Leiters is a trusted FDA-registered 503B outsourcing provider of compounded sterile preparations committed to providing healthcare professionals and their patients with the highest-quality medications.
Company Background
Leiters, founded in 1926, is an FDA-registered 503B outsourcing provider of high-quality compounded sterile preparations and pharmacy services. Leiters has a long history of evolving and innovating to meet the latest regulatory requirements and market needs.
All sterile preparations are produced under Section 503B of the FD&C Act (503B Guidance), follow current good manufacturing practices (cGMP), and USP <797>. The Leiters facility consistently upholds all standards based on the audits conducted by the FDA, the states of California and Florida Boards of Pharmacy, multiple health systems, group purchasing organizations, and other independent accreditation organizations.
The Leiters team of experts in sterile pharmaceutical manufacturing, repackaging, and compounding provide a sophisticated understanding of what it takes to elevate the quality and consistency of supply in pharmaceutical outsourcing. Leiters combines a highly experienced team, with robust processes, in a state-of-the-art outsourcing facility to ensure delivery of the highest-quality products and services.
Product Overview
Leiters provides ready-to-use compounded sterile preparations and pharmacy services across the continuum of healthcare, including hospitals, surgery centers, physician offices, and clinics.
• Hospital Products
• Prefilled syringes, I.V. bags, and vials.
• PCA (patient-controlled analgesia) prefilled syringes.
• Surgical Pain Services portfolio including opioid free medications.
• Ophthalmology Products
• Prefilled syringes, vials, and dropper bottles including: injections, antibiotics, dilating agents, and topical anesthetics.
• FDA-Compliant† Repackaged Avastin® Service.
• ON-Q* Pump Fill Service
• Pharmacy fill service for the Avanos Medical opioid sparing ON-Q* Pain Relief System.
• Prefill pump services offered for both Bupivacaine HCl and Ropivacaine HCl.
Additional Information
We combine our team, robust processes, and state-of-the-art outsourcing facility to ensure the highest-quality medications for healthcare professionals and their patients. Through three key pillars: people, place, and product, we are elevating the standards in pharmaceutical outsourcing.
Key Business Partners
Leiters is partnered with many market leading innovative healthcare companies that compliment what we do. The products and services offered by these companies may provide additional value to your organization. Our business partners include: Avanos Medical, Besse Medical, Bluesight, Cardinal Health, End Drug Shortages Alliance, Eye Connect International, Prodigy Health, and The Academy.
Trade Shows/Meetings Attended
Leiters supports and attends various regional and national industry trade shows and conferences. Please visit www.leiters.com to view a list of 2023 events we will attend.
GPO Affiliations
Leiters provides its products and services to many leading health systems, community hospitals, clinics, and physician offices. In addition, we currently have national contracts with: AmerisourceBergen, Captis, Cardinal Health, Healthtrust, Premier, US Retina, and Vizient. Please contact us for additional information regarding our contracts.
Ordering Information
Leiters offers four convenient ways to place your order.
1. Toll-Free Phone: (800) 292-6772
2. Fax: (408) 288-8252
3. Email: orders@leiters.com
4. Visit the Leiters Online Ordering Portal: orders.leiters.com
Site Visits
We don’t want to simply tell you about what we do, we want to show you! 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. To schedule a site visit or learn more about how Leiters is Compounding Health™, please visit www.leiters.com.
COMPOUNDING HEALTH™ is a registered trademark of Leiters. Avastin® is a registered trademark of Genentech, Inc. ON-Q* is a registered trademark of Avanos Medical, Inc., or its affiliates. 1BUD is from date compounded. † Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Guidance for Industry https://www.fda.gov/downloads/drugs/guidances/ucm434176.pdf
Leiters Health is a trusted FDA-registered 503B outsourcing provider of high quality ophthalmology and hospital-based services. 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.
This post is related to:
Manufacturing: 503B Outsourcing Facilities, Compounding Services
