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.

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Elevating CDMO Standards.

FDA Approved FINAL
FDA Approved

Our U.S.-based facilities ensure global partners quality and domestic reliability.

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EXPERT SUPPORT

Direct access to our experts for seamless operations and fast results.

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Precise Manufacturing

Advanced fill-finish lines support efficient scale-up and consistency.

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Consistent Quality

cGMP standards and continuous controls deliver sterility, compliance, and reliability.

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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.

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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.

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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...

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Momentum and Milestones: 2025 in Review

Year End Reflections at American Injectables As we conclude the year, American Injectables stands at...

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Manufacturing Commercial Success

Delivering Our First Commercial Success American Injectables recently completed commercial productio...

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Let's Connect.

Reach out to discuss your program needs and explore how we can best support your journey from development to delivery. 

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