FAQ: Where US Pharma Reshoring Stands in 2026

A hard Section 232 tariff deadline arriving July 31, 2026, and an FDA program offering earlier regulatory engagement for new domestic plants have pushed pharma reshoring from talking point to active build-out. This FAQ breaks down the compliance timeline, who's already moving, and what's still ahead.

What is pharma reshoring and why is it in focus now?

Reshoring, or onshoring, is the process of relocating pharmaceutical manufacturing and supply chain operations back to the US to reduce dependence on foreign production. It isn't a new idea, but two developments have pushed it back to the top of the agenda in 2026: a new tariff regime tied to hard compliance deadlines, and the FDA offering a more predictable regulatory pathway for companies willing to build domestic capacity.

Why is momentum accelerating right now?

• A new Section 232 tariff regime, with rates as high as 100% on patented drugs, begins phasing in July 31, 2026, turning what had been a longer-term strategic push into a hard compliance deadline.¹
• The FDA's PreCheck Pilot Program, launched in February 2026, gives companies building new US facilities early technical guidance and pre-submission engagement before they file a formal drug application.
• China's April 2026 Regulations on Industrial and Supply Chain Security add a further layer of urgency, turning routine US compliance actions into potential triggers for Chinese retaliation.

What's the tariff timeline, and what's still ahead?

The clock on Section 232 tariffs is already running. Under an April 2026 proclamation, patented pharmaceuticals, their active ingredients, and key starting materials face a default 100% tariff.¹ Companies with an approved onshoring plan get a reduced 20% rate for the time being; those that pair onshoring with a Most Favored Nation pricing agreement get 0%, at least until 2029, while products from the EU, Japan, South Korea, and Switzerland carry a base 15% rate under existing trade deals.² For the 17 manufacturers named in the proclamation's Annex III, that structure takes effect July 31, 2026. Every other company has until Sept. 29, 2026. Generic drugs and biosimilars remain exempt, though the order directs Commerce to revisit that exemption within a year.¹

The 0% rate for companies that sign both an onshoring commitment and an MFN pricing deal is the central mechanism in the whole structure, delivering immediate tariff relief in exchange for a pledge to reshore manufacturing and match global drug pricing. But that relief expires Jan. 20, 2029, and the 20% onshoring-only rate is set to climb to 100% by April 2, 2030, for any company that hasn't reached an MFN agreement by then.² The result is a series of escalating deadlines layered on top of each other, each one tighter than the last, designed to convert reshoring from a slow-moving strategic bet into a near-term compliance problem.

What is the FDA PreCheck Pilot Program, and who's in it?

PreCheck is a two-phase engagement model: Phase 1 gives the FDA a chance to assess facility readiness and offer technical guidance before a plant is even operational; Phase 2 adds pre-submission meetings to support faster evaluation and inspection planning. The inaugural cohort, selected from more than 80 applicants, includes:

• Amneal Pharmaceuticals — sterile small-molecule liquids, Long Island, NY
• Cellares Corp. — cell-based gene therapies for oncology and hematology, Bridgewater, NJ
• Eli Lilly and Company — APIs, Lebanon, IN
• FUJIFILM Biotechnologies — commercial-scale cell culture biomanufacturing, Holly Springs, NC
• Kriya Therapeutics — AAV-based gene therapies for chronic disease, Durham, NC
• Kyowa Kirin — biotech drug substance for rare diseases, Sanford, NC
• Regeneron Pharmaceuticals — biotech drug substance, sterile injectables, novel proteins, Saratoga Springs, NY

What does the investment picture look like so far?

The dollar figures are large. Since Eli Lilly kicked off the wave with a $27 billion API and sterile-injectables commitment in 2025, 13 more manufacturers, including AbbVie, AstraZeneca, Bristol Myers Squibb, Gilead, GSK, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Roche, and Sanofi, have pledged a combined total of more than $480 billion in US-based production over the next four to ten years. Collectively, those announcements point to 22 new manufacturing sites and roughly 44,000 new jobs, spanning APIs and sterile generics, radioligand therapies, gene and weight-management therapies, biologics, and small molecules.²

Whether the money actually shows up is a separate question. A 2025 Council on Foreign Relations analysis suggested that upstream equipment suppliers, the companies that sell the bioreactors, filtration systems, and single-use components new plants actually need, were cautiously optimistic about the demand as of the third quarter of 2025, and share prices across the sector had largely not moved to reflect the scale of the pledges. Researchers there noted that even a conservative estimate of 15% of the pledged capital going toward equipment would represent more than $75 billion in new orders, a surge that hadn't yet materialized as of their analysis.³

Why can't the US just reshore everything?

Economics pose a challenge to reshoring. Generics account for roughly 90% of US prescriptions but only 13.1% of total drug spending, a margin structure that leaves manufacturers little room to invest in domestic capacity.⁴ A 2025 CSIS analysis found that tariffs and executive orders alone can't overcome the regulatory complexity, commercial disincentives, and workforce shortfalls constraining domestic manufacturing.⁴ That's why in a previous interview with Pharmaceutical Commerce, Gerren McHam of the API Innovation Center argued the realistic goal isn't reshoring every medicine, but targeting the most critical and fragile ones.

What would effective reshoring actually require?

According to McHam, closing the exposure gap means going further upstream than most current investment reaches, to the key starting materials where China's leverage is greatest. That takes two parallel tracks: modernizing existing FDA-regulated manufacturing infrastructure and scaling consortium models that develop new synthesis routes with committed customers already lined up. Neither works, he says, without long-term federal purchasing commitments and policy that rewards resiliency and quality rather than the lowest price alone.

What could a realistic outcome look like in five to ten years?

Not a fully reshored supply chain, McHam says, but a more resilient one: a "horizontal model” where key starting materials, APIs, and finished-dose manufacturing operate in coordination rather than as segmented, disconnected steps, supported by continuous flow chemistry, better process analytics, and flexible production platforms.

Which therapeutic categories are the priority?

The categories where a disruption would carry the most serious patient care consequences include cardiovascular drugs, respiratory agents, antimicrobials, oncolytics, and the injectables used in acute care. McHam points to staples like albuterol and metoprolol as examples of exposure hiding in plain sight, categories with little brand-name visibility but daily clinical dependence.

Which stakeholders are most affected?

• Generic and branded manufacturers reassessing footprint strategies
• CDMOs and API suppliers building or expanding US capacity
• FDA and other regulators shaping early-engagement pathways like PreCheck
• Federal policymakers overseeing tariffs, MFN pricing, and purchasing commitments
• Hospitals, providers, and patients who depend on continuity of supply for essential medicines

References

1. The White House. "Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States." Presidential Actions, April 2, 2026. https://www.whitehouse.gov/presidential-actions/2026/04/adjusting-imports-of-pharmaceuticals-and-pharmaceutical-ingredients-into-the-united-states/.
2. DeepCeutix. "100% Tariffs on Pharma Imports. Your Formulation Has 120 Days." Strategic Briefings, 2026. https://deepceutix.com/insights/pharma-tariff-reshoring-crisis.
3. Yadav, Prashant, and Chloe Searchinger. "Tracking Pharma's Progress on U.S. Onshoring Efforts to Avoid Tariffs." Council on Foreign Relations, Think Global Health, Nov. 24, 2025. https://www.thinkglobalhealth.org/article/tracking-pharmas-progress-on-u-s-onshoring.
4. Wessner, Charles, and Sujai Shivakumar. "Rebuilding Resilience in U.S. Pharmaceutical Manufacturing." Center for Strategic and International Studies, Sept. 29, 2025. https://www.csis.org/analysis/rebuilding-resilience-us-pharmaceutical-manufacturing.