Sterile Injectable CDMOs

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 Biologics

United States

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

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.

Boston Institute of Biotechnology (BIB)

United States

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

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.

BSP Pharmaceuticals

Italy

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

Cambrex

Canada

Halo Pharmaceuticals, acquired by Cambrex in 2018 for $425 million and later sold to SK Capital Partners in 2023, is a drug product CDMO specializing in oral solids, liquids, creams, sterile and non-sterile ointments, complex formulations, pediatric indications, and controlled substances. The company operates 430,000 square feet of GMP-compliant manufacturing space across Whippany, New Jersey and Montreal, Quebec, serving over 85 clients.

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.

CARBOGEN AMCIS

CHina

CARBOGEN AMCIS is a leading CDMO offering drug substance and drug product development and manufacturing services from early development through commercialization. Part of the Indian Dishman Carbogen Amcis group, the company has facilities in Switzerland, France, UK, Netherlands, and China, specializing in complex small molecule APIs, ADC payloads, and sterile drug products.

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.

Concord Biotech

India

Concord Biotech Limited is a leading Indian biopharmaceutical company specializing in fermentation-based API manufacturing and formulations. With over 25 years of expertise, the company manufactures 30+ APIs across immunosuppressants, oncology, and anti-infective therapeutic areas, serving 250+ global customers in 70+ countries. Concord operates four manufacturing facilities in Gujarat, India, including a new injectable manufacturing facility at Valthera producing liquid and lyophilized dosage forms.