American Injectables

American Injectables is a privately held contract development and manufacturing organisation (CDMO) specialising in sterile injectable pharmaceuticals. ​

Established in 2020 and based in Florida, USA, American Injectables focuses on bringing quality injectable manufacturing back to U.S. soil, aiming to improve reliable access for patients and transparency for clients. The company offers end-to-end solutions for the development and production of sterile injectables, serving both U.S. and global markets. With a leadership team boasting over 100 years of combined experience, American Injectables emphasises collaboration, transparency, and an unwavering commitment to quality. ​

Key Products and Services:

Injectable Manufacturing Services: Specialising in ready-to-use glass or plastic vials and ready-to-use nested syringes, utilising state-of-the-art, FDA-registered GMP fill-finish facilities equipped with the latest technology. ​

Formulation Development: Expertise in formulation optimisation, starting with proof-of-concept studies and evaluating APIs with various excipients and delivery systems. ​
American Injectables

Analytical and Stability Services: Conducting raw-material, in-process, and finished product testing to verify drug purity and potency, along with ICH stability studies to determine shelf life and storage conditions. ​

Process Engineering: Providing comprehensive process development and optimisation to ensure scalable and efficient manufacturing processes. ​

Regulatory Support: Assisting with Chemistry, Manufacturing, and Controls (CMC) documentation and offering expertise in regulatory strategy and compliance. ​

American Injectables is dedicated to reducing the complexity of drug development by offering flexible partnerships, including profit/risk-sharing models and adaptable collaborations. By integrating comprehensive services under one organisation, the company aims to streamline the pathway from formulation to patient-ready products, ensuring timely delivery of high-quality therapies to patients worldwide