Analytical Services CDMOs

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).

KriSan Biotech is a Taiwan-based CDMO founded in 2015, located in Tainan Science Park. They provide one-stop CDMO services for small molecule APIs, peptides, oligonucleotides, antibody-drug conjugates (ADC), and high-potency drugs from preclinical to commercialization. The company has a professional team averaging 10+ years of API experience. KriSan has partnered with CMIC BIO for ADC/XDC innovation, signed MoU with Mycenax for ADC capabilities, and has supplied kg-scale API to companies such as Atossa Genetics (NASDAQ: ATOS) and OncoArendi Therapeutics. They hold PIC/S GMP certification from TFDA.

Kuhnil Pharm Co., Ltd. is a South Korean pharmaceutical company headquartered in Seoul with manufacturing facilities in Cheonan. They are a prescription drug-oriented, fully-integrated pharmaceutical company that also provides CMO (contract manufacturing) services, specialized in penicillin and injection formulations. Their facilities include production lines for solid oral doses (tablets, film-coated tablets, capsules, powders), soft gelatin capsules, inhalation products, and sterile injectables (freeze-dried, liquid vials, ampoules). They achieved EU GMP approval in 2022 and have established global GMP systems with LIMS, WMS, and RWS systems.

Laboratorios Farmaceuticos ROVI S.A. is a major Spanish CDMO and pharmaceutical company, one of the leading European contract manufacturers for high-value-added injectable products. Their CDMO division (ROIS) operates three industrial complexes: two for injectables (Madrid and San Sebastian de los Reyes) and one for oral solid forms and packaging (Alcala de Henares). They also have two facilities in Granada for their own products (bemiparin and enoxaparin). ROVI's Madrid injectables plant is approved by EMA, FDA, and regulators in Korea, Brazil, and Gulf States, with ISO 9001, ISO 14001, and OSHAS certifications. They recently acquired a Bristol-Myers Squibb injectable drug product manufacturing site in Phoenix, Arizona for $250 million, expanding their capacity. ROVI provides end-to-end services from development to final product release, including clinical trials, stability studies, and analytical services. They have collaborated with Roche for manufacturing new medicines in development.

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.

Lundbeck Pharmaceuticals Italy SpA

Italy

Lundbeck Pharmaceuticals Italy SpA is an Italian API manufacturer with 80 years of industry experience, producing Active Pharmaceutical Ingredients including Metoclopramide Hydrochloride. Part of the Lundbeck Group (Denmark), they operate multiple FDA-registered facilities with extensive inspection history. While primarily a proprietary pharma manufacturer (Lundbeck is known for CNS drugs), their Italian operation manufactures APIs and has FDA-approved products across injectable and oral dosage forms. They also have clinical trial activity in CNS/Neurology and Immunology.

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.

National Resilience Inc.

Canada

Major North American biomanufacturing CDMO (branded as 'Resilience') focused on complex medicines including large molecule biologics, cell therapies, and aseptic drug product manufacturing. Operates facilities across the US and Canada. Delivers 100+ million vials and pre-filled syringes annually. Secured $825 million in financing to accelerate CDMO strategy. Offers proprietary technology platforms including Sprout Solutions, Auto-T, DAR-T (next-gen CAR-T), and Idea to Clinic services. FDA registered with 7 FEI numbers, 17 inspections.

Naveh Pharma Ltd.

Israel

Israeli pharmaceutical CDMO providing contract development and manufacturing services for solid oral dosage forms, oral liquids, and semi-solid/topical products. Offers formulation development through commercial manufacturing.

Nectar Lifesciences Ltd.

India

Indian pharmaceutical company with vertically integrated API and formulation manufacturing. FDA registered with 2 FEI numbers (operations: ANALYSIS, API, FDF). Offers CDMO services alongside own branded products. Manufactures both APIs (including beta-lactam antibiotics) and finished dosage forms across oral solids, injectables, and lyophilized products.

Nilogen Oncosystems

United States

Nilogen Oncosystems is a US-based contract research organization (CRO) specializing in 3D cancer models using its patented tumoroid technology for translational immuno-oncology. The company creates 3D cancer models from fresh patient tissue that retain the intact tumor microenvironment (TME), providing preclinical testing services for antibody-based therapeutics, cell therapies, and oncolytic viruses. It does not manufacture drugs.

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.

North China Pharmaceutical Group Corp. (NCPC) is one of China's largest pharmaceutical enterprises with multiple GMP manufacturing sites capable of both biological transformations and chemical synthesis. The company specializes in antibiotics, anti-allergy preparations, and antiviral products. NCPC has 3 FDA-registered FEI numbers and 7 FDA inspections (all VAI), indicating substantial but compliance-challenging export operations.

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.

Pharmaceutical Manufacturing Research Services (PMRS) is a U.S.-based cGMP contract manufacturer providing sterile CDMO manufacturing services. Located in Horsham, Pennsylvania, the company specializes in sterile injectable manufacturing and spray drying capabilities.

PHT International is a full-service Contract Research, Development, and Manufacturing Organization (CRDMO) headquartered in China, providing innovative solutions to leading life science companies. Offers global solutions in contract research and manufacturing to partners within the pharmaceutical, agrochemical, and specialty chemical industries. Includes import/export services and sterile CDMO manufacturing capabilities.

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.

Quintara Bio

United States

Quintara Biosciences is a US-based biotech service company specializing in DNA sequencing (Sanger, NGS, Nanopore, PacBio), gene synthesis, cloning, plasmid preparation, recombinant antibody production, bi-specific antibodies, and IVT mRNA synthesis. They are a contract research/service organization for molecular biology and sequencing, not a drug manufacturer.

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.

Ropack Pharma Solutions is a privately held CMO/CDMO based in Montreal, Canada, specializing in solid oral dose contract manufacturing and comprehensive packaging services. With nearly 50 years of experience, the company provides drug development, tech transfer, clinical and commercial manufacturing, and serialized packaging services for solid oral dosage forms.

Scientia Clinical Research

Australia

Scientia Clinical Research is an Australian contract research organization providing clinical trial services. The company operates a clinical research facility at the University of New South Wales (UNSW) Randwick Hospitals Campus and provides clinical development and business development services for pharmaceutical and biotech companies.

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

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

Solvias

Germany

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

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.

Stelis Biopharma is a leading, fully integrated biopharmaceutical CDMO based in India (Bangalore) with over 30 years of operational excellence. They brand themselves as 'OneSource' -- a multimodal specialty pharma CDMO with end-to-end capabilities across multiple tech platforms and therapeutic modalities. Their capabilities span biologics (microbial and mammalian cell culture, drug substance and drug product), complex sterile injectables (35 approved ANDAs and 19 commercialized drug products in the US), drug-device combinations (20+ automatic/semi-automatic assembly stations for prefilled syringes, pen injectors, autoinjectors), and soft gelatin capsules (2.4 billion per year capacity). They operate 5 state-of-the-art facilities approved by various regulatory bodies. Syngene acquired Stelis Biopharma's Unit 3 plant in Bangalore for biologics manufacturing.

Syneos Health

Canada

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

Texcell Group

China

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

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.

Vivotecnia

Spain

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