Sterile Injectable CDMOs

Pierre Fabre (CDMO)

France

Pierre Fabre CDMO is the contract development and manufacturing arm of the Pierre Fabre Group, a French pharmaceutical and dermo-cosmetics company. Offers over 20 years of CDMO services across pharma and non-pharma active ingredients, dry forms, non-sterile liquids, and biologics including monoclonal antibodies and ADCs. Operates R&D site in Toulouse and 3+ industrial sites in France. Expertise spans extraction, chromatographic purification, chemical synthesis, cytotoxic compound production, plant cell culture, and supercritical CO2 technology. Manufactures 2,100 metric tons of plant extracts and 100+ active ingredients annually.

Prahem Laboratories LLP

India

Prahem Laboratories LLP is an Indian pharmaceutical company and sister company of Sneha Medicare Pvt Ltd (established 1985). Based in Mumbai, they operate as a CMO/CDMO with capabilities in development, production, and marketing of specialty medicines, generic medicines, OTC products, and new therapeutic development. Listed on CPHI Online as CMO/CDMO with distributor/import-export and generics/biosimilars manufacturing capabilities. Their business verticals include APIs, finished dosage forms (including oncology and contrast media), and export to LATAM, CIS, and Southeast Asian markets.

Prasfarma

Spain

Prasfarma is a Spanish pharmaceutical company operating as a CMO and CDMO, headquartered in Cerdanyola del Valles (Barcelona) with a manufacturing plant in Manlleu (Barcelona). They are recognized as a reference in the sector for production of oncology (cytostatic) and high potency products. Their product range includes cytostatic oral forms (hard capsules, sachets, film coated and sugar coated tablets), non-cytostatic parenteral forms (vials, ampoules, prefilled syringes), and cytostatic parenteral forms (liquids, lyophilized). Services encompass development, co-development, regulatory affairs, clinical research, production, logistics, and marketing agreements. ISO 14001:2015 certified.

Prime Pharmaceuticals Pvt Ltd.

India

Prime Pharmaceuticals Pvt Ltd. (also known as PRIME PHARMACEUTICALS PVT. LTD) is an Indian R&D-driven CMO and CDMO with significant manufacturing capabilities. IMPORTANT NOTE: The website at primepharmaceuticals.in appears to be a different entity -- an ayurvedic/herbal product brand based in Hissar, India. The actual PRIME PHARMACEUTICALS PVT. LTD. on PharmaSource is a contract manufacturer with FDA-registered facilities (3 FEI numbers), 7 FDA inspections (1 NAI, 6 VAI), 4 Class I recalls, clinical trials in cardiovascular/oncology/ophthalmology, and 3 FDA-approved products (cream, spray, tablet via oral and topical routes). They are listed on CPHI for biosimilars, injectables, and contract manufacturing, and appear at CPHI Frankfurt.

ProMed Pharma

United States

ProMed Pharma is a US-based CDMO specializing in long-acting injectable and implantable dosage forms with nearly 20 years of operational history. The company has mastered polymer-based drug delivery including molding, extrusion, and microencapsulation techniques using silicones, thermoplastics, and biodegradable excipients. ProMed supports projects from early-stage feasibility through commercial manufacturing and has expanded with the acquisition of a 28,000 sq ft facility in Plymouth, Minnesota.

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.

Renaissance Lakewood, LLC

United States

Renaissance Lakewood is a US-based pure-play CDMO specializing in nasal spray and sterile injectable dosage forms. Founded in 1979 (originally Paco Packaging Labs), they have nearly 20 years of nasal spray experience and offer bench-to-shelf services including formulation development, spray characterization, clinical through commercial manufacturing. Recently acquired by LTS Lohmann Therapie-Systeme AG to expand LTS's CDMO capabilities. FDA-registered with manufacturing, analysis, labeling, and packaging operations in Lakewood, NJ. They have invested over $100M in facility improvements over the past five years.

Sanochemia Pharmazeutika AG

Austria

Sanochemia Pharmazeutika AG is an Austrian pharmaceutical manufacturer specializing in contrast media (MRI and CT), APIs, and finished dosage forms. Located in Neufeld an der Leitha with over 130 years of history, the company produces over 4 million units of sterile injectable contrast media annually and offers CDMO/CMO services for APIs and drug products.

ScinoPharm (scinopharm.com)

China

ScinoPharm Taiwan is a CDMO headquartered in Tainan Science Park, Taiwan, specializing in high-tech oncology APIs, peptide synthesis, and sterile injectable drug products. With FDA-approved facilities and 18 flexible manufacturing lines, ScinoPharm provides end-to-end services from API development through sterile injectable fill/finish, with a strong focus on complex generics and oncology therapeutics.

Serumwerk Bernburg AG

Germany

Serumwerk Bernburg AG is a medium-sized German pharmaceutical company with over 60 years of tradition in the development and production of medicines, medical devices, and APIs. The company offers APIs and contract manufacturing (Lohnproduktion) services, manufactures sterile infusion and rinsing solutions for hospitals and dialysis centers, ophthalmic products, veterinary medicines, wound care products, and specialty biopolymer-based formulations. Serumwerk has FDA-registered API manufacturing and exports to partners in 60+ countries.

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.

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.

Standard Chem. & Pharm. Co. Ltd

Taiwan

Standard Chem. & Pharm. Co., Ltd. (SCP), established in 1967 in Taiwan, is a renowned global pharmaceutical manufacturer and CDMO with a strong international presence. Their investor materials and pharma alliance documents explicitly describe them as offering CMO/CDMO services. They have manufacturing plants in Tainan (Plant 1 and Plant 2) and operations in Vietnam, Philippines, Thailand, Samoa, China (Taizhou/Jiangsu and Shanghai). The company has collaborated with major Japanese pharmaceutical companies and offers drug development and innovative drug delivery systems. They are a publicly listed company on the Taiwan stock exchange (Stock Symbol: 1720).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Bliss GVS Pharma Ltd.

India

Bliss GVS Pharma Ltd. is an Indian pharmaceutical company and the world's largest manufacturer of suppositories and pessaries, operating in 60+ international markets. The company operates six manufacturing units in Maharashtra and Daman with WHO-GMP and EU-GMP (PIC/S) approvals, producing suppositories, pessaries, tablets, dry syrups, dry powder injectables, ointments, creams, and gels. Bliss GVS offers contract manufacturing (CMO/CDMO) services alongside its own product portfolio.

Bluepharma

Portugal

Bluepharma is a Portuguese CRDMO with over 55 years of experience, offering an integrated approach from R&D through to commercial manufacturing of medicines. The company produces 2 billion units of oral solid pharmaceutical forms and has an industrial plant for high potency products. Bluepharma's facilities are EMA/Infarmed and FDA approved, and the company has expanded into advanced therapies beyond small molecules.

Bruschettini S.r.l.

Italy

Bruschettini S.r.l. is an Italian pharmaceutical company based in Genoa that provides contract manufacturing services for sterile injectable and lyophilized products. The company is listed on CMO/CRO directories and appears in contract pharmaceutical dose manufacturing industry reports as a provider of sterile manufacturing capabilities.