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

Robin Smith Hoke

Chief Executive Officer

Rick Schindewolf

Chief Financial Officer

Chris Zuccarelli

Chief Operating Officer

Marc Mullen

Executive Vice President of Sales and Marketing

Ron Stephens

Vice President of Quality and Compliance

Will Shearer

General Counsel

JOIN OUR TEAM

Our Careers

Leiters values the depth of experience and diversity in its employees.

Leiters employs a group of people who care about delivering quality healthcare and have a passion for excellence. Leiters employees have deep experience in ophthalmology and hospital pharmacy services, pharmaceutical manufacturing, quality, and other pharmaceutical capabilities. Bringing a fresh perspective to 503B hospital and ophthalmology outsourcing, we focus on the health of our patients in everything we do. As a result, our employees are setting a new standard of quality within the industry.

Our Investors

Our Strategic Partners

Our GPO Partners

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