FDA approval status
American Injectables is currently in the process of becoming an FDA-approved CDMO. With most of the process already complete, we are confident we’ll receive this status before the end of 2024.
\Facility design and construction
Built our manufacturing facilities 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
Established a robust quality management system that encompasses all aspects of the manufacturing process, including documentation, training, change control, deviation management, and corrective and preventive actions (CAPA).
\Facility registration
Registered manufacturing facilities with the FDA.
\Establishment inspection
Awaiting FDA inspection.
\Approval and licensing
Awaiting FDA approval and licensing.
Start the process
Though the FDA approval process takes time, we are actively serving customers and adhere to stringent quality standards.
