CMC Regulatory Submission Support CDMOs
121 published
121 published CDMOs match CMC Regulatory Submission Support.
Locations in this set include United States, United Kingdom, China, Germany, France, 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
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.
CuriRx, Inc.CuriRx, Inc. is a Wilmington, Massachusetts contract research and development organization. It offers formulation development, prefilled syringe and lyophilization services, bioprocessing, and analytical testing to pharmaceutical companies of all sizes.
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.
Cytovance BiologicsU.S.-based CDMO offering end-to-end biomanufacturing services for antibodies, recombinant proteins, vaccines, and other biologics modalities, with dedicated microbial and mammalian facilities and in-house cell line development capabilities.
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.
DipharmaGlobal CDMO and API manufacturer with 600 employees, 4 cGMP plants, and 75+ years of experience in hazardous chemical synthesis, offering exclusive synthesis services and catalogue APIs with FDA, AIFA, and PMDA inspections since 1970.
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.
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.
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.
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.
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.
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.
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