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Leiters
Overview
Leiters is a United States-based company operating in the manufacturing sector, specifically within the pharmaceuticals industry. Founded in 1926, the company has established itself as a provider of outsourced pharmaceutical services, particularly in the context of 503B outsourcing facilities. These facilities are subject to stringent regulatory requirements, including current Good Manufacturing Practices (cGMP) as mandated by the FDA, which are more rigorous than those for traditional 503A pharmacies. Leiters emphasizes the importance of compliance with these regulations to ensure the safety and quality of compounded sterile products (CSPs) for health systems. The company’s expertise is highlighted in a recent document discussing the differences between 503B and 503A facilities, the regulatory landscape, and the critical role of quality and compliance in the supply of sterile products. With a workforce of 51 to 200 employees and reported revenue of approximately $22 million, Leiters aims to support health system pharmacies by providing high-quality, ready-to-use sterile products while maintaining adherence to regulatory standards.