EMA-Certified CDMOs

Acebright Group (Shanghai Acebright Pharmaceuticals) is a Chinese pharmaceutical company providing CDMO services through NMPA, FDA, EMA, and WHO-approved sites. They specialize in API manufacturing with over 20 years of technology development, and have a joint venture with Cipla for respiratory products in China.

Amarex Clinical Research, LLC

United States

Amarex Clinical Research, LLC is a full-service global Contract Research Organization (CRO) co-founded in 1998 and acquired by NSF International. The company provides clinical trial management, regulatory affairs, biostatistics, data management, pharmacovigilance, and medical writing services across all phases of drug development.

Aurisco Pharmaceutical Co., Ltd. is a CRDMO (contract research, development and manufacturing organization) headquartered in Taizhou, Zhejiang, China, specializing in generic and complex APIs and finished dosage forms. The company focuses on small-molecule drugs, peptide therapeutics, and oligonucleotide pharmaceuticals. Aurisco operates 4 manufacturing sites and 5 R&D centers in China with 1,500+ staff, has passed 5 cGMP inspections in 2023 (USFDA, EUGMP, PMDA, NMPA, KFDA), and is expanding peptide manufacturing capacity. Their steroid product portfolio includes abiraterone acetate and complex hormone formulations.

Cayman Pharma s.r.o. is a Czech pharmaceutical manufacturer specializing in cGMP prostaglandin Active Pharmaceutical Ingredients (APIs) for ophthalmology and vascular applications. The company owns a patented route to the prostaglandin core structure developed at its headquarters near Prague, and produces APIs including Latanoprost, Travoprost, Bimatoprost, Tafluprost, and Epoprostenol. cGMP compliance is continuously verified by Czech NCAs (SUKL, USKVBL) and the US FDA.

Chanelle Pharma is Ireland's largest indigenous pharmaceutical manufacturer producing both human health and veterinary products. The company operates 4 manufacturing facilities with 550 employees, holding 1,200+ human health licenses, and provides contract manufacturing services for B2B pharmaceutical customers. Chanelle Pharma was acquired by the private equity firm Exponent and has appointed a new CEO to drive international growth, with manufacturing plants in Ireland and near Rome, Italy.

Charles River Laboratories

Australia

Charles River Laboratories is a global contract research organization (CRO) providing drug discovery, safety assessment, and preclinical services across the drug development lifecycle. The company recently divested its CDMO business, indicating it is focused on research services rather than contract manufacturing. It has extensive FDA-registered facilities worldwide.

Chongqing Huapont Shengchem Pharmaceutical Co., Ltd., founded in 1994, is a subsidiary of listed company Huapont Life Sciences. The company provides integrated R&D, production, and CDMO services for APIs and intermediates with 30+ years of experience, 700m3 reaction volume, 100+ R&D products, and registrations across US, EU, Japan, Korea, and China.

Conscio Group

Austria

Conscio Group is a European scientific service provider headquartered in Munich, Germany, offering laboratory services across pharmaceuticals, food, and environmental sustainability. The pharma division provides formulation development, analytical R&D, bioanalytical testing, clinical trials, IMP manufacturing, batch release testing, biologics and biosimilars testing, microbiology, and pharma analysis. Conscio operates GMP/GCP/GLP and FDA-certified laboratories in Germany, Czech Republic, Austria, and Slovakia.

Cromos Pharma Ireland Ltd

Ireland

Cromos Pharma is a US-based international contract research organization (CRO) with expertise in Central and Eastern Europe, Central Asia, and Turkiye. The company offers clinical trial services including multicountry feasibility, site management, patient recruitment with their No Patients No Payment program, and regulatory consulting from early- to late-phase studies.

Huayi Pharmaceutical (Anhui) Co., Ltd. is an EU cGMP-approved Sino-British joint venture CDMO located in Hefei, Eastern China. The company specializes in contract development and manufacturing of high-quality generic pharmaceuticals across various dosage forms, offering integrated services from API production through finished dosage form manufacturing.

Intertek

Canada

Intertek is a global quality assurance provider operating over 1,000 locations in 100+ countries, with specialized pharmaceutical services including GLP/GCP/GMP contract laboratory expertise, CMC analytical services, method development and validation, stability testing, and formulation development. The company has over 30 years of pharma experience with particular expertise in inhaled and nasal drug delivery systems and biopharmaceutical characterization.

I Peace Inc. is a Palo Alto, California-based biotech CDMO specializing in cGMP manufacturing of iPSC (induced pluripotent stem cells) and iPSC-derived cell products for cell and gene therapy development. The company provides custom GMP cell manufacturing, process development, cell banking (MCB/WCB), gene editing, differentiation services, and regulatory support compliant with FDA, PMDA, and EudraLex standards. I Peace has manufactured 100+ GMP iPS cell lines and tripled its CDMO facility capacity.

IQVIA

Australia

IQVIA is a global leader in clinical research services, commercial analytics, and healthcare data technology, serving the pharmaceutical and life sciences industry. Named to Fortune's Most Admired Companies for nine consecutive years, IQVIA provides clinical trial management, real-world evidence, safety and regulatory compliance, and commercialization services powered by AI and Connected Intelligence. IQVIA does not manufacture drugs but provides CRO and data analytics services.

Olive HealthCare is a fully-integrated Indian pharmaceutical company specializing in the development, manufacturing, and marketing of soft gelatin capsule formulations for pharmaceutical, OTC, and dietary supplement products. Operating three state-of-the-art manufacturing units in India, the company provides CDMO services including toll manufacturing and full development for global partners.

PSM GmbH is a German pharmaceutical CDMO specializing in aseptic fill and finish services for drugs, biologics, and biopharmaceutical products. The company offers end-to-end commercial fill and finish services with state-of-the-art flexfill filling-line technology and formulation development capabilities. Limited website data is available, but search results consistently identify PSM as a specialized aseptic fill/finish CDMO.

ReciBioPharm (now Recipharm Advanced Bio) is the advanced therapies division of Recipharm, a global CDMO devoted to process development and GMP manufacturing for advanced therapeutics including xRNA therapies, viral vectors, microbial/live biotherapeutic products, and recombinant proteins. They offer end-to-end services from preclinical development to commercial manufacturing, with operations on two continents. They have partnerships with the University of Oxford, NewBiologix (AAV cell lines), LenioBio, and Hongene Biotech.

Reig Jofre (Laboratorio Reig Jofre, S.A.) is a Spanish pharmaceutical company founded in 1929 that operates both as a pharmaceutical company with its own products and as a CDMO. They have four development and production centres in Europe (two in Toledo, one in Barcelona, one in Sweden) with over 1,100 employees. Their CDMO capabilities include sterile lyophilizates, sterile liquids, non-sterile liquids, and beta-lactam manufacturing. Known for excellence in freeze-drying technology and advanced sterile manufacturing. FDA-registered with manufacturing and analysis operations, though regulatory history shows 3 OAI inspections.

SCI Pharmtech Inc. is a Taiwan-based API manufacturer originally founded by Switzerland-based Siegfried Ltd. in 1987, now publicly listed on the Taiwan Stock Exchange. The company specializes in APIs, advanced intermediates, and custom products with US FDA and EDQM inspected, ISO-certified facilities. SCI Pharmtech focuses on rapid development and cost-effective production.

SK Pharmteco is a leading global CDMO providing drug development and manufacturing services across small molecules, gene therapy, and analytical testing. The company operates cGMP facilities in the United States (240-acre California headquarters in Rancho Cordova, King of Prussia PA), Ireland (Dublin - 60+ years of API production), South Korea, and France. They offer custom API manufacturing including HPAPIs, viral vector manufacturing (lentivirus via LentiSure and AAV via AAVelocity platforms, 230+ batches manufactured, 100+ supporting clinical trials), plasmid DNA manufacturing, and analytical services. Recently invested in expanding peptide development capabilities and opened a new HPAPI testing lab.

Solvias

Germany

Solvias is a global cGMP contract research organization (CRO) founded in 1999 with 800+ employees across 5 locations worldwide. The company provides comprehensive analytical services for small molecules, biologics, and cell and gene therapies, including release testing, stability studies, extractables/leachables testing, and biosafety testing. Solvias also offers API development and manufacturing services for small molecules up to Phase III.

Syneos Health

Canada

Syneos Health is a leading fully integrated biopharmaceutical solutions organization and CRO, formerly known as InVentiv Health / INC Research. The company provides clinical development (full-service and FSP), commercialization, and consulting services. With 40+ years of clinical trial experience, 480+ MDs, and 750+ PhDs, Syneos Health has helped develop or commercialize 96% of novel oncology drugs approved by the FDA in the last five years. The company is NOT a manufacturer -- it provides research, regulatory, and commercial services to biopharma companies.

Texcell Group

China

Global CRO specializing in biosafety services for the pharmaceutical industry. Founded in 1987 at the Pasteur Institute in Paris to address HIV safety testing. Provides viral safety, biosafety testing, viral clearance studies, bioassays (in vitro and in vivo), and cell banking services for biologics, cell and gene therapies, and medical devices. Employs 140 people across offices and laboratories in France, US, Germany, China, Taiwan, and Japan. Also recently added BioManufacturing services, though the core business is contract testing/research, not drug manufacturing.

Greek advanced biotechnology company focused on cell and gene therapy (CDMO activity). Subsidiary/partner of Orgenesis Inc. Designated as a priority investment in Greece in collaboration with Orgenesis. Aims to make advanced therapies accessible and affordable. Recognized as a top precision medicine solution company in Europe. Note: website has SSL certificate error and is inaccessible, so information is primarily from search results and SEC filings indicating CDMO activity for cell/tissue-based therapies.

uBriGene Biosciences Inc is the same entity as uBriGene (duplicate entry, different ID). This is the China-headquartered entity of the same global CRDMO providing one-stop viral vector-based CDMO services for research and clinical applications. Series C+ funding of 150M CNY (~$20M USD). Same website, same capabilities. See uBriGene entry (ID 10a6a05c) for full details.

Veeda Lifesciences

India

Veeda Lifesciences (formerly Veeda Clinical Research) is a tech-driven global CRO headquartered in Ahmedabad, India with presence in 9 countries and sites across 26 geographies. They rebranded in January 2025 and now operate through four Strategic Business Units: Clinical Trials, Healthy Volunteer Services, Biopharma Services, and a fourth unit. Services include pre-clinical research, bioanalytical testing, clinical development for generics/innovators/biotherapeutics, real-world evidence, regulatory affairs, medical writing, pharmacovigilance, and data science. They have 2,100+ employees and are transitioning to a CRO-CDMO model per recent announcements, though their current core business remains contract research. Specializations include hemato-oncology, monoclonal/bispecific/trispecific antibody development, and multiple myeloma trials.

VelaLabs (Tentamus Group)

Austria

VelaLabs GmbH, a Tentamus Group company, is an Austrian GMP/GLP-certified contract analytical laboratory based in Austria. They provide analytical testing services for biologics (ATMPs, biopharmaceuticals, originator products, biosimilar candidates, biosimilars, blood and blood components, vaccines), chemicals, and excipients from early development (non-clinical, clinical) through market release testing. They offer GMP-compliant storage facilities and all types of microbiological and sterility analyses. They are GLP certified, GMP certified, GCLP-compliant, and FDA-approved. They recently announced a strategic partnership with EarlyHealth Group to support biological drugs development. They are a contract research laboratory (CRO), not a drug manufacturer.

Vivotecnia

Spain

Vivotecnia is a Spanish preclinical CRO (Contract Research Organization) and toxicology CRO with 25+ years of experience supporting pharmaceutical, biotechnology, and chemical companies. Provides preclinical safety studies under certified GLP standards, aligned with EMA and FDA regulatory expectations. Services include in vivo and in vitro laboratory platforms, toxicological assessments, and IND/IMPD submission support. This is a testing/research organization, not a manufacturer.

Chongqing Daxin Pharmaceutical Co., Ltd. is a Chinese API manufacturer with 3 FDA-registered facilities and CEP certifications from Europe. The company produces small molecule APIs including amikacin and kitasamycin, appearing in multiple contract manufacturing industry reports as a significant API manufacturer.

Olon SpA is a global leader in the development and production of Active Pharmaceutical Ingredients (APIs) for CDMO and generic markets, integrating chemical synthesis and microbial biomanufacturing. The company operates 14 GMP facilities primarily in Italy, with additional sites in France (via GTP Bioways acquisition), the US, Germany, and China, with 450+ DMFs and 35+ years of regulatory experience.

Quality Chemicals S.L. is a European chemical manufacturer based in Esparreguera, Barcelona, Spain, specializing in high-purity chemicals, laboratory reagents, CDMO contract manufacturing, fine chemical synthesis, and PSR (micronization and milling) services. The company has manufacturing facilities in Barcelona and Palencia, Spain. Note: The company's website (qcsa.es) appears to redirect to the Quality Corn agricultural subsidiary; the pharmaceutical CDMO operations are referenced in CPHI and PharmaSource listings. Quality Chemicals has 17 FDA-registered FEI numbers and an extensive regulatory inspection history.

SOMAI Pharmaceuticals is a Portuguese EU-GMP certified vertically integrated Multi-Country Operator (MCO) specializing in the manufacturing of medical-grade cannabis APIs and oral solutions. The company holds INFRAMED authorization for its Lisbon facility and has partnerships for distribution in the German market.

Zach System is the chemical division of Zambon Company SpA, specializing in Active Pharmaceutical Ingredient (API) manufacturing, quality intermediates, and custom synthesis services for the pharmaceutical industry. Located in Avrille, France, with multipurpose equipment and reactors ranging from 50L to 10,000L.

Clinigen

United Kingdom

Clinigen is a global specialist pharmaceutical services company focused on accelerating access to medicines. The company provides clinical trial supplies management, pre-approval and managed access programs, licensed and unlicensed pharmaceutical distribution, regulatory affairs services, and marketing authorisation holding, operating in 130+ countries. Clinigen divested its manufacturing arm (Lamda Laboratories) to Adragos Pharma.

Pharma-Bio Serv (assumed)

Puerto Rico

PharmaBioServ is a consulting firm founded in 1993 in Puerto Rico that provides integrated quality and compliance services to highly regulated manufacturers worldwide. Services include cGMP consulting, commissioning/qualification/validation, and regulatory compliance support across pharmaceuticals, biotechnology, advanced therapies, medical devices, and food industries.

PPD (Pharmaceutical Product Development) is a leading global contract research organization (CRO) providing clinical research solutions across 20+ therapeutic areas. The company offers end-to-end drug development services including clinical trial management, bioanalytical laboratory services, biostatistics, regulatory consulting, and functional service provider solutions. PPD does not manufacture drugs.

PPD, now part of Thermo Fisher Scientific, is one of the world's largest contract research organizations (CROs). While the URL references 'integrated CRO and CDMO solutions' under the Thermo Fisher umbrella (Accelerator Drug Development program combining Patheon CDMO and PPD CRO), PPD itself is fundamentally a CRO providing clinical research services: clinical trial management, laboratory services, biostatistics, regulatory affairs, and pharmacovigilance. The CDMO capabilities belong to Thermo Fisher's Patheon division, not PPD. PPD as a standalone entity is a CRO.

Selvita is a Poland-based integrated drug discovery and development service provider (CRO) with expanding CDMO capabilities following its 2024 acquisition of PozLab. The company offers comprehensive services spanning drug discovery (medicinal chemistry, pharmacology, DMPK, protein sciences), drug development (analytical, formulation, clinical trial batch manufacturing), and contract testing under GMP/GLP. Selvita has operations in Krakow, Poznan, and Wroclaw (Poland) and Zagreb (Croatia).

Jiangsu Hengrui Medicine Co., Ltd. is China's largest listed pharmaceutical company, founded in 1970, with over 20,000 employees globally. Hengrui is primarily an innovation-driven pharma company developing and manufacturing its own drugs across oncology, cardiovascular, metabolism, autoimmune, pain, and anti-infection therapeutic areas, with a pipeline of 257 drugs and 24 Class 1 innovative drugs. While it has some CDMO references in search results, Perplexity research confirms it primarily specializes in proprietary drug development and manufacturing rather than contract services.

Phillips Medisize

United States

This is a duplicate entry for Phillips Medisize (a Molex company), listed with China as the headquarters. It is the same company as entry index 21. Phillips Medisize designs and manufactures drug delivery devices, medical technology, and in vitro diagnostics. See the primary entry for full details. Classified as equipment_supplier because the company manufactures devices, not drugs.

Roquette

China

Roquette is a French global leader in plant-based ingredients serving health, nutrition, and pharma markets. In pharmaceuticals, Roquette provides excipients, drug delivery solutions, and active pharmaceutical ingredients derived from plant-based sources. The company recently acquired IFF Pharma Solutions and Qualicaps (capsule manufacturing), opened a $25M Pharmaceutical Innovation Center near Philadelphia, and expanded its portfolio of pharmaceutical-grade excipients. Roquette is a raw material and excipient supplier to the pharmaceutical industry, not a contract drug manufacturer.

Selectchemie AG

Switzerland

Selectchemie AG is an independent Swiss company serving the pharmaceutical and nutrition industries since 1969 as a supplier of APIs, excipients, generic finished dosage forms, and dossiers. The company operates as a full-service distribution and regulatory support provider across 17 countries, offering commercial, scientific, regulatory, and supply chain support. Selectchemie is a pharmaceutical ingredients supplier and dossier provider, not a drug manufacturer.

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is one of the world's largest specialty generic pharmaceutical companies, headquartered in Mumbai, India. While the company has massive manufacturing operations (1,075 FDA-approved products, 25+ FDA-registered FEI numbers), it primarily manufactures and markets its own branded and generic pharmaceutical products rather than providing contract manufacturing services to third parties as a CDMO.

Tjoapack

Netherlands

Tjoapack is a contract pharmaceutical packaging organization (CPO) specializing in primary and secondary packaging solutions for oral solid dose and injectable products. With over 35 years' experience and 200+ experts in the Netherlands and 180+ in the US (Clinton, Tennessee), the company provides packaging, labeling, logistics management, postponement services, and clinical trials packaging across 40 markets on seven continents. Tjoapack is a packaging-only company, not a drug manufacturer.

TRADICHEM / TRADICHEM Industrial Services

Spain

TRADICHEM is a Spanish company that develops innovative, science-based ingredients for the pharmaceutical and nutraceutical industries, with 15 proprietary ingredients backed by clinical studies, present in 2,500+ final products across 52 countries. Its subsidiary TIS Pharma operates EU GMP-certified facilities providing pharmaceutical API compaction and granulation services using their patented HIPERING technology. TRADICHEM also operates MarenostrumTech for botanical extract production. While TIS Pharma provides contract processing services (compaction/granulation of APIs), the company is primarily an ingredients supplier rather than a full CDMO.

Venus Pharma GmbH

Germany

Venus Pharma GmbH (VPG) is a German pharmaceutical company and wholly-owned subsidiary of Venus Remedies Limited (India). Established in 2006 in Werne, Germany, VPG operates as a pharmaceutical hub providing licensing (EU CTD dossiers), contract manufacturing via partner facilities, packaging, warehousing, batch release, product testing, and distribution services. They hold 138+ marketing authorizations across 20 countries. Key products include anti-infectives (Meropenem flagship with 50% German market share, Ceftriaxone) and anti-cancer products (Gemcitabine with 33% UK market share). They achieved EU-GMP certification and WHO Prequalification for Meropenem. While they provide contract manufacturing services, the actual manufacturing appears to be performed at Venus Remedies Limited facilities in India rather than at VPG's own manufacturing plants. VPG functions primarily as a European regulatory, licensing, packaging, and distribution hub.

West Pharmaceutical Services

Germany

West Pharmaceutical Services is a leading global provider of injectable packaging and delivery solutions for the pharmaceutical, biotech, and generic drug industries. With approximately 10,000 team members across 50 sites worldwide, the company manufactures drug containment and delivery systems including vial stoppers, syringe components, cartridge components, and prefillable syringe systems. West also offers contract manufacturing of medical devices and drug delivery systems, but is primarily a components and packaging supplier rather than a drug manufacturer.