FDA PreCheck Pilot: Inside the seven companies reshaping US drug manufacturing — 2026-06-29

The FDA announced today (June 29, 2026) the selection of seven companies for the FDA PreCheck Pilot Program, a regulatory pathway designed to accelerate US-based pharmaceutical manufacturing capacity. Below is a deep analysis of the selection process, the seven companies, and what this means strategically for each one and for the broader biopharma manufacturing landscape.

What the PreCheck Pilot actually is

The PreCheck Pilot was launched on February 1, 2026, in response to Executive Order 14293 (signed by President Trump in May 2025) and following a public meeting on domestic manufacturing challenges. The program is structured in two phases:

• Phase 1 — Facility Readiness: Participants receive early technical guidance from FDA before the facility is operational, including reviews of facility information submitted through a facility-specific Drug Master File (DMF). FDA assesses and helps enhance facility readiness before a drug or biologics application is submitted.
• Phase 2 — Application Submission: Participants get enhanced engagement through facility-focused pre-submission meetings, intended to support expedited facility evaluation and enable inspections earlier in the review cycle.

The pilot is the first concrete regulatory mechanism to operationalize EO 14293’s goal of reducing US dependence on foreign drug manufacturing, particularly for generic sterile injectables and active pharmaceutical ingredients (APIs) where overseas concentration creates supply-chain vulnerabilities.

How the seven were selected

Between February 1 and March 1, 2026, the FDA received over 80 applications. To be eligible, a company had to:

1. Propose a new domestic manufacturing facility that will be capable of manufacturing drug products to address a market supply need or improve patient access to therapies for unmet medical needs.
2. Commit to submitting an NDA, BLA, ANDA, or supplement that relies on the new manufacturing facility.

The FDA evaluated all 80+ requests using an objective framework and scoring rubric with four explicit criteria:

• Products to be manufactured (whether they address supply gaps or unmet medical needs)
• Stage of facility development (how far along construction / qualification)
• Anticipated timeline for bringing products to the US market
• Innovation in facility development and manufacturing operations

The 7 chosen represent roughly 9% of applicants. The 73+ that were not selected are not publicly named, which limits external validation of the rubric’s consistency — but the seven that were selected reveal what FDA prioritized.

The seven companies, in detail

1. Amneal Pharmaceuticals (NYSE: AMRX)

• Site: Long Island, New York
• Products: Small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases
• Public: Yes, NASDAQ: AMRX (note: the FDA press release and most media call this Long Island; the NYSE ticker is actually the right one — minor naming confusion worth noting)

Strategic significance: This is Amneal’s most meaningful domestic expansion play. The company has been actively reshuffling its US footprint — it shuttered an oral solids plant in Hauppauge, NY in 2022-2023 with layoffs — and this Long Island sterile injectables facility represents a pivot toward higher-margin, supply-critical dosage forms. Sterile injectables, particularly for pain management (post-op, oncology supportive care) and ophthalmics, are a category with chronic US shortages and heavy India/China API dependency. PreCheck status de-risks the facility qualification timeline and effectively gives Amneal a fast-track to ANDA approval for products manufactured there.

Risk to watch: Amneal is a heavily-levered generics player (carrying meaningful debt) and a sterile injectable facility is capital-intensive. PreCheck doesn’t change the underlying economics — but it changes the regulatory clock.

2. Cellares Corp.

• Site: Bridgewater, New Jersey
• Products: Cell-based gene therapy products for oncology and hematology diseases
• Public: No (private; raised $257M Series C in January 2026 with BMS as anchor partner)

Strategic significance: Cellares is the most strategically interesting pick. The company is not a drug developer — it’s a CDMO specializing in cell therapy manufacturing automation (its “Cell Shuttle” platform and integrated IDMO Smart Factory model). BMS, one of the company’s anchor partners, is among the largest cell therapy developers (Breyanzi, Abecma). Selecting a CDMO rather than a sponsor validates two things: (a) FDA is willing to put regulatory weight behind manufacturing innovation as a criterion (Cellares’ automation is genuinely novel), and (b) the supply crisis in autologous CAR-T manufacturing — where vein-to-vein time is dominated by production slots at contract manufacturers — is real enough that the regulator is intervening at the manufacturing layer.

Risk to watch: The Bridgewater facility was under construction in early 2026 with completion targeted Q1 2026 and commercial-scale manufacturing services targeted for 2027. PreCheck status could accelerate commercial timeline by 6-12 months. But cell therapy CDMO is capacity-overhang-prone — there are 5+ competing CDMOs (Lonza, Cell & Gene Therapy Catapult, AGC Biologics, plus academic medical centers running GMP suites). Cellares’ bet is that automation-driven cost reduction wins the next phase of cell therapy commercialization.

3. Eli Lilly and Company (NYSE: LLY)

• Site: Lebanon, Indiana
• Products: Drug substance (active pharmaceutical ingredients) for existing and future medicines
• Public: Yes, NYSE: LLY

Strategic significance: The biggest company by far in the cohort. Lilly’s Lebanon site is part of its multi-billion-dollar API manufacturing buildout — the company announced a $9B investment at Lebanon in May 2024 (doubled from $4.5B initial commitment) and added another $4.5B across Indiana sites in May 2026. Lilly’s Lebanon site will eventually support tirzepatide (Mounjaro/Zepbound) API production, plus API for its incretin pipeline (retatrutide, orforglipron). PreCheck status is essentially a regulatory fast-pass that ensures the API from this site will hit the application review clock without facility-related delays.

Risk to watch: Lilly’s selection is the strongest signal that EO 14293 is being interpreted by FDA as “domestic capacity for ANY drug” — including blockbusters whose commercial value is already proven. Lilly’s selection alongside Kriya (clinical-stage, untested modality) and Cellares (private CDMO) shows the rubric is genuinely product-agnostic. This is good for the program but raises a policy question: did Amneal, Kriya, and Kyowa Kirin really need PreCheck status as much as Lilly did? Or is FDA using PreCheck to legitimize a broader reshoring agenda than the EO text implied?

4. FUJIFILM Biotechnologies (private subsidiary of FUJIFILM Holdings, Tokyo: 4901)

• Site: Holly Springs, North Carolina
• Products: Commercial-scale cell culture biomanufacturing (mammalian cell culture, biologics drug substance)
• Public: Parent company public (FUJIFILM Holdings, Tokyo Stock Exchange); CDMO subsidiary private

Strategic significance: FUJIFILM Biotechnologies is the second-largest CDMO globally by biologics capacity (behind Lonza), and the Holly Springs plant is its flagship US site — a $3.2 billion commercial-scale cell-culture biomanufacturing facility that opened in 2025-2026 with phased capacity buildout. PreCheck status effectively gives FUJIFILM a regulatory halo that it can pass through to its sponsor customers: any biotech whose BLA references drug substance from the Holly Springs site gets the FDA-engagement benefit indirectly.

This is the most commercially significant pick in the cohort — Holly Springs is the only commercial-scale mammalian cell culture facility in the program. Every other pick is either sterile fill-finish (Amneal), API small molecule (Lilly), cell therapy (Cellares, Kriya), or specialized biologics (Kyowa Kirin, Regeneron).

Risk to watch: FUJIFILM has been on a multi-year capacity expansion tear (also expanding in UK and Japan). PreCheck status is essentially regulatory validation of that scale-up. The downside: as a CDMO, FUJIFILM’s fortunes are tied to its sponsor customers’ pipeline success, not its own pipeline.

5. Kriya Therapeutics, Inc.

• Site: Durham (Research Triangle Park), North Carolina
• Products: AAV-based gene therapy products for chronic disease conditions
• Public: No (private; clinical-stage)

Strategic significance: Kriya is the clinical-stage gene therapy company selected. The company is building in-house GMP manufacturing at RTP — a notable strategic departure from the typical gene therapy CDMO-out-source model. Kriya is pursuing AAV-based gene therapies for common chronic diseases (Type 1 diabetes, obesity, oncology supportive care), which is a different therapeutic-area emphasis than most AAV companies (rare diseases, ophthalmology, neurology). PreCheck status is critical for Kriya because gene therapy manufacturing is the single hardest category in biologics to scale — AAV production has notoriously low yields, complex supply chains, and FDA scrutiny on CMC (chemistry, manufacturing, and controls) is intense.

Risk to watch: Kriya is much earlier-stage than the other picks. Its Series C funding (2022, $270M led by Patient Square Capital) gives it runway through 2025-2026 but a clinical-stage gene therapy company with one selected facility in PreCheck is a much riskier bet than Lilly’s established API site. If Kriya’s clinical programs stumble, the PreCheck facility becomes a stranded asset.

6. Kyowa Kirin, Inc. (parent: Kyowa Kirin Co., Ltd., Tokyo: 4151)

• Site: Sanford, North Carolina
• Products: Biotechnology drug substance for rare diseases
• Public: Yes (Japanese parent, Tokyo Stock Exchange)

Strategic significance: Kyowa Kirin’s Sanford facility was announced in June 2024 as a $530 million investment for a biologics drug substance plant for the company’s rare-disease pipeline (potybatrop alfa for FOP, rocatinlimab for atopic dermatitis, etc.). The facility is the company’s first US manufacturing site and represents a strategic deepening of US presence after years of being a Japan-anchaged operation. PreCheck status is meaningful because Kyowa Kirin’s biologics are typically for ultra-rare diseases (some with patient populations in the hundreds), and FDA facility-related delays disproportionately hurt rare-disease programs.

Risk to watch: Foreign-headquartered companies with US manufacturing footprints are an interesting case under EO 14293 — the EO is about US self-reliance, but a Japanese parent operating a US facility fits the spirit (US jobs, US capacity) even if it doesn’t fit a strict “US-headquartered” reading. Kyowa Kirin’s selection signals that FDA is interpreting “domestic” geographically (facility in US) rather than by corporate parent nationality. This is favorable for any non-US company building US capacity (Ipsen, Sanofi, Roche, Novo Nordisk, etc.) — but it raises a policy question about how rigorously “domestic” is being defined.

7. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

• Site: Saratoga Springs, New York
• Products: Biotechnology drug substance, sterile injectables, novel protein therapeutics for multiple diseases
• Public: Yes, NASDAQ: REGN

Strategic significance: Regeneron’s Saratoga Springs plant was announced in April 2025 as part of a $7 billion NY + NC investment commitment, with $2 billion specifically for the Saratoga Springs plant. The facility is Regeneron’s first new manufacturing campus in years and supports Eylea HD, Dupixent (with Sanofi), and Regeneron’s bispecific antibody pipeline (linvoseltamab, odronextamab). Like Lilly, Regeneron’s selection reflects the program’s product-agnostic approach.

Risk to watch: Regeneron is the second publicly-traded US biotech (after Lilly) in the cohort. Notably absent: Vertex, Gilead, BMS, Pfizer, J&J, Merck, AbbVie, Amgen, Biogen — every other major US biotech. The selection of Lilly + Regeneron over Vertex/Pfizer/Merck suggests FDA may have weighted committed facility capex (i.e., real money spent, real construction underway) over company size. Both Lilly’s Lebanon and Regeneron’s Saratoga Springs were announced with hard capex commitments and visible construction activity before PreCheck launched.

What this means strategically for each company

Company	Strategic win	What changes for them
Amneal	Regulatory fast-pass for sterile injectable ANDAs in a chronic-shortage category	De-risks $X facility qualification timeline; access to FDA facility-readiness review before Phase 1 inspection
Cellares	Validates CDMO-as-pick and manufacturing innovation as a criterion	Can market PreCheck status to cell-therapy sponsor customers as a competitive differentiator vs Lonza/AGC/Catalent
Eli Lilly	Ensures API from Lebanon hits the BLA review clock without facility delays	Mostly symbolic — Lilly has the resources to manage any FDA engagement — but PreCheck status pre-empts any “but is the site ready?” questions from investors
FUJIFILM Biotechnologies	Regulatory halo that flows through to all sponsor customers using Holly Springs	Most commercially valuable pick of the cohort; could be the inflection point that makes the US biologics CDMO market bi-modal (FUJIFILM/Lonza at top, everyone else fighting for the next tier)
Kriya Therapeutics	Critical for gene therapy CMC de-risking at exactly the right time	Without PreCheck status, Kriya’s clinical-stage gene therapy pipeline would face CMC-related FDA delays that could push BLA timing 12-18 months
Kyowa Kirin	First US manufacturing site gets regulatory fast-pass; “domestic” interpretation is facility-based, not parent-nation-based	Opens the door for other foreign-pharma US facilities to qualify for similar programs
Regeneron	Same as Lilly — symbolic regulatory validation for a committed facility	Mostly a PR win + preemptive defense against any “site readiness” pushback from regulators

What this means for the broader US biopharma manufacturing landscape

The 7-company cohort reveals FDA’s selection philosophy in four patterns:

1. Geography doesn’t matter as much as facility-readiness. The cohort spans 4 states (NY, NJ, IN, NC) and 3 manufacturing sub-regions (Long Island, RTP, Indiana). No Pacific Northwest, no Texas, no California site. The geographic pattern is mid-Atlantic + Midwest + NC — the legacy biomanufacturing belt.

2. Modality diversity is intentional. The cohort covers small molecule sterile injectables (Amneal), cell therapy (Cellares), small molecule API (Lilly), mammalian cell culture biologics (FUJIFILM), AAV gene therapy (Kriya), novel biologics for rare disease (Kyowa Kirin), and bispecific antibodies (Regeneron). FDA is signaling that PreCheck is a cross-modality program, not focused on any one therapeutic area.

3. Public/private mix is balanced. 3 public (Amneal, Lilly, Regeneron), 3 private (Cellares, Kriya, Kyowa Kirin’s US subsidiary is private even though parent is public, FUJIFILM Biotechnologies is private even though parent is public). FDA is not favoring either side.

4. CDMOs are in the mix. Cellares and FUJIFILM are both CDMOs. This is the first time a federal manufacturing program has formally recognized CDMOs as eligible for the same regulatory benefits as drug sponsors — and it reflects the reality that the US drug supply depends on CDMOs as much as on sponsors.

What’s NOT in the cohort:

• No mRNA facilities (despite the COVID-era mRNA buildout, no Pfizer, Moderna, or BioNTech US site made the cut)
• No biosimilars (despite biosimilars being a major Trump-administration pricing focus)
• No CAR-T sponsors themselves (BMS, Gilead/Kite, Novartis — they all use CDMOs like Cellares; sponsor-side facility expansion hasn’t happened)
• No top-5 pharma giants except Lilly (Pfizer, Merck, J&J, AbbVie all declined to participate or didn’t have qualifying facility capex)
• No companies from Europe operating US sites (Sanofi, Ipsen, Roche/Genentech — surprising given EO 14293’s broad scope)

Open questions

• Will the program scale beyond 7? The FDA press release hints at “future program development” but doesn’t commit to expansion. With 80+ initial applicants and 7 selected, the bottleneck is FDA staff capacity for Phase 1 facility-readiness reviews.
• What happens to the 73+ unselected applicants? Not publicly disclosed. Some are likely still proceeding without PreCheck status; some may have abandoned their facility plans.
• Will the next round favor different modalities? mRNA and biosimilars are conspicuous absences. A future round could explicitly target these categories.
• Is “domestic” facility-based or parent-nation-based? Kyowa Kirin’s selection answers this for now (facility-based), but a future administration could reverse that interpretation.
• Will PreCheck status become a market signal? If investors start pricing PreCheck inclusion as a positive catalyst (similar to how FDA Breakthrough Therapy Designation is treated), the program could become competitive in a way the original EO text didn’t anticipate.

Bottom line

The PreCheck Pilot cohort is well-curated: it spans modalities, geographies, and company sizes; it includes CDMOs alongside sponsors; and it prioritizes facilities that are already in active construction or qualification. The 7 picks represent roughly $15+ billion of committed US manufacturing capex (Lilly’s $9B + Regeneron’s $2B + FUJIFILM’s $3.2B + Kyowa Kirin’s $530M + Amneal/Cellares/Kriya unannounced amounts).

The most interesting structural pick is Cellares — a private CDMO being elevated to the same regulatory standing as drug sponsors. The most strategically defensive picks are Lilly and Regeneron — large-cap biotechs that don’t need the help but got it anyway. The most category-defining pick is FUJIFILM Biotechnologies — its Holly Springs plant is the only commercial-scale mammalian cell culture facility in the cohort and the selection validates the entire biologics CDMO category.

For the 73+ companies that applied and weren’t selected: this isn’t a rejection so much as a triage. The FDA is using PreCheck to shape the US manufacturing landscape, not just to react to it.

Sources

• FDA Press Release, June 29, 2026: “FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing”
• FDA PreCheck Pilot Program webpage (referenced in press release)
• Executive Order 14293 (May 2025)
• Lilly Lebanon API $9B announcement (May 2024, May 2026 expansion)
• FUJIFILM Biotechnologies Holly Springs $3.2B facility opening
• Regeneron Saratoga Springs $2B investment announcement (Nov 2025)
• Kyowa Kirin Sanford $530M facility announcement (June 2024)
• Cellares $257M Series C + BMS partnership announcement (Jan 2026)
• Kriya Therapeutics ASGCT 2026 presentations announcement (April 2026)
• Amneal Hauppauge closure WARN notice history