Prefilled Syringe CDMOs

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.

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.

Akums Drugs & Pharmaceuticals Ltd

India

Akums Drugs & Pharmaceuticals Ltd. is India's largest CDMO with 30% domestic market share, operating 15+ state-of-the-art manufacturing facilities with over 4,100 commercialized formulations across 60+ dosage forms. The company serves 1,500+ pharmaceutical companies and provides end-to-end services including API manufacturing (737 MT annual capacity across 3 facilities), formulation development, clinical trial materials, and commercial-scale production of tablets, capsules, injectables, soft gels, syrups, topicals, and nutraceuticals.

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.

ApiJect Systems

United States

ApiJect Systems is a U.S.-based medical technology company that manufactures prefilled injectors using Blow-Fill-Seal (BFS) technology. They are opening an FDA-registered 503B outsourcing facility in Apex, NC to produce generic injectable medicines. They combine BFS containers with pen needle hubs to create prefilled injection devices, focusing on reshoring essential drug manufacturing and addressing drug shortages.

ASCIL Biopharm (Ascil Proyectos S.L.)

Spain

ASCIL Biopharm (Ascil Proyectos S.L.) is a clinical-stage drug delivery systems company based in Spain, specializing in controlled-release formulations and precision medical devices. They also act as a CDMO for early-stage drug product development, providing formulation, analytics, and manufacturing services for injectable depot formulations.

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.

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.

B. Braun Melsungen AG (Contract Manufacturing)

Germany

B. Braun Melsungen AG's Contract Manufacturing division provides outsourcing solutions for medical and pharmaceutical products. They offer contract manufacturing of sterile injectables, medical devices, and pharmaceutical solutions. With multiple FDA-registered facilities, 12 FDA inspections (7 NAI, 5 VAI), and 6 clinical trials, they are an established contract manufacturer with global reach.

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.

BioTechnique LLC

United States

BioTechnique LLC is a full-service CRDMO based in York County, Pennsylvania, specializing in cytotoxic and therapeutic sterile injectable fill-finish services. The company provides services from investigational/clinical through to final marketed products, handling both small and large batch sizes. BioTechnique operates an FDA-registered facility with capabilities spanning sterile manufacturing, lyophilization, and high-potency compound handling.

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 Pharmaceutical

Canada

Bora Pharmaceuticals is a global CDMO headquartered in Canada with manufacturing facilities across North America and Asia. The company offers comprehensive contract development and manufacturing services for oral solid dosages, sterile injectables, topicals, and liquids, serving both clinical and commercial supply needs with FDA and EMA approved facilities.

Bryllan

United States

Bryllan is a US-based CDMO specializing in the production and filling of potent and cytotoxic compounds, with a focus on aseptic powder and liquid filling for complex drug and device combination products. The company operates a high-containment, state-of-the-art facility in Brighton, Michigan, supporting both clinical and commercial supply of ADCs and other cytotoxic products.

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.

GULF BIOTECH B.S.C CLOSED

Bahrain

Gulf Biotech is a pharmaceutical company based in Bahrain that manufactures injectable formulation products and offers contract manufacturing services for sterile formulations. The company provides lyophilized vials, cartridges, ampoules, pre-filled syringes, and sterile emulsion technology from its state-of-the-art manufacturing facility.

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.

Hikma Pharmaceuticals

Algeria

Hikma Pharmaceuticals is a global pharmaceutical company with 29 manufacturing plants across the US, Europe, and MENA, producing injectable, oral, and respiratory medicines. The company offers CMO services and has announced a $1 billion investment by 2030 to expand US manufacturing and R&D capabilities. Hikma has 76 FDA-approved products, produces 500 million injectable units annually, and has maintained zero critical FDA observations in 20+ years.

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.

Lonza

Switzerland

Lonza is a pioneer and world leader in the CDMO industry, founded in Switzerland in 1897. The company provides integrated development and manufacturing services across biologics, small molecules, cell and gene therapy, mRNA, and bioconjugates (ADCs/HPAPIs). With over 20,000 employees across five continents, Lonza serves the global pharmaceutical, biotech, and nutrition industries with end-to-end capabilities from early development to commercial-scale manufacturing.

Novartis Contract Manufacturing

Austria

Novartis Contract Manufacturing is the CDMO arm of Novartis, offering fully integrated end-to-end manufacturing solutions across biologics (mammalian up to 15,000L, microbial up to 13,000L), small molecules (API to fill & finish), cell & gene therapy (CAR-T, AAV, LV), xRNA/LNP/pDNA, and comprehensive fill & finish services. The operation spans multiple state-of-the-art facilities across Austria, Switzerland, Slovenia, Belgium, France, Singapore, and the United States, with 107 FDA inspections and 27 FEI registrations.

Novocol Pharma

Canada

Novocol Pharma is a CDMO headquartered in Cambridge, Ontario, Canada, specializing in sterile injectable fill-finish and combination drug product assembly. With over 40 years of experience, the company offers aseptic and terminally sterilized manufacturing from development through commercialization. Novocol Pharma is a Septodont company and has a fill-finish partnership with Moderna for mRNA vaccines.

Orofino Pharmaceuticals Group

Italy

Orofino Pharmaceuticals Group (OPG), headquartered in Rome, Italy, is a group of companies specializing in third-party pharmaceutical manufacturing services. The group includes Biopharma (betalactam finished products), Injectalia (small sterile liquids including hormones, biologicals, heparins, vaccines), K24 Pharmaceuticals (chemical testing, EU release, secondary packaging), and Drug'On Pharma Switzerland (API manufacturing). Focused on sterile injectables and betalactam oral/injectable dosage forms.

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.

PENMIX Co. Ltd.

South Korea

PENMIX is Korea's largest CDMO, fully committed to globalization of the pharmaceutical industry. The company operates dedicated penicillin manufacturing and general injection manufacturing plants with KGMP and FDA registration. PENMIX provides contract manufacturing services for penicillin formulations (tablets, injections) and sterile injectable products including lyophilized vials, liquid vials, ampoules, and pre-filled syringes, with full automation lines conforming to PICS GMP guidelines.

Pfizer CentreOne

Belgium

Pfizer CentreOne is a global CDMO embedded within Pfizer, specializing in commercial manufacturing of oral solid doses, sterile injectables, biologics including monoclonal antibodies, and antibody-drug conjugates. It leverages Pfizer's global manufacturing network across six continents with cGMP-compliant sites and over 170 years of pharmaceutical manufacturing expertise, backed by $1B+ annual manufacturing investments.

Pharmaniaga Manufacturing Berhad

Malaysia

Pharmaniaga Manufacturing Berhad is a Malaysian pharmaceutical manufacturer and CDMO offering contract manufacturing services. The company produces oral solid dosages (7 billion tablets/capsules capacity), liquids (2.9 million bottles), creams (5 million tubes), small volume injectables including ampoules/vials (43 million units), pre-filled syringes and insulin cartridges (25 million units each), and dry syrups. Products include general pharmaceuticals, penicillin, cephalosporin, and OTC products. Facilities are designed to international pharmaceutical engineering guidelines.

Pharmaron

China

Pharmaron is a premier life science CRO/CDMO providing comprehensive R&D and manufacturing services across the entire drug discovery to commercialization process. The company serves small molecules, biologics, ADCs, cell & gene therapies, and protein degraders. It offers laboratory services, chemistry/manufacturing/controls (CMC), clinical development, and biologics/CGT manufacturing. Pharmaron acquired a commercial API manufacturing facility in the UK and operates a gene therapy CDMO in Liverpool with a 20-year track record. The company has over 20 years of experience across 7+ facilities in the UK, US, and China.

Pharmathen

Greece

Pharmathen is a Greek research-centred CDMO specializing in complex drug delivery and formulation development. Founded in 1969 and acquired by Partners Group for $1.89 billion, the company operates two state-of-the-art manufacturing facilities: Rodopi (FDA-approved, 15,300 m2, capacity 3.3 billion tablets, 1.2 billion capsules, 175 million blisters, 4 million sterile syringes/vials) and Pallini/Attica (4,000 m2, 800 million tablets/capsules, 1.5 million sterile vials, 6 million ampoules). Pharmathen has also acquired CBL Patras. Key technology platforms include Long Acting Injectables (biodegradable microparticles, nanosuspensions, self-assembled nanogel systems), modified release oral formulations, preservative-free ophthalmic formulations, and solubility/permeability enhancement technologies.

Pyramid Laboratories

United States

Pyramid Laboratories (now Pyramid Pharma Services) is a California-based CDMO established in 1988, specializing in aseptic manufacturing, development, and analytical services for parenteral drugs. The company supports biologics, peptide, and small molecule drugs from pre-clinical development through commercial supply. Pyramid operates a 90,000 sq ft GMP-compliant facility in Costa Mesa, California, and has received investment from Audax Private Equity.

Sever Pharma Solutions

France

Sever Pharma Solutions is a specialized CDMO focused on high-potent and cytotoxic drug products (up to OEB6), polymer-based controlled-release delivery systems (implants, vaginal rings), hot melt extrusion for bioavailability enhancement, and prefilled syringe/autoinjector aseptic fill-finish. With sites in Malmö (Sweden) and Putnam (Connecticut, USA), they offer end-to-end services from formulation development through commercial manufacturing.

Simtra BioPharma Solutions

Germany

Simtra BioPharma Solutions is a global CDMO focused exclusively on sterile injectable drug products. With over 65 years of expertise, Simtra offers formulation development, lyophilization cycle optimization, technology transfer, analytical services, fill/finish operations, specialized containment, and global regulatory support. They handle cytotoxics, highly potent compounds, biologics, vaccines, small molecules, ADCs, and diluents. They have a strategic alliance with MilliporeSigma for ADC manufacturing. The company has transferred 60+ ADC candidates including six commercial products to their German site.

Stira Pharmaceuticals (Sterile Injectable CDMO)

United States

Stira Pharmaceuticals is a U.S.-based CDMO specializing in the development and cGMP manufacture of complex sterile injectable products, with integrated analytical capabilities. Founded in 2019, the company serves the U.S. market with services spanning small molecules, peptides, oligonucleotides, and biosimilars in formats including vials, syringes, IV bags, and cartridges with batch sizes up to 2,000L.

Symbiosis Pharmaceutical Services

United Kingdom

Symbiosis Pharmaceutical Services is a world-class sterile fill-finish CDMO based in Stirling, UK, specializing in the GMP manufacture of liquid and lyophilized biological and small molecule drug products. The company serves clinical trial and commercial scale with FDA-inspected and MHRA-licensed facilities. Symbiosis has manufactured its first 10,000-vial commercial batch for a cancer immunotherapy currently in Phase III trials. The company handles a full range of biologics including ATMPs, viral vectors, mAbs, ADCs, RNA/peptide therapies, and vaccines.

ten23 health

Switzerland

Swiss CDMO specializing in formulation, analytical and process development, sterile manufacturing (fill and finish), and testing of injectable medicines. First CDMO in the pharmaceutical industry for injectables to be B Corp certified. Operates from Basel and Visp, Switzerland. Opened new VIVA2 facility with expanded sterile manufacturing lines. QC laboratories approved by both Swissmedic/RHI and FDA. Partners with BD on Libertas wearable injector commercialization. Supports biologics, small molecules, and RNA therapeutics.

Thermo Fisher Scientific Inc.

China

One of the world's largest pharmaceutical CDMOs through its Patheon pharma services division. Provides end-to-end pharmaceutical development and manufacturing services for both small molecules and biologics, from API manufacturing through drug product, sterile fill/finish, packaging, and commercial supply. Operates 31+ FDA-registered facilities globally. 158 FDA inspections on record (52 NAI, 104 VAI, 2 OAI). Also provides cell therapy manufacturing solutions (CTS Rotea cell processing system), laboratory informatics, bioprocessing equipment, and reagents. 4 FDA-approved drug products. Revenue >$40B (full company).

WuXi Biologics

China

WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) for biologics, with over 12,000 employees across the US, Ireland, Germany, China, and Singapore. The company provides end-to-end solutions from discovery through commercial manufacturing for biologics including monoclonal antibodies, bispecifics, ADCs, vaccines, and mRNA products using both mammalian and microbial expression systems.

YooYoung Pharmaceutical Co., Ltd.

South Korea

YooYoung Pharmaceutical Co., Ltd. is a South Korean pharmaceutical manufacturer founded in 1981. The company operates a KGMP-certified factory in Jincheon with capabilities for oral solid dosage (800 million tablets/year), ampoule injectables (25 million/year), and prefilled syringe injectables (15 million syringes/year after 2021 expansion). Offers CMO/contract manufacturing services and exports to Japan, Asia, Europe, and South America.

Afton Scientific

United States

Afton Scientific is a pharmaceutical CDMO with over 20 years of expertise in aseptic manufacturing for biologics and small molecules. The company operates FDA-inspected facilities with a 99.9% on-time delivery rate and is investing in multi-year expansion of sterile fill-finish capabilities, including new technologies for improved efficiency and increased production capacity.

Alcami

United States

Alcami is a US-based CDMO with 45+ years of experience providing integrated drug product manufacturing, laboratory services, and cGMP pharmaceutical storage. The company specializes in sterile fill-finish manufacturing (liquid and lyophilized injectables, prefilled syringes) and oral solid dose, with DEA licensing for controlled substances and EU/Annex 1 compliance.

American Injectables

United States

American Injectables is a privately held, FDA-approved CDMO specializing in sterile injectable drug products. Based in Florida, the company provides end-to-end services from formulation development through commercial manufacturing, with capabilities in aseptic fill/finish for vials and syringes, analytical testing, packaging, and serialization.

Artesan Pharma

Germany

Artesan Pharma is a German full-service CDMO based in Luechow, specializing in pharmaceutical contract development and manufacturing with 501-1,000 employees. They provide services spanning formulation development to commercial manufacturing across multiple dosage forms including oral solid doses (tablets, capsules, pellets), sterile prefilled syringes with innovative production processes, and liquids. They also offer serialization, final packaging (blister), and terminal steam sterilization capabilities.

August Bioservices

United States

August Bioservices is a US-based CDMO headquartered in Nashville, Tennessee, specializing in sterile injectable drug product development and manufacturing. They offer end-to-end services from lab-scale process development through commercial manufacturing, including formulation, analytical method development and validation, sterile filling for vials, syringes, and IV bags using both stainless steel and single-use technology (1L to 4000L), lyophilization, automated visual inspection, assembly, labeling, packaging, and serialization. The company operates fully isolated filling lines and drug-device combination product capabilities.