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- 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.