Analytical Services CDMOs

PolyCrystalLine S.r.l.

Italy

PCL Research & Manufacturing (PolyCrystalLine S.r.l.) is an Italian privately owned CRO/CDMO leader in contract research, development, and manufacturing, specializing in crystal form science for active pharmaceutical ingredients. Over 15 years of experience in solid state and crystallization chemistry. FDA-inspected analytical laboratories, GMP-certified by AIFA (Italian Medicines Agency). Authorized for HPAPI handling up to OEB5. Offers services from early-phase drug discovery to kilogram supply including polymorph screening, salt/co-crystal screening, crystallization process development, and kilo-lab scale manufacturing (up to 50L).

PRIMA LAB SA

Switzerland

PRIMA LAB SA is a Swiss company (part of the Sentinel group) that manufactures rapid diagnostic test kits including pregnancy tests, HIV self-tests, Strep A tests, and other lateral flow rapid tests for both self and professional use. Listed on CPHI Online with company types including CMO/CDMO, but their actual products are diagnostic test kits, not drug manufacturing. They are a medical diagnostics/IVD manufacturer, not a pharmaceutical CDMO.

Raybow PharmaScience

China

Raybow PharmaScience (Raybow USA), a subsidiary of Jiuzhou Pharma, is a chemical CDMO specializing in custom synthesis, process development, analytical services, and cGMP production for small molecule APIs, specialty chemicals, and polymers. They offer services from benchtop R&D to commercial-scale production with facilities in North America, Europe, and Asia. FDA-registered for API manufacture and analysis.

Recordati is an Italian pharmaceutical company with both a proprietary product business (rare diseases, specialty/primary care) and a fine chemicals/CDMO division. Recordati Fine Chemicals (also known as Recordati Industria Chimica e Farmaceutica) provides contract API manufacturing. They have FDA-registered facilities, 26 approved products across multiple dosage forms, and significant industrial operations. The fine chemicals division offers API development and manufacturing services to third-party pharmaceutical companies.

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.

Reliance Life Sciences (RLS), part of Reliance Industries, is a premier Indian biotechnology company providing contract manufacturing and development services across pharmaceuticals and biosimilars. They have FDA-registered manufacturing facilities with 7 FDA-approved products (injectables, powders, tablets). Their capabilities span API manufacturing, formulation development, biologics/biosimilar manufacturing, and cell and gene therapy R&D. They are a vertically integrated biotech company with 1,000-5,000 employees, offering CDMO services alongside their own product portfolio.

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.

Scale Up Laboratory s.r.o.

Czechia

Scale Up Laboratory s.r.o. is a small, privately owned CDMO based in the Czech Republic, operating since 2019. The company provides contract development and manufacturing of APIs and advanced intermediates, including clenbuterol hydrochloride, fluorinated pyrrolidines, and other specialty small molecules. The production facility is located in the Krkonose Mountains area at Mostek.

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.

SEDICO Pharmaceutical Company is an Egypt-based pharmaceutical manufacturer and API producer, providing contract manufacturing (CMO/CDMO) services. The company manufactures a broad range of pharmaceutical products including oral solids, injectables, and various dosage forms. SEDICO has recently entered oncology drug production through a partnership with Sandoz Global to localize oncology pharmaceutical products in Egypt.

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.

Softigel (by Procaps Group)

Brazil

Softigel, a subsidiary of Procaps Group, is a CDMO headquartered in Brazil specializing in the development and manufacturing of soft gelatin capsules (softgels). With over 4 decades of experience, 7 manufacturing plants across the Americas, and 8+ patented softgel technologies, the company has developed 500+ products and has presence in 50+ countries.

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.

DUPLICATE ENTRY: This is the same company as Standard Chem. & Pharm. Co. Ltd (companyId: 6a650983). See primary entry for full profile. Standard Chem. & Pharm. Co., Ltd. (SCP) is a Taiwanese CDMO established in 1967.

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.

Taiwanese CDMO specializing in transdermal drug delivery systems (TDDS), topical patches, and oral films. Over 30 years of experience in hydrogel patch, NSAID patch, and cosmetic patch development and manufacturing. Covers over 70% of OTC patches on the Taiwan market and exports to Asia, Europe, and North America. Also offers CMO and CRO services for transdermal patch development.

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.

Chinese pharmaceutical manufacturer specializing in corticosteroid, hormone, and steroid API production. Subsidiary of Shanghai Pharmaceuticals (Shanghai Xinyi Pharmaceutical Factory). Founded in 1992, located in Tianjin with approximately 170,000 sq meters across two factory areas and 507 employees. Main products include hydrocortisone, spironolactone, hydrocortisone acetate, clobetasol propionate, and related corticosteroid APIs. Also produces tablet formulations (9 approved products). Has 11 API production licenses and 9 tablet production licenses. FDA-registered with 3 FEI numbers, 13 inspections (4 NAI, 8 VAI, 1 OAI), and 2 FDA-approved finished dosage form products.

TopChem Pharmaceuticals

Ireland

TopChem Pharmaceuticals Limited is an Irish GMP manufacturer of niche, low-volume active pharmaceutical ingredients (APIs), excipients, and other cGMP materials for the global generic and specialty pharmaceutical sector. Established in 2006, the company targets difficult-to-source products where volumes are low or special high grades are required. TopChem holds EU cGMP certification and has been FDA-inspected, operating from sites in Ballymote and Collooney, County Sligo, Ireland.

TOT BIOPHARM is a China-based biopharmaceutical CDMO headquartered in Suzhou Industrial Park, providing end-to-end CDMO services with established technology platforms focused on biologics and ADC manufacturing. The company operates a large-scale GMP-compliant commercial production base with 20,000L monoclonal antibody drug substance capacity, and has achieved PMDA (Japan) accreditation. Listed on HKEX (1875.HK).

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.

Unither Pharmaceuticals is a global CDMO specializing in sterile and non-sterile liquid pharmaceutical forms, and the world leader in Blow-Fill-Seal (BFS) technology with annual production capacity exceeding 5 billion doses. Founded in 1993 in France, they operate 9 production sites across Europe, North America, South America, and China with 2,500+ employees. They offer contract manufacturing (clinical and commercial), formulation/analytical development, out-licensing of turnkey products, co-development partnerships, and regulatory support including CTD/eCTD submissions. Products include BFS single-doses, multi-doses, vials, sprays, stick packs, and ophthalmic solutions.

Vectron Biosolutions

Norway

Vectron Biosolutions AS is a Norwegian CDMO and strain development service provider based in Trondheim, specializing in microbial (E. coli) protein production. They leverage proprietary next-generation expression technologies including the VB Secretion Technology for efficient large-scale protein secretion in E. coli. They offer customized E. coli strain development, expression vector optimization, and bioprocessing services. They partner with CDMOs like Cytovance Biologics to add customized strain development capabilities for complex microbial molecules. Despite having no website content available, multiple search results and press releases confirm their CDMO positioning. The company website (vectronbiosolutions.com) was not accessible at scrape time.

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.

WeylChem

Germany

WeylChem is the fine and specialty chemicals platform of International Chemicals Investors Group, operating as a CDMO for custom manufacturing of fine chemicals and pharmaceutical intermediates. With nine companies and around 1,400 employees across seven manufacturing sites in Europe, North America, and Asia, WeylChem provides custom synthesis from pilot scale through to large-scale commercial production in vessels up to 20 cubic meters.

Zhejiang Davi Pharmaceutical Co., Ltd., established in 2004, is an exclusively foreign-owned high-tech manufacturer of active pharmaceutical ingredients and intermediates located in Huzhou City, Zhejiang, China. With a total investment of $8M USD and 35,000 m2 floor space, they operate FDA and COS-required GMP workshops. They specialize in folate-related APIs: Methotrexate, Methotrexate Sodium, Calcium Folinate (Leucovorin Calcium), Calcium Levofolinate, and L-5-Methyltetrahydrofolate Calcium. The company is FDA-registered with 3 FEI numbers, has 8 FDA inspections (2 NAI, 6 VAI, 0 OAI), 1 Class II recall, 4 FDA-approved products (tablet, extended-release tablet), and participates at CPHI events globally. They undertake OEM orders for intermediates. Classified as API manufacturer rather than CDMO because they primarily manufacture their own specialty APIs; contract services appear limited to OEM intermediate orders.

Zhejiang Hisoar Pharmaceutical Co., Ltd. (stock code 002099, Shenzhen Exchange), founded in 1966 and headquartered in Taizhou, Zhejiang, China, is a diversified pharmaceutical and chemical company with ~3,000 employees and 426 R&D personnel. Their pharmaceutical division produces specialty APIs, intermediates, formulations, and fine chemicals -- specifically antibiotics (penem/carbapenem series, clindamycin series), cardiovascular agents, and anti-diabetic APIs. Over 70% of products are exported. They also have a major dye/pigment business segment (~70% global market share in Reactive Blue KN-R). The company has 3 FDA-registered FEI numbers for API manufacture, 7 FDA inspections (4 NAI, 3 VAI, 0 OAI), 2 FDA-approved products (capsule, tablet), 40+ invention patents, and partnerships with Boehringer Ingelheim, Merck, Sanofi, Novartis, GSK, and others. Classified as API manufacturer because the core pharma business is own-brand API and intermediate production with limited CDMO positioning, though PharmaSource lists them under CMO/CDMO.

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.

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.

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.

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.

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.