American Injectables is licensed and registered with the State of Florida Department of Business and Professional Regulations as a Prescription Drug Manufacturer.

Facilites maintenance manager smiling.

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.
American Injectables employees in full PPE.