BROOKSVILLE, FL (January 9, 2025) — 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, Founder and 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.”

To read the original press release, click here.

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. For more information, please visit americaninj.com.

About Bourne Partners Strategic Capital

Headquartered in Charlotte, N.C., Bourne Partners Strategic Capital (“BPSC”) is a private equity and growth equity investment firm focused exclusively on the pharmaceutical, pharma services and consumer healthcare sectors (10 current portfolio companies). As owners and operators with over 20 years of experience, BPSC has investment, strategic and operational experience in companies ranging from $5M to $3B in equity value and seeks to align and partner with management teams and other owners in these sectors to grow their business. BPSC is a related company of Bourne Partners, which offers investment banking and advisory services in the same key focus areas. For more information, please visit Bourne Partners Strategic Capital at https://www.bourne-partners.com/strategic-capital/