American Injectables expands its FDA-approved sterile fill-finish facility

American Injectables, a contract development and manufacturing organization (CDMO) based in Brooksville, Florida, announced a major expansion of its FDA-approved sterile fill-finish facility. The project includes additional aseptic manufacturing lines for syringes and vials, expanded formulation and R&D capabilities, as well as new commercial-scale inspection, labeling, packaging, and serialization services.

The company said the expansion is intended to support a wider range of batch sizes, from small clinical to large commercial campaigns. Construction began in July 2025, with equipment installation underway this month. Engineering batches are expected in the fourth quarter of 2025, and GMP readiness is targeted for the first quarter of 2026.

“We’re not expanding for the sake of size. We’re expanding because our clients need more capacity, speed, and flexibility. And we’re building to deliver exactly that,” said CEO Travis Allen, in a blog post.

According to the CDMO, the expanded facility will enable faster technology transfers and process scale-up while maintaining compliance and sterility standards. Capacity is now available for pre-booking batches in 2026.