Stability Studies CDMOs

UPM Pharmaceuticals

United States

UPM Pharmaceuticals is a U.S.-based CDMO specializing in late-stage commercial manufacturing of semi-solid and oral solid dose products. Operating from a 475,000 sq ft cGMP FDA-registered facility in Bristol, Tennessee, UPM is a family-owned company with 30+ years of experience. They handle DEA-controlled substances and provide services from technology transfer and scale-up through commercial manufacturing. Capabilities include formulation development, analytical development, coated tablet manufacturing, pharmaceutical serialization, aggregation, and full packaging and warehousing.

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.

Hennig Arzneimittel GmbH & Co. KG

Germany

Hennig Arzneimittel GmbH & Co. KG is a German family-owned pharmaceutical company with over 120 years of experience, based in Floersheim am Main near Frankfurt. The company operates as both a branded pharmaceutical manufacturer and CDMO, specializing in solid dosage forms including sustained-release tablets, pellets, granules, and capsules. Acquired by Italian company Polifarma S.p.A. in January 2025.

Help S.A. (HELP Pharmaceuticals)

Greece

HELP Pharmaceuticals is a Greek pharmaceutical company founded in 1971, operating an EU-GMP certified production facility in Ioannina, Greece. The company manufactures pharmaceuticals, medical devices, nutraceuticals, and cosmeceuticals across sterile and non-sterile lines, including solid, liquid, and semi-solid dosage forms. HELP serves partners in more than 50 countries and provides clinical manufacturing and packaging services.

Heraeus Precious Metals GmbH & Co. KG

Germany

Heraeus Precious Metals GmbH & Co. KG is the pharmaceutical ingredients division of the Heraeus Group, specializing in the production of generic highly potent active pharmaceutical ingredients (HPAPIs) for cancer treatment. The company is the global market leader for platinum-based active ingredients including cisplatin, carboplatin, and oxaliplatin. In 2021, Heraeus made a multi-million euro investment expanding HPAPI manufacturing capacity in Hanau, Germany.

Symbiotec Pharmalab is a leading Indian manufacturer of corticosteroid and steroidal-hormone APIs with a global leadership position. With over 30 years of experience, the company has evolved from lab-scale manufacturing to industrial-scale production, operating two FDA-approved facilities (Rau and Pithampur, Indore). The company offers integrated CDMO solutions across organic chemistry, biotechnology/fermentation, and complex injectable platforms. It holds a 50%+ global market share in key steroid API molecules and serves 200+ customers in 40+ countries.

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.

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.

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.

HIPRA Biotech Services

Spain

HIPRA Biotech Services is the CDMO division of HIPRA, a Spanish biopharmaceutical company with over 50 years of experience in vaccine research, production, and commercialization. The CDMO unit offers comprehensive biologics contract development and manufacturing services across mammalian, avian, and insect cell culture, microbial fermentation (E. coli, yeast), and aseptic fill-and-finish. HIPRA has experience with over 300 biological entities and demonstrated rapid development capability during COVID-19 vaccine production.

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.

Accugen Laboratories, Inc.

United States

Accugen Laboratories is a contract microbiological quality control, research, and testing services laboratory based in Willowbrook, Illinois. They specialize in pharmaceutical microbiology testing, cosmetics and personal care microbiology testing, and environmental monitoring. Note: the website at accugen.com belongs to ACUGEN Software (a test generation software company), not Accugen Laboratories.

Wheeler Bio

United States

Wheeler Bio is a biologics CDMO based in Oklahoma City, specializing in accelerating antibody-based therapeutics from discovery to cGMP clinical supply. The company uses its proprietary Modular CMC approach to reduce risk and accelerate timelines for drug developers. Wheeler Bio offers cell line development, process development, analytics, and manufacturing services for monoclonal antibodies, bispecific antibodies, and fusion proteins.

Intas Pharmaceuticals

India

Intas Pharmaceuticals is a leading vertically integrated pharmaceutical company headquartered in Ahmedabad, India, with CDMO capabilities spanning API manufacturing through finished formulations. The company operates 14 manufacturing facilities globally (11 in India, plus UK and Mexico), serving 85+ countries with particular strength in oncology, biosimilars, and plasma-derived therapies. Its flagship Pharmez 2 facility can produce over 1 billion solid oral units monthly and 5 million injectable units.

Symphony Pharma Life Sciences Pvt Ltd

India

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

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).

AdhexPharma

France

AdhexPharma is an independent French CDMO specializing in the development and manufacturing of transdermal patches, topical patches, and oral dissolving films. With over 40 years of experience, they produce 180 million units annually and have 15+ ongoing development projects. They are cGMP compliant with both EMA and FDA standards and recently acquired tesa Labtec GmbH to expand capabilities.

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.

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.

TBD Pharmatech

Estonia

TBD Pharmatech (formerly TBD-Biodiscovery) is an EU-based small-molecule API CDMO headquartered in Tartu, Estonia. They are a dual-site, EU-GMP-certified organization specializing in small-molecule API development and niche-to-mid-volume commercial manufacturing. Services include end-to-end CDMO (route scouting to commercial supply), technology transfer, clinical and commercial batch production under cGMP, analytical method development, QP (Qualified Person) release, CMC regulatory support, and API distribution/sourcing under GDP. EU-GMP certified since 2008, ISO 9001 certified, FDA-registered for API manufacture and analysis. They operate two GMP facilities (Tiigi and Valja sites) in Tartu.

Tedor Pharma Inc

United States

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

AMSA S.p.A. (CFM Group)

Italy

AMSA S.p.A. is part of CFM Group, a custom API synthesis and contract manufacturing organization with three production plants in Italy and Ireland. The group specializes in small-medium volume API manufacturing for both generics and custom synthesis, operating under full cGMP compliance with a strong FDA inspection track record.

Tekro Lab

Czechia

Czech pharmaceutical CRO and CDMO specializing in veterinary pharmaceuticals and animal health. Offers GMP-certified contract manufacturing of solid dosage forms (premixes, pellets, tablets) with various active substances including penicillins, tetracyclines, and potentiated sulphonamides. Also provides contract research (preclinical studies), pharmacovigilance services, and regulatory affairs for veterinary medicinal products. Over 30 years of experience in the pharma industry.

Seda Pharma Development Services Ltd

United Kingdom

Seda Pharma Development Services Ltd is a UK-based pharmaceutical development consultancy and clinical manufacturing services provider. Through its subsidiary Seda Clinical Manufacturing Services (MHRA-licensed), the company provides formulation development, clinical pharmacology, DMPK, modelling, and GMP manufacturing of clinical trial materials. The company focuses on product design, performance prediction, and clinical supply.

Hanmi Pharm. Co. Ltd

South Korea

Hanmi Pharmaceutical is a major South Korean pharmaceutical company providing comprehensive CDMO services across the entire pharmaceutical lifecycle. The company operates through Paltan Smart Plant (producing 6+ billion chemical drug tablets annually), Pyeongtaek Bioplant (FDA-approved biopharmaceutical manufacturing with 12,500L bioreactors), and Hanmi Fine Chemical (API and raw materials including mRNA cap analogs, NTP, and lipids). Hanmi has partnerships with global pharma companies including Lilly, Roche, and Sanofi.

Andelyn Biosciences

United States

Andelyn Biosciences is a gene therapy and viral vector CDMO with deep expertise in the development and production of viral vectors. The company has produced 450+ cGMP clinical batches, supported 75+ INDs, and operates 225,000+ sq ft of facility space. Andelyn offers viral vector manufacturing, plasmid manufacturing, process development, and laboratory services, with a proprietary AAV Curator platform.

Amaran Biotechnology Inc.

Taiwan

Amaran Biotechnology Inc. is a Taiwan-based CDMO established in 2010, providing drug process development, manufacturing, and analytical services. The company specializes in drug substance manufacturing including bio-conjugation, purification, and lyophilization, as well as aseptic drug product filling with robotic systems in a PIC/S GMP-certified facility.

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.

Helix Biotech, Inc.

United States

Helix Biotech, Inc. is a U.S.-based CDMO specializing in GMP formulation and RNA manufacturing, including DNA, RNA, and LNP (lipid nanoparticle) formulations. The company offers end-to-end services from RNA construct design through its StrandSolve platform to GMP manufacturing via its NOVA IJM nanoparticle formulation platform.

Tiofarma

Netherlands

Tiofarma is a Dutch CDMO specializing in complex semi-solid formulations (creams and ointments) and emergency nasal sprays, offering services from pre-formulation through commercial supply. The company operates an EU-GMP and FDA-licensed manufacturing facility in Oud-Beijerland, Netherlands, with in-house R&D and analytical laboratories.

Sunny Pharmtech Inc. is a Taiwan-headquartered integrated specialty pharmaceutical CDMO specializing in high-potency APIs and drugs, including small molecules, peptides, and ADC linker-payloads. The company develops complex, high-barrier, niche drugs including ANDAs and 505(b)(2) filings, with state-of-the-art facilities offering OEB 5 containment and capabilities from early-stage formulation development to commercial manufacturing.

Lannett CDMO

United States

Lannett CDMO is the contract development and manufacturing arm of Lannett Company, a generic pharmaceuticals company. Specializes in oral solid dose (OSD) and liquid formulations, including high-potency compounds and DEA-controlled substances. Operates a 425,000 sq ft cGMP-certified manufacturing facility in Seymour, Indiana with dedicated suites for potent drugs. Capabilities include technology transfers, modified release technology, complex formulations, and reformulation. Has over 100 product families currently in distribution. Acquired by Aurobindo Pharma USA Inc. for $250 million in July 2025. Revenue of $306 million in FY 2025.

Aphena Pharma Solutions

United States

Aphena Pharma Solutions is a U.S.-based contract pharmaceutical manufacturing and packaging company operating from two FDA-registered locations. They specialize in liquid dose manufacturing, oral solid dose packaging, blister packaging, bottling, tube filling, injectable assembly, and clinical packaging. They are DEA-licensed for Schedule II-V controlled substances and ISO 13485 certified for medical devices.

Latitude Pharmaceuticals Inc

United States

Latitude Pharmaceuticals Inc is a San Diego, CA-based CRO/CMO (CRDMO) providing innovative drug formulation development and GMP manufacturing services. Founded in 2003, the company has completed over 900 pharmaceutical formulation development projects for 250+ client companies. Specializes in solving complex drug formulation challenges, particularly for insoluble APIs using their proprietary CLEARSOL platform. Provides GLP- and GMP-compliant manufacturing and analytical testing services for IND-enabling studies and Phase 1-2 clinical trial materials, including sterile injectables, fill/finish, lyophilization, vials, pre-filled syringes, and IV bags.

Apace Packaging LLC

United States

Apace Packaging is a U.S.-based FDA-registered contract pharmaceutical packaging and manufacturing company. They specialize in pharmaceutical packaging (blistering, bottling, tube filling, sachet packaging, clinical trial packaging) and also perform liquid and semi-solid manufacturing (blending, tube filling). They are DEA-licensed for Schedule II-V controlled substances.

Argonaut Manufacturing Services

United States

Argonaut Manufacturing Services is a U.S.-based CMO headquartered in Carlsbad, California, specializing in aseptic fill and finish, lyophilization (LyoDose beads, LyoDots, powders, and cakes), in-vitro diagnostics (IVD) and life science kit manufacturing, and drug-device combination products (DDCP). They recently secured $45M in financing to expand their aseptic fill/finish capabilities. They serve pharmaceutical, life science, IVD, and applied markets from small N-of-1 fills to high-scale commercial products.

Hovione

China

Hovione is a specialist integrated CDMO dedicated to helping pharmaceutical customers bring new and off-patent drugs to market. Founded in 1959, the company provides API development and manufacturing, drug product development, and particle engineering services across four GMP manufacturing sites worldwide.

Arran Chemical Company (Almac Group)

Ireland

Arran Chemical Company, now part of the Almac Group, is an Irish chemical manufacturer with over 40 years of experience specializing in custom synthesis of pharmaceutical intermediates, APIs, and registered starting materials (RSMs). Based in Athlone, Ireland, they offer specialized reaction technology including organometallic synthesis, catalytic transfer hydrogenation, and biocatalysis/chemocatalysis capabilities from kilo lab/pilot plant (10L to 1400L) through multi-tonne commercial scale.

Servier (Servier CDMO)

France

Servier CDMO is the contract manufacturing arm within the global pharmaceutical company Servier, bringing 60 years of expertise in drug product manufacturing and packaging. With 9 manufacturing sites and 16 locations globally, Servier CMO offers services from development through commercial-scale production of tablets, capsules, and powders, distributing over 450 million boxes annually across 150 countries.

Argenta (Animal Health CRO/CDMO)

Germany

Argenta is the world's only global animal health contract research, development, and manufacturing organization (CRO/CDMO). They provide end-to-end support for veterinary medicinal products including immunologicals/vaccines, biological non-immunologicals, pharmaceuticals, and novel therapies. They offer contract manufacturing for both sterile and non-sterile animal health products, with FDA-registered facilities across multiple sites globally. Note: they serve the animal health market, not human pharmaceuticals.

Iberfar – Industria Farmaceutica, S.A.

Portugal

Iberfar, Industria Farmaceutica, S.A. is a privately owned Portuguese pharmaceutical contract manufacturer founded in 1924. The company specializes in contract manufacturing of solid forms and non-sterile liquid products, including controlled drugs, at its EU cGMP-certified facility near Lisbon.

Artesan Pharma

Germany

Artesan Pharma is a German full-service CDMO based in Luechow, specializing in pharmaceutical contract development and manufacturing with 501-1,000 employees. They provide services spanning formulation development to commercial manufacturing across multiple dosage forms including oral solid doses (tablets, capsules, pellets), sterile prefilled syringes with innovative production processes, and liquids. They also offer serialization, final packaging (blister), and terminal steam sterilization capabilities.

ARL Bio Pharma

United States

ARL Bio Pharma is a U.S.-based contract testing laboratory headquartered in Oklahoma City, providing analytical and microbiological testing services for the pharmaceutical industry. They serve compounding pharmacies, outsourcing facilities, and pharmaceutical manufacturers with comprehensive laboratory quality testing including analytical testing, microbiology testing, raw material testing, forensics testing, and bioanalytical testing. They are FDA-registered for analytical operations.

Arxada (CDMO)

Australia

Arxada (formerly part of Lonza Specialty Ingredients) is a CDMO with over 40 years of experience in custom development and manufacturing of advanced intermediates and active ingredients. They operate from sites in Visp (Switzerland) and Kourim (Czech Republic), offering both chemical synthesis and biotechnology/fermentation routes from gram to multi-metric-ton commercial scale. Their backward-integrated site with on-site waste and energy management provides a comprehensive CDMO offering spanning process development, analytical development, formulation, and regulatory support.

Lifecore Biomedical

United States

Lifecore Biomedical (Nasdaq: LFCR) is a fully integrated CDMO headquartered in Chaska, Minnesota, specializing in sterile injectable drug product development and manufacturing. The company has over 40 years of experience in aseptic fill/finish, with particular expertise in highly viscous formulations. Lifecore is also a premium producer of non-animal-sourced sodium hyaluronate.

Aspire Pharmaceuticals (Aspire LLC)

United States

Aspire Pharmaceuticals (Aspire LLC) is a contract manufacturer specializing in softgel encapsulation and oral solid dosage forms. They offer proprietary technologies including GummiCore (gummy-centered softgels), Vecell Liposomes (liposomal delivery), and softgel manufacturing using tapioca, carrageenan, and gelatin. They also have FDA-approved inhaled and ophthalmic products in their portfolio.

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.

Liof Pharma

Spain

Liof Pharma is a European CDMO headquartered in the Basque Country, Spain, specializing in aseptic manufacturing and lyophilization of sterile injectable biologics. With over 15 years of experience, the company provides clinical and commercial manufacturing of biologics drug products including monoclonal antibodies, peptides, proteins, mRNA, AAV viral vectors, and vaccines. The facility operates in compliance with EMA, FDA, ANVISA, and AEMPS regulations.

Aton Biotech

China

Aton Biotech is a China-based biologics CDMO backed by Henlius Biotech, offering one-stop solutions from early development to commercial production. They provide services in process development, GMP manufacturing, analytical testing, and ADC development. With access to up to 144,000L bioreactor capacity from parent company Henlius, they focus on monoclonal antibodies, recombinant proteins, and antibody-drug conjugates.

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.