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

Joseph C. Cosgrove

President, Chief Executive Officer and Board Member

Tim Askew

Senior Vice President & General Manager of Ophthalmology

Darrell Brown

Vice President of Pharmaceutical Manufacturing Operations

David Cain

Vice President of Engineering

Carie Edquist

Chief Financial Officer

Harry Gill

Chief Quality Officer

Dan Harvey

Chief Human Resources Officer

Barbara Knightly

Vice President of Regulatory Affairs & Pharmacy Operations

Iván C. Martínez

Senior Vice President of Quality and Technical Services

Marc Mullen

Chief Commercial Officer

Antonio Di Nicola

Vice President of Pharmaceutical Manufacturing Operations

Danielle Perkins

Senior Vice President of Customer Experience & Commercial Operations

Blair Philbrick

Chief of Staff

Will Shearer

Chief Legal Officer & Corporate Compliance Officer

Michael Weiblinger

Senior Vice President of Strategy & Execution

Chris Zuccarelli

Chief Technical Officer

Meet Our Board of Directors

Mike Butler

Chairman of the Board

Lee Cooper

Board Member

Joseph C. Cosgrove

President, Chief Executive Officer and Board Member

Tom Flynn

Board Member

Ting Gu

Board Member

Gary Kerr

Board Member

Brian Morfitt

Board Member

Nicholas O’Leary

Board Member

Matthew Stober

Board Member

Alex Zisson

Board Member

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

Memorial Hermann
Corewell Health Logo

Our Strategic Partners

Bluesight logo
Angels for Change logo

Our GPO Partners

Health Trust Logo
Eye Pro GPO logo
Health Trust Logo
Vizient Logo

Awards

Certifications

NABP Logo