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, 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 quality and consistency of supply in pharmaceutical outsourcing. Leiters combines a highly experienced team, with robust processes, in a new state-of-the-art outsourcing facility, to ensure delivery of the highest quality products and services.
Leiters provides ready-to-use compounded sterile preparations and pharmacy services across the continuum of healthcare, including hospitals, surgery centers, physician offices, and clinics.
• Prefilled operating room syringes and I.V. bags.
• PCA (patient-controlled analgesia) prefilled syringes.
• Surgical Pain Services portfolio including opioid-free medications.
• 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.
We combine our team, our robust processes, and our 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, Cardinal Health OptiFreight®, Comprehensive Pharmacy Services, Eye Connect International, Hibernation Therapeutics, Kit Check, and Prodigy Health.
Trade Shows/Meetings Attended
Leiters supports and attends a variety of regional and national industry trade shows and conferences. Please visit leiters.com to view a list of 2021 events we’ll be attending.
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: HealthTrust, Intalere, JDJ Consulting, Kaiser, Premier, The Resource Group, and US Retina. Please contact us for additional information regarding our contracts.
Leiters offers four convenient ways to place your order:
1. Phone: (800) 292-6772
2. Fax: (408) 288-8252
3. Email: firstname.lastname@example.org
4. Visit the Leiters Online Ordering Portal at orders.leiters.com
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 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
This post is related to:Admixture Compounding Services (503B Outsourcing Facilities)