Sterile Injectable 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.

Abiogen Pharma S.p.A.

Italy

Abiogen Pharma S.p.A. is an Italian pharmaceutical company established in 1997 with a century-long heritage, performing CMO and CDMO activities alongside its own product portfolio. They offer formulation development, analytical testing, scale-up, and commercial production from their cutting-edge manufacturing plant in Pisa. They specialize in bone metabolism, hypovitaminosis D, pain, dermatology, respiratory, and gastroenterology.

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).

ACIC Pharmaceuticals Inc

Canada

ACIC Pharmaceuticals Inc is a CDMO headquartered in Coral Springs, Florida, providing integrated pharmaceutical solutions from molecule to market. They offer API manufacturing, CDMO services for complex injectables including long-acting and cytotoxic injectables, regulatory support, and pharmaceutical equipment solutions. They have 249 FDA-approved products across a wide range of dosage forms.

ACS DOBFAR S.p.A.

Italy

ACS DOBFAR S.p.A. is an Italian pharmaceutical company established in 1973, specializing in anti-infective APIs (Cephalosporins, Carbapenems, Penicillins) and finished dosage forms. With 23 production facilities across four continents and over 3,000 employees, they operate as both an API manufacturer and a CMO for multinational pharmaceutical companies. They are approved by AIFA, FDA, ANVISA, and Health Canada.

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.

Aggrega Pharma, LLC

France

Aggrega Pharma LLC is a U.S.-based pharmaceutical company created in 2019 by four European-based pharmaceutical companies (Bluepharma, Rafarm, Substipharm, Welding) focused on developing, manufacturing, and marketing generic drug products. The company leverages its shareholders' development and commercial manufacturing facilities, including FDA-inspected sites in Portugal and Greece, with capabilities in oral solids, sterile injectables, and complex ophthalmics.

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.

Agno Pharmaceuticals

United States

Agno Pharmaceuticals is a U.S.-headquartered global end-to-end CDMO providing comprehensive solutions from API development and intermediates through complex drug product formulation to cGMP manufacturing for both clinical trials and commercial production. The company supports both innovative and generic pharmaceutical sectors with capabilities in small molecule APIs, highly potent APIs (HPAPIs), sterile APIs, and drug products.

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.

Akriti Pharmaceuticals Pvt. Ltd.

India

Akriti Pharmaceuticals Pvt. Ltd. is an Indian pharmaceutical manufacturer with EU GMP and TGA approved manufacturing facilities. The company delivers affordable quality medicines across the world with efficient manufacturing services backed by a qualified technical team, operating as a contract manufacturer for global healthcare partners.

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.

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.

Antibiotice S.A.

Romania

Antibiotice S.A. is a Romanian pharmaceutical company with over 70 years of experience, specializing in the manufacturing of antibiotics (injectable and oral), APIs, and nystatin. They hold FDA approval for injectable ampicillin, nafcillin, and nystatin API, and operate eight GMP-certified manufacturing lines. They provide contract manufacturing services for APIs and finished products.

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.

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.

APL (Apotek Produktion & Laboratorier AB)

Sweden

APL (Apotek Produktion & Laboratorier AB) is a Swedish state-owned pharmaceutical company and one of Europe's leading companies in development, analysis, and manufacturing of extemporaneous and stock preparations. They also operate as an established CDMO for the life science industry, offering formulation development, analytical method development, stability studies, and sterile manufacturing. They have invested in 3D printing technology for automated drug dispensing.

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).

AqVida GmbH

Germany

AqVida GmbH is a German CDMO specializing in sterile oncology injectable products. Based in northern Germany, they manufacture cancer medicines using a state-of-the-art robotic filling line designed for aseptic production of cytostatics for parenteral use. Their facility features OEB5 containment with isolator technology for handling toxic parenteralia, with vial sizes from 2 to 100ml and batch sizes of 5 to 300 liters. They also provide GMP consulting services.

Ardena

Belgium

Ardena is a Belgian-headquartered global specialist CDMO and CRO focused on precision medicine development of complex and innovative molecules, with a leading position in nanomedicine development. They offer integrated services spanning drug substance manufacturing, drug product manufacturing (oral solids, injectables, nanomedicines), bioanalytical testing, and CMC regulatory support. Their multi-site network includes capabilities for HPAPI manufacturing, spray drying, hot melt extrusion, and aseptic sterile manufacturing.

Ascendia Pharmaceutical Solution

United States

Ascendia Pharmaceutical Solutions is a CDMO specializing in formulation development and cGMP manufacturing of drug products. Known for novel enabling technologies such as NanoSol (nanoparticle), AmorSol (amorphous solid dispersion), EmulSol (nano-emulsion), and LipidSol (lipid nanoparticle), they help partners advance poorly soluble compounds from pre-formulation through commercialization.

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.

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.

AtomVie Global Radiopharma Inc.

Canada

AtomVie Global Radiopharma Inc. is a leading radiopharmaceutical CDMO dedicated to cGMP manufacturing and global distribution of radiopharmaceuticals. They specialize in radiolabeling with isotopes including Lu-177, Ac-225, I-131, In-111, Zr-89, and Tb-161. They have delivered 3,000+ doses to 26 countries with >99% accuracy. Their new 72,300 sq ft Hamilton, Ontario facility (opening 2026) will have 18+ production lines and 10x current capacity. Clients include Radiopharm Theranostics, Cellectar, and POINT Biopharma.

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.

Avrio Biopharma (Avrio Biopharmaceuticals, LLC)

United States

Avrio Biopharmaceuticals LLC is a US-based CDMO operating a cGMP facility focused on clinical trial services, formulation development, aseptic fill and finish, lyophilization, CMC support, and packaging and labeling. They offer comprehensive pre-formulation services, parenteral and solid/semisolid/liquid dosage form development, lyophilization cycle development, ophthalmics, emulsions, suspensions, and liposome/microsphere encapsulation. The company also provides clinical trial management, regulatory submissions support, and has received California Drug Manufacturing and Medical Device Manufacturing licenses. Their product portfolio includes generic formulations of gabapentin, pregabalin, and modafinil.

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.

Bilim Pharmaceuticals

Turkey

Bilim Pharmaceuticals is a major Turkish pharmaceutical company with comprehensive manufacturing capabilities across three production facilities in Gebze and Cerkezkoy. Provides contract manufacturing services alongside its own branded portfolio. Facilities produce a wide range of dosage forms including solid oral doses, liquids, semi-solids, sterile injectables, and inhalation products. Subject to international regulatory inspections and has clinical trials experience.

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.

Biofer S.p.A.

Italy

Biofer S.p.A. is an independent Italian pharmaceutical company specializing in the manufacture of Active Pharmaceutical Ingredients (APIs) for nearly 40 years. Core products include iron complexes (antianemics), heparin and glycosaminoglycans, steroids, enzymes, and folinates. The company operates under strict GMP standards with an emphasis on quality, safety, and efficacy. FDA-registered with 3 inspections (0 NAI, 3 VAI).

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.

Bioiberica S.A.U.

Spain

Bioiberica S.A.U. is a Spanish life science company and global leader in the manufacturing of heparin and glycosaminoglycan-based APIs. Core products include heparin sodium, heparin calcium, enoxaparin sodium, chondroitin sulfate, and hyaluronic acid. FDA-registered for API manufacture with 12 inspections (11 VAI, 1 OAI). The company supplies APIs to pharmaceutical companies globally but also has its own branded products. Operates major manufacturing facilities in Spain.

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.

Biolab (Thailand) – Biolab Company Limited

Thailand

Biolab Company Limited is a leading Thai pharmaceutical manufacturer with 45+ years of experience, producing pharmaceuticals, dietary supplements, and cosmeceuticals. The company operates a 24,000 sqm factory in Samut Prakan, Thailand with OEM/ODM contract manufacturing capabilities. Certified PIC/S GMP (Singapore HSA), EU GMP, ISO/IEC 17025, Halal, and Thai FDA Quality Award. Exports to 20+ countries.

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.

Biomatrix Healthcare Pvt. Ltd.

India

BioMatrix Healthcare Pvt. Ltd. is an Indian pharmaceutical company established in 2007, headquartered in Ahmedabad, specializing in 100% export of pharmaceutical products to 40+ countries. Their manufacturing facility is WHO-GMP, EU-GMP certified and compliant with US-FDA, UK-MHRA, and ANVISA standards, with Health Canada site approval. Capacity: 5 billion tablets, 1 billion capsules, 24 million liquids, and 18 million dry syrups per annum. 1,000+ product registrations. Expanding with a new API manufacturing facility in Vadodara.

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.

Biophore India Pharmaceuticals

India

Biophore India Pharmaceuticals Pvt. Ltd. is a Hyderabad-based research-driven pharmaceutical company specializing in the development and manufacturing of niche active pharmaceutical ingredients (APIs) for global markets. Focus areas include oncology, contrast agents, peptides, injectable APIs, and orphan drugs. They have 110+ US DMFs, 150 global DMFs, 20+ CEPs, and 4 US FDA and EU approved manufacturing facilities. FDA-registered with 5 approved products (capsules, tablets). Partner relationships include Oakrum Pharma.