Milestones in Sterile Fill-Finish for Future Therapies

milestones

Purpose-built for sterile fill-finish.

American Injectables continues to grow through ongoing strategic investments and facility expansions. These milestones reflect our commitment to delivering the consistent excellence pharmaceutical innovators rely on.

Milestones that define our growth + progress.

Each milestone, from sterile manufacturing facility expansion to increased fill-finish capacity and continued pharmaceutical manufacturing investment, strengthens our ability to bring critical therapies to patients faster, more safely, and more reliably.

Phase 1

2020 - 2021

Facility Build

Laying the foundation for a modern, U.S.-based CDMO built for sterile injectables.

Construction of the main facility in Brooksville, Florida
Recruitment of a highly experienced sterile operations team

Phase 2

2022 - 2024

Site Validation (2022)

Transforming infrastructure into operational excellence.

Site validation completed (Q1 2022)
Syntegon vial line qualified and operational, supporting batches up to 20K (Q3 2022)

Site Validation (2023)

Florida manufacturing license secured (Q1 2023)
Commercial filling lines ordered (Q4 2023)

Site Validation (2024)

Warehouse and R&D lab build-out complete (Q2 2024)
Successfully passed FDA inspection (Q3 2024)

Phase 3

2025 - Beyond

Commercial Expansion (2025)

Scaling capacity, capability, and impact.

Commercial supply to U.S. market begins (Q2 2025)
Installation of Groninger vial filling Line (Q3 2025)
Site Acceptance Test (SAT) completed for Groninger line (Q4 2025)

Continued Facility Expansion (2026)

Installation of Optima syringe filling Line (Q1 2026)
Site Acceptance Test (SAT) completed for Optima line (Q3 2026)
New filling machines media-fill qualified, and cGMP validated
Integration of dedicated partners offering secondary packaging services and full serialization capabilities

we’re growing

Let's chat about the future of sterile injectables.

Connect with our team to learn how our continued growth and investments can support your sterile injectable program.