American Injectables, a contract development and manufacturing organisation (CDMO) specialising in sterile injectables, has announced that it has received FDA approval. This is a key moment for American Injectables and its clients, ensuring its high-quality injectables meet the stringent regulatory standards required for patient safety and efficacy. 

"This is a transformative achievement for our organisation. Receiving FDA approval not only validates the strength of our manufacturing processes and our team's dedication to quality but also reinforces our commitment to our clients. It enables them to bring life-saving therapies to market faster and with greater confidence," said Travis Allen, Interim CEO of American Injectables.

"Our team's focus on operational excellence and continuous improvement was instrumental in achieving this approval," added Allen.

American Injectables is a privately held CDMO, that specialises in ready-to-use glass or plastic vials and ready-to-use nested syringes.  In addition to manufacturing, the company is into formulation optimisation, analytical and stability services and process engineering. They are currently seeking partnerships and offer flexible terms as well as priority timelines. Based in Florida, their facilities serve both US and global markets.