Region
CDMOs in North America
Compare US and Canadian CDMOs with FDA-registered facilities. Filter by manufacturing type, therapeutic focus, and certifications for domestic drug development and production.
412 companies listed
North American CDMO Manufacturing
North America is the largest pharmaceutical market by revenue and home to hundreds of contract manufacturers. The US alone has over 500 FDA-registered drug manufacturing facilities. For US-based sponsors, domestic CDMOs reduce supply chain risk, simplify regulatory interactions, and shorten shipping timelines for temperature-sensitive biologics.
The BIOSECURE Act is reshaping outsourcing decisions. Companies that previously relied on certain Chinese CDMOs are actively reshoring manufacturing to North American and European partners. This has tightened capacity in biologics and cell therapy manufacturing, making early CDMO engagement more important than ever.
Where are the manufacturing clusters? The Boston-Cambridge corridor leads in biologics and cell therapy. The Research Triangle (NC) has strong small molecule and drug product capacity. San Francisco and San Diego anchor West Coast biologics. Canada offers competitive pricing through federal SR&ED tax credits, with hubs in Montreal and Toronto.
Browse North America CDMOs by country
Every country below has its own page with a ranked CDMO list, a country-zoomed facilities map, and the local regulatory picture. Counts are live manufacturing-site totals.
Companies (412)
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Triclinic Labs, Inc.
United States
Triclinic Labs is a US-based contract research organization specializing in solid-state chemical development and materials characterization. Founded in 2009, they are an FDA-registered and inspected laboratory (2024) with a DEA Controlled Substance License (Class I-V). They provide physical and analytical chemistry services including solid-form screening, polymorph analysis, and intellectual property support. They do NOT manufacture drugs.
Analytical ServicesMethod DevelopmentStability Testing
Upsher-Smith Laboratories
United States
Upsher-Smith Laboratories is a U.S. pharmaceutical company (now a subsidiary of Bora Pharmaceuticals following a $210 million acquisition in April 2024) that manufactures and markets brand and generic pharmaceutical products. It has a 270,000 sq ft manufacturing facility in Plymouth/Maple Grove, Minnesota. Key products include branded medications for migraine and seizure disorders plus a wide variety of generics (48 products). In December 2025 it launched KYMBEE (deflazacort) for Duchenne muscular dystrophy. While Bora Pharmaceuticals is a CDMO, Upsher-Smith itself manufactures and markets its own branded/generic portfolio rather than providing contract manufacturing services to third parties.
Frequently Asked Questions
Why choose a North American CDMO?+
Proximity to the FDA simplifies regulatory interactions and inspections. Shorter supply chains reduce risk for temperature-sensitive products. Time zone alignment improves project communication. For US-market products, domestic manufacturing avoids import complexities and potential trade disruptions. The BIOSECURE Act may also require US government-funded programs to use non-restricted CDMOs.
How does the BIOSECURE Act affect CDMO selection?+
The BIOSECURE Act restricts US government agencies from contracting with companies that use certain foreign biotechnology companies of concern for manufacturing. While primarily targeting government-funded work, it signals broader supply chain decoupling. Pharma and biotech companies are proactively shifting manufacturing to North American and European CDMOs to avoid future restrictions and supply disruptions.
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