American Injectables Receives FDA Approval for Sterile Injectables Manufacturing

• American Injectables has received FDA approval for its sterile injectables, meeting the regulatory standards for patient safety and efficacy.

• The company, based in Florida, offers manufacturing services for ready-to-use vials and syringes, along with formulation optimization and process engineering.

American Injectables, a contract development and manufacturing organization (CDMO) based in Florida, has announced its achievement of FDA approval for its sterile injectables. This certification marks a significant milestone for the company, ensuring its products meet the stringent regulatory standards required for patient safety and efficacy.

The FDA approval demonstrates American Injectables’ commitment to quality, innovation, and reliability in pharmaceutical manufacturing. The approval enables the company to enhance its services to clients, allowing them to bring life-saving therapies to market faster and with greater confidence. “This is a transformative achievement for our organization,” said Travis Allen, Founder and CEO of American Injectables.

The approval also underscores the company’s dedication to operational excellence and continuous improvement. Allen emphasized that this success was made possible by the talent and commitment of the company’s team. American Injectables specializes in ready-to-use glass or plastic vials and nested syringes, providing flexible manufacturing solutions for both U.S. and global markets.

In addition to manufacturing, the company offers formulation optimization, analytical and stability services, and process engineering. It is currently seeking new partnerships and offering priority timelines to potential clients.