Why this matters right now
In December 2025, Eli Lilly announced a >$6B investment to build a new U.S. API manufacturing facility in Huntsville, Alabama—part of a broader domestic manufacturing expansion and supply-chain resilience push. (Reuters) That announcement is not an isolated event; it reflects a policy-and-capital cycle that is reshaping how sponsors think about API sourcing, qualification, and long-term capacity planning.
At the same time, U.S. policy is explicitly framing domestic pharma manufacturing as a national priority. A May 5, 2025 executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” set a policy direction to reduce barriers and increase competitiveness for U.S.-based pharmaceutical manufacturing. (The White House)
The structural driver: supply chain concentration risk
One of the persistent constraints in drug supply resilience is geographic concentration of API capacity. A 2025 white paper from the API Innovation Center notes that a large share of FDA-approved API manufacturing facilities are located outside the U.S., and that many drugs consumed in the U.S. lack a U.S. API source. (API Innovation Center)
Whether your organization’s driver is supply assurance, federal customer requirements, speed-to-market, or reputational risk, the playbook is shifting from “lowest cost wins” to “lowest risk that still meets cost and quality targets.”
What’s changing operationally: FDA PreCheck and faster pathways for facilities
In August 2025, FDA announced FDA PreCheck, described as a two-phase approach intended to facilitate new U.S. drug manufacturing facilities and improve predictability and timeliness. (U.S. Food and Drug Administration) FDA also held a public meeting in September 2025 explicitly focused on onshoring manufacturing of drugs and biological products, tied back to the May 2025 executive order. (U.S. Food and Drug Administration)
For sponsors and CDMOs, this matters because it signals a world where:
- The regulatory dialogue for new/expanded U.S. capacity may become more structured,
- Timelines for facility readiness and inspection planning may become more predictable,
- “Domestic capacity” becomes a more explicit element in strategic sourcing decisions.
Practical implications for sponsors and procurement teams
If you are responsible for API sourcing, tech transfer, or outsourcing strategy, the near-term impact is less about headlines and more about day-to-day execution:
1) Supplier qualification will increasingly reward depth, not just price
Reshoring typically increases focus on:
- Documentation quality (traceability, change control discipline)
- Analytical readiness (methods, reference standards, impurity strategy)
- Transparency on raw material sourcing and capacity commitments
2) Dual sourcing becomes a board-level resilience tool, not a “nice to have”
Even when you stay global, sponsors are increasingly building:
- Primary supplier + validated secondary
- Or regional redundancy (e.g., North America + EU/UK, or North America + APAC)
3) DMF strategy and lifecycle change management become more central
If you expect to add/replace a supplier, change control and regulatory strategy become part of the cost of resiliency—not an exception you handle at the end.
A 60-day action checklist (what to do now)
- Map your API risk: which products rely on single geography/single supplier.
- Classify criticality: patient impact, revenue exposure, and substitution difficulty.
- Define “resilience requirements”: lead time, inventory policy, redundancy.
- Assess supplier maturity: quality system, deviation handling, transparency.
- Stress-test analytics: can your methods and specs survive a site transfer?
- Validate alternate raw materials where feasible (starting materials/intermediates).
- Document a transfer playbook: timelines, stability bridging, comparability.
- Engage partners early: reshoring is a multi-quarter activity, not a sprint.
Where Agere Sciences fits
Agere Sciences is positioned around APIs, research compounds, and CDMO services, which aligns well with sponsors seeking redundancy, scale-up pathways, or alternate sourcing strategies.