Stability Studies CDMOs

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Glatt Pharmaceutical Services is a CDMO division of the Glatt Group that supports pharmaceutical and biotech companies from initial formulation design to commercial-scale manufacturing. The company specializes in oral solid dosage forms using advanced technologies including fluidized bed systems, spray granulation, Wurster coating, hot-melt extrusion, and amorphous solid dispersions for solubility enhancement and modified release.

Luye Pharma (EU CDMO)

China

Luye Pharma's EU CDMO operation is based in Germany and is among the largest and most respected European manufacturing sites for Matrix Transdermal Therapeutic Systems (TDS). They offer one-stop-shop CDMO services for transdermal patches covering feasibility, formulation, upscaling, clinical trial material supply, analytical services, blending & coating, cutting/packaging, and full-scale manufacturing. They have a dedicated facility for hormone-containing patches and are fully compliant for handling controlled substances.

Mac-Chem Products (India) Pvt. Ltd.

India

Mac-Chem Products (India) Pvt. Ltd., part of the NMM Group (Naprod), is a pharmaceutical API manufacturer specializing in Oncology, General APIs, and Bulk Sterile products. They have manufacturing plants in four locations employing around 800 professionals. Naprod (parent) is a pioneer in lyophilization with an ultra-modern manufacturing facility. They hold multiple international regulatory approvals including USFDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, and WHO-GMP/ISO certifications.

Morgen Pharmaceutical Services (MPhS), operating as Stason Pharmaceuticals, is a US-based CDMO offering end-to-end drug development and manufacturing services. Located in Irvine, California, the facility can produce over 2 billion oral doses per year with batch sizes from 0.5 kg to 600 kg. The company offers API synthesis (through offshore affiliates), formulation development, pre-formulation studies, solid dosage manufacturing (tablets and capsules), high-containment operations for highly potent compounds (OEL < 1 µg/m³), and injectable/liquid manufacturing through a partner facility in Tainan, Taiwan. FDA-registered with 2 FEI numbers and 11 FDA inspections (8 NAI, 3 VAI).

Indian pharmaceutical CDMO specializing in pre-finished formulation intermediates (PFI) and finished dosage forms (FDF). Manufactures oral solids, oral liquids, injectables, ophthalmics, topicals, and inhalation products. Strong focus on pellet technology and nanotechnology-based drug delivery systems. CRAMS (Contract Research and Manufacturing Services) provider.

NCK A/S (Niels Clauson-Kaas)

Denmark

Danish CDMO founded in 1956 specializing in process development and API manufacturing for biotech and pharma companies taking new chemical entities (NCEs) from discovery to commercialization. Operates a multi-purpose GMP pilot plant with glass/glass-lined reactors (40-280L) including cryogenic capability (-80 degrees C). Services include process development, analytical development, reference samples, supply of API for toxicology and clinical studies, API release, ICH stability studies, and GMP documentation. QC lab equipped with HPLC (DAD/CAD), IC, GC-MS, and LC-MS/MS (QTOF).

Advanced Analytical Testing Laboratories (AATL / AATS) is an FDA-registered contract testing laboratory located in New Jersey and Rancho Cucamonga, California. They provide analytical testing, method development and validation, stability studies, microbiology testing, and R&D services for pharmaceutical, nutraceutical, and dietary supplement products. They comply with cGMP, USP, and ISO 17025 standards.

Coriolis Pharma is a Germany-based contract research and development organization (CRDO) specializing in biopharmaceutical drug product development, analytical services, and formulation for liquid and lyophilized biologics. The company is headquartered in Martinsried near Munich with a new campus and a $10M R&D laboratory in Morrisville, North Carolina.

Coriolis Pharma Research GmbH is the legal entity of Coriolis Pharma, a global contract research and development organization (CRDO) headquartered in Martinsried, Germany. The company is the premier partner for drug product development, analytical services, and manufacturing services for biological therapeutics, with a focus on liquid and lyophilized drug products under both R&D and GMP conditions.

Kaneka Eurogentec (part of Kaneka Group, Japan) is a Belgian CDMO established in 1985, FDA inspected, GMP accredited. Manufactures starting materials and APIs for clinical and commercial phases. Core products: GMP plasmid DNA (gram to kg scale), GMP recombinant proteins and antibody fragments, GMP mRNA (50g per batch, commercial-ready facility accredited June 2025), GMP oligonucleotides (pre-clinical and Phase 1/2), GMP conjugates. Also supplies research-grade oligonucleotides and diagnostic tools. 475 employees. FDA registered with 2 FEI numbers, 7 inspections (1 NAI, 6 VAI). Plasmid DNA serves as starting material for viral vector and mRNA production.

Just - Evotec Biologics (wholly owned by Evotec) is a biologics CDMO specializing in monoclonal antibodies, next-generation biologics, and biosimilar products. Differentiated by proprietary integrated end-to-end continuous manufacturing platform (J.POD) which uses perfusion cell culture with continuous purification, achieving higher output in smaller footprint than traditional batch manufacturing. Two manufacturing sites in Seattle and Redmond, WA. Offers cell line development, analytical services, process development, and early clinical through commercial cGMP manufacturing. Uses AI/ML technologies in development.

KCAS Bio

Australia

KCAS Bio is a leading bioanalytical contract research organization (CRO) with 45+ years of experience. Supported 315+ approved drugs on market, developed 6,200+ assays. Services include bioanalytical development, biomarker analysis, immunogenicity testing, cellular and molecular assays, clinical kitting and sample management. Specializes in advanced modalities (cell therapy, gene therapy). Globally harmonized Cytek spectral flow cytometry across US, EU, and Australia sites. 20+ FDA audits with no major findings.

Lyophilization Technology, Inc. (LTI)

United States

Lyophilization Technology, Inc. (LTI) is a US-based CDMO focused on lyophilization (freeze-drying) development and sterile clinical supply manufacturing. They offer development sciences (formulation development, thermal analysis, cycle design, product characterization, pilot plant scale-up), clinical manufacturing (Phase I, II, and toxicology), and technical services. They have specialized capabilities in dual chamber cartridges and syringes, and isolation/containment for potent compounds.

Macsen Laboratories

India

Macsen Laboratories (N.K Agrawal Group), a chemical manufacturing organization with origins dating back to 1952, manufactures niche Active Pharmaceutical Ingredients, pharmaceutical application dyes, and specialty chemicals. They are the world's only cGMP manufacturer of a complete range of pharma application and injectable dyes. They specialize in cGMP manufacturing of niche, atypical, and rare-to-find APIs and also offer custom synthesis/contract research services. FDA-registered with FEI for API manufacturing. They are building a new API manufacturing facility to expand CDMO capabilities.

PPD (Pharmaceutical Product Development) is a leading global contract research organization (CRO) providing clinical research solutions across 20+ therapeutic areas. The company offers end-to-end drug development services including clinical trial management, bioanalytical laboratory services, biostatistics, regulatory consulting, and functional service provider solutions. PPD does not manufacture drugs.

PPD, now part of Thermo Fisher Scientific, is one of the world's largest contract research organizations (CROs). While the URL references 'integrated CRO and CDMO solutions' under the Thermo Fisher umbrella (Accelerator Drug Development program combining Patheon CDMO and PPD CRO), PPD itself is fundamentally a CRO providing clinical research services: clinical trial management, laboratory services, biostatistics, regulatory affairs, and pharmacovigilance. The CDMO capabilities belong to Thermo Fisher's Patheon division, not PPD. PPD as a standalone entity is a CRO.