- American Injectables has begun expanding its FDA-approved sterile injectable fill-finish facility, adding more than 30 million units of syringe and vial capacity.
- The project, set for GMP readiness in Q1 2026, will also introduce expanded formulation development, packaging, and commercial-scale inspection capabilities.
American Injectables has announced a major expansion of its FDA-approved fill-finish facility to increase capacity and enhance flexibility for sterile injectable manufacturing.
The expansion, which began construction in July 2025, includes new aseptic manufacturing lines for syringes and vials, additional formulation and laboratory capabilities, as well as commercial-scale inspection, labelling, packaging, and serialisation. The company said the project will provide more than 30 million units of extra capacity.
CEO and Board Director Travis Allen said, “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.”
American Injectables said the investment is designed to support both small clinical and large commercial campaigns, offering faster technology transfers, shorter lead times, and end-to-end support from formulation through to packaging.
Engineering batches are scheduled for the fourth quarter of 2025, with GMP readiness expected in the first quarter of 2026.
