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
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.- 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.
IDT AustraliaIDT Australia is a cGMP CDMO delivering end-to-end pharmaceutical development and manufacturing services from active pharmaceutical ingredients to finished dosage forms, with expertise in small molecule APIs, specialty orals, advanced therapies, and integrated regulatory support.
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.
Lupin LimitedGlobal pharmaceutical manufacturer with robust quality systems aligned to US FDA, UK MHRA, and EU GMP standards; operates diversified manufacturing across generics, complex formulations, and specialty segments with advanced automation and digital quality infrastructure.
Neuland LaboratoriesGlobal API CDMO supporting biotechnology and pharmaceutical companies in design, development, and manufacturing of complex active pharmaceutical ingredients from early-stage drug development through commercial scale.
Optimus Drugs Private LimitedLeading CDMO delivering end-to-end small molecule drug substance and drug product development and manufacturing from clinical to commercial scale, with 21+ years of expertise and GMP-certified facilities.
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.
PI Health SciencesPI Health Sciences is an integrated CRDMO offering end-to-end drug discovery, development, and manufacturing services with R&D and manufacturing locations in Europe and India.
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.
SK pharmtecoSK pharmteco is a CDMO offering comprehensive drug development and manufacturing services.
Sai Life SciencesIntegrated CRDMO offering discovery, development, and manufacturing services for small molecule NCE programs across 280+ global pharma and biotech clients.
Samsung BiologicsLeading CDMO offering end-to-end biologics development and manufacturing from cell line development through aseptic fill-finish, with capabilities in drug substance, drug product, ADC, and mRNA services.
Syngene InternationalInnovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S.
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.
Winkem Labs Pvt. Ltd.Contract development and manufacturing organization (CDMO) offering complex chemical synthesis, process development, API manufacturing, and supply services for pharmaceutical clients globally.
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