Method Development & Validation CDMOs

Regis Custom Pharma (Regis Technologies, Inc.)

United States

Regis Technologies (now part of ESTEVE CDMO/Esteve Quimica) is a US-based API CDMO specializing in small molecule custom API synthesis, process development, analytical development, and cGMP manufacturing. They combine expertise in organic synthesis with chromatography separations (including chiral separations) to provide customized solutions from discovery to commercial delivery. They also manufacture chromatography products. FDA-registered for API manufacture with clean inspection history.

SB-PEPTIDE

France

SB-PEPTIDE (formerly Smart-Bioscience) is a French company specializing in custom peptide synthesis with over 10 years of industrial experience. The company provides peptide synthesis services to pharmaceutical, biotech, and research laboratories worldwide, including custom peptides, PNA synthesis, peptide libraries, process development, and analytical services. All synthesis is performed in France.

Seda Pharma Development Services Ltd

United Kingdom

Seda Pharma Development Services Ltd is a UK-based pharmaceutical development consultancy and clinical manufacturing services provider. Through its subsidiary Seda Clinical Manufacturing Services (MHRA-licensed), the company provides formulation development, clinical pharmacology, DMPK, modelling, and GMP manufacturing of clinical trial materials. The company focuses on product design, performance prediction, and clinical supply.

Sekisui XenoTech LLC

United States

Sekisui XenoTech LLC is a US-based specialty Contract Research Organisation (CRO) providing comprehensive drug metabolism and drug-drug interaction (DDI) studies. Now operating as XenoTech, a BioIVT company following acquisition, the company provides ADME testing services, cell culture products, and preclinical testing services for drug development. It is not a drug manufacturer.

Shanghai Haoyuan Chemexpress Co., Ltd.

China

Shanghai Haoyuan ChemExpress Co., Ltd. (688131.SS) is a China-based integrated CRO/CDMO founded in 2006, specializing in small molecule and new modalities CDMO services for pharmaceutical and biotech companies. Listed on the Shanghai Stock Exchange, ChemExpress provides services spanning drug discovery CRO through commercial-scale CDMO, with recent expansion into ADC manufacturing via a new GMP production site.

SONEAS

Hungary

SONEAS Chemicals Ltd is a European CRO/CDMO based in Budapest, Hungary, now part of the UQUIFA group. With over 25 years of experience, the company supports customers from preclinical through Phase 1-3 clinical trials with kilo lab, pilot plant, and large-scale cGMP manufacturing of APIs and key starting materials (KSMs). SONEAS brings over 180KL of KSM cGMP capacity to the UQUIFA portfolio.

STA Pharmaceutical Co., Ltd. (WuXi STA) is a subsidiary of WuXi AppTec and one of the world's leading CDMOs, specializing in integrated CMC services for small molecule APIs and drug products (oral and injectable/sterile) from preclinical to commercial scale. They also have capabilities in oligonucleotides, peptides, and bioconjugates. WuXi STA operates 9-14 global manufacturing sites across Asia, North America, and Europe with uniform quality/EHS standards approved by major regulators. They have supported 50+ first-time drug approvals since 2017 across 105 countries. The company has 5,100+ scientists, claims 100% PPQ success rate, and serves 1,200+ customers. Their Changzhou site has passed US FDA inspection and they have a continuous manufacturing line for oral solid dose.

Stason Pharmaceuticals, Inc. is a US-based pharmaceutical company headquartered in Irvine, California, with CDMO services provided through its affiliate Western PharmSci. The company operates in both branded/generic pharmaceuticals and contract services. Their CDMO capabilities include turn-key drug development and manufacturing for oral solid dosage forms with particular expertise in high containment products (OEL down to 0.1 ug/m3) for oncology, CNS, and other potent compounds. Services span from pre-formulation characterization and API synthesis through commercial production (up to 600 kg), including analytical method development/validation, formulation development, clinical trial materials, and serialization. They hold 30+ ANDAs and have operations in 13 locations across 9 countries. Note: FDA issued a warning letter on July 8, 2020, citing significant CGMP violations for finished pharmaceuticals.

Sterling Italy (Sterling S.p.A.) is a long-established Italian manufacturer specializing in the development, optimization, and manufacturing of steroidal APIs including corticosteroids, hormones, anabolics, estrogens, and progestinics. The company operates GMP production plants in Perugia, Italy and exports APIs to over five continents.

ST Pharm is a South Korean global API CDMO company founded in 1983, specializing in small molecule APIs, oligonucleotide therapeutics (ASO, siRNA, aptamers), and mRNA-LNP manufacturing. The company operates cGMP manufacturing facilities in South Korea and has a CRO subsidiary (AnaPath) in Switzerland and Spain for preclinical pathology services.

Sunny Pharmtech Inc. is a Taiwan-headquartered integrated specialty pharmaceutical CDMO specializing in high-potency APIs and drugs, including small molecules, peptides, and ADC linker-payloads. The company develops complex, high-barrier, niche drugs including ANDAs and 505(b)(2) filings, with state-of-the-art facilities offering OEB 5 containment and capabilities from early-stage formulation development to commercial manufacturing.

Symbiotec Pharmalab is a leading Indian manufacturer of corticosteroid and steroidal-hormone APIs with a global leadership position. With over 30 years of experience, the company has evolved from lab-scale manufacturing to industrial-scale production, operating two FDA-approved facilities (Rau and Pithampur, Indore). The company offers integrated CDMO solutions across organic chemistry, biotechnology/fermentation, and complex injectable platforms. It holds a 50%+ global market share in key steroid API molecules and serves 200+ customers in 40+ countries.

TBD Pharmatech

Estonia

TBD Pharmatech (formerly TBD-Biodiscovery) is an EU-based small-molecule API CDMO headquartered in Tartu, Estonia. They are a dual-site, EU-GMP-certified organization specializing in small-molecule API development and niche-to-mid-volume commercial manufacturing. Services include end-to-end CDMO (route scouting to commercial supply), technology transfer, clinical and commercial batch production under cGMP, analytical method development, QP (Qualified Person) release, CMC regulatory support, and API distribution/sourcing under GDP. EU-GMP certified since 2008, ISO 9001 certified, FDA-registered for API manufacture and analysis. They operate two GMP facilities (Tiigi and Valja sites) in Tartu.

US-based topical and transdermal pharmaceutical CDMO, now merged with MedPharm (Durham, NC). Provides end-to-end services from formulation development through commercial manufacturing for topical, transmucosal, and transdermal drug products. Specializes in semi-solids, aerosols, liquids, injections, and transdermal patches. Offers in-vitro permeation testing (IVPT), in-vitro release testing (IVRT), disease activity models, tissue protein binding, and continuous flow technologies. GMP-certified manufacturing for generics, OTC, and prescription products.

TriLink BioTechnologies LLC

United States

TriLink BioTechnologies LLC is a US-based CDMO (part of Maravai LifeSciences) specializing in nucleic acid chemistry and mRNA production. They offer CleanCap capping technology, custom mRNA synthesis and manufacturing (research through GMP clinical and commercial), custom oligonucleotide synthesis, guide RNA (gRNA) for CRISPR, and NTP (nucleotide) manufacturing. Their 118,000 sq ft facility contains multiple specialized GMP manufacturing suites. Over 110 GMP mRNA batches manufactured and 500+ CleanCap mRNA constructs enabled for preclinical/clinical programs.

Velesco Pharma (Pace Life Sciences)

United States

Velesco Pharmaceutical Services, now part of Pace Life Sciences (acquired by Pace Analytical), is a U.S.-based pharmaceutical CDMO specializing in drug development services. Per search results and industry listings, they provide analytical drug development, drug formulation, and pharmaceutical CDMO services. The acquisition by Pace Life Sciences expanded their capabilities in drug development services. The website (velescopharma.com) was blocked by Cloudflare security at scrape time, so detailed capability information is limited. They are listed on PharmaSource and CMOCRO as a CDMO.

Duplicate entry for VGXI Inc (see companyId 58cac364). Same company -- leading plasmid DNA CDMO in Texas. Same website URL (vgxii.com). Same capabilities, facilities, and services.

Vibalogics is a specialized global CDMO for virotherapy manufacturing, now operating as Recipharm Advanced Bio after acquisition by Recipharm AB. The company offers process and analytical development, GMP manufacturing of viral vectors, oncolytic viruses, and advanced therapies. Capabilities include xRNA therapies, viral vectors (AAV, lentivirus), microbial/live biotherapeutic products, recombinant proteins, plasmid DNA, and lipid nanoparticles. Major $50M expansion of Cuxhaven facility (500L manufacturing line) completed. 118,000 sq ft GMP facility in Massachusetts (US) also completed.

Yuki Gosei Kogyo Co., Ltd.

Japan

Yuki Gosei Kogyo Co., Ltd. is a Japanese fine chemical manufacturer providing GMP-compliant contract manufacturing of pharmaceutical intermediates, new drugs, and generics. The company has extensive experience in drug development, manufacturing, and commercialization, exporting to more than 30 countries worldwide.

2bind GmbH

Germany

2bind GmbH is a biophysics CRO based in Regensburg, Germany, specializing in biophysical analytical services for drug discovery. They support pharmaceutical and biotech clients with fragment-based drug discovery, covalent drug discovery, PROTAC characterization, antibody lead selection, and biologics characterization using technologies like GCI, MST, nanoDSF, DLS, ITC, and SEC-MALS.

360biolabs (a BioAgilytix company)

Australia

360biolabs, a BioAgilytix company, is Australia's most comprehensive bioanalytical laboratory offering pharmacokinetic, pharmacodynamic, immunogenicity, biomarker, and vaccine/infectious disease assay services. They support early-phase clinical studies with GLP-compliant testing across 6 global locations.

Accugen Laboratories, Inc.

United States

Accugen Laboratories is a contract microbiological quality control, research, and testing services laboratory based in Willowbrook, Illinois. They specialize in pharmaceutical microbiology testing, cosmetics and personal care microbiology testing, and environmental monitoring. Note: the website at accugen.com belongs to ACUGEN Software (a test generation software company), not Accugen Laboratories.

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.

Anacura

Belgium

Anacura is a Belgian group of analytical service companies with 25+ years of experience in end-to-end analytical and laboratory services. The group includes AnaBioTec and Labo Nuytinck, plus OHMX.bio for multi-omics. Anacura provides analytical testing, quality control, and laboratory services for pharmaceutical and life science clients with FDA-registered operations.

ARL Bio Pharma

United States

ARL Bio Pharma is a U.S.-based contract testing laboratory headquartered in Oklahoma City, providing analytical and microbiological testing services for the pharmaceutical industry. They serve compounding pharmacies, outsourcing facilities, and pharmaceutical manufacturers with comprehensive laboratory quality testing including analytical testing, microbiology testing, raw material testing, forensics testing, and bioanalytical testing. They are FDA-registered for analytical operations.

Asha Pharma LLC

United States

Asha Pharma LLC is a contract research organization specializing in solid form screening, polymorph screening, salt screening, cocrystal screening, and crystallization process development. They focus on solid-state characterization and crystallization optimization for small molecule drugs, including DEA-scheduled substances. They do not manufacture drug product at commercial scale.

Axcelead Drug Discovery Partners (DDP)

Japan

Axcelead Drug Discovery Partners (DDP) is a Japan-based contract research organization formed in 2017 as a Takeda spin-out, specializing in preclinical drug discovery and development. Their end-to-end platform covers target identification/validation, hit identification, lead generation/optimization, and candidate selection through IND-enabling studies. Axcelead focuses on small molecules, targeted protein degraders (TPDs), RNA-targeted small molecules, oligonucleotides, and peptides across oncology, immunology, and neuroscience therapeutic areas. The company leverages high-throughput screening, omics technologies, bioinformatics, and chemistry capabilities. They are a pure discovery/preclinical CRO and do not manufacture drug products.

AZIDUS LABORATORIES LIMITED

India

Azidus Laboratories Limited is a full-service clinical research organization (CRO) based in Chennai, India, supporting the pharmaceutical and biotechnology industries. Their services include bioavailability/bioequivalence (BA/BE) studies, Phase I-IV clinical trials management, regulatory submissions (CTD preparation), bioanalytical services (LC-MS/MS), clinical data management, statistical analysis, pharmacovigilance, and medical writing. They maintain a volunteer pool of over 45,000 participants. Azidus adheres to GCP, GLP, and international regulatory standards across therapeutic areas including oncology, cardiology, nephrology, urology, and diabetology. They are a CRO, not a drug manufacturer.

Berko Pharmaceuticals is a Turkish pharmaceutical company involved in the development, manufacturing, and marketing of pharmaceutical products including solid dosage forms and suppositories. Listed on CPHI as a CDMO specializing in development and manufacturing, with FDA-registered facilities and a long track record of FDA-inspected production (2 NAI inspections). Also has 27 FDA recalls on record, indicating substantial US market supply history.

Bio Basic Inc.

Canada

Bio Basic Inc. is a Canadian CRO/CMO offering a range of life science research services and reagent products. Services include oligo synthesis, gene synthesis, peptide synthesis, protein services, antibody production, and DNA sequencing. The company also sells molecular biology kits, culture media, biochemicals, and lab supplies. Primarily a research services and reagent supplier rather than a pharmaceutical manufacturer.

BiomimX Srl

Italy

BiomimX Srl is an Italian Contract Research Organisation (CRO) pioneering Organ-on-Chip (OoC) technology. They provide next-generation in vitro models (Beating Organs-on-Chip) for preclinical drug safety/toxicology testing, efficacy evaluation, and compound profiling. Their uBeat platform creates 3D human tissue models for cardiac, liver, gut, and tumor applications. Based in Milan, Italy.

Bioneer A/S

Denmark

Bioneer A/S is a Danish not-for-profit Contract Research Organisation and subsidiary of the Technical University of Denmark (DTU). They specialize in in vitro modeling, drug formulation, and recombinant protein R&D services and manufacturing. While they offer CDMO services for recombinant protein production, their primary identity is as a CRO providing customized research services. Based in Horsholm, Denmark.

Biotrial

France

Biotrial is a leading full-service CRO (Contract Research Organization) founded in 1989, specializing in drug development with expertise in preclinical pharmacology, clinical development (Phase I with healthy volunteers and special populations), bioanalysis, biometrics, ECG, CNS, and imaging core lab. The company operates from locations in France, the US (Newark, NJ), and Canada (Laval, QC), performing hundreds of studies each year.

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.

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.

Chimete S.R.L.

Italy

Chimete S.R.L. is an Italian outsourcing R&D services company specializing in organic synthesis and analytical research since 1997. Located in the Rivalta Scrivia Science and Technology Park between Milan, Turin, and Genoa, the company provides contract research services for pharmaceutical clients but operates at laboratory scale rather than manufacturing scale.

Chongqing Carelife Pharmaceutical Co., Ltd. (Kailin Pharmaceutical) is a Chinese pharmaceutical company offering CDMO services for API manufacturing. The company has 2 FDA-registered facilities with 10 FDA inspections on record, producing APIs including clindamycin and amenamevir for domestic and international markets.

Concept Life Sciences

United Kingdom

Concept Life Sciences is a UK-based contract research organization (CRO) providing integrated drug discovery and development services from early-stage research to IND-enabling studies. The company offers biology, chemistry, ADME/DMPK services, and has GMP manufacturing capabilities for clinical niche APIs through its facility in Chapel-en-le-Frith. Acquired by Spectris, CLS has delivered 5 drugs to market, 28 candidates to clinic, and 44 to pre-clinical stage.

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.

Doppel Farmaceutici

Italy

Doppel Farmaceutici Srl is an Italian CDMO operating since 1994, specializing in contract manufacturing and packaging of finished dosage forms for pharmaceutical companies. The company offers formulation development, R&D, manufacturing of soft and hard gelatin capsules, tablets, oral liquids, and semi-solids, along with full packaging services.

Dottikon Exclusive Synthesis AG

Switzerland

Dottikon Exclusive Synthesis AG is a Swiss CDMO that manufactures high-quality performance chemicals, intermediates, and exclusive active pharmaceutical ingredients (APIs) for the global chemical, biotech, and pharmaceutical industry. The company has over 110 years of experience in hazardous chemical reactions and operates an FDA and Swissmedic approved cGMP manufacturing site.

Firalis Molecular Precision

France

Firalis Molecular Precision is a French CRO providing multi-omics analytical services including mass spectrometry (via its Lodiag brand), genomics, and biobanking across the entire drug development pipeline. The company is ISO 9001, ISO 13485, and GCLP certified, with R&D focused on cardiovascular and neurodegenerative biomarkers.

Flamma Group

China

Flamma Group is a privately held, family-owned small molecule CDMO with experience since 1950, offering cGMP manufacturing of APIs, new chemical entities (NCEs), registered starting materials (RSMs), and pharmaceutical intermediates. The company operates FDA-inspected facilities in Italy, a GMP site in the USA (Philadelphia area), and a GMP facility in Dalian, China, providing services from early-stage development to commercial-scale manufacturing.

Formosa Laboratories is a Taiwan-based CDMO specializing in custom synthesis and contract manufacturing of active pharmaceutical ingredients (APIs) for the global pharmaceutical industry. The company provides services from process development through commercial-scale API manufacturing, with FDA-registered facilities.

FreeThink Technologies

United States

FreeThink Technologies is a U.S.-based contract research organization specializing in accelerated stability testing, shelf life prediction, formulation development, and analytical services for pharmaceutical compounds. The company develops ASAP prime software for stability modeling and provides integrated services from molecule to clinic for small molecule drug development.

Fuji Chemical Industries Co., Ltd. is a Japanese pharmaceutical company specializing in API synthesis, spray drying contract manufacturing, drug product manufacturing, and excipient production. Founded in 1946 in Toyama, the company has been an FDA-inspected API manufacturer since 1981, and holds proprietary spray drying technology as well as excipient brands including Neusilin, Fujicalin, and F-melt.

FUJIFILM Biotechnologies (formerly FUJIFILM Diosynth Biotechnologies) is a global biologics CDMO operating 10 facilities across the US, UK, Denmark, and Japan with over 4,800 employees. The company provides end-to-end cGMP manufacturing services for biologics, advanced therapies, and vaccines, from preclinical through commercialization, with $8.6 billion invested in recent years and 20+ commercial licenses.

Fusion Antibodies

United Kingdom

Fusion Antibodies is a Belfast-based antibody engineering CRO providing end-to-end antibody development services from antigen design through cell line development. The company specializes in antibody humanization (OptiMAL platform), sequencing, and engineering but does not perform GMP drug manufacturing itself. Clients use external CMOs for GMP production of the antibodies Fusion develops.