About Leiters
Leiters. Where quality means everything.
Leiters is a trusted FDA-registered 503B outsourcing provider of compounded sterile preparations.
We are committed to providing healthcare professionals and their patients with high-quality medications.
Our team of experts in sterile pharmaceutical manufacturing, repackaging, and pharmacy provides a sophisticated understanding of what it takes to elevate the 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.
We believe the most important consumer of our products are patients, and patients have trusted Leiters with their health for nearly a century.
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
Senior Vice President & General Manager of Ophthalmology
Chief Operating Officer
Chief Financial Officer
Chief Quality Officer
Chief Commercial Officer
Chief Legal Officer & Corporate Compliance Officer
Senior Vice President of Strategy & Execution
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
Board Member
Our Mission
We are a passionate team of innovators dedicated to anticipating, addressing, and exceeding the expectations of our healthcare partners by creating and consistently delivering customized pharmaceutical solutions of uncompromising quality.
Our Vision
To be the essential partner in providing the highest quality critically needed medicines that healthcare providers need to treat and care for patients that ultimately enhance the quality of patients’ lives.
Our Values
People First
Be It!
Celebrating a best-in-class workplace where people are the critical ingredient in our success.
Innovation
Think It!
A passionate pursuit of new ways of thinking, continuous improvement, and adding value to all those we serve.
Integrity
Live It!
Relentless commitment to always making right and ethical choices every day.
Accountability
Own It!
Delivering on high expectations and taking ownership of our responsibilities.
Collaboration
Share It!
Embracing a culture where diversity of thought and sharing of ideas is expected, valued, and respected.
JOIN OUR TEAM
Grow your career with Leiters.
We invite applications from qualified candidates who enjoy working with a team of highly skilled professionals and who are committed to serving others with integrity and compassion.
We are an Equal Opportunity Employer, dedicated to ensuring reasonable accommodation and fair treatment for all employees.
Our Investors
Our Industry Partners
Our GPO Partners
Awards
Certifications
