, impurities, particulate (sub visible), visual appearance and pH testing.
- A Certificate of Analysis (CoA) provided with every shipment.
- Beyond Use Dates (BUD) range from 90-180 days.
Meet Our Leaders
President, Chief Executive Officer and Board Member
Chief Operating Officer
Chief Financial Officer
Chief Quality Officer
Chief Commercial Officer
Chief Legal Officer & Corporate Compliance Officer
Senior Vice President & Head of Product Development
In Memoriam
1959 - 2024
Meet Our Board of Directors
Chairman of the Board
Board Member
President, Chief Executive Officer and Board Member
Board Member
Board Member
Board Member
Board Member
Board Member
Our Mission Inspires Us, Our Vision Guides Us,
Our Values Unite Us.
At Leiters Health, our Mission, Vision, and Values reflect our unwavering commitment to excellence, our employees and the healthcare partners and patients we serve. Together, they define who we are, what we stand for, and where we’re headed as we strive to make a meaningful impact in healthcare.
From the medications we compound to the partnerships we build, we are committed to delivering quality and reliability while working collaboratively with healthcare providers to support patient care. Grounded in integrity and driven by results, we embrace agility, collaboration and exploration to meet the evolving needs of the healthcare community and lead the way in 503B compounding solutions.
Our Investors
Our Industry Partners
Our GPO Partners
Awards
Certifications
