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)
Fortis Life Sciences
United States
Fortis Life Sciences is a CDMO partner to diagnostics and life science companies, offering an integrated portfolio of reagents, components, and service solutions. The company provides antibody development and manufacturing, conjugation services, lyophilization, cell and gene therapy support, and diagnostic assay CDMO services.
LyophilizationAnalytical ServicesMethod Development & Validation
Gannet BioChem
United States
Gannet BioChem is a specialty CDMO based in Huntsville, Alabama, focused on polymer science, PEG chemistry, and bioconjugation. Built on the legacy of Shearwater Polymers and Nektar Therapeutics, the company provides end-to-end capabilities from early discovery through cGMP and commercial manufacturing of activated polymers, PEG reagents, and bioconjugates. The FDA-inspected facility spans over 124,000 square feet across four buildings and has supported 50+ global partners.
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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