CMC Regulatory Submission Support CDMOs in Europe
49 published
49 published CDMOs match CMC Regulatory Submission Support in Europe.
Locations in this set include United States, United Kingdom, Germany, France, Switzerland, and China.
Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Biologics (Monoclonal Antibodies), Peptide, and Antibody-Drug Conjugate (ADC).
Matching companies
AGC BiologicsGlobal CDMO offering development and manufacturing for protein expression biologics, pDNA, mRNA, viral vectors (AAV, LVV, RVV), and genetically engineered cells with scale-out manufacturing capabilities.
AbzenaFully integrated biologics and bioconjugates CDMO+CRO offering drug design, development, and GMP manufacturing for antibodies, ADCs, AOCs, RDCs, and vaccines from discovery through commercial scale.
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.
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.- 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.
BachemGlobal leader in peptide and oligonucleotide development and manufacturing, offering GMP-compliant clinical and commercial supply from early research through commercial scale.
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.
Cell and Gene Therapy CatapultUK-based innovation and manufacturing support organization for cell and gene therapies, offering infrastructure, expertise, and collaboration across the ATMP lifecycle.
CelonicSwiss-based pure-play biologics CDMO specializing in next-generation bioprocessing technologies including process intensification and full perfusion to reduce cost of goods for biotech and biosimilar clients.
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.
CuriaGlobal CDMO with 30+ years of experience offering integrated services across small molecule, generic APIs, sterile drug product, and biologics manufacturing, backed by 20+ facilities and 3,000+ professionals across North America, Europe, and India.
DelpharmTop-5 global CDMO with 18 production sites across Europe and North America, specializing in solid, semi-solid, non-sterile and sterile liquid dosage forms including prefilled syringes, nasal sprays, and injectables; capacity to produce over 300 million units annually.
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.
Dr. Reddy's LaboratoriesIntegrated global pharmaceutical company manufacturing generics, APIs, biosimilars, and innovative medicines across 66 countries with capabilities in small molecule and biologics development and manufacturing.
Enable Biotech LtdEnable Biotech provides clinical GMP manufacturing for cell therapies, exosome therapies, and gene therapies, with SwissMedic accreditation pending for gene therapy operations as of summer 2024.
EthypharmEthypharm is a leading mid-size international specialty pharmaceutical company with strong European roots.
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