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 reliable domestic operations.
Our experts work with your team to streamline operations and accelerate results at every stage.
Advanced fill-finish lines support agile tech transfers, batch scale-up, and precise execution.
Our team maintains strict cGMP compliance to support safety, efficacy, and product 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.
What’s Trending
Explore developments shaping the future of sterile injectables.
American Injectables and Ensera have partnered to enhance the biotech and pharmaceutical landscape in North America. This alliance streamlines the process from aseptic fill-finish to packaging, offering a seamless solution for companies bringing critical therapies to market.
Discover the newly redesigned American Injectables website, where our expanded capabilities and commitment to excellence come to life. Explore a streamlined view of our sterile manufacturing services, from formulation to commercial-scale production.
American Injectables, a leading contract development and manufacturing organization, has achieved a significant milestone by receiving FDA approval for its sterile injectables. This accomplishment underscores the company’s commitment to quality and innovation.
let’s chat
Reach out to discuss your program needs and explore how we can support your journey from development to delivery.
