CDMOs offering CMC Regulatory Submission Support with Small Molecule
57 published
57 published CDMOs match CMC Regulatory Submission Support and Small Molecule.
Locations in this set include United States, India, United Kingdom, France, Germany, and Italy.
Capabilities that show up most often in this set: CMC Analytical Development, Process Development, Quality Control Testing, Technology Transfer, and Formulation Development.
Matching companies
ARSI Canada IncARSI Canada is a specialized CRO offering custom synthesis, API scale-up, analytical method development, and drug development services with over 50 years of combined experience and a GMP manufacturing facility in Bangladesh.
Adragos PharmaGlobal CDMO headquartered in Munich offering end-to-end development and manufacturing for small molecules and biologics, including sterile/non-sterile liquids, solids, semi-solids, lyophilization, and prefilled syringes across seven facilities in Europe and Japan.
Akums Drugs and Pharmaceuticals Ltd.India's largest CDMO with 15+ state-of-the-art facilities and 30% domestic market share, manufacturing 4,100+ formulations across tablets, capsules, injectables, APIs, and specialty dosage forms under WHO-GMP, USFDA, EU-GMP, and TGA compliance.
Almac GroupGlobal CDMO with 7,900+ employees across 18 facilities, offering integrated drug development and manufacturing services including analytical development, formulation, process development, fill-finish, and specialized chemistry capabilities.
Applied Pharmaceutical InnovationEdmonton-based not-for-profit offering integrated CDMO services in sterile fill-finish, oral solid dosage, topical application, and highly potent controlled substance manufacturing. Also provides CRO research, regulatory and quality, and clinical and quantitative support.
ArdenaArdena is an integrated CDMO and bioanalytical CRO specializing in advanced drug product development, nanomedicine, and bioanalysis for complex molecules including poorly soluble compounds, highly potent APIs, and controlled substances.
Ascendia Pharmaceutical SolutionsAscendia is a specialty CDMO providing formulation development, analytical services, and GMP manufacturing for small molecules and biologics from pre-formulation through commercialization, with proprietary nanotechnologies including LipidSol, EmulSol, AmorSol, and NanoSol.- Asymchem LaboratoriesAsymchem is a CDMO providing integrated API synthesis, drug product development, and biologics manufacturing with specialized capabilities in peptides, oligonucleotides, highly potent compounds, and flow chemistry.
AxploraGlobal CDMO and API manufacturer specializing in complex small molecule development, ADC manufacturing, HPAPIs, and hazardous chemistry across ten production sites in Europe, India, and the US.- BSP PharmaceuticalsBSP Pharmaceuticals is a CDMO specializing in development and manufacturing of cytotoxic oncology drugs, ADCs, peptides, proteins, and lipid-based formulations from preclinical GLP through commercial supply.
Bend BioscienceU.S. pharmaceutical CDMO offering design, development, and manufacturing of oral solid and liquid dosage forms, from early formulation to commercial-scale production across three domestic locations.
BioVectraNorth American CDMO specializing in clinical-to-commercial biologics, small molecules, HPAPIs, and bioreagents with 50+ years of microbial fermentation and complex chemistry expertise across cGMP facilities in Canada.- Burrard PharmaceuticalsVancouver-based CDMO delivering technology transfer, formulation development, and GMP manufacturing for 75+ molecules across oncology, diabetes, and respiratory therapeutics since 2005.
CMC Pharmaceuticals, Inc.CMC Pharma provides integrated formulation development, analytical testing, stability studies, and cGMP manufacturing oversight for small molecule drug programs from preclinical through post-approval, with hands-on regulatory expertise and CMO management built in.
CambrexCDMO offering drug substance and drug product development, manufacturing, and analytical services across small molecules, peptides, and specialty chemistries.
Carbogen AmcisFull-service CDMO offering integrated drug substance and sterile drug product development and manufacturing from early phase through commercialization, with specialized capabilities in API synthesis, process development, analytical services, and stability testing across multiple scales.
CatalentGlobal CDMO providing end-to-end contract development and manufacturing for pharma, biotech, and consumer health. Delivers 60+ billion doses annually across small molecules, biologics, cell & gene therapies, and clinical supply.
Charles River LaboratoriesCharles River Laboratories provides contract research, development, and manufacturing services across the full drug discovery and development continuum, supporting 80% of FDA-approved drugs over the past five years.
CodisGlobal CDMO specializing in commercial-scale spray drying, amorphous solid dispersions, microencapsulation, and continuous granulation with 400,000 sq ft of GMP manufacturing across US and UK facilities.
CordenPharmaFull-service CDMO offering cGMP development and manufacturing of APIs, lipid excipients, drug products, injectables, peptides, LNPs, oligonucleotides, and oral solid dose across 10 facilities in 6 countries with 3000+ employees.
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