FDA-Approved | U.S.-Based CDMO
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.
Why American Injectables
U.S.-based facilities provide sponsors with quality assurance and domestic reliability.
Our experts work with your team to streamline operations and accelerate results.
Advanced fill-finish lines enable agile tech transfers, batch scale-up, and accuracy.
Our team maintains strict cGMP-compliance for safety, efficacy, and consistency.
solutions
Integrated disciplines under one quality system to move your program seamlessly from concept to commercial supply.
Turning promising molecules into stable, safe, and compliant drug products.
Delivering the robust data and insights needed for regulatory compliance.
Translating formulations into compliant processes ready for GMP production.
Sterile manufacturing supports clinical development through commercial supply.
Every process, system, and decision is designed to support accurate execution.
Ensuring submissions are compliant, complete, and audit ready.
capabilities
Specialized in vial and syringe manufacturing, we deliver precision, scalability, and reliability backed by the highest standards expected of a quality-driven CDMO partner.
infrastructure
Our FDA-registered facilities integrate cleanroom, laboratory, and manufacturing space designed for efficiency, control, and reliability supporting scalable execution.
Analytical and microbiology labs for compliant programs.
Automated aseptic fill-finish lines for vials and syringes.
Controlled storage from material to distribution.
Advanced equipment supports consistent performance.
Quality
A single, disciplined quality system runs across development, testing, and supply. Compliance and data integrity are built in, not bolted on.
Oversight from raw materials to finished product ensures every batch meets specifications.
In-house testing supports development through commercial manufacturing with reliable results.
Processes align with sponsor regulations delivering consistent compliance and performance.
Controlled systems protect records, upholding traceability, accuracy, and audit readiness.
Explore developments shaping the future of sterile injectables.
Discover the redesigned American Injectables website, showcasing our expanded sterile manufacturing capabilities! Easily explore our services, from formulation to commercial manufacturing. Our improved navigation ensures you find relevant resources quickly.
American Injectables announced key leadership changes to support growth in sterile injectable manufacturing. Travis Allen becomes CEO, with Paul Campanelli as Executive Chairman and Kimberlee Steele joining the board, enhancing
The FDA’s new ANDA Prioritization Pilot aims to enhance U.S. manufacturing of generic drugs by expediting approvals for domestically produced products, boosting supply resilience and patient access to affordable medications.
let’s chat
Reach out to discuss your program needs and explore how we can support your journey from development to delivery.
