Your Integrated Contract Manufacturing Partner
![QC manager at work.](https://americaninj.com/hs-fs/hubfs/American_Injectables_2024/images/800x800_0014_services-formula-fda.jpg?width=800&height=800&name=800x800_0014_services-formula-fda.jpg)
From formula to FDA approval
Explore our end-to-end solutions or ask about a rapid site transfer. With an experienced team and tested transfer plan, our goal is to make this transition your last.
![American Injectables employee working on formulation project.](https://americaninj.com/hs-fs/hubfs/American_Injectables_2024/images/800x800_0013_services-formulation.jpg?width=800&height=800&name=800x800_0013_services-formulation.jpg)
Formulation
With expertise in solutions, our team is ready to shepherd your project through this critical phase. Starting with optimization and proof-of-concept studies, we’ll evaluate APIs with various excipients and delivery systems. Once the initial formulation concepts are established, we can start manufacturing clinical trial materials using our comprehensive manufacturing capabilities.
![Small rack of injectables.](https://americaninj.com/hs-fs/hubfs/American_Injectables_2024/images/800x800_0012_services-analytical.jpg?width=800&height=800&name=800x800_0012_services-analytical.jpg)
Analytical and stability services
Our team is equipped to run raw-material, in-process, and finished product testing to verify your drug’s purity, potency, and compliance with regulatory requirements. To determine the shelf life, storage conditions, and packaging requirements for your drug, we’ll conduct ICH studies and evaluate its stability under various conditions over time.
![American Injectables employee in full PPE working on process engineering.](https://americaninj.com/hs-fs/hubfs/American_Injectables_2024/images/800x800_0011_services-process-engineering.jpg?width=800&height=800&name=800x800_0011_services-process-engineering.jpg)
Process engineering
- Engineering batches
- Validation batches
- Registration batches
![Injectables manufacturing equipment.](https://americaninj.com/hs-fs/hubfs/American_Injectables_2024/images/800x800_0010_services-manufacturing.jpg?width=800&height=800&name=800x800_0010_services-manufacturing.jpg)
Manufacturing
With expertise in orphan state and branded drugs, we prioritize all our clients regardless of size. We’re equipped for flexible batch sizes, anywhere from <1K to 150K units at a time. Through strict adherence to cGMP, we deliver consistent quality.
![Supply chain coordinator standing in warehouse.](https://americaninj.com/hs-fs/hubfs/American_Injectables_2024/images/800x800_0009_services-quality-assurance.jpg?width=800&height=800&name=800x800_0009_services-quality-assurance.jpg)
Quality assurance
Though QA is ingrained in all our processes, this step is dedicated to the final inspection of every batch.
![American Injectables employee mixing materials in full PPE.](https://americaninj.com/hs-fs/hubfs/American_Injectables_2024/images/800x800_0008_services-aerilization.jpg?width=800&height=800&name=800x800_0008_services-aerilization.jpg)
Packaging
Our team can currently execute small-scale packaging. We can also outsource for larger-scale projects. Beginning in 2026, we’ll expand our capabilities to include:
- Automated cartoning of syringes and vials
- Automated syringe assembly
![American Injectables employee extracting material from vial in full PPE.](https://americaninj.com/hs-fs/hubfs/American_Injectables_2024/images/800x800_0007_services-launch.jpg?width=800&height=800&name=800x800_0007_services-launch.jpg)
Launch and regulatory planning
- Material and finished goods management
- GMP warehousing
This is where you come in
Regardless of where you fall in the process, we’re excited to support you.
![Smiling American Injectables employee.](https://americaninj.com/hs-fs/hubfs/American_Injectables_2024/images/800x800_0006_services-this-is-where-you-come.jpg?width=800&height=800&name=800x800_0006_services-this-is-where-you-come.jpg)