Biologics Drug Substance CDMOs

AbbVie Contract Manufacturing (AbbVie CMO)

Italy

AbbVie Contract Manufacturing is an embedded CMO within AbbVie, providing third-party contract manufacturing services for over 40 years across 12 locations in the US and Europe. They offer services spanning antibody drug conjugates, aseptic fill/finish, biologics (mAbs and derivatives), custom API, eye care, hot melt extrusion, HPAPI, and oral solid dose manufacturing.

ABL (ABL, Inc. / ABL Europe)

France

ABL Inc. (also operating as Ascend Advanced Therapies - ABL Inc.) is a biologics CDMO focused on viral vector GMP manufacturing for gene therapies, vaccines, oncolytic viruses, and immunotherapies. They operate facilities in Rockville, MD (USA) and Strasbourg and Lyon (France), with 35+ years of experience. This is the same entity as ABL (ABL, Inc. / ABL Europe), appearing as a duplicate record in the database.

Abzena

United States

Abzena is a leading complex biologics and bioconjugates CDMO+CRO headquartered in the UK with 20+ years of experience. They provide fully integrated services from antibody discovery through commercial GMP manufacturing, specializing in ADCs, AOCs, RDCs, mAbs, fusion proteins, and bispecifics. With over 1,400 lead candidates discovered, 100+ production cell lines developed, and 2,000+ bioconjugates produced, they operate state-of-the-art facilities in San Diego, Bristol (PA), and Cambridge (UK).

AGC (AGC Biologics & AGC Pharma Chemicals)

United States

AGC Biologics is a leading global CDMO providing contract development and manufacturing services for biologics, cell and gene therapies, and advanced modalities. With facilities in Seattle, Copenhagen, Heidelberg, Milan, Chiba, and Yokohama, AGC operates mammalian and microbial expression systems and offers end-to-end services from process development through commercial-scale manufacturing.

Agilent Advanced Therapeutics

United States

BioVectra is a Canadian full-service CDMO specializing in biologics, small molecules, nucleic acids, and fill/finish, now a part of Agilent Technologies. With over 50 years of pharmaceutical manufacturing experience, the company leverages microbial fermentation expertise and complex chemistry to support partners from clinical to commercial stage. BioVectra operates multiple manufacturing facilities in Canada and recently opened a 36,000 sq ft mRNA facility as part of a $90M expansion in Charlottetown.

Ajinomoto Bio-Pharma Services

Belgium

Ajinomoto Bio-Pharma Services (Aji Bio-Pharma) is a fully integrated global CDMO providing comprehensive development and cGMP manufacturing services for both small and large molecule pharmaceuticals. With facilities in Belgium, the United States, Japan, and India, the company offers platform technologies including oligonucleotide manufacturing, ADC conjugation, small molecule API synthesis, and aseptic fill-finish services. The Althea fill-finish site was acquired by PCI Pharma Services.

Altruist Biologics

China

Altruist Biologics is a China-based biologics CDMO backed by Innovent Biologics, offering end-to-end development and GMP manufacturing for monoclonal antibodies, bispecific/multispecific antibodies, fusion proteins, recombinant proteins, and antibody-drug conjugates (ADCs). The company operates large-scale facilities in Suzhou (60,000L) and Hangzhou (172,000L) with bioreactors from 1,000L to 20,000L, achieving a 99.8% batch success rate and 180+ global regulatory approvals.

Alvotech

Czech Republic

Alvotech is a vertically integrated biosimilar company specializing in the development and manufacturing of high-quality biosimilar biologic medicines. The company operates from cell line development through fill and finish manufacturing, with FDA-registered facilities and operations spanning API manufacture, labeling, manufacturing, and packaging.

Amaran Biotechnology Inc.

Taiwan

Amaran Biotechnology Inc. is a Taiwan-based CDMO established in 2010, providing drug process development, manufacturing, and analytical services. The company specializes in drug substance manufacturing including bio-conjugation, purification, and lyophilization, as well as aseptic drug product filling with robotic systems in a PIC/S GMP-certified facility.

API Co., Ltd. (Japan)

Japan

API Co., Ltd. is a Japanese pharmaceutical company specializing in contract manufacturing (CMO/CDMO) of antibiotics (vials, lyophilized products), APIs (including heparinoid), and biotech products. Their Ikeda Pharmaceutical Plant handles antibiotic formulation, lyophilization, powder filling, and packaging under GMP conditions.

Apotex (incl. Apotex Pharmachem)

Canada

Apotex is Canada's largest pharmaceutical company with global operations spanning API manufacturing, finished dosage form production, and CDMO/co-development services. With capacity to produce approximately 25 billion finished doses annually and three API manufacturing sites, they serve both their own generic portfolio and external partners through Apotex Pharmachem (API CDMO) and Apotex Fermentation (fermentation-based manufacturing).

Aragen Life Sciences Ltd.

India

Aragen Life Sciences Ltd. (formerly GVK Biosciences) is a CRDMO (Contract Research, Development, and Manufacturing Organization) headquartered in Hyderabad, India, with over 4,000 scientists. They provide integrated services spanning small molecules and large molecules (biologics) from discovery through commercialization. Their capabilities include HPAPI handling (cytotoxics, immunosuppressants, ADC toxins), particle science, process validation, and IND enabling services across multiple FDA-registered facilities.

AsymBio (Asymchem Group)

China

AsymBio, a strategic business unit of Asymchem Group (stock code: 002821.SZ / 6821.HK), is a biologics CDMO focused on antibodies, recombinant proteins, bioconjugates (including ADCs), and mRNA. They provide end-to-end services from cell line construction through commercial manufacturing, with a 130,000+ sq meter Shanghai Fengxian facility featuring 200L/500L/2000L single-use bioreactors. They have supported FDA IND approvals for partners including Radiopharm Theranostics.

Aton Biotech

China

Aton Biotech is a China-based biologics CDMO backed by Henlius Biotech, offering one-stop solutions from early development to commercial production. They provide services in process development, GMP manufacturing, analytical testing, and ADC development. With access to up to 144,000L bioreactor capacity from parent company Henlius, they focus on monoclonal antibodies, recombinant proteins, and antibody-drug conjugates.

Aurigene Services

India

Aurigene Pharmaceutical Services (formerly Aurigene Services) is a leading global CRDMO with 25+ years of experience, offering integrated CRO (discovery) and CDMO services for both small and large molecules. The company provides end-to-end drug development solutions from target identification through commercial manufacturing, operating 16 USFDA-approved sites. Aurigene has 700+ scientists, 400+ completed projects, and 18 successfully commercialized NCEs. Their small molecule CDMO capabilities span drug substance development and manufacturing, formulations, and specialty areas including peptides, high potent APIs, mPEGs, steroids, carbohydrates, and flow chemistry. Their biologics division offers process development and clinical scale manufacturing for monoclonal antibodies, bispecific antibodies, and proteins, with a new biomanufacturing facility in Hyderabad.

Aurobindo Pharma (incl. Eugia/Generis)

India

Aurobindo Pharma Limited is one of the world's largest vertically integrated generic pharmaceutical companies, headquartered in Hyderabad, India, operating 29 manufacturing facilities globally with capacity to produce 50+ billion formulation units and 19,000+ MT of APIs annually. Through subsidiaries Eugia Pharma Specialities (sterile injectables, oncology), CuraTeQ Biologics (biosimilars), and TheraNym Biologics, Aurobindo operates as a major CDMO. The company holds 830 US ANDA filings with 600+ approvals, and has manufacturing and packaging facilities across India, the US, Portugal, Brazil, and China. CuraTeQ received EMA GMP certification in 2024 for mammalian and microbial drug substance production, prefilled syringe and vial filling. Aurobindo's CDMO expansion includes a contract with MSD for biologics manufacturing with 15,000L bioreactors and 25-30 million vial annual capacity.

Avid Bioservices, Inc.

United States

Avid Bioservices, Inc. is a dedicated biologics CDMO based in Costa Mesa, California, with 30+ years of experience in mammalian cell culture-based biologics manufacturing. The company provides end-to-end drug substance and drug product services for monoclonal antibodies, bispecific antibodies, enzymes, and recombinant proteins. Avid operates from its main facility plus a new 78,000 sq ft Early Phase Center of Excellence (opened February 2026) for early-stage development. Services include cell line development, process development, analytical method development, cGMP manufacturing, and late-stage clinical and commercial biologics production. Avid has built a track record as one of the few US-based pure-play biologics CDMOs.

Axcellerate Pharma LLC

United States

Axcellerate Pharma LLC is an award-winning CDMO based in Piscataway, New Jersey, providing CRO and CDMO services for both large and small molecules. Their capabilities span cGMP API manufacturing (small molecules), sterile aseptic filling (vials, syringes, cartridges, bags), lyophilization, mammalian cell culture, microbial fermentation, oligonucleotide synthesis, PEGylation, and commercial manufacturing including generics, controlled substances, hormones/steroids, and cytotoxic/oncology compounds. The company operates from a multi-faceted facility that includes ISO Class 5-8 sterile areas, dedicated process areas for biologics development, chemical development, and sterile manufacturing.

Baxter International

China

Baxter International is a global medtech and biopharma company. Through its BioPharma Solutions (BPS) division, Baxter operates as a major CDMO providing sterile fill/finish manufacturing services. BPS invested over $150M in expanding sterile fill/finish capacity at its Bloomington, Indiana facility. Note: Baxter has signed a definitive agreement to divest its BioPharma Solutions business. Baxter has 308 FDA-approved products, extensive manufacturing facilities worldwide, and 93 FDA inspections on record.

BioDuro (BioDuro-Sundia)

China

BioDuro-Sundia is a global CRDMO (Contract Research, Development and Manufacturing Organization) offering end-to-end integrated drug discovery and development services. The company provides comprehensive chemistry services (medicinal, peptide, synthetic, analytical, scale-up), biology/DMPK, drug substance process R&D and manufacturing, drug product formulation and manufacturing, and biologics services. Has acquired a US-based Phase III/commercial drug product manufacturing facility.

BioGeneric Pharma (BGP)

Egypt

BioGeneric Pharma S.A.E (BGP) is an Egyptian international biopharmaceutical company specializing in the development, production, analysis, and marketing of therapeutic recombinant proteins, biosimilars, and vaccines. BGP operates a state-of-the-art biomanufacturing facility in 10th of Ramadan Industrial City, Egypt. The company offers contract manufacturing (CMO) and toll manufacturing services with capabilities spanning biomanufacturing, fill/finish (vials, PFS, cartridges), quality control labs, and mRNA technology (WHO mRNA technology transfer hub partner). Has single-use technology for upstream (25L to 2,000L bioreactors) and downstream processing.

BioInvent International AB

Sweden

BioInvent International AB is a clinical-stage biotech company focused on immuno-oncology antibody drug development, with an integrated contract manufacturing business unit (BioInvent Manufacturing) that has offered CDMO/CMO services since 1988. The cGMP manufacturing facility in Lund, Sweden produces monoclonal antibodies and fusion proteins using fully disposable technology in 40L to 1,000L bioreactors. Licensed by the Swedish Medical Products Agency and has French CIR accreditation. Has produced clinical-grade drug substance for trials in Europe, USA, Japan, Australia, and China.

Biological E Limited

India

Biological E Limited is an Indian biopharmaceutical company focused on vaccine development and manufacturing, with production capacity of up to 1 billion vaccines annually. They offer contract manufacturing for vaccines and biologics, with FDA-registered facilities performing analysis, API manufacture, labeling, manufacturing, and packing. Partners include Bavarian Nordic for chikungunya vaccine manufacturing.

Biomay AG

Austria

Biomay AG is a fully integrated Austrian CDMO founded in 1984, specializing in GMP manufacturing of plasmid DNA (pDNA), messenger RNA (mRNA), and recombinant proteins. They operate two manufacturing sites in Vienna (Seestadt and mRNA Competence Center), offering end-to-end services from gene sequence to large-scale product supply. Biomay has manufactured 200+ GMP plasmid batches and offers personalized patient-specific batches. Member of the Alliance for mRNA Medicines (AMM). Expanding capacity tenfold with new production facility.

Bionova Scientific

United States

Bionova Scientific is a US-based biologics CDMO (part of Asahi Kasei Group) focused on the development and GMP manufacturing of monoclonal antibodies and other therapeutic proteins using mammalian cell culture processes. They offer cell line development, upstream/downstream process development, formulation development, pilot production, GMP manufacturing, and process characterization. Expanding into plasmid DNA (pDNA) manufacturing with a new facility in The Woodlands, Texas.

BioNTech

Germany

BioNTech SE is a global biotechnology company headquartered in Mainz, Germany, that develops and manufactures mRNA-based immunotherapies and vaccines. While primarily a pharmaceutical innovator, BioNTech operates extensive in-house GMP manufacturing capabilities for mRNA, antibodies, and cell therapies across multiple global sites. They pioneered the BioNTainer modular mRNA manufacturing solution. FDA-registered for API manufacture and analysis. Active in 10+ clinical trials across oncology and infectious disease.

Biose Industrie

France

Biose Industrie is a French CDMO specialized in microbiome therapeutics, established in 1951. They focus on manufacturing Live Biotherapeutic Products (LBPs) and Next-Generation Probiotics (NGPs) for pharmaceutical and consumer health markets. They combine aerobic and anaerobic microbiology expertise with industrial-scale GMP manufacturing. Investing EUR 80 million to expand capacity from 8,000L to 32,000L fermentation volume at their Aurillac site. They offer full CDMO services from process development to GMP drug product manufacturing.

BMI Korea

South Korea

BMI Korea is a South Korean CDMO offering contract development and manufacturing services spanning small molecule APIs, oral solid dosage forms, biologics, vaccines, and mRNA products. The company provides integrated services from formulation development through commercial-scale manufacturing with cGMP-compliant facilities.

Boehringer Ingelheim Biopharmaceuticals GmbH (BioXcellence)

Germany

Boehringer Ingelheim BioXcellence is the contract biopharmaceutical manufacturing arm of Boehringer Ingelheim, one of the world's largest pharmaceutical companies. BioXcellence offers end-to-end biologics CDMO services including mammalian cell culture, microbial fermentation, viral vector production, and aseptic fill/finish with extensive FDA, EMA, and PMDA regulatory approvals across multiple global facilities.

Bora Biologics

United States

Bora Biologics is a biologics-focused CDMO based in the United States offering contract development and manufacturing services for monoclonal antibodies, recombinant proteins, and other biologic drug substances and drug products. The company provides end-to-end biologics services from cell line development through cGMP manufacturing, analytical testing, and aseptic fill/finish.

Boston Institute of Biotechnology (BIB)

United States

Boston Institute of Biotechnology (BIB) is a US-based full-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy services. The company features the world's first ultra-large bioreactor with 30,000L working volume capacity and provides end-to-end services from cell line development through commercial-scale cGMP manufacturing.

BSP Pharmaceuticals

Italy

BSP Pharmaceuticals is an Italian CDMO specializing in cytotoxic, ADC (antibody-drug conjugate), and non-cytotoxic sterile injectable manufacturing. The company provides development, clinical, and commercial supply services including API synthesis, ADC conjugation and fill/finish, and oral solid dose manufacturing, with FDA and EMA approved facilities near Rome.

Canton Biologics Co., Ltd.

China

Canton Biologics Co., Ltd. is a biologics CDMO founded by Chinese returnee scientists at Guangzhou International Biological Island. The company provides integrated R&D and manufacturing services for biologics including CMC development, GMP manufacturing up to 2000L, analytical development, and aseptic fill/finish with GMP certifications from China, US, Japan, and Europe.

Catalent Pharma Solution

Argentina

Catalent is a leading global CDMO trusted by pharma, biotech, and self-care companies to accelerate the development, manufacturing, and delivery of products that improve lives. With a worldwide network of facilities, advanced technologies, and deep expertise, Catalent provides integrated end-to-end solutions spanning oral dose, biologics, specialty therapies, cell and gene therapy, and clinical supply. The company partners with innovators from early-stage design through commercial manufacturing.

Celltrion

South Korea

Celltrion is a major South Korean biopharmaceutical company offering CDMO services for biologics, biosimilars, and small molecules. The company operates production capacities from 1,000L to 15,000L with a 98.5% batch success rate across 2,100+ cGMP drug substance batches, holding 400+ regulatory approvals in 90+ countries. Celltrion recently acquired Eli Lilly's Branchburg, New Jersey facility and launched Celltrion BioSolutions as a dedicated CDMO subsidiary, with plans to expand DS capacity to 132,000L by 2030.

Chime Biologics

China

Chime Biologics is a leading global CDMO focused on biologics and biosimilars, offering end-to-end services from cell line development through drug substance and drug product manufacturing. The company pioneered modular facilities with single-use bioprocessing technology and has partnerships with companies like MedPacto and Polpharma Biologics.

CuraTeQ Biologics

India

CuraTeQ Biologics is an EU GMP-certified biopharmaceutical CDMO based in Hyderabad, India, and a subsidiary of Aurobindo Pharma. The company specializes in biosimilar development and manufacturing with a focus on oncology and immunology therapies, including monoclonal antibodies. CuraTeQ has filed multiple biosimilars with EMA and is building CDMO capabilities for contract biologics manufacturing.

Curida

Norway

Curida is a European CDMO headquartered in Oslo, Norway with over 50 years of GMP experience, specializing in biologics and liquid pharmaceutical formulations. The company offers contract development and manufacturing for monoclonal antibodies, nasal sprays, ophthalmic products, and sterile/non-sterile liquids using Blow-Fill-Seal technology. Curida operates multiple GMP-certified sites across Norway serving 40+ global partners.

Daewoong Pharmaceutical Co., Ltd. (Daewoong Bio)

South Korea

Daewoong Pharmaceutical is a major South Korean pharmaceutical company whose subsidiary Daewoong Bio provides CMO services for biopharmaceutical manufacturing. Daewoong Bio opened a Bio-Center in Hyangnam for end-to-end CMO services and completed a bioplant in Hwaseong for microbial-based drug production. The company is FDA-registered with 5 FEI numbers and has 2 FDA-approved injectable products.

Emcure Pharmaceuticals Limited

India

Emcure Pharmaceuticals Limited is a leading Indian pharmaceutical company and CDMO founded in 1981, headquartered in Pune, India, with operations spanning over 70 countries. Originally established as a CDMO, Emcure now operates 14 manufacturing facilities (including US FDA-approved sites) producing APIs, oral solid dosage forms, injectables (including liposomal and lyophilized), biotherapeutics, and vaccines. The company specializes in complex generics, chiral molecules, high-potency APIs, and novel drug delivery systems including lipid nanoparticles and long-acting injectables.

Emergent BioSolutions

Canada

Emergent BioSolutions is a specialty life sciences company with CDMO capabilities, though it has been actively pivoting away from its CDMO business. The company has sold its Baltimore-Bayview drug substance facility to Syngene and its Baltimore-Camden sterile fill/finish facility to Bora Pharmaceuticals. Emergent retains four manufacturing facilities across North America (US and Canada) and holds FDA registrations, 6 approved products, and has conducted 5 clinical trials in infectious disease. The company previously invested $75M in viral vector and gene therapy capabilities at its Canton site.

HALIX

Netherlands

HALIX is a biologics CDMO based in Leiden, Netherlands, specializing in end-to-end development and GMP manufacturing of viral vectors, vaccines, and recombinant proteins. The company operates a 6,700 square meter cGMP facility at the Leiden Bio Science Park with 10 clean rooms and 7 bioreactors. HALIX successfully manufactured the AstraZeneca COVID-19 vaccine at commercial scale and serves over 75 customers with a 90% retention rate.

Hangzhou Jiuyuan Gene Engineering Co., Ltd

China

Hangzhou Jiuyuan Gene Engineering Co., Ltd., a subsidiary of Huadong Medicine Co., Ltd., is a Chinese biopharmaceutical company that was among the first national high-tech enterprises to realize biopharmaceutical manufacturing. The company produces finished dosage forms including oncology injections and is FDA-registered. It operates as part of the larger Huadong Medicine group which includes Doer Biologics.

Hanmi Pharm. Co. Ltd

South Korea

Hanmi Pharmaceutical is a major South Korean pharmaceutical company providing comprehensive CDMO services across the entire pharmaceutical lifecycle. The company operates through Paltan Smart Plant (producing 6+ billion chemical drug tablets annually), Pyeongtaek Bioplant (FDA-approved biopharmaceutical manufacturing with 12,500L bioreactors), and Hanmi Fine Chemical (API and raw materials including mRNA cap analogs, NTP, and lipids). Hanmi has partnerships with global pharma companies including Lilly, Roche, and Sanofi.

Hebei Changshan Biochemical Pharma Co. Ltd

China

Hebei Changshan Biochemical Pharmaceutical Co., Ltd., founded in 2000, is a leading Chinese manufacturer of heparin and related products. The company has a complete heparin industry chain from crude products to APIs to finished injectable preparations, including heparin sodium APIs, low molecular weight heparin calcium injections, and sodium hyaluronate.

HIPRA Biotech Services

Spain

HIPRA Biotech Services is the CDMO division of HIPRA, a Spanish biopharmaceutical company with over 50 years of experience in vaccine research, production, and commercialization. The CDMO unit offers comprehensive biologics contract development and manufacturing services across mammalian, avian, and insect cell culture, microbial fermentation (E. coli, yeast), and aseptic fill-and-finish. HIPRA has experience with over 300 biological entities and demonstrated rapid development capability during COVID-19 vaccine production.

IDT Biologika

Germany

IDT Biologika is a leading global biologics CDMO headquartered in Germany, specializing in end-to-end development and manufacture of viral vaccines, gene and immune therapeutics, and aseptic fill-finish of sterile injectables. Founded in 1921 with over a century of experience in vaccines, the company operates BSL-2 facilities and has completed over 200 development, clinical, and commercial projects. IDT Biologika is a subsidiary of SK bioscience.

Indian Immunologicals Ltd

India

Indian Immunologicals Ltd (IIL) is an Indian market leader in veterinary and human biologicals, manufacturing over 150 registered products. The company offers contract manufacturing services, producing safe and efficacious bio-pharmaceuticals for several leading pharma and vaccine companies in India and internationally. IIL exports animal and human vaccines to more than 50 countries and has sold billions of doses of vaccines.