CMC Regulatory Submission Support CDMOs in Asia-Pacific
40 published
40 published CDMOs match CMC Regulatory Submission Support in Asia-Pacific.
Locations in this set include United States, China, India, Japan, United Kingdom, and France.
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.
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.
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.
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.
BioconFully integrated biopharmaceutical company developing affordable biosimilars, generic formulations, and complex APIs for diabetes, cancer, and autoimmune diseases.
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.
Cell TherapiesGMP contract manufacturer of autologous and allogeneic cell therapies from first-in-human trials through commercial supply, with two decades of experience in CAR-T, mesenchymal stromal cells, TILs, and pluripotent stem cell derivatives. Offers end-to-end cold chain management, process development, quality control analytics, and regulatory consulting across Australia and Asia-Pacific.
CellaresCellares operates a global network of Smart Factories delivering integrated development and manufacturing (IDMO) services for cell therapies, with proprietary Cell Shuttle® and Cell Q™ platforms enabling cGMP-compliant, automated manufacturing and quality control at clinical and commercial scale.
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.
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.
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.
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.
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