CDMOs in Australia

Charles River Laboratories

Australia

Charles River Laboratories is a global contract research organization (CRO) providing drug discovery, safety assessment, and preclinical services across the drug development lifecycle. The company recently divested its CDMO business, indicating it is focused on research services rather than contract manufacturing. It has extensive FDA-registered facilities worldwide.

CMAX Clinical Research

Australia

CMAX Clinical Research is one of Australia's largest and most experienced clinical trial centres, established in 1993 in Adelaide. The company conducts Phase I-III clinical trials with up to 78 inpatient beds, specializing in supporting national and international pharmaceutical sponsors with clinical research services in its Bio-Med City precinct location adjacent to The Royal Adelaide Hospital.

Recce Pharmaceuticals

Australia

Recce Pharmaceuticals (ASX:RCE) is a clinical-stage biotech company developing its own proprietary synthetic anti-infectives (RECCE 327, RECCE 529) for antibiotic-resistant bacterial and viral infections. They have an in-house pilot manufacturing facility in Macquarie Park, Sydney for their own compounds only -- they are NOT a contract manufacturer (CDMO/CMO). They conduct clinical trials (Phase I-III) for their own drug pipeline. The FDA registration data and approved products listed in the regulatory summary likely belong to a different entity sharing the FEI numbers, not this clinical-stage company.

Blue Yonder

Australia

Blue Yonder is a supply chain management software company that provides AI-powered end-to-end supply chain planning and execution solutions. The company serves industries including retail, manufacturing, and logistics with cloud-based platforms for demand planning, warehouse management, and transportation optimization.

KCAS Bio

Australia

KCAS Bio is a leading bioanalytical contract research organization (CRO) with 45+ years of experience. Supported 315+ approved drugs on market, developed 6,200+ assays. Services include bioanalytical development, biomarker analysis, immunogenicity testing, cellular and molecular assays, clinical kitting and sample management. Specializes in advanced modalities (cell therapy, gene therapy). Globally harmonized Cytek spectral flow cytometry across US, EU, and Australia sites. 20+ FDA audits with no major findings.

Harvest Integrated Research Organization (HiRO)

Australia

Harvest Integrated Research Organization (HiRO) is a full-service global Contract Research Organization (CRO) providing end-to-end clinical trial services. The company focuses on clinical research and regulatory support across global markets.

Luina Bio, now rebranded as AcuraBio after acquisition by Dr. Glenn Haifer and Ampersand Capital Partners, is an Australian-origin biologics CDMO. They specialize in plasmid DNA CDMO services and have expanded cGMP capabilities using Cytiva purification technology to support mRNA and cell & gene therapies. Merged with RoslinCT to create a combined cell therapy CDMO.

Scientia Clinical Research

Australia

Scientia Clinical Research is an Australian contract research organization providing clinical trial services. The company operates a clinical research facility at the University of New South Wales (UNSW) Randwick Hospitals Campus and provides clinical development and business development services for pharmaceutical and biotech companies.

Novotech

Australia

Novotech is a global full-service clinical research organization (CRO) headquartered in Australia, specializing as a biotech partner across all clinical trial phases. The company operates extensively in Asia-Pacific and globally, providing clinical trial management, regulatory advisory, and scientific consulting services for biotech and small to mid-sized pharma companies.

PCI Pharma Services

Australia

PCI Pharma Services is a global CDMO providing fully integrated drug development, manufacturing, clinical trial services, and commercial packaging solutions. With over 8,000 employees in 38 GMP facilities worldwide, PCI offers services spanning sterile fill-finish, lyophilization, oral solid dose manufacturing, complex formulations, and advanced drug delivery including drug-device combination products.

IQVIA

Australia

IQVIA is a global leader in clinical research services, commercial analytics, and healthcare data technology, serving the pharmaceutical and life sciences industry. Named to Fortune's Most Admired Companies for nine consecutive years, IQVIA provides clinical trial management, real-world evidence, safety and regulatory compliance, and commercialization services powered by AI and Connected Intelligence. IQVIA does not manufacture drugs but provides CRO and data analytics services.

Medisca Inc.

Australia

Medisca Inc. is a global leader in pharmaceutical compounding solutions founded in 1989, headquartered in Canada with operations in Australia, North America, Europe (Germany launch), South America, Middle East, and Africa. The company provides active pharmaceutical ingredients (APIs) for compounding, compounding equipment and mixing technologies, analytical testing services, and education/training for pharmacy professionals. Medisca has over 2,000 products and serves compounding pharmacies, hospitals, and healthcare professionals. While they offer some contract manufacturing services, their core business is supplying APIs, ingredients, and compounding solutions rather than drug product CDMO services.

360biolabs (a BioAgilytix company)

Australia

360biolabs, a BioAgilytix company, is Australia's most comprehensive bioanalytical laboratory offering pharmacokinetic, pharmacodynamic, immunogenicity, biomarker, and vaccine/infectious disease assay services. They support early-phase clinical studies with GLP-compliant testing across 6 global locations.

Arxada (CDMO)

Australia

Arxada (formerly part of Lonza Specialty Ingredients) is a CDMO with over 40 years of experience in custom development and manufacturing of advanced intermediates and active ingredients. They operate from sites in Visp (Switzerland) and Kourim (Czech Republic), offering both chemical synthesis and biotechnology/fermentation routes from gram to multi-metric-ton commercial scale. Their backward-integrated site with on-site waste and energy management provides a comprehensive CDMO offering spanning process development, analytical development, formulation, and regulatory support.

BioCina

Australia

BioCina is a global end-to-end biologics CDMO and the only biologics CDMO in Australia approved by the US FDA. Following the merger with NovaCina, the company provides comprehensive biologics CDMO services spanning cell line development, process development, analytical development, GMP manufacturing of biologics drug substance and drug product, and mRNA manufacturing. Operates facilities in Adelaide, Australia with GMP manufacturing capacity up to 1,000L bioreactors.

Eurofins Biopharma Services (CDMO)

Australia

Eurofins Biopharma Services CDMO is a division of Eurofins Scientific offering integrated API and drug product outsourcing services across small molecules and biologics. The company provides services from early-stage development through commercial manufacturing including highly potent drug development, sterile manufacturing/fill-finish, lyophilization, and biologics development through its Alphora brand.

Mimotopes

Australia

Mimotopes is a peptide company, primarily based in Australia with offices in Germany and the US (Roseville, MN), providing custom peptide synthesis, catalog peptides, peptide libraries, antibody and immunology services for the research market. The company offers custom peptides, combinatorial chemistry (SynPhase Lanterns), amino acids, and peptide synthesis reagents. Mimotopes is a research reagent and custom peptide supplier, not a pharmaceutical contract manufacturer.

GreenLight Clinical

Australia

GreenLight Clinical is an Australian full-service Contract Research Organisation (CRO) specializing in ophthalmology, oncology, rare diseases, and gene and cell therapy clinical trials. The company provides clinical monitoring, project management, data management, regulatory affairs, and site management services for biotech and pharmaceutical sponsors.

CCL Healthcare

Australia

CCL Healthcare, a division of CCL Label, is a global manufacturer specializing in custom printed pharmaceutical labels, leaflets, folding cartons, booklets, clinical booklet labels, expanded content labels, and smart packaging solutions for the pharmaceutical and life science industries. The company is a packaging and labeling supplier, not a drug manufacturer or CDMO.

Sypharma Pty Ltd

Australia

Sypharma is an Australian specialty contract manufacturing group operating since 2005. They develop and manufacture therapeutic goods, veterinary products, and specialty consumer products. They specialize in contract manufacturing for early clinical through Phase III clinical trials and have multipurpose cleanrooms for oral, topical, and parenteral drug products. They manufacture both large and small volume parenterals and have a veterinary manufacturing suite. Licensed by FDA, TGA, and ISO 13485 certified. They partnered with Schott on sterile fill/finish capabilities.

NovaCina is a sterile injectable CDMO based in Perth, Western Australia, launched by Bridgewest Group. The company manufactures sterile injectable drug products for all phases from development through commercial production. NovaCina has expanded its facility with a high-tech SA25 GMP filling line for small-batch sizes and has since merged with BioCina to create an end-to-end CDMO offering integrated biopharmaceutical and small molecule contract manufacturing services.

Formulytica

Australia

Formulytica is an Australian specialty contract research, development and manufacturing organisation (CRDMO) with expertise in formulation, analytical method development, and drug product development. The company specializes in developing innovative drug formulations and analytical methods essential for clinical trial entry.

UNSW RNA Institute

Australia

The UNSW RNA Institute is an academic research institute at the University of New South Wales in Sydney, Australia. It links multidisciplinary teams in RNA biology, RNA chemistry, and RNA medicine with clinical experts. While it has a pilot-scale RNA Accelerator facility for pre-clinical RNA and nanoparticle formulation production, it is a university research center, not a commercial CDMO. It leads the NSW RNA Production Research Network (NSW-RPRN) and partners with universities and medical organizations to advance RNA therapeutics.

ICON plc

Australia

ICON plc is a leading global clinical research organization (CRO) providing end-to-end drug development services. The company offers bioanalytical laboratory services, specialty laboratory solutions, clinical supplies management, regulatory consulting, and early clinical development across all phases of drug development. ICON operates globally with GMP-trained experts.

Australian ALKALOIDS Trading PTY LTD

Australia

Australian Alkaloids Trading (AAT) is a 100% Australian-owned API manufacturer specializing in naturally extracted alkaloid APIs and semi-synthetic compounds derived from Duboisia plants. AAT is a joint venture of Phytex and Australian Alkaloids, with 60+ years of combined experience. The company controls its entire supply chain domestically in Australia, from Duboisia plantations through extraction, purification, and final API release. Products include scopolamine (hyoscine) derivatives, atropine derivatives, and methscopolamine bromide. AAT's facilities are cGMP licensed with the TGA, USFDA inspected, and supply USP and PMRJ reference standards. They have a history of zero product recalls.

CSL (incl. CSL Behring)

Australia

CSL is a global biotechnology company headquartered in Melbourne, Australia, operating through CSL Behring, CSL Seqirus, and CSL Vifor. The company specializes in plasma-derived biotherapies for rare and serious diseases including bleeding disorders and immunodeficiencies, vaccines, and iron deficiency treatments, but operates as an integrated developer/manufacturer for its own products rather than as a CDMO offering contract services to external clients.