FDA approved
As of January 2025, American Injectables is an FDA-approved CDMO. This reflects our commitment to excellence, giving our clients confidence that their therapies are produced according to the highest regulatory standards.
\Facility design and construction
Our manufacturing facilities are built in accordance with current Good Manufacturing Practices (cGMP), including the appropriate cleanroom environments, HVAC systems, material and personnel flows, and other regulatory requirements.
\Quality management system
Our robust quality management system encompasses all aspects of the manufacturing process, including documentation, training, change control, deviation management, and corrective and preventive actions (CAPA).
\Facility registration
Our manufacturing facilities are registered with the FDA.
\Establishment inspection
Thorough FDA inspection of our equipment and facilities demonstrates our adherence to regulatory expectations.
