CMC Analytical Development CDMOs in United States
97 published
97 published CDMOs match CMC Analytical Development in United States.
Locations in this set include United States, United Kingdom, China, Germany, Japan, and India.
Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Biologics (Monoclonal Antibodies), Gene Therapy, and Cell Therapy.
Matching companies
Divi's LaboratoriesWorld's largest API manufacturer and trusted CDMO partner for 25+ years, offering generic APIs, custom synthesis, peptides, and nutraceutical ingredients to 100+ countries with complete backward integration and green chemistry principles.
ElevateBioAdvanced therapies CDMO providing discovery, process development, manufacturing, and regulatory support for cell therapies, viral vectors, mRNA, and gene editing programs from preclinical through commercial scale.
Enzene BiosciencesGlobal CDMO specializing in cost-effective biologics and biosimilars manufacturing using patented continuous bioprocess technology (EnzeneX®). Offers integrated drug discovery, development, and manufacturing services with facilities in India and expanding presence in the USA and Europe.
ExpericSpecialist powder-handling CDMO offering clinical trial supply, development, manufacturing, and packaging services for pharmaceutical products.
FUJIFILM BiotechnologiesCDMO partner offering end-to-end biologics development and manufacturing from pre-clinical through commercialization, with expertise in cell culture, microbial fermentation, cell and gene therapy, and cGMP manufacturing across US and European facilities.
FlammaPrivately held small molecule CDMO with FDA-inspected cGMP facilities in Italy, USA, and China, offering custom manufacturing, development, and specialized technologies including HPAPI, continuous flow, and cryogenic API synthesis from early-stage to commercial scale.
Forge BiologicsDedicated AAV gene therapy CDMO with a 200,000+ sq. ft. cGMP facility featuring 20 suites and bioreactors up to 5,000L, supporting 60+ clients across 35+ indications with high-yield manufacturing and seamless regulatory compliance.
FreeThink TechnologiesFreeThink Technologies is a contract laboratory specializing in stability testing, formulation development, analytical method development, and packaging solutions for pharmaceutical and biotech clients.
GBI BiomanufacturingFull-service biologics CDMO offering integrated development and manufacturing services including cell banking, upstream/downstream processing, bioconjugation, aseptic fill-finish, and regulatory support for complex biopharmaceuticals.
Gannet BiochemGannet BioChem is a specialized CDMO focused on activated polymer, PEG, and bioconjugation services for complex therapeutics, from early development through cGMP manufacturing. It operates facilities in Huntsville and Arab, Alabama.
GenezenViral vector CDMO specializing in AAV, lentiviral, and retroviral manufacturing for gene and cell therapies, with cGMP facilities in Indiana and Massachusetts supporting preclinical through commercial-scale production.
GileroGilero provides design, development, and contract manufacturing services for medical devices, drug delivery systems, and combination products, with global manufacturing facilities in the U.S., Mexico, Europe, and Asia.
GlattGlatt Pharmaceutical Services is a CDMO specializing in complex oral solid dosage forms, multiparticulate systems (pellets, micropellets, granules), and advanced drug delivery solutions including controlled release, solubility enhancement, and taste masking from early development through commercial manufacturing.
Global Biotech LaboratoriesGlobal Biotech Laboratories is a peptide and oligonucleotide CDMO offering end-to-end contract development and manufacturing from route scouting through validated commercial supply, with cGMP and ICH Q7 compliance across manufacturing sites on three continents.
Grand River Aseptic ManufacturingSterile injectable CDMO specializing in fill-finish services for liquid and lyophilized vials, syringes, and cartridges, with Annex 1 compliant facilities and experience in biologics, small molecules, and vaccines.
Halo PharmaHalo Pharma provides end-to-end pharmaceutical development and manufacturing for small molecule therapeutics across solids, semi-solids, oral liquids, and sterile injectables, with two North American cGMP facilities and an accelerated 16–20 week tech transfer program.
HovioneSpecialist integrated CDMO with over 60 years of experience in contract development and manufacturing for pharmaceutical customers, supporting both new and off-patent drug programs.
Jubilant HollisterStierComprehensive sterile fill-finish and lyophilization CDMO with decades of experience, advanced automation, and white-glove service for global pharmaceutical partners.
KBI Biopharma, Inc.Global CDMO offering cell line development, process and analytical development, formulation development, and clinical and commercial manufacturing for mammalian and microbial biologics.
Kincell BioLeading cell therapy CDMO delivering GMP manufacturing, analytics, and CMC strategy from early development through commercial launch across purpose-built U.S. facilities.
Markdown mirror: /services/cmc-analytical-development/us.md