Method Development & Validation CDMOs

Global Pharma CM S.A. (Poland)

Poland

Global Pharma CM S.A. is a Polish pharmaceutical contract manufacturing company. Limited information is available from the website, but search results reference it as a GMP manufacturing and pharmaceutical contract manufacturing organization based in Poland.

Good Biomarker Sciences (GBS Leiden)

Netherlands

Good Biomarker Sciences (GBS Leiden) is a Dutch contract research laboratory specializing in preclinical and clinical biomarker services in hemostasis and thrombosis, immunobiology, and cellular bioenergetics. The company provides fit-for-purpose analytical services and biocompatibility testing to biotech and pharma clients, supporting clinical trials and population studies. It is a spinoff from TNO (Netherlands Organisation for Applied Scientific Research).

Goodwin Biotechnology (GBI) is a full-service biopharmaceutical CDMO based in Florida, specializing in biologics development and manufacturing. Named Manufacturer of the Year by BioFlorida, GBI offers its Single-Source Solution for monoclonal antibodies, ADCs, recombinant proteins, and other complex biologics from cell line development through cGMP commercial manufacturing. The company provides mammalian cell culture manufacturing using CHO and other expression systems.

Holodiag (HoloDiag)

France

Holodiag is a French Contract Research Organization (CRO) dedicated to solid-state characterization and crystallization process development for small molecule active pharmaceutical ingredients. Founded with over 15 years of experience, the company supports pharmaceutical clients with polymorph screening, crystal form analysis, crystallization process development, and electron diffraction. Holodiag was recently acquired by ICROM and operates from a 540 m2 facility in Val-de-Reuil, France.

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.

Hypha Discovery Ltd

United Kingdom

Hypha Discovery Ltd is a UK-based specialist CRO supporting pharmaceutical and agrochemical companies worldwide through metabolite identification (MetID), metabolite synthesis, purification, and structure elucidation. The company also provides custom natural product synthesis via contract fermentation and NMR spectroscopy services.

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.

JSR Life Sciences (KBI Biopharma / Selexis)

Switzerland

JSR Life Sciences is the parent organization of KBI Biopharma (CDMO) and Crown Bioscience (CRO), plus Selexis (cell line development). KBI Biopharma is a biologics CDMO providing mammalian and microbial expression, process development, analytical development, and clinical through commercial GMP manufacturing. Crown Bioscience is a separate CRO arm focused on preclinical oncology. This entity spans CDMO and CRO, but the primary CDMO identity is through KBI Biopharma. FDA registered with 4 FEI numbers and 5 inspections (4 NAI, 1 VAI).

Jubilant Biosys Limited

India

Jubilant Biosys is a CRDMO (Contract Research, Development and Manufacturing Organization) under Jubilant Pharmova. Over 20 years experience, 2,400+ employees, five sites across India and Europe. Offers integrated drug discovery (IDD), chemistry services, biology services, and CDMO services including process R&D, analytical development, technology transfer, GLP/non-GMP/GMP manufacturing. Recently expanding into biologics and ADC discovery at European site. FDA registered with 3 FEI numbers, 14 inspections including 4 OAI -- regulatory risk flag. Note: Website claims biologics/ADC capability but this is at discovery stage only, not GMP manufacturing.

KareBay Biochem

China

KareBay Biochem (Monmouth Junction, NJ) is a custom synthesis and contract manufacturing company offering organic synthesis, peptide synthesis (including cGMP peptide synthesis), antibody production, protein expression, bioconjugation, oligonucleotide synthesis, RNA synthesis, polymer synthesis, and immunoassay services. Also sells catalog products (small molecule inhibitors, bioactive compounds, peptides, antibodies, amino acids, fluorescent dyes). Products are for research, laboratory and further evaluation purposes. cGMP peptide and organic synthesis services are explicitly offered.

KBI Biopharma

Switzerland

KBI Biopharma is a global biologics CDMO (part of JSR Life Sciences) providing mammalian and microbial-based biopharmaceutical development and manufacturing services. Offers cell line development (SUREtechnology Platform powered by Selexis for CHO, PUREplatform for E. coli), process development, analytical development, formulation development, characterization, clinical and commercial GMP manufacturing. FDA registered (FEI 3004638264) with ANALYSIS, API MANUFACTURE, and MANUFACTURE operations. Positioned as a 'next-generation CDMO' with standalone services portal for analytical testing.

KD Pharma Group

Germany

KD Pharma Group is a pure-play, technology-driven CDMO with unique expertise in lipids (omega-3 APIs from fish and algae) and specialized small molecule products. Offers vertically integrated services: API manufacturing (lipid-based and small molecule), finished dosage forms (softgels, liquid bottling, packaging). Pharma division (KD Pharma) provides pharmaceutical APIs and custom synthesis. Nutra division (KD Nutra) serves nutritional supplement companies. KD Biopharma runs Phase 3 clinical trials for lipid-based therapeutics (FAP, UC, COVID-19). Recently expanded manufacturing site in Seal Sands, UK. FDA registered with 2 FEI numbers, 3 inspections (3 VAI).

Lake Chemicals Pvt Ltd

India

Lake Chemicals Pvt Ltd is an Indian pharmaceutical company based in Bangalore, Karnataka, specializing in the manufacture of Active Pharmaceutical Ingredients (APIs). Operating from an EU GMP-certified facility, the company focuses on pharmaceutical manufacturing and API development with a commitment to greener processes and safety standards. They provide DMF documentation support for regulatory registration and serve global markets. Listed on CPHI Online and PharmaCompass as an API manufacturer.

Laxai

India

LAXAI Life Sciences is an Indian small molecule CRDMO (Contract Research, Development and Manufacturing Organization) headquartered in Hyderabad. Offers end-to-end services spanning discovery (medicinal chemistry, synthetic chemistry, in-vitro/in-vivo biology, DMPK, safety assessment), development (chemical process development, drug product development, analytical development including method development and validation, impurity profiling, forced degradation studies), and manufacturing (preclinical to FIH supplies, late-phase and commercial, tech transfer, process validation, API manufacturing). Also manufactures specialty chemicals. Recently received investment from SIGNET Healthcare Partners. Passed USFDA audit in March 2025 with zero 483 observations.

LOTTE BIOLOGICS

South Korea

LOTTE BIOLOGICS is a global biologics CDMO headquartered in South Korea, offering end-to-end development and cGMP manufacturing services for biological Drug Substance. Operates the Syracuse Bio Campus (New York, USA) with 40,000L capacity and the Songdo Bio Campus (Incheon, South Korea) planned for 120,000L by 2027. Also operates a $100M ADC manufacturing facility.

LTS Lohmann Therapie-Systeme

Germany

LTS Lohmann Therapie-Systeme AG is a leading CDMO specializing in non-invasive drug delivery systems for nearly 40 years. They are platform specialists in Transdermal Therapeutic Systems (TTS), Oral Thin Films (OTF), and Microneedle Array Patches (MAP). Their full-service CDMO offer covers the entire product lifecycle from API evaluation and feasibility through prototyping, clinical trial supply, and commercial-scale manufacturing. They have manufactured transdermal systems for nicotine, nitroglycerin, and hormone patches, as well as platforms for Parkinson's, Alzheimer's, and pain management.

Mabion S.A.

Poland

Mabion S.A. is a Polish end-to-end biologics CDMO offering Drug Substance manufacturing, fill/finish, process development, cell line development and banking, and analytical services. Headquartered in central Poland (1.5 hours from Warsaw airport), they position themselves as a European CDMO partner for pharma and biotech companies. Their capabilities span the full biologics lifecycle from gene to vial.

MabPlex International

China

MabPlex International is a China-headquartered CDMO providing comprehensive biomanufacturing services for the global biopharmaceutical and biotechnology industry. They offer innovative CRO and CMO services for biologics, with facilities in China and the USA (MabPlex USA). They are expanding CDMO services and manufacturing capacity to meet global biologics demand, with multiple manufacturing sites.

mAbxience

Spain

mAbxience, a Fresenius entity, is a global CDMO with 14+ years of experience in the development and manufacture of biopharmaceuticals, specializing in biosimilars and monoclonal antibodies. They are FDA-registered with two FEI numbers for analysis and API manufacture. They have partnered with HP to develop AI solutions for optimizing monoclonal antibody and biosimilar production. Their CDMO platform offers tailored solutions with quality, agility, and flexibility in manufacturing.

Macleods Pharmaceuticals Ltd

India

Macleods Pharmaceuticals Ltd is one of India's top 10 pharmaceutical companies, operating as a CDMO for developing, manufacturing, and globally distributing pharmaceutical products. They produce diverse dosage forms including solid orals, liquid orals, topical formulations, injectables, metered dose inhalers, and dry powder inhalers across therapeutic areas including anti-TB, antimalarials, antiretrovirals, antidiabetics, antihypertensives, and antiasthmatics. They have 152 FDA-approved products, WHO prequalified medicines, and manufacturing facilities compliant with UK MHRA, US FDA, TGA, and WHO guidelines. They operate in 100+ countries.

MassBiologics, a division of UMass Chan Medical School, is a US-based biologics CDMO with over 100 years of history driving discoveries to products. The organization develops novel biologics for diseases of public health importance and offers CMO services including bulk drug manufacture of monoclonal antibodies, vectored therapeutics (gene therapy), and aseptic fill finish. The facility includes approximately 25,000 sq ft of cGMP manufacturing space with dedicated aseptic fill finish and bulk drug substance areas. FDA-registered with 3 FEI numbers. Produces the FDA-licensed Td vaccine and has partnerships for gene therapy manufacturing (SparingVision, PTC Therapeutics).

Nanoform Finland Oyj

Finland

Finnish CDMO specializing in proprietary nanoparticle engineering technology to improve drug bioavailability, enable higher drug loading, and unlock alternative delivery routes (subcutaneous, inhaled). Services span from early development through commercial GMP supply for both small molecules and biologics/peptides. Publicly listed (Nanoform Finland Oyj). Focuses on solving formulation challenges for poorly soluble compounds and enabling patient-centric dosage forms.

Noble Life Sciences, Inc.

United States

Noble Life Sciences is a full-service preclinical CRO based in Sykesville, Maryland. The company provides contract research and development, bioanalysis, analytical testing, pharmacodynamic modeling, and preclinical safety testing services across drug, device, and vaccine development. It acquired Spring Valley Laboratories to enhance its preclinical capabilities.

Novecal

France

Novecal is a French fine chemical company offering CRO services focused on synthetic route design and custom synthesis for APIs, NCEs, and intermediates. The company specializes in organometallic catalysts and ligands (palladium catalysts for cross-coupling reactions, C-H activation), oleochemistry, particle functionalization, and formulation R&D. Novecal produces small batches and provides route scouting and process optimization services but is not a drug manufacturer.

OLIC (Thailand) Limited is one of the largest toll and contract manufacturers in Southeast Asia for branded pharmaceutical and healthcare products. The company is a subsidiary of Fuji Pharma and serves over 30 multinational companies including most Big Pharma organizations. OLIC's PIC/S-compliant manufacturing facility produces a wide range of dosage forms including sterile liquids, oral solids, semi-solids, and liquids, serving markets in Thailand, Southeast Asia, Japan, Australia, the US, and Europe.

Pii (Pharmaceutics International, Inc.), acquired by Jabil in February 2025, is a US-based CDMO specializing in complex formulations. With over 30 years of experience and 300+ scientists and support staff, Pii handles potent compounds, complex formulations, aseptic injectables, complex oral dosage forms, and high-potency soft gels. Offers phase-appropriate support from early development through commercial manufacturing. Located in Hunt Valley, Maryland. 100% FDA licensed with 5 drug product approvals in 2023.

Polymun Scientific Immunbiologische Forschung GmbH is an Austrian specialist CDMO in biopharmaceuticals and liposomal/lipid nanoparticle (LNP) formulations. Offers contract development and manufacturing from gene to clinical grade material for innovator and biosimilar products. Unique expertise in liposomal drug formulations that protect, transport, and release drugs at target sites. Also maintains R&D projects including liposomal superoxide dismutase, recombinant porcine trypsin, and HIV antibodies/antigens. FDA registered for analysis, API manufacture, and manufacture.

Portrett Pharmaceuticals

United States

Portrett Pharmaceuticals is a U.S.-based cGMP-compliant contract research organization specializing in expedited pharmaceutical laboratory analytical testing for small molecule drugs. They provide testing services for IND submissions, NDA filings, and ANDA submissions with a focus on rapid turnaround times. Their services include assay testing, content uniformity, dissolution, impurities/degradation, stability studies, and method validation. They position themselves as a specialized testing partner for small and mid-size pharmaceutical companies.

QPS (QPS Holdings)

Austria

QPS (QPS Holdings) is a global contract research organization (CRO) headquartered in Austria, providing bioanalysis, preclinical, and clinical research services. The company offers toxicology, pharmacology, DMPK, bioanalysis (800+ assays), PBMCs, central lab services, clinical trial units, and full clinical research support services across multiple therapeutic areas. QPS emphasizes agility, speed, and quality in drug development research but does not manufacture drugs.

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.

Rho (Rho, Inc.)

United States

Rho, Inc. is a US-based global Contract Research Organization (CRO) specializing in clinical trial management, biostatistics, data management, and regulatory strategy. The company focuses on neurology, psychiatry, respiratory, pain, and immunology therapeutic areas. Rho provides end-in-mind trial design, pharmacovigilance, and regulatory submissions support but does not manufacture drugs.

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.

Spectrasynth Pharmachem

India

Spectrasynth Pharmachem is an ISO 9001:2015 and GMP certified Indian contract research organization specializing in custom synthesis of pharmaceutical impurities and in-house standards per pharmacopoeia specifications. The company operates a manufacturing facility at Bakrol GIDC, Ahmedabad. While listed on some platforms as CRO/CDMO, its core business is impurity reference standard synthesis, not drug product manufacturing.

Stabicon Life Sciences Pvt.

India

Stabicon Life Sciences Pvt Ltd is an Indian Contract Research Organization (CRO) established in 2010, based in India. PharmaSource explicitly classifies them as a CRO. They provide support throughout all phases of product development including stability testing, formulation R&D, analytical R&D, microbial analysis, and technology transfer for OTC, nutraceutical, natural, and pharmaceutical products. Their services include analytical method development and validation, reverse engineering, stability programs (ICH), and formulation development using QbD principles. They work with pharma and FMCG companies worldwide. They also have a nutraceutical/dietary supplement and patented augmented absorption technology division. A related entity, Lyrus Life Sciences, is described as a CDMO, but Stabicon itself is primarily a CRO.

trenzyme GmbH

Germany

trenzyme GmbH is a German research service provider (CRO) specializing in highly customized cell culture and protein production services. Founded in 2000, they offer cell line development, iPSC differentiation and characterization, and recombinant protein production for research purposes. They provide GMP-compliant Research Cell Banks (RCBs) but are primarily a research services company, not a drug manufacturer.

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.

YUMAB GmbH

Germany

YUMAB GmbH is a German biotechnology company specializing in contract research for the discovery and development of fully human therapeutic antibodies. They provide antibody discovery, engineering, humanization, and characterization services using proprietary human-derived antibody libraries (>10^11) and in-vitro selection technology.

Ash-LongChem Technology Limited (Longchem) is a Chinese CDMO specializing in custom synthesis and contract manufacturing of small molecule APIs and advanced intermediates. They offer process development services including asymmetric reduction, chiral resolution, fluorination, Grignard reactions, and cryogenic reactions, with a CDMO regulatory platform and quality assurance.

BirdoTech is a Shanghai-based CRO/CDMO providing drug discovery and custom synthesis services to pharmaceutical companies worldwide. The company has CDMO manufacturing sites in Chongqing (cGMP), Shanghai (GMP-like), and Shandong (non-GMP), supporting research through manufacturing stages. This is a duplicate entry for the same company as Birdo (Shanghai) Pharmatech Co., Ltd.

BirdoTech is a Shanghai-based CRO/CDMO providing drug discovery and custom synthesis services to pharmaceutical companies worldwide. The company has CDMO manufacturing sites in Chongqing (cGMP), Shanghai (GMP-like), and Shandong (non-GMP), supporting research through manufacturing stages. This is a duplicate entry for the same company as Birdo (Shanghai) Pharmatech Co., Ltd.

BSV BioScience GmbH is a German CDMO specializing in biological API manufacturing, providing contract development and manufacturing services for biologics drug substances. The company is FDA-registered for API manufacture and offers process development, analytical services, and cGMP manufacturing for biopharmaceutical clients.

Dubourgel Medical is a French company specializing in the design and manufacture of medical devices for various medical procedures including hyaluronic acid injection syringe accessories, blood analysis tools, surgical instruments, and orthopedic devices. The company is not a pharmaceutical drug manufacturer.