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The Americas host some of the world’s most advanced and well-established Contract Development and Manufacturing Organizations (CDMOs). With strong regulatory oversight, cutting-edge infrastructure, and robust biotech ecosystems, CDMO companies in America are at the forefront of pharmaceutical innovation.
From startups to global pharma giants, companies rely on American CDMOs to deliver comprehensive solutions across the full product lifecycle, including formulation, clinical supply, commercial manufacturing, and regulatory support.
CDMOs in America offer a unique combination of scientific innovation, regulatory strength, and manufacturing scale. These organizations operate under rigorous FDA oversight and often meet or exceed international standards, making them trusted partners for both domestic and global markets.
American CDMOs have deep experience across therapeutic areas, from small molecules to biologics and cell & gene therapies. Their geographic presence across North and South America ensures flexible service models and access to a wide talent pool and innovation clusters.
Formulation and Process Development: Expertise in complex drug delivery systems, bioavailability enhancement, and scale-up strategies.
Clinical and Commercial Manufacturing: GMP-certified facilities for small and large batch production, including high-potency and sterile products.
Analytical and Quality Testing: Full-suite analytical services and QC labs to ensure safety, stability, and regulatory compliance.
Regulatory Affairs: In-depth understanding of FDA regulations and international guidelines for smooth global submissions.
Specialty Capabilities: Advanced modalities such as mRNA, cell therapy, and personalized medicine manufacturing.
FDA Compliance and Global Standards: American CDMOs adhere to some of the world’s strictest regulatory requirements.
Innovation Leadership: Access to leading-edge technology, AI-driven process optimization, and advanced automation.
Flexible and Scalable Solutions: Ability to rapidly adjust to project demands, from early-phase trials to high-volume production.
Integrated Services: End-to-end support covering R&D, manufacturing, packaging, and regulatory submission.
Strategic Locations: Facilities positioned near major biotech hubs and logistics networks to streamline distribution.
Some of the top CDMO companies in America:
Actylis: American CDMO specialized in Chemical Process Discovery, Development, cGMP, and Commerical Manufacturing Services. [See CDMO profile]
Lannett CDMO: Lannetts main manufacturing site sits in Seymour, Indiana, and includes capabilities for Oral Solid Dose (OSD) and Liquids. [See CDMO profile]
Aenova: Solids packaging CDMO in America. [See CDMO profile]
Cambrex: American CDMO specialized in Drug Substance related services. [See CDMO profile]
Pharmaron: Small Molecule (RSM/APIs) commercial facility. [See CDMO profile]
Finding the right CDMO in the America requires insight, experience, and a network of trusted providers. MAI CDMO helps you identify and connect with top-performing CDMO companies in America that meet your technical, regulatory, and commercial needs.
Whether you’re developing a novel therapy or scaling an existing product, our experts guide you through the process, aligning your goals with the strengths of the best American CDMOs.
Get in touch today to explore leading CDMOs in America and bring your pharmaceutical project to life with confidence.
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