Stability Studies CDMOs

Bushu Pharma is Japan's premier CDMO with over 25 years of experience, specializing in contract manufacturing of solid dosage formulations, sterile injectables, lyophilized products, and prefilled syringes for both clinical trial supplies and commercial products. The company operates five factories in Japan with GMP certifications from 56 countries including FDA, EMA, and PMDA, serving over 90 pharmaceutical companies globally with nearly 50% of sales from foreign-affiliated clients.

Cenra Pharma (formerly CCPC, China Chemical & Pharmaceutical Co.) is a Taiwanese pharmaceutical company established in 1952 that develops and manufactures APIs and generic drugs, also providing CMO/CDMO services. The company has FDA and PMDA facility approvals, PIC/S GMP compliance, and offers services from API selection through formulation development and commercial manufacturing. Cenra specializes in high-potency drugs including immunosuppressants and oncology drugs, with dedicated production lines for penicillins, cephalosporins, carbapenems, and immunosuppressants.

Chiracon GmbH

Germany

Chiracon GmbH, founded in 1998, is a German API manufacturer and CDMO based in Brandenburg with over 25 years of experience. The company provides contract research, intermediates, scale-up, GMP-quality API manufacturing, stability studies, and clinical trial supplies for the pharmaceutical industry.

Corealis Pharma Inc. is the same entity as Corealis Pharma, a privately held GMP-compliant CDMO based in Laval, Quebec, Canada. The company specializes in oral solid dosage forms, providing formulation development and cGMP clinical supply manufacturing for Phase I through early Phase III trials. Corealis has expanded its facilities in Laval's Biotech City with an investment of over $10 million and partners with Rottendorf Pharma and Bora Pharmaceuticals for integrated development-to-commercial services.

CTX Life Sciences Pvt. Ltd.

India

CTX Life Sciences Pvt. Ltd. is a vertically integrated API and intermediate manufacturer based near Surat, Gujarat, India. The company operates a world-class manufacturing facility with a total area of 147,227 sqm, capable of handling complex and hazardous reactions, with DSIR-approved R&D and a collective reactor capacity of around 900 KL. The facility has been inspected by US FDA (6 times), EDQM, BfArM (Germany), TGA (Australia), PMDA (Japan), Health Canada, ANVISA (Brazil), and COFEPRIS (Mexico).

Dipharma Francis S.r.l.

Italy

Dipharma Francis S.r.l. is an Italian CDMO and manufacturer of Active Pharmaceutical Ingredients and advanced intermediates, offering exclusive synthesis services for custom API development and manufacturing alongside a catalogue of generic APIs. They have completed a second phase of cGMP expansion and operate multiple global locations supporting pharmaceutical customers from development through commercial supply.

Dishman Carbogen Amcis Ltd

China

Dishman Carbogen Amcis Ltd is a global CDMO and pharmaceutical outsourcing partner with operations across India, Switzerland, UK, France, Netherlands, and China. With 30 years of experience, they offer custom API development and manufacturing up to 100 metric ton scale, drug product capabilities including highly potent compounds and ADCs, plus finished dosage forms including soft gel capsules and encapsulation. They have received successful USFDA, PMDA, and EDQM inspections.

Diverchim CDMO

France

Diverchim is a French boutique CDMO founded in 2000, specializing in developing and manufacturing small-quantity Active Pharmaceutical Ingredients including drug candidates, orphan drug APIs, and radiopharmaceutical precursors. They offer services from preclinical stage through commercial supply, with GMP certification since 2015, FDA site registration since 2021, and capabilities including lyophilization and solid aliquoting of radiopharmaceutical precursors.

Divis Laboratories Limited

India

Divis Laboratories is one of the world's top 3 API manufacturers and a trusted CDMO partner for over 25 years, serving 12 of the top 20 Big Pharma companies. Operating three world-class manufacturing facilities near Hyderabad, Visakhapatnam, and Kakinada in India with over 16,500 m3 combined reaction capacity, they manufacture generic APIs (30 commercial products), custom synthesis for Big Pharma (small molecules, high potent, peptides), and nutraceutical ingredients including carotenoids and vitamins.

Domixtar Pharmaceuticals SpA

Italy

Domixtar Pharmaceuticals (DMX Pharma) is Italy's largest CDMO, formed from the merger of Doppel Farmaceutici and Mipharm, and part of the group that includes Alfa Omega for nutraceuticals. With 1,000 professionals serving 105 partners across 30 countries, they offer full-service outsourcing from formulation development through post-marketing, including production, packaging, R&D, logistics, and quality control for pharmaceutical products.

DPT Laboratories, LTD.

United States

DPT Laboratories, Ltd., a Mylan company with over 80 years of experience, is a leading CDMO specializing in semi-solid and liquid dosage forms including creams, gels, ointments, lotions, solutions, suspensions, emulsions, and aerosol formulations. The company provides integrated services from pre-formulation through commercial-scale cGMP manufacturing and packaging.

ElevateBio (BaseCamp)

United States

ElevateBio is a US-based genetic medicines company whose BaseCamp division operates as a cGMP manufacturing CDMO for cell therapy, gene therapy, and mRNA products. BaseCamp provides development and manufacturing services from concept through commercialization, leveraging state-of-the-art facilities and proprietary technologies. The company has achieved six consecutive years of revenue growth and holds ICMC certification for its manufacturing operations.

Esteve CDMO (Esteve Química)

Spain

Esteve CDMO (Esteve Quimica) is a global pure-play third-party CDMO specializing in high-quality small-molecule active pharmaceutical ingredients. The company operates manufacturing sites in Spain and recently acquired Regis Technologies to expand U.S. capabilities, with FDA-registered facilities across multiple locations.

EUROAPI

France

EuroAPI is the global leader in small molecule APIs with a unique European industrial footprint of 6 manufacturing sites. Spun out from Sanofi with 15 years of oligonucleotide and 45 years of peptide experience, the company provides full CMC services from drug substance development through registration and commercial supply, including complex molecule segments like Tides (peptides and oligonucleotides).

Eurofins Biopharma Services (CDMO)

Australia

Eurofins Biopharma Services CDMO is a division of Eurofins Scientific offering integrated API and drug product outsourcing services across small molecules and biologics. The company provides services from early-stage development through commercial manufacturing including highly potent drug development, sterile manufacturing/fill-finish, lyophilization, and biologics development through its Alphora brand.

Euticals (now part of Curia)

France

Euticals, now part of Curia Global, is a global CDMO with over 30 years of experience in drug discovery, development, and manufacturing across small molecules, generic APIs, sterile drug products, and biologics. Curia (which acquired Euticals through AMRI) operates an extensive global network with hundreds of FDA-registered facilities and provides end-to-end services from API manufacturing through sterile fill/finish.

Evonik Industries AG

Canada

Evonik Industries AG is a global specialty chemicals company that operates as a leading CDMO for complex parenteral drug products, focusing on polymeric and lipid-based delivery systems including liposomes, nanoparticles, microparticles, implants, and LNP formulations. The company's Health Care division provides end-to-end CDMO services for small molecules, peptides, nucleic acids (mRNA, siRNA), and HPAPIs, with FDA-inspected facilities in the US and Canada and 34 FDA inspections with zero OAI outcomes.

FAMAR

Greece

FAMAR is a leading European pharmaceutical CDMO headquartered in Greece with a network of 7 production sites and 2 R&D centers across Europe, employing approximately 1,800 people. The company provides development, manufacturing, quality, regulatory, and logistics services for a wide range of pharmaceutical and consumer care products across 80+ international markets, with capabilities spanning from oral solid dose to sterile injectables and HPAPI products.

Fermion, a wholly owned subsidiary of Orion Corporation (Finland), is a CDMO specializing in developing, manufacturing, and marketing small molecule Active Pharmaceutical Ingredients (APIs), including HPAPIs, cytotoxics, steroids, generics, and controlled substances. Together with its parent Orion, it offers integrated contract development and manufacturing services for both drug substances and drug products, covering the full lifecycle from preclinical to commercial scale. FDA-approved since 1979 and EMA-approved since 1971.

Formulated Solutions

United States

Formulated Solutions is a U.S.-based CDMO providing formulation development, analytical development, manufacturing, regulatory affairs, and packaging services for pharmaceutical and consumer health products. The company offers flexible manufacturing from small-scale clinical batches to large-scale commercial production across multiple dosage forms.

Formulytica

Australia

Formulytica is an Australian specialty contract research, development and manufacturing organisation (CRDMO) with expertise in formulation, analytical method development, and drug product development. The company specializes in developing innovative drug formulations and analytical methods essential for clinical trial entry.

Fortrea

United States

Fortrea is a leading global contract research organization (CRO) spun off from Labcorp in 2023, providing Phase I through IV clinical trial management, clinical pharmacology, and market access solutions for biopharma and MedTech companies. While Fortrea has some onsite Phase I manufacturing capability for small molecule clinical supplies, its core business is clinical trial services, not contract drug manufacturing.

Gaelic Laboratories Limited

Ireland

Gaelic Laboratories Limited is an Irish contract manufacturer specializing in Beta-Lactam (penicillin) products in tablet, capsule, and powder for suspension form. Established in 2022 on a site with 40 years of FDA-approved Beta-Lactam manufacturing history, the company serves EU, UK, and MENA markets. The facility spans 8,000 sqm across two GMP manufacturing plants on an 11-acre site, with HPRA licensing.

Global Calcium Pvt. Ltd.

India

Global Calcium Pvt. Ltd. is a leading API manufacturer based in Bangalore, India, specializing in specialty APIs including benzodiazepines, ophthalmics, oncology compounds, and chelated mineral salts. The company operates 14 manufacturing plants with over 1,400 employees and exports to 80 countries. Facilities are cGMP, EU GMP, COFEPRIS certified, and WHO cGMP accredited with HACCP and ISO certifications.

GMP Laboratories of America, Inc.

United States

GMP Laboratories of America, Inc. is a US-based CDMO providing contract development and manufacturing services for oral solid dosage forms, liquids, semi-solids, and topical products. The company offers formulation development, analytical testing, stability studies, and commercial-scale manufacturing from its FDA-registered facility. It serves pharmaceutical and dietary supplement markets.

Gofarm Sp. z o.o. Sp.k

Poland

Gofarm Sp. z o.o. Sp.k is a Polish CDMO providing contract development and manufacturing services for pharmaceutical products, dietary supplements, and cosmetics. The company offers formulation development, analytical testing, stability studies, and commercial manufacturing for oral solid dosage forms, liquids, and semi-solid products. It operates from EU GMP-compliant facilities in Poland.

Groupe PARIMA

Canada

Groupe PARIMA is a Canadian CDMO founded in 1994 specializing in the development and manufacturing of non-sterile liquids, suspensions, and semi-solid drug products. Operating from a 67,000 sq ft facility in Montreal, the company provides turnkey services from formulation development through commercial production, supplying drug products to over 30 global markets.

Groupe SYNERLAB CDMO

France

Groupe SYNERLAB (now operating as Meribel Pharma Solutions) is a mid-size European CDMO with an integrated network of manufacturing sites across Europe, providing end-to-end services from API manufacturing through finished dosage forms. The company specializes in sterile multidoses, sterile and non-sterile lyophilized products, sachets, stick packs, oral solid dose, liquids, and semi-solids.

Grupo Azevedos (Sofarimex)

Portugal

Grupo Azevedos, operating through its Sofarimex manufacturing unit, is a Portuguese CDMO specializing in freeze-dried injectables and sterile eye drops, with over 20 years of contract manufacturing experience. The company manufactures pharmaceutical medicines and health products for third parties across non-sterile solid, semi-solid, and liquid forms, as well as sterile products, and holds manufacturing licenses from INFARMED and multiple international authorities.

Grupo Medinfar

Portugal

Grupo Medinfar is a Portuguese pharmaceutical company founded in 1970, with an industrial unit that has provided contract manufacturing services for over 20 years. The company manufactures non-sterile solid, semi-solid, and liquid pharmaceutical products for third-party clients, offering turnkey and custom services including bulk manufacturing, packaging, analytical release, and scale-up support.

Gruppo Farma Impresa S.r.l.

Italy

Gruppo Farma Impresa is an Italian contract manufacturer specializing in medical devices based on substances, food supplements, and dermocosmetics, offering private label production (conto terzi) and out-licensing of over 1,000 ready-to-market products. The company provides formulation development, R&D with over 200 new formulations annually, regulatory affairs support, and clinical trial services across multiple therapeutic areas.

GTP Bioways

France

Duplicate entry of GTP Bioways (company ID 1f8658ec). GTP Bioways, acquired by Olon Group in 2024, is a French biologics CDMO specializing in process development and GMP manufacturing of monoclonal antibodies, recombinant proteins, bispecifics, ADCs, and nanodrugs across four sites in France.

Guangzhou RiboBio Co., Ltd.

China

Guangzhou RiboBio Co., Ltd. operates a CDMO/CMO platform (RiboPharm) that is Asia's largest GMP oligonucleotide API manufacturer, with over 20,000 sqm of planned production area. The company provides comprehensive oligonucleotide drug discovery, process and analytical development, CMC services, API production, and aseptic fill-finish, serving global pharmaceutical companies in bringing nucleic acid drugs from development to market.

Hapila GmbH

Germany

Hapila GmbH is an independent chemical-pharmaceutical CDMO based in Gera, Thuringia, Germany, specializing in the development and GMP manufacturing of active pharmaceutical ingredients, including high-potency APIs. The company provides services from early development through to market supply for approved medicinal products.

HAS Healthcare Advanced Synthesis SA

Switzerland

HAS Healthcare Advanced Synthesis SA, based in Biasca, Switzerland, is a full-service CDMO with over 40 years of experience in pharmaceutical development and manufacturing. The company recently acquired Cerbios-Pharma SA to create a leading international CDMO group, backed by 65 Equity Partners.

HealthTech BioActives (HTBA)

Spain

HealthTech BioActives (HTBA) is a Spanish company and global leader in citrus flavonoids and Vitamin B12 active forms, with over 45 years of experience. The company specializes in the clean production of naturally sourced active pharmaceutical ingredients and nutraceutical ingredients from its manufacturing facilities in Murcia, Spain.

HIKAL

India

HIKAL is an Indian CDMO established in 1988, headquartered in Mumbai, partnering with global pharmaceutical, biotech, agrochemical, and specialty chemical companies. The company provides contract research, process development, and commercial-scale API manufacturing. HIKAL operates five manufacturing facilities and recently inaugurated a new High Potency API (HPAPI) laboratory at its Pune Innovation Centre to expand CDMO capabilities.

Histocell

Spain

Histocell is a Spanish clinical-stage biopharmaceutical company and CDMO specializing in regenerative medicine and advanced therapy medicinal products (ATMPs). Based in the Basque Country, the company develops and manufactures cell therapy products from iPSCs, MSCs, secretomes, and exosomes. Histocell recently achieved GMP certification from AEMPS for iPSC manufacturing in partnership with REPROCELL, and has produced over 350 GMP batches treating approximately 300 patients from its 800 m2 EMA-registered facility.

Honour Lab Limited

India

Honour Lab Limited is an India-based CDMO providing end-to-end development and manufacturing of drug substance (APIs). The company offers services from route scouting and process development through preclinical and clinical supply to commercial API manufacturing, including specialty chemicals and GMP production.

Shenzhen Hybio Pharmaceutical Co., Ltd. (Hybio) is a Chinese pharmaceutical company founded in 1998, specializing in peptide drug R&D, manufacturing, and commercialization with a CRDMO division. The company focuses on peptide APIs (including semaglutide) and sterile injectable formulations, with products sold in 30+ countries. Hybio has 7 FDA-registered facilities and a strategic partnership with Dr. Reddy's for peptide API supply, and recently partnered with Huawei for AI-driven drug development.

ICON plc

Australia

ICON plc is a leading global clinical research organization (CRO) providing end-to-end drug development services. The company offers bioanalytical laboratory services, specialty laboratory solutions, clinical supplies management, regulatory consulting, and early clinical development across all phases of drug development. ICON operates globally with GMP-trained experts.

Jubilant HollisterStier CMO

Canada

Jubilant HollisterStier CMO (subsidiary of Jubilant Pharma) specializes in sterile fill-finish, lyophilization, injectables, ophthalmics, otics, topicals, and liquids for pharmaceutical and biopharmaceutical clients. End-to-end services from process development to inspection and packaging. Facilities in Spokane, WA and Montreal, QC. Won AWB Manufacturer of the Year 2024 and Manufacturing Excellence Award 2025. Largest manufacturer by employees in Spokane area. 92% repeat customer rate. FDA registered with 4 FEI numbers, 28 inspections (6 NAI, 18 VAI, 4 OAI -- elevated regulatory risk).

Kingchem Life Science LLC

China

Kingchem Life Science LLC is a global small molecule CDMO specializing in the end-to-end development and manufacturing of APIs, intermediates, RSMs (regulated starting materials), excipients, and specialty chemicals. Their vertically integrated model spans from R&D through commercial production with facilities in St. Francis, Wisconsin (FDA-registered cGMP) and Fuxin, Liaoning, China, plus R&D in Dalian, China. They handle complex chemistry challenges, and their FDA facility (FEI 2129414) has had 9 inspections (1 NAI, 8 VAI, 0 OAI).

KINSY, S.L.

Spain

KINSY, S.L. is an independent Spanish CDMO with over 30 years of experience, located in Alhama de Murcia, specializing in the development, scale-up, and commercial production of pharmaceutical APIs and key intermediates under cGMP. They operate from a single site offering end-to-end services from early clinical stages through commercial manufacturing. KINSY is FDA-registered (FEI 3013310589) and holds ISO certification. They serve the fine chemical and pharmaceutical industry, working in close collaboration with partners on custom API synthesis.

KLEVA PHARMA (M.J. Kleva SA)

Greece

KLEVA Pharmaceuticals S.A. is a Greek pharmaceutical company established in 1974, specializing in contract manufacturing and technology transfer services. They operate two manufacturing sites in Greece, including a sterile area with filling capability expanded in 2019. KLEVA holds ISO 9001:2015 and EU GMP certification. Their R&D department develops generic pharmaceutical dossiers in CTD format, from patent search and API sourcing through formulation development, pilot-scale batches, stability studies, and dossier compilation. They have 190 marketing authorizations across Europe, Asia, Oceania, and Africa, serving over 50 customers in 30+ countries since 2012.

Kolon Biotech

South Korea

Kolon Biotech Inc. is a South Korean cell and gene therapy CDMO, part of the Kolon Group. They operate 17,000 sqm of facilities designed for both development and GMP manufacturing of cell and gene therapy products. Their B1 plant supports multiple simultaneous products and development projects, while B2 is optimized for mass production targeting global markets with flexible customization. Kolon Biotech is FDA-registered (FEI 3019016602) for analysis, API manufacture, labeling, manufacturing, and packaging. They offer end-to-end CDMO services aimed at shortening time-to-market, including a 2D Automated Closed Platform for large-scale adherent cell manufacturing.

Labcorp (incl. Labcorp Drug Development/Covance)

United States

Labcorp (including Labcorp Drug Development, formerly Covance) is one of the world's largest contract research organizations (CROs). They provide comprehensive drug development services including nonclinical development (toxicology, pharmacology, metabolism), central laboratory services (bioanalytical, biomarkers, genomics, companion diagnostics), and commercialization services. Labcorp supported 76% of all FDA-approved drugs in 2024. They operate across 100+ countries with services spanning from drug discovery to post-approval. While they offer CMC consulting services, their core business is contract research, not contract drug manufacturing.

Labialfarma

Portugal

Labialfarma is a Portuguese CDMO established in 1981, specializing in the development and contract manufacturing of nutraceuticals, medicines, cosmetics, medical devices, and complementary feed products. They serve over 15 million people worldwide annually. Their capabilities span solid, semi-solid, and liquid dosage forms, with proprietary technologies including flavoring, sealed benefit protection, rapid disintegration, and SmartPACKAGING innovations. They offer end-to-end services from formulation development to finished product packaging. Labialfarma is primarily focused on the nutraceutical/food supplement space rather than prescription pharmaceuticals.