Method Development & Validation CDMOs

ProteoGenix SAS

France

ProteoGenix SAS is a French antibody production company founded in 2003, providing integrated solutions for custom antibody development, recombinant protein expression, and bioproduction services. The company offers therapeutic antibody discovery, humanization using proprietary AI, ADC development, bispecific antibody development, CAR-T platforms, and custom cell line development across 6 manufacturing sites. ProteoGenix serves the therapeutics, diagnostics, research, and animal health markets.

Purisys

United States

Purisys is a US-based CDMO specializing in custom Active Pharmaceutical Ingredients (APIs) and chemical synthesis projects, with over 40 years of commercial pharmaceutical production experience. The company is a global leader in pharmaceutical-grade cannabinoids and psychedelic compounds, with DEA-secure manufacturing capabilities. Purisys also offers reference standard synthesis and qualification with over 300 commercial standards. The company was recently acquired by Siegfried alongside Noramco.

Quality Chemical Laboratories (QCL)

United States

Quality Chemical Laboratories (QCL) is a US-based CDMO located in Wilmington, North Carolina, specializing in comprehensive analytical testing, formulation development, and GMP clinical manufacturing. The company offers API synthesis, method development, taste masking, enteric coating, tablet film coating, and controlled/immediate release formulation development. QCL is FDA-registered for analysis, API manufacture, drug product manufacturing, and packaging.

Quotient Sciences

United Kingdom

Quotient Sciences is a UK-headquartered pharmaceutical CRDMO (contract research, development, and manufacturing organization) specializing in small molecule and synthetic peptide drug product development and manufacturing. They offer integrated formulation development, clinical manufacturing, and commercial production, with their proprietary Translational Pharmaceutics approach integrating clinical activities with real-time cGMP manufacturing. They have facilities in the US and UK, with capabilities including HPAPI manufacturing, sterile fill/finish, and oral solid dose.

RD‑Biotech

France

RD-Biotech is a French biotechnology CRO/CDMO founded in 2002, offering custom solutions in molecular biology, immunology, and cellular engineering for R&D, preclinical, and clinical programs. They specialize in plasmid DNA production (including GMP grade), monoclonal antibodies, recombinant antibodies, recombinant proteins, and cell culture/banking. They have a strategic partnership with ABL for cell and gene therapy GMP manufacturing.

Recipharm AB

Sweden

Rechon Life Science AB is a subsidiary/entity within the Recipharm group, the global CDMO headquartered in Stockholm, Sweden. This entry represents the same Recipharm organization (same website: recipharm.com) with its extensive global manufacturing footprint of 15+ FDA-registered FEI numbers and 52 FDA inspections. The Perplexity research confirms Recipharm's specialization in oral solid dose, inhalation, sterile manufacturing, and HPAPI capabilities. Rechon may represent a specific Recipharm site or legacy entity. Duplicate of Recipharm AB entry -- capabilities are identical.

ReiThera Srl

Italy

ReiThera is an Italian CDMO dedicated to process development and GMP manufacturing of viral vectors for genetic vaccines and advanced therapy medicinal products (ATMPs). They have extensive expertise in developing scalable processes for Adeno-Associated Vectors (AAV), Lentivirus, Adenoviral vectors (AdV), Modified Vaccinia Ankara, and Herpes Simplex Vectors. Their state-of-the-art facility in Rome features stirred-tank bioreactors at 50L, 200L, 1000L, and 2000L scales, fixed-bed bioreactors, a filling suite, and quality control laboratories. They also develop their own vaccine candidates (e.g., GRAd-COV2).

Renejix Pharma Solutions

United States

Renejix Pharma Solutions (operating as HyCON Labs) is a US-based CDMO specializing in small molecule oral dosage form development and multi-modality manufacturing. The company offers end-to-end services from preformulation through commercial manufacturing, with 14+ technologies, 300+ pieces of equipment, 350+ employees, and 2+ facilities. They serve as a single-partner CDMO across all development stages.

Rezon Bio

Poland

Rezon Bio is a European biologics CDMO headquartered in Poland, specializing in mammalian drug substance development and GMP manufacturing. The company operates two FDA-approved facilities with mirrored capabilities, employs approximately 1,300 people (10% PhDs), and has 16 years of biologics development experience. Rezon Bio offers end-to-end services from cell line development through commercial manufacturing with 2,000L bioreactors.

Saurav Chemicals Ltd

India

Saurav Chemicals Ltd (SCL Lifesciences) is an Indian manufacturer of Active Pharmaceutical Ingredients and advanced intermediates, with over three decades of experience serving regulated markets in Europe, the USA, and Japan. The company is the largest supplier of cephalosporin and penem intermediates and also provides CDMO services, custom synthesis, and mRNA vaccine ingredients.

Scientific Protein Laboratories (SPL)

United States

Scientific Protein Laboratories (SPL) is a CDMO specializing in cGMP biopharmaceutical manufacturing of APIs from biological sources, with over 30 years of experience. Core products include heparin derivatives (Heparin Sodium USP) and pancreatic enzymes (Pancreatin USP, Pancrelipase USP). The company also provides custom development services including fermentation, natural product extractions, and recovery/purification of therapeutic proteins from preclinical through commercial scale.

Scinai Immunotherapeutics

Israel

Scinai Immunotherapeutics is a NASDAQ-listed biopharmaceutical company that provides boutique biologics CDMO services through its Scinai Bioservices business unit, alongside its own I&I therapeutics pipeline. The CDMO offers end-to-end drug development and manufacturing from molecule selection through Phase 3 manufacturing, with over 20 years of experience in recombinant protein development. Scinai acquired a manufacturing site in Yavne, Israel from Recipharm and established a US subsidiary (Scinai Bioservices Inc.).

SCN BestCo

United States

SCN BestCo is a contract manufacturer of innovative pharmaceutical dosage forms for OTC drugs, vitamins, and dietary supplements. It specializes in gummy, soft chew, coated chew, and lozenge dosage forms and operates as a contract manufacturer of consumer healthcare products since 1976.

Scorpius BioManufacturing

United States

Scorpius BioManufacturing is a US-based biologics CDMO focused on mammalian, microbial, and cell therapy manufacturing. The company provides cGMP manufacturing, bioanalytical, and process development services from its San Antonio, Texas facility. Note: Tivic Health acquired manufacturing assets from Scorpius, and the company has undergone corporate restructuring under Scorpius Holdings / NightHawk Biosciences.

SCTbio

Czechia

SCTbio is a Czech CDMO specializing in cell and gene therapy (ATMP) manufacturing, spun out from SOTIO. The company provides cGMP production of cell-based therapies and retroviral/lentiviral vectors from its 2,000 sqm facility in Prague, Czech Republic. SCTbio has specialized expertise in dendritic cell therapeutics, CAR-T, and viral vector production, supported by a global network of 150 apheresis collection centers.

Senn Chemicals AG

Switzerland

Senn Chemicals AG is a Swiss CDMO specializing in peptide APIs, peptide fragments, amino acid derivatives, and small molecules. Founded in 1963 in Dielsdorf near Zurich, the company provides cGMP custom manufacturing services from early research to commercial phase. Senn Chemicals has been inspected multiple times by the US FDA and was acquired by Granules India in 2025 to expand peptide therapeutics and CDMO capabilities.

SEQENS

Canada

SEQENS is a global integrated CDMO and specialty ingredients leader with 15 production sites across 9 countries and 5 R&D centers. The company manufactures custom and generic APIs, intermediates, excipients, custom lipids for drug delivery (mRNA/siRNA, LNP), HPAPIs, and specialty chemicals. SEQENS also operates CELLforCURE, an EMA-authorized CDMO for Advanced Therapy Medicinal Products (ATMPs/Cell & Gene Therapy). The company serves 1,500+ customers in 80+ countries with approximately 2,700 employees and ~1B EUR revenue.

Serán BioScience

United States

Seran BioScience is a US-based CDMO headquartered in Bend, Oregon, recognized as a world leader in drug delivery and formulation development. The company provides comprehensive drug development and clinical/commercial manufacturing services, specializing in spray drying and particle engineering, preformulation, dosage form development, and cGMP manufacturing. Seran recently secured $200M+ from Bain Capital to build a new 100,000 sqft commercial manufacturing facility for non-sterile oral solid dose pharmaceuticals.

SERATEC

Germany

SERATEC is a French-German CDMO specializing in the development and production of active pharmaceutical ingredients (APIs) for rare and orphan diseases as well as high-value small molecules. Founded in 1970, the company provides end-to-end API solutions from molecule design through development, registration with leading regulatory agencies, and cGMP commercial production. SERATEC is FDA-registered and has been FDA-inspected for API manufacturing.

SGS

Brazil

SGS Integrated CDMO Solutions is the contract development and manufacturing division of the global testing and inspection company SGS SA. Established in 2002 with a specialized UK-based CDMO site (MHRA and FDA inspected), SGS provides formulation development, API manufacturing, sterile fill/finish, lyophilization, and analytical services. A new 55,000 sq ft cGMP facility in Hudson, NH expands their North American capabilities across Phase I-III clinical trials and commercial supply.

SIDEFARMA

Portugal

SIDEFARMA is a Portuguese CMO with over 45 years of experience, specialized in the manufacture of small and medium-size batches of solid dosage forms (coated tablets, tablets, capsules), semi-solids (creams, gels, ointments), and liquid pharmaceuticals. The company provides contract manufacturing, contract packaging, and contract development services following European quality standards, while also commercializing its own branded pharmaceutical products.

Siegfried Group

China

Siegfried Group is a leading global CDMO with 150+ years of pharmaceutical and chemical heritage, operating 13 production sites across Switzerland, Germany, Spain, France, Malta, the USA, and China. The company provides integrated services from early-phase API development through commercial-scale drug substance and drug product manufacturing, including exclusive synthesis, generic APIs, controlled substances, HPAPI handling, sterile formulations, and viral vector manufacturing through subsidiary DINAMIQS. In January 2026, Siegfried announced acquisition of additional US-based small molecule drug substance capacity.

Singota Solutions

United States

Singota Solutions is a CDMO based in Bloomington, Indiana, focused on aseptic injectable drug development and manufacturing for pharmaceutical, animal health, and biotechnology clients. They specialize in small-batch aseptic filling using the gloveless robotic SA25 Aseptic Filling system (first commercial site in North America). Services include aseptic manufacturing of small volume parenterals (vials, syringes, cartridges), QC testing, formulation and method development, labeling and kitting, and supply chain management including GMP-compliant warehousing and cold chain storage. They recently expanded into Europe with a GDP-certified facility in Balerna, Switzerland.

SmaBio Labs

United States

SmaBio Labs is a USA-based CDMO located in Research Triangle Park, North Carolina, delivering end-to-end drug development solutions from molecule discovery to market launch. They specialize in Chemistry Manufacturing and Control (CMC) services for small molecules, peptides, biologics, and complex APIs. Their capabilities include analytical services (IND/ANDA support, method development and validation, ICH stability testing, HPLC/UPLC, LC-MS, ICP-MS, NMR, XRPD), drug discovery and process development, API manufacturing (kg-scale cGMP), product development (formulation for oral solid dose, injectables, lyophilized products), and clinical trial material manufacturing (Phase I-III). FDA registered for analytical services. They support HPAPI compounds up to OEB 5.

STC Biologics

United States

STC Biologics, Inc. is a boutique turn-key biologics CDMO located in Newton, Massachusetts, USA, founded in 2009. The company provides full CMC services and consulting to enable partners to advance biologic products from discovery to commercialization. Their team brings expertise from Genentech, Novartis, Shire, EMD Serono, Lonza, Alexion, and Merrimack. STC offers a Speed-To-Clinic Platform for monoclonal antibodies that can go from royalty-free cell line development directly to cGMP manufacturing and released drug substance within 12 months. They opened a single-use mammalian GMP facility in 2019 and have filed 8+ BLAs, dozens of INDs, and 20+ comparability protocols. They also developed their own biosimilar product, STC101.

Sterling Pharma Solutions

Ireland

Sterling Pharma Solutions is a global CDMO with over 50 years of experience providing API development and manufacturing services to pharmaceutical and biotech companies. The company specializes in high potency APIs, hazardous chemistry, controlled substances, peptides, flow chemistry, biocatalysis, and ADC bioconjugation across six facilities in the UK, Ireland, and US.

Steroid S.p.A.

Italy

Steroid S.p.A. is one of the oldest privately-owned steroid API manufacturing companies, founded in the early 1950s in Italy. The company specializes in the synthesis of steroid esters including corticosteroids, progestinics, hormones, anabolics, and estrogens for both human and veterinary use, with over 15 tons installed capacity.

SuanFarma

Italy

SuanFarma is an Italian-headquartered CDMO providing comprehensive API and intermediate manufacturing services combining fermentation, purification, and chemical synthesis. The company operates GMP facilities in Europe (Italy and Portugal) with over 2,000 m3 fermentation capacity and 800 m3 reaction capacity, serving 400+ customers in 70+ countries.

Supriya Lifescience Ltd.

India

Supriya Lifescience Ltd. is a publicly listed Indian generic pharmaceutical company established in 1987, primarily focused on API manufacturing and supply. The company has a leadership position in therapeutic segments including antihistamines, anti-asthma, and analgesic APIs, serving 1,500+ customers in 86+ countries. While the company mentions CDMO services, its core business is manufacturing and selling its own API portfolio.

Sussex Research Laboratories

Canada

Sussex Research Laboratories Inc. is a Canadian CRO and CDMO specializing in glycoscience -- the study and application of carbohydrates (glycans) in drug discovery and development. The company provides custom carbohydrate synthesis, GalNAc-based drug delivery strategies, glycoconjugate development, and scale-up services for pharmaceutical and biotech clients, with over 25 years of industry experience and 1,000+ clients globally.

Symphony Pharma Life Sciences Pvt Ltd

India

Symphony Pharma Life Sciences is a CRO and CDMO based in Hyderabad, India, founded in 2008 by research-driven scientists. The company operates a 25,000+ sq. ft. research facility in Genome Valley, providing contract research, custom synthesis, and contract development and manufacturing services. Symphony has executed 40+ NCE intermediate projects for global innovator companies, developed 8 new APIs (including Lacosamide with USFDA-approved DMF), and synthesized 250+ API impurities for global MNCs.

SynOligo Biotechnologies

China

SynOligo Biotechnologies is a Contract Research and Development Organization (CRDO) headquartered in Morrisville, North Carolina (Research Triangle Park), specializing in custom oligonucleotide synthesis. The company provides research, diagnostic, and therapeutic-grade oligonucleotides from nanomole to multi-gram/100+ gram scale. SynOligo handles complex modified oligos including antisense, siRNA, aptamers, CRISPR gRNA, MERFISH probes, and lipid-modified oligos with guaranteed ultra-low endotoxin. The company expanded in 2024 with a new 5,000 sq. ft. high-throughput facility.

Takara Bio

Japan

Takara Bio (a Takara Holdings company) is a Japanese biotechnology company with a significant CDMO business for cell and gene therapy products. They operate the Center for Gene and Cell Processing (CGCP) at their headquarters in Shiga, Japan, which they have expanded to accommodate a variety of advanced therapy modalities. Their CDMO services cover comprehensive cellular and gene therapy product manufacturing and quality testing. Takara Bio also supplies reagents and instruments (research tools business) but the CDMO division is a distinct contract manufacturing operation. They have GMP-grade manufacturing capabilities in both Japan and Goteborg, Sweden (Takara Bio Europe AB).

Tedor Pharma Inc

United States

Tedor Pharma is a US-based CDMO with 20+ years of experience specializing in solid oral dosage forms. Located in Cumberland, Rhode Island, they provide end-to-end outsourcing from IND/NDA/ANDA through commercial manufacture. Services include formulation development, clinical trial manufacturing (including placebo), commercial GMP manufacturing at various scales, analytical services (characterization, testing, development, QA), and clinical supply chain management. FDA-registered and inspected (5 inspections, all VAI), DEA-licensed for controlled substances Schedules II-V. They have 2 FDA-approved products (tablets, oral route). The company announced a recapitalization and new management.

TITAN PHARMAPLUS PVT. LTD

India

Titan Pharmaplus Pvt. Ltd. is an Indian pharmaceutical API manufacturer and CDMO committed to innovation, quality, and sustainability. The company produces a wide range of small molecule APIs including Apixaban, Dapagliflozin, Acyclovir, Dexlansoprazole, and controlled substances, with state-of-the-art cGMP facilities and advanced chemical synthesis capabilities including high-pressure hydrogenation, Grignard reactions, and asymmetric oxidation.

UniD Manufacturing

Belgium

UniD Manufacturing is a Belgian CDMO fully dedicated to polymer-based long-acting formulations for sustained release and local delivery of drugs. They offer end-to-end services from proof of concept to commercialization, specializing in non-biodegradable (up to 9 years release), biodegradable (3-18 months), and resorbable (1 day to 3 months) polymer technology platforms. Applications include vaginal rings, ophthalmic implants, inserts, and other implantable dosage forms. They have 20+ years of expertise and GMP-approved cleanrooms accredited for multi-product manufacturing, with required facilities for high-potent APIs (hormones, peptides).

Vamsi Labs Ltd

India

Vamsi Labs Ltd. is a major Indian manufacturer of Active Pharmaceutical Ingredients (APIs) based in Solapur, Maharashtra. Founded over 28 years ago, the company operates a USFDA-approved, ISO 9001:2015/ISO 14001:2015/ISO 45001:2018 certified facility. Specializes in anti-asthmatic (respiratory), anti-migraine, and anti-psychotic APIs, with 60% of sales from antiasthma products. Products are manufactured in 3 blocks with 8 dedicated product lines containing 70 reactors (10L to 10,000L). Also offers CRAMS (Custom Research and Manufacturing Services) with capability for reactions from -60C to 280C. Has micronization capability for inhaled products using Malvern Mastersizer 2000. Holds US FDA EIR, CEP certifications for multiple APIs (Formoterol Fumarate, Salmeterol Xinafoate, Tiotropium Bromide, Fluticasone Propionate, etc.), WHO-GMP, and EcoVadis sustainability scorecard.

Vector BioMed

United States

Vector BioMed is a U.S.-based public benefit corporation and CDMO specializing in lentiviral vector design and manufacturing for cell and gene therapies. Launched following $15M in funding, the company provides essential lentiviral vector capabilities using their proprietary LENTIVERSE platform. They produce high-titer (>10^9 TU/mL) lentiviral vectors using a serum-free, chemically-defined process. Key differentiators include algorithm-optimized vector design, rapid turnaround (months from onboarding to GMP batch release), modular pre-validated systems to reduce costs and avoid royalty-based constraints, and a focus on making advanced therapies accessible in lower-resource settings. They partner with CIRM (California Institute for Regenerative Medicine) on lentiviral vector manufacture.

Vianex S.A.

Greece

Vianex S.A. is a prominent Greek pharmaceutical company listed on PharmaSource as a CDMO. The company is described as specializing in contract development and manufacturing. While the website content is primarily in Greek and could not be fully parsed, PharmaSource confirms CDMO services. The company appears to have multiple manufacturing facilities (Factory A, B, C, D mentioned in navigation) and covers a broad range of dosage forms. Founded by Paul J. Giannacopoulos.

Vihita Chem (P) Ltd

India

Vihita Chem Private Limited is an Indian API and intermediates manufacturer established in 1990 in Ankleshwar, Gujarat. The company manufactures APIs (Donepezil, Valsartan, Losartan, Atorvastatin, Pinaverium Bromide), API intermediates, fragrance intermediates, specialty chemicals, and customized products. Three manufacturing facilities in Ankleshwar GIDC, with additional land acquired at Dahej and Jhagadia for Units 3 and 4. ISO 9001:2015, ISO 14001:2015, ISO 45001:2018 certified. FEI number 3004562353. R&D recognized by DSIR, Ministry of Science and Technology, Government of India. 200+ employees, 100+ products. Building EU-GMP facility in Unit-2.

West Bengal Chemical Industries Limited

India

West Bengal Chemical Industries Limited (WBCIL) is a GMP and ISO certified API manufacturer based in Kolkata, India, with over 60 years of experience. The company specializes in producing active pharmaceutical ingredients including injectable iron APIs, chelated minerals, and liposomal technology products. WBCIL holds multiple FDA registrations across four FEI numbers.

Xedev

Belgium

Xedev is a flexible CDMO based in Belgium, specialized in formulation and process development for oral solid dosage forms. They offer early-phase development services including spray drying, hot melt extrusion, amorphous solid dispersions, and GMP clinical manufacturing for Phase I and Phase II batches.

3PBiovian

Finland

3P Biovian is a global biologics CDMO providing end-to-end services from early-stage development to commercialization. They specialize in proteins, viral vectors, plasmid DNA, and cell therapy products with cGMP manufacturing facilities in Turku, Finland, and Pamplona-Noain, Spain. The company has invested over 50 million euros in facility expansion.

53 Biologics

Spain

53 Biologics is a Spanish CDMO specializing in biologics production from plasmid DNA to proteins. They provide services from preclinical development to cGMP manufacturing, with over 4,500 sqm of facilities including microbial and mammalian manufacturing lines. They hold ISO 9001, ISO 13485, ISO 14001 certifications and operate under GMP.

ABC Farmaceutici, an ICE Pharma company, is an Italian CDMO established in 1925 specializing in oral solid and liquid formulation manufacturing. Their 76,000 sqm facility in Ivrea (near Turin) is fully GMP certified and regularly inspected by AIFA and FDA. As part of ICE Pharma, they manage the entire drug supply chain from API through finished dosage form manufacturing.

Accela ChemBio

China

Accela ChemBio is a China-based CRO and CMO providing custom synthesis, building block chemicals, and contract manufacturing services for pharmaceutical, material science, and chemical industries. They have 3 R&D centers in Shanghai and Shandong, with manufacturing facilities that have passed GMP audits and FDA registration. They supply research chemicals from gram to commercial scale.

Adesis Inc

United States

Adesis Inc is a US-based CDMO and chemistry solutions company, a subsidiary of Universal Display Corporation (Nasdaq: OLED). With approximately 80% PhD scientists on their R&D team, they provide discovery chemistry, process chemistry, specialty manufacturing, and custom peptide synthesis services across 100,000 sq ft of lab, manufacturing, and client services space. All facilities are 100% US-based.

Advaxia Biologics is a CDMO near Rome, Italy, specializing in adenovirus vaccine development and cGMP manufacturing. With over 10 years of biologics expertise and a 100% batch approval rate, Advaxia provides fully integrated services from expression systems and process development to analytical development and GMP manufacturing, and is EMA, FDA, and AIFA compliant.