SENTINEL API GROUP, INC.

Legislation, policies, appropriations, and regulatory relief to support the development, construction, and operation of new U.S.-based active pharmaceutical ingredient (API) manufacturing facilities; initiatives to strengthen domestic API supply chains and reduce reliance on foreign-sourced APIs; FDA regulatory streamlining and expedited review for new API manufacturing plants; federal grant, tax incentive, and contracting mechanisms to increase private investment in domestic API production; implementation of Executive Order(s) or federal policy aimed at boosting U.S.-based pharmaceutical manufacturing; relevant provisions of H.R. 1405 (Enhancing Domestic Drug Manufacturing Act), S. 257 (Promoting Resilient Supply Chains Act of 2025), the RAPID Reserve Act, and other pending bills and actions to advance U.S. pharmaceutical supply chain resilience and capacity.

BIOSECURE Act implementation (H.R.8333) restricting Chinese pharmaceutical supply chains and supporting domestic API manufacturing. SBIR/STTR reauthorization (S.1573, H.R.3169) for pharmaceutical manufacturing eligibility. Strategic API Reserve funding under August 2025 Executive Order. FDA regulatory reforms including PreCheck Program and expedited facility approvals. Defense Production Act Title III pharmaceutical investments and Defense Manufacturing Community Support Program inclusion. HHS, ASPR, and BARDA appropriations for domestic manufacturing infrastructure.