Strengthening Commercial API Supply With Large‑Scale Manufacturing In Italy

Located in Bulciago, Italy, this GMP manufacturing site is purpose‑built to support commercial‑stage supply at scale. With large‑volume glass‑lined and stainless‑steel reactors — reaching up to 25,000 liters —t he facility is equipped to reliably produce APIs, RSMs, NCEs, and related materials in hundreds‑of‑kilograms to multi‑ton quantities. Its focus on late‑stage and commercial manufacturing helps shift earlier development work to other sites, improving network efficiency and long‑term capacity planning.

Regulatory readiness is reinforced through FDA and AIFA inspections and Japanese Pharmacopoeia accreditation, supporting global market needs. The site also plays a critical role in supply chain resilience, offering internal back‑up manufacturing and a European alternative for programs seeking geographic flexibility. Ongoing investments in reactors, automation systems, utilities, and production areas continue to expand capabilities and improve operational robustness.

Read the brochure to learn how this facility supports dependable, large‑scale supply for mature programs.