Leiters is an organization where quality means everything.

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The World of Healthcare Is Evolving

With increased pressure to reduce costs and improve the patient experience, our need for quality medicine is greater than ever before. But how do we deliver quality with the ongoing challenge of inefficiency? How do we add value when the focus is merely on volume? It starts with a different perspective. Prioritizing what matters most. Putting the patient at the center of everything we do. Defining a source for greater accountability. Before you know it, the need for greater quality suddenly becomes the opportunity to make the world a healthier place to live.

The World of Healthcare Is Evolving

With increased pressure to reduce costs and improve the patient experience, our need for quality medicine is greater than ever before. But how do we deliver quality with the ongoing challenge of inefficiency? How do we add value when the focus is merely on volume? It starts with a different perspective. Prioritizing what matters most. Putting the patient at the center of everything we do. Defining a source for greater accountability. Before you know it, the need for greater quality suddenly becomes the opportunity to make the world a healthier place to live.
To ensure the highest quality outsourcing services, Leiters focuses on three Pillars: People, Place, Product

The People

We are defining a new standard of quality that starts with an experienced, passionate team that cares about the health and safety of the patient. Our multi-disciplinary team of professionals consists of quality assurance experts, microbiologists chemists, and pharmacists. The experienced team ensures only the highest and most rigorous standards are satisfied for each batch of product manufactured, tested and released. The Leiters’ multi-disciplinary team brings years of experience from large sterile injectable pharmaceutical companies, hospital pharmacies, and academia. A quality mindset is deep rooted in our highly skilled team through extensive training, which includes cGMP training, and aseptic processing training. This highly trained team ensures quality, consistency and compliance with all released products. Leiters stands apart by focusing on one singular purpose: bringing health to outsourcing.

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. Leiters’ facility in Denver was designed to exceed traditional outsourcing facilities and was constructed with the patient in mind. We are defining a source for greater accountability with our facility in Colorado. Our state-of-the-art facility 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.

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The Product

Defining a source for greater accountability is imperative to drive better medicine. We believe that making better medicine starts with a broader perspective. Prioritizing what matters most and putting patients at the center of everything that we do helps us make better medicine. All sterile hospital and ophthalmology preparations are produced under the Human Drug Outsourcing Facilities under 503B of the FD&C Act (503B Guidance), Current Good Manufacturing Practices (cGMP) and exceed USP <797>. This strict set of manufacturing standards is designed to ensure the highest quality of compounded medications and maximum patient safety. For a full list of available hospital and ophthalmology products, see Products tab. Leiters compliance with strict guidance ensures quality, consistency, and compliance with all released products. Leiters stands apart by focusing on one singular purpose: bringing health to outsourcing.