Your Integrated Contract Manufacturing Partner

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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.

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.

Connect With Us About Our Formulation Services
Small rack of injectables.

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.

Process engineering

With an integrated electronic management system, our team of seasoned engineers will provide the critical data and documentation you need for a successful FDA filing.
  • Engineering batches
  • Validation batches
  • Registration batches
Injectables manufacturing equipment.

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.

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.

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.

Launch and regulatory planning

Just as important as the manufacturing process is its documentation for regulatory applications. Get support from our bench of experts in creating an air-tight review of your drug’s Chemistry, Manufacturing, and Controls (CMC). Plus, rely on our expertise for: 
  • 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.
Get Started
Smiling American Injectables employee.