Your Medicine. Our Mission.
U.S.-Based CDMO for Sterile Injectables with Global Impact.
American Injectables manufactures sterile injectables with quality, speed, and consistency. As an FDA-approved, U.S.-based CDMO, we combine modern infrastructure and seamless operations to advance programs with confidence from early development through commercial supply.
Elevating CDMO Standards.
FDA Approved
Our U.S.-based facilities offer global partners assured quality and domestic reliability.
EXPERT SUPPORT
Direct access to our experts ensures seamless operations and accelerates results.
Precise Manufacturing
Advanced fill-finish lines enable agile tech transfers, efficient scale-up, and consistency.
Consistent Quality
cGMP standards and continuous controls deliver sterility, compliance, and reliability.
Precision in Every Dose
Specialized in vial and syringe manufacturing, American Injectables delivers precision, scalability, and reliability backed by the highest standards expected of a quality driven CDMO partner.
Lab to Launch Solutions
Our facilities support development, analytical testing, fill-finish, packaging, and serialization in one coordinated network to deliver fast, reliable, and compliant results.
Premier Facilities
Purpose-built for sterile injectable manufacturing, our FDA-approved facilities integrate cleanroom and laboratory space designed for efficiency, control, and reliability. With precise systems, real-time monitoring, and new vial and syringe fillers, we support scalable execution from clinical development through commercial production.
Insights and updates
American Injectables Earns FDA Approval
BROOKSVILLE, FL (January 9, 2025) — American Injectables, a contract development and manufacturing o...
Momentum and Milestones: 2025 in Review
Year End Reflections at American Injectables As we conclude the year, American Injectables stands at...
Manufacturing Commercial Success
Delivering Our First Commercial Success American Injectables recently completed commercial productio...
