High-quality Compounded Ophthalmic
In an era of rapid regulatory change and heightened demand for high-quality compounded and repackaged drugs, Leiters, an FDA-registered 503B outsourcing facility, has emerged as a leader. Specializing in ophthalmology and hospital services, Leiters provides hospitals, surgery centers, clinics and physician offices access to high-quality compounded ophthalmic sterile preparations.
Leiters currently offers the following ophthalmic sterile preparations and services:
- FDA-compliant1 repackaged Avastin® service
- Lidocaine / Phenylephrine
- Cyclopentolate / Tropicamide / Phenylephrine
- Tropicamide / Phenylephrine
- Founded in 1926, Leiters is a trusted FDA-registered 503B outsourcing provider of high-quality 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 and full microbiological and chemistry testing is completed prior to releasing batches.
- A Certificate of Analysis (CoA), detailing the testing performed, is provided with every shipment.
- We are licensed to ship to all 50 states (+ the District of Columbia).
- Our ophthalmic sterile preparations have 90+ day Beyond Use Dates (BUD)2 .
- No patient prescription or name required.
Ophthalmology News and Resources
Robin Smith Hoke, President and Chief Executive Officer of Leiters, recently sat down with Ophthalmology Management Magazine to discuss the importance of compounded ophthalmic medications and the importance of working with a trusted FDA-registered 503B outsourcing facility.
Leiters and EyeConnect International Announce Continued Corporate Partnership
Joseph C. Cosgrove Appointed as President and Chief Executive Officer of Leiters
Leiters, a WCAS Portfolio Company, Joins the End Drug Shortages Alliance
Memorial Hermann Health System Joins Existing Investors in Leiters, a 503B Outsourced Pharmaceutical Compounding Industry Leader
Leiters Announces Facility Acquisition to Increase Capacity, Accommodate Growth and Expand Portfolio
1 Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Guidance for Industry
2 BUD is from date compounded
3 Some exclusions apply. Contact customer service for more details
Avastin® is a registered trademark of Genentech, Inc.