CMC Regulatory Submission Support CDMOs in China
15 published
15 published CDMOs match CMC Regulatory Submission Support in China.
Locations in this set include China, United States, Switzerland, France, Japan, and United Kingdom.
Capabilities that show up most often in this set: Small Molecule, Biologics (Monoclonal Antibodies), Biologics (Other), Antibody-Drug Conjugate (ADC), and Cell Therapy.
Matching companies
Altruist BiologicsGlobal CDMO offering end-to-end development and GMP manufacturing for monoclonal antibodies, bispecific antibodies, fusion proteins, recombinant proteins, and antibody-drug conjugates, with facilities in Suzhou and Hangzhou featuring up to 20,000-liter bioreactors.
Boston Institute of Biotechnology, LLCFull-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy manufacturing from preclinical to commercial scale, with bioreactor capacity up to 50,000L.
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.
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.
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.- HillgeneHillgene is a leading CDMO provider specializing in cell therapy manufacturing, offering end-to-end solutions for CAR-T, TCR-T, CAR-NK, and UCAR-T cell therapies with GMP facilities in Suzhou and Belgium.
JYMed PeptidePeptide CDMO offering custom synthesis from milligrams to metric tons, with 13 cGMP lines and FDA-, NMPA- and EDQM-approved sites. Provides peptide API manufacturing plus syringe, cartridge and lyophilized finished-dose filling at its Shenzhen site.
PHT International, Inc.PHT International is a Contract Research, Development, and Manufacturing Organization (CRDMO) offering small-molecule process R&D, cGMP manufacturing from milligrams to multi-tons, and chemical sourcing with global facilities across North America, Europe, and Asia.
PharmaBlockLeading provider of innovative chemistry products and services for pharmaceutical R&D and commercial manufacturing, with expertise in process development, GMP manufacturing, and low-carbon chemistry solutions.
PharmaronPremier life science CRO and CDMO offering integrated R&D and manufacturing across drug discovery, preclinical, clinical development, and commercialization for small molecules, biologics, and cell & gene therapies. 25,000+ employees across China, US, and UK.
Piramal Pharma SolutionsCDMO specializing in HPAPIs, ADCs, peptides, vaccines, and biologics with 4,700+ team members across 15 global sites and 500+ customers. Offers integrated development and manufacturing with backward integration capabilities and global program management.
Porton AdvancedEnd-to-end ATMP CDMO provider offering cell engineering, lentiviral vectors, mRNA/LNP, plasmid development, and GMP manufacturing from preclinical through commercialization with 24 IND approvals across NMPA, FDA, and MedSafe.
Unither PharmaceuticalsGlobal CDMO specializing in sterile and non-sterile liquid manufacturing, including Blow-Fill-Seal (BFS) single-dose technology with over 5 billion annual capacity, plus formulation development, analytical services, and ophthalmic expertise across six production sites.
Vetter PharmaIndependent CDMO specialist in aseptic fill-finish, drug product development, analytical services, and combination product assembly with 76 years of experience and 7,300+ employees globally.
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