American Injectables Earns FDA Approval

BROOKSVILLE, Fla., Jan. 9, 2025 /PRNewswire/ -- American Injectables, a contract development and manufacturing organization (CDMO) specializing in sterile injectables, is proud to announce it has received FDA approval. This milestone marks a pivotal moment for American Injectables and its clients, ensuring that its high-quality injectables meet the stringent regulatory standards required for patient safety and efficacy. 

"This is a transformative achievement for our organization," said Travis Allen, Interim CEO of American Injectables. "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."  

Setting a New Standard for Excellence 

FDA approval signifies more than regulatory compliance — it represents American Injectables' dedication to innovation, quality, and reliability in pharmaceutical manufacturing. This milestone positions the company as a trusted partner for pharmaceutical companies seeking scalable and compliant sterile injectable solutions. 

"Our team's focus on operational excellence and continuous improvement was instrumental in achieving this approval," Allen added. "This success is a testament to the incredible talent and commitment of everyone at American Injectables." 

About American Injectables

American Injectables is a privately held contract development and manufacturing organization (CDMO). They specialize in ready-to-use glass or plastic vials and ready-to-use nested syringes.

In addition to manufacturing, American Injectables excels in formulation optimization, 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 U.S. and global markets. Learn more at americaninj.com or follow them on LinkedIn. 

Media Contact

Brittany Siqueiros
Senior Vice President of Business Development
[email protected]
949-291-5102

SOURCE American Injectables Inc.