Lyophilization 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.

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).

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.

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.

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.

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.

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.

Beijing Sunho Pharmaceutical Co., Ltd

China

Beijing Sunho Pharmaceutical Co., Ltd is a Chinese pharmaceutical company manufacturing oral dosage forms. They have FDA-approved capsule products, are FDA-registered, and have passed FDA inspection with NAI status. They produce products including Tranexamic Acid Injection, Aripiprazole freeze-dried orally disintegrating tablets, and Erlotinib. They are publicly listed in China.

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.

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.

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.

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.

Biose Industrie

France

Biose Industrie is a French CDMO specialized in microbiome therapeutics, established in 1951. They focus on manufacturing Live Biotherapeutic Products (LBPs) and Next-Generation Probiotics (NGPs) for pharmaceutical and consumer health markets. They combine aerobic and anaerobic microbiology expertise with industrial-scale GMP manufacturing. Investing EUR 80 million to expand capacity from 8,000L to 32,000L fermentation volume at their Aurillac site. They offer full CDMO services from process development to GMP drug product manufacturing.

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.

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.

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.

Catachem, Inc.

United States

Catachem, Inc. is a U.S.-based, ISO 13485-certified and FDA-registered manufacturing company headquartered in Oxford, Connecticut, specializing in enzyme-based chemistries, custom reagent solutions, and lyophilization services. The company provides contract development and manufacturing services to the medical device, pharmaceutical, and biotechnology industries. They are targeting cGMP compliance by July 2026.

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.

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.

C.O.C. Farmaceutici Srl

Italy

C.O.C. Farmaceutici Srl (Content Group) is an Italian pharmaceutical CDMO specializing in contract development, manufacturing, and filling of liquid, gel, and lyophilized pharmaceuticals, medical devices, and cosmetics. The company operates three production plants in Italy (Sant'Agata Bolognese, Rovereto sul Secchia, and Pomezia) with 500+ employees, generating 108.3 million euros in turnover in 2025, with particular expertise in ophthalmic and respiratory products. The Pomezia facility (Tubilux Pharma) is FDA approved.

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.

CreoSalus

United States

CreoSalus Inc. is a Louisville, KY-based cGMP CDMO specializing in custom peptide synthesis, process development, and manufacturing of peptide drug substances (API) and sterile injection drug products. The company has pioneered personalized peptide cancer vaccine manufacturing since 2016, producing thousands of personalized peptide vaccines for clinical trials with a 100% patient order success rate.

Daewoong Pharmaceutical Co., Ltd. (Daewoong Bio)

South Korea

Daewoong Pharmaceutical is a major South Korean pharmaceutical company whose subsidiary Daewoong Bio provides CMO services for biopharmaceutical manufacturing. Daewoong Bio opened a Bio-Center in Hyangnam for end-to-end CMO services and completed a bioplant in Hwaseong for microbial-based drug production. The company is FDA-registered with 5 FEI numbers and has 2 FDA-approved injectable products.

Egis Pharmaceuticals PLC

Hungary

Egis Pharmaceuticals PLC is a Hungarian generic pharmaceutical company with over 110 years of history, now offering CDMO services through its Egis Pharma Services division. The company operates three production sites in Hungary (two in Budapest, one in Kormend) and manufactures APIs, tablets, injections, and galenic formulations including ointments, suppositories, and syrups. Egis specializes in highly potent API development and manufacturing using organic chemical synthesis on GMP-compliant multi-functional lines for oncology and rheumatic arthritis therapies.

Emcure Pharmaceuticals Limited

India

Emcure Pharmaceuticals Limited is a leading Indian pharmaceutical company and CDMO founded in 1981, headquartered in Pune, India, with operations spanning over 70 countries. Originally established as a CDMO, Emcure now operates 14 manufacturing facilities (including US FDA-approved sites) producing APIs, oral solid dosage forms, injectables (including liposomal and lyophilized), biotherapeutics, and vaccines. The company specializes in complex generics, chiral molecules, high-potency APIs, and novel drug delivery systems including lipid nanoparticles and long-acting injectables.

Ethypharm

China

Ethypharm is a leading mid-size international specialty pharmaceutical company and CDMO with 5 manufacturing plants across France, UK, and Spain. The company specializes in oral solid dosage forms, sterile injectables in ampoules, pre-filled syringes and IV bags, with particular expertise in high potent APIs and controlled substances including opioids and psychotropics.

Gland Pharma

Belgium

Gland Pharma is one of the largest generic injectable manufacturing companies globally, established in Hyderabad, India in 1978. The company operates under a B2B/CDMO business model with four cGMP-compliant formulation facilities and four API facilities, supplying products across 60 countries. It focuses on sterile injectables, oncology, and ophthalmics, including complex injectables and 505(b)(2) filings.

Grifols (Grifols Partnership)

Spain

Grifols Partnership is the CDMO arm of Grifols, a Spanish multinational with over 100 years of pharmaceutical experience, specializing in added-value small molecule injectable products manufactured in flexible bags and vials. The company operates FDA-approved manufacturing facilities and serves mid-size, large, and generic pharmaceutical companies with sterile parenteral drug products, including terminal sterilization and Form-Fill-Seal processes.

Gufic Biosciences Ltd

India

Gufic Biosciences Ltd is an Indian pharmaceutical company established in 1970, recognized as one of the largest manufacturers of lyophilized injections in India. The company operates a fully automated lyophilization plant and offers CMO/CDMO services for lyophilized injectables across antibiotic, antifungal, cardiac, infertility, antiviral, and proton-pump inhibitor segments.