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
1Mixing, 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.