Sterile Injectable CDMOs

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.

SK bioscience

South Korea

SK bioscience is a South Korean vaccine-focused biopharmaceutical company that also operates as a CDMO. Listed on KOSPI (302440), they develop proprietary vaccines (influenza, varicella, COVID-19, pneumococcal, HPV, RSV) and provide CDMO/CMO services for vaccine manufacturing. They acquired a controlling stake in German CDMO IDT Biologika for approximately $244M, gaining manufacturing sites in Dessau (Germany) and Rockville (Maryland, USA). SK bioscience collaborates with the Bill & Melinda Gates Foundation, CEPI, and international vaccine initiatives. They have WHO prequalified products.

SOFIE

United States

SOFIE (formerly SOFIE Biosciences) is a U.S.-based radiopharmaceutical company that develops, manufactures, and distributes PET imaging agents and theranostic radiopharmaceuticals. The company operates 14 network pharmacy sites and a Theranostics Center of Excellence in Totowa, NJ. SOFIE offers contract manufacturing services for radiopharmaceuticals under 21 CFR 211 and 212 cGMP standards.

SpectronRx

Belgium

SpectronRx is a radiopharmaceutical CDMO headquartered in Belgium with manufacturing facilities in Indiana, USA, and Danbury, Connecticut. The company specializes in end-to-end radiopharmaceutical and theranostic services including mAb, nanobody, and peptide radiolabeling with a wide range of isotopes (Ac-225, Pb-212, Lu-177, I-123/131, Cu-64/67, etc.), isotope production via cyclotron (16-70 MeV), worldwide cold-chain logistics, and regulatory consulting from IND filing through FDA approval. They operate 3 CDMO facilities with multiple cleanrooms and GMP-aligned space totaling approximately 200,000 sq-ft.

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.

Sumitomo Chemical Co., Ltd.

Japan

Sumitomo Chemical Co., Ltd. is a major Japanese chemical company whose Advanced Medical Solutions Sector provides CDMO services for small molecule APIs and intermediates, oligonucleotide production (including gRNA for genome editing), and regenerative medicine/cell therapies through its S-RACMO joint venture with Sumitomo Pharma. The company also operates large agrochemical, IT materials, and essential materials businesses.

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.

Syngene International

India

Syngene International is a leading Indian Contract Research, Development and Manufacturing Organization (CRDMO) that provides integrated services spanning drug discovery through commercial manufacturing for both small and large molecules. The company has long-term research collaborations with Bristol Myers Squibb (extended until 2035) and Amgen. Syngene recently opened its first US manufacturing facility in Rockville, Maryland, and added a bioconjugation suite in Bengaluru for end-to-end ADC development. The company has 20 kL single-use drug substance capacity for biologics.

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.

SyVento BioTech

Poland

SyVento BioTech is a Polish biotechnology CDMO specializing in lipid-based nanocarrier formulations and LNP (lipid nanoparticle) technology for mRNA-based drug products. They offer comprehensive CDMO services for pharma and biotech innovators, covering mRNA synthesis and LNP encapsulation. The company opened a new mRNA manufacturing facility (FlexFactory by Cytiva) spanning over 7,000 m2 including lab and production areas. They have partnerships with Cytiva and signed a Letter of Intent with Mabion S.A. for biologics manufacturing collaboration.

Tanvex Biopharma USA, Inc

Taiwan

Tanvex BioPharma USA is a vertically-integrated biopharmaceutical company that has launched a CDMO division (Tanvex CDMO) offering pre-clinical through commercial-scale contract manufacturing of microbial and mammalian-derived biotherapeutics. Founded by Dr. Allen Chao (former founder/CEO of Watson Pharmaceuticals). They received FDA approval for Nypozi (biosimilar filgrastim) and have an FDA-accepted biosimilar BLA. The CDMO offers end-to-end biologics manufacturing services. Their San Diego facility is FDA-registered with 1 approved product (injectable). They have capabilities in both biosimilar development and contract manufacturing for third parties.

TAPI (Teva API)

Netherlands

TAPI (Teva Active Pharmaceutical Ingredients) is the API division of Teva Pharmaceutical Industries, positioned as the world's leading international supplier of APIs with 350+ products in their portfolio. They offer integrated API and CDMO services, leveraging 85+ years of API development and manufacturing expertise. TAPI provides customized solutions including complex API development, peptide manufacturing (including GLP-1 capability), and end-to-end manufacturing. They have a partnership with Antheia for biosynthetic pharmaceutical ingredients and with Sagimet Biosciences for resmetirom API. TAPI operates globally with multiple manufacturing sites.

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.

Theon Pharmaceuticals Ltd.

India

Indian pharmaceutical contract manufacturer (third-party manufacturer) based in Baddi, Himachal Pradesh. WHO-GMP and ISO 9001:2008 certified. Specializes in manufacturing tablets, capsules, dry syrups, and injectables. Ranked among top 10 leading injectable companies. Launched new state-of-the-art injectable and ophthalmic formulations facility in October 2024 for regulated markets. Has multiple production sections: General, Beta Lactam, Cephalosporins, Dry Powder Injectable. Exports to Africa, South East Asia, CIS, Latin America, and Asia Pacific. Has 12 FDA-approved products including injectables and oral tablets.

The Ritedose Corporation

United States

The largest US CDMO specializing in sterile Blow-Fill-Seal (BFS) technology for aseptic manufacturing of unit-dose medications. Based in Columbia, South Carolina with a 500,000+ sq ft facility and production capacity of over 2.6 billion units annually. Delivered more than 12 billion doses since 2012 with no patient interruptions. Provides both CDMO services and has a generics division. Offers the largest nebulized drug portfolio in the US. Key products include ophthalmic, respiratory, and inhalation medications. Has co-developed 80%+ of new BFS products over the past decade. 100% customer retention for 25 years. Recent investments include $17M cGMP lab expansion and seventh Syntegon packaging line. 16 FDA-approved products.

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).

UI Pharmaceuticals

United States

UI Pharmaceuticals (UIP) is the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the United States, operated by the University of Iowa. They offer comprehensive drug product CDMO services from formulation development through commercialization. In 2023, they launched a new 16,000 sq ft sterile processing facility with fill lines. They serve pharmaceutical, biotech, pediatrics, oncology, and research organizations worldwide.

Unison Pharmaceuticals Private Limited

India

Unison Pharmaceuticals Private Limited is an Indian pharmaceutical company established in 1981, recognized as a Contract Manufacturing Organisation (CMO) providing quality and affordable medicines. They handle testing, production, and full packaging. The company website has minimal content but search results confirm they are a CMO supplying pharmaceutical formulations including tablets.

Unolab Manufacturing

Spain

Unolab Manufacturing is a Spanish CDMO founded in 2008, specialized in development and manufacturing of sterile unit-dose liquid formulations using Blow-Fill-Seal (BFS Bottelpack) technology. Focused primarily on ophthalmic and respiratory products including saline solutions, hyaluronic acid formulations, and inhalation products. Operates an 18,000 m2 facility in Getafe, Spain with capacity exceeding 600 million doses per year. Products exported to 25+ countries. Also offers tech transfer, out-licensing, and product development services across the full product lifecycle.

Upperton Pharma Solutions

United Kingdom

Upperton Pharma Solutions is a UK-based CDMO with an award-winning 60,000 sq ft development and manufacturing facility (Trent Gateway) in Nottingham. They provide integrated services from pre-clinical through late-phase manufacture for oral solids, nasal, pulmonary, and parenteral dosage forms. They recently built a new 7 million GBP sterile fill/finish manufacturing facility with MHRA submission. Services include formulation development, clinical supply manufacturing (Phase I-III), process scale-up and optimization, quality control, and analytical development and validation.

VintaBio

United States

VintaBio is a US-based viral vector CDMO that recently emerged from stealth, specializing in simplified viral vector manufacturing for gene therapies. The company claims 60% reduction in process time, 30% reduction in raw material costs, 5x increase in high-purity vector production, and 90% full capsids through its proprietary VintaProcess technology. Team has 120+ years of combined cell and gene therapy experience. Recently opened a custom-built manufacturing facility in Philadelphia.

Viralgen

Spain

Viralgen is a premier CDMO specializing exclusively in AAV-based gene therapy manufacturing, founded in 2017 as a subsidiary of AskBio within the Bayer AG group. Claims the world's largest manufacturing capacity dedicated to AAV. Operates from a cGMP facility in San Sebastian, Spain with bioreactors up to 2,000L. Offers end-to-end services from early construct optimization to commercial campaigns. 50+ clients across US, Europe, Asia, and Australia. 10+ years of lentiviral/AAV experience. 200+ batches in bioreactor. 130+ employees. 7 dedicated cleanrooms. Proprietary TESSA technology platform (from AskBio).

ViroCell Biologics

United Kingdom

ViroCell Biologics is a UK-based CDMO specializing exclusively in the design, optimization, and GMP manufacturing of lentiviral and retroviral vectors for clinical trials. Described as the UK's first clinical trial-focused viral vector manufacturer. Operating from a facility at Great Ormond Street Hospital in London, the company focuses on innovation-driven viral vector design, de-risking, and delivery. The facility reportedly more than doubles Britain's viral vector manufacturing capacity.

Wacker Biotech

Germany

Wacker Biotech is the CDMO division of Wacker Chemie AG, specializing in advanced biologics manufacturing including proteins, plasmid DNA, mRNA, LNP formulations, live microbial products, and vaccines. With over 30 years of experience and five GMP-compliant facilities in Germany, the Netherlands, and the United States, Wacker Biotech offers process development through commercial-scale manufacturing with E. coli-based technology platforms.

Waisman Biomanufacturing

United States

Waisman Biomanufacturing is an academic CDMO based at the Waisman Center at the University of Wisconsin-Madison, specializing in advancing novel biologics and vaccines into early clinical trials. The facility manufactures plasmid DNA, recombinant proteins, cell therapeutics, extracellular vesicle/secretome products, live biotherapeutic products, and viral vectors under cGMP conditions.

Wheeler Bio

United States

Wheeler Bio is a biologics CDMO based in Oklahoma City, specializing in accelerating antibody-based therapeutics from discovery to cGMP clinical supply. The company uses its proprietary Modular CMC approach to reduce risk and accelerate timelines for drug developers. Wheeler Bio offers cell line development, process development, analytics, and manufacturing services for monoclonal antibodies, bispecific antibodies, and fusion proteins.

Woodstock Sterile Solutions

United States

Woodstock Sterile Solutions is a leading CDMO specializing in aseptic pharmaceutical manufacturing of sterile liquid formulations using advanced blow-fill-seal (BFS) technology. Based in Woodstock, Illinois, the company has a decades-long track record in clinical development through full-scale commercial production, with particular expertise in ophthalmic and respiratory products as well as complex solutions, suspensions, and emulsions.

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.

Xellia Pharmaceuticals

China

Xellia Pharmaceuticals is the global leader in fermentation-based non-beta-lactam anti-infective APIs and finished dosage forms (FDFs). With over 120 years of pharmaceutical manufacturing heritage, they supply APIs and sterile injectables to over 500 pharmaceutical companies across 80 countries. Also operates as a CMO for third-party sterile injectable production.

Xi'an Wanlong Pharmaceutical

China

Xi'an Wanlong Pharmaceutical Co., Ltd. is a comprehensive modern pharmaceutical enterprise founded in 1995, primarily producing formulations, APIs, and intermediates with GMP and DMF compliance. The Yangling facility spans 200,000 sq.m. with 18 production lines for injections, tablets, capsules, powder, and raw materials.

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.

Yposkesi (an SK pharmteco company)

France

Yposkesi, an SK pharmteco company, is one of Europe's largest Contract Development and Manufacturing Organizations (CDMO) for gene therapy viral vector manufacturing. Based near Paris (Evry-Courcouronnes), the company provides end-to-end gene therapy CDMO services including process development, cGMP manufacturing, analytical testing, and regulatory support for AAV, lentivirus, and other viral vectors.

Zydus Lifesciences Ltd

India

Zydus Lifesciences Ltd. (formerly Cadila Healthcare) is a major Indian pharmaceutical company headquartered in Ahmedabad, Gujarat, ranked 4th in the Indian pharma industry with 29,000+ employees globally. In June 2025, Zydus entered the global biologics CDMO business by acquiring Agenus Inc.'s U.S. manufacturing facilities in Emeryville and Berkeley, California for $75M upfront (plus $50M milestones), now operating as independent subsidiary Zylidac Bio LLC. These facilities provide end-to-end biologics development and manufacturing from pre-clinical to commercial stages, including monoclonal antibody manufacturing for Phase-3 immuno-oncology products (Botensilimab and Balstilimab). Zydus has 15 FDA-registered facilities, 156 FDA-approved products across capsules, tablets, creams, gels, injectables (including liposomal), ointments, suppositories, and transdermal patches. They have 58 FDA inspections (25 NAI, 28 VAI, 5 OAI) and 51 recalls (2 Class I, 40 Class II, 9 Class III). Manufacturing sites span Gujarat, Maharashtra, Goa, Himachal Pradesh, Sikkim (India), plus US (Vermont, Pennsylvania, Missouri) and Brazil. Their CDMO services are specifically the biologics arm through Zylidac Bio -- the broader Zydus business is primarily own-brand generic pharmaceuticals.

ACON Pharmaceuticals

United States

ACON Pharmaceuticals Inc is a specialty contract research organization (CRO) based in Cranbury, New Jersey, focused on drug product development. They specialize in drug delivery systems including siRNA, mRNA, liposomes, nanocrystals, and complex generics development via the 505(b)(2) pathway. They are primarily a development-focused CRO, not a manufacturing organization.

Adragos Pharma

Germany

Adragos Pharma is a globally operating CDMO headquartered in Munich, Germany, specializing in small molecule finished dosage forms. They operate six manufacturing sites across Europe and Japan: Athens (Greece, HPAPI capabilities), Halden (Norway, BFS sterile production), Jura (Switzerland, small-batch clinical/commercial), Kawagoe (Japan, ampoules and tablets), Livron (France, sterile liquids and suppositories), and Leipzig (Germany, semi-solid and non-sterile liquids).

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.

Altasciences

Canada

Altasciences is a North American CRO/CDMO offering integrated early-phase drug development services. The company provides preclinical safety testing, clinical pharmacology (Phase I-II), bioanalysis, and manufacturing/analytical services including formulation development, drug product manufacturing (tablets, capsules, suspensions, creams, terminally sterilized injectables), and ICH stability testing, with DEA licensing for Schedule I-V substances.

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.

Argonaut Manufacturing Services

United States

Argonaut Manufacturing Services is a U.S.-based CMO headquartered in Carlsbad, California, specializing in aseptic fill and finish, lyophilization (LyoDose beads, LyoDots, powders, and cakes), in-vitro diagnostics (IVD) and life science kit manufacturing, and drug-device combination products (DDCP). They recently secured $45M in financing to expand their aseptic fill/finish capabilities. They serve pharmaceutical, life science, IVD, and applied markets from small N-of-1 fills to high-scale commercial products.

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.

Astrea Pharma

France

Astrea Pharma is a CDMO founded with the purpose of building a customer-focused manufacturing network covering development to commercial supply. They acquired the Fontaine-les-Dijon solid dose manufacturing site from Recipharm and offer oral solid dose and aseptic manufacturing capabilities from development through commercial supply, with a focus on efficiency and value in the pharma supply chain.

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.

Avara Pharmaceutical Services

United States

Avara Pharmaceutical Services is an international contract manufacturing organization (CMO) headquartered in Norman, Oklahoma, specializing in commercial-scale drug product manufacturing. Their core capabilities include oral solid dose (including potent compounds and targeted release formulations) with capacity of 1.5 billion doses per year, liquid and lyophilized sterile injectable fill-finish with terminal sterilization and high containment, and integrated packaging with serialization, automated inspection, and specialty packaging. Avara operates former branded pharmaceutical facilities in the US (Norman, Oklahoma and Arecibo, Puerto Rico) and Italy (Liscate), serving 40+ countries. Facilities hold approvals from FDA, DEA, ANVISA, MPA (Sweden), and other international agencies.

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.

BioConnection

Netherlands

BioConnection is a contract manufacturing organization (CMO) based in Oss, The Netherlands, specializing in aseptic fill and finish services for sterile drug products. The company offers flexible development and GMP-compliant manufacturing for both innovative and generic biopharmaceutical companies, with capabilities in vials, syringes, and lyophilized products. Partnered with AGC Biologics for drug product services. FDA-registered with 17 inspections (6 NAI, 11 VAI), demonstrating extensive regulatory history.

Biopharma Group CDMO

United Kingdom

Biopharma Group is a UK-headquartered CDMO specializing in lyophilized (freeze-dried) and liquid pharmaceutical formulations for clinical manufacturing. They offer services from R&D through technical transfer, engineering batches, and clinical manufacturing to Annex 1 GMP standards. The company can handle substances classified up to OEB 6 and also manufactures non-sterile diagnostic formulations. They operate three Category D cleanrooms and a dedicated lyophilization center.

Birgi Mefar Group (BMG)

Turkey

Birgi Mefar Group (BMG) is one of Turkey's leading producers of sterile injectable products, recently acquired by Abu Dhabi-based ADQ. The company provides contract manufacturing services for sterile injectables with manufacturing sites in Turkey. BMG is listed on pharmaceutical CDMO directories and provides fill-finish and sterile manufacturing services.