About Leiters
Leiters. Where quality means something.
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.
Our Executive Team
President & Chief Executive Officer
Chief Financial Officer
Chief Operating Officer
Chief Technology Officer
Executive Vice President of Sales and Marketing
Chief Strategy Officer & Chief Pharmacy Officer
Senior Vice President of Quality and Technical Services
General Counsel
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 Strategic Partners
Our GPO Partners
