Stability Studies CDMOs

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.

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.

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.

Applied Laboratories, Inc.

United States

Applied Laboratories, Inc. is a cGMP contract manufacturer headquartered in Columbus, Indiana, specializing in liquids, semi-solids (creams, ointments, gels), and topical pharmaceutical products. Originally founded in 1984 as an FDA regulatory consulting firm, it evolved into a full-service contract manufacturer with 200,000 sq-ft of cGMP facilities registered for both drug and medical device production. They provide formulation development through commercial-scale manufacturing, filling, labeling, and packaging for OTC pharmaceuticals and healthcare products.

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.

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.

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.

Aspen API

Netherlands

Aspen API (part of Aspen Global) is a CDMO specializing in complex chemical API and peptide manufacturing. With multiple FDA- and EMA-inspected manufacturing sites, they offer end-to-end API development from process R&D to commercial-scale production, including high-potency API (HPAPI) manufacturing with containment capabilities. They are part of the larger Aspen CDMO network.

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.

Astrea Pharma

France

Astrea Pharma is a CDMO founded with the purpose of building a customer-focused manufacturing network covering development to commercial supply. They acquired the Fontaine-les-Dijon solid dose manufacturing site from Recipharm and offer oral solid dose and aseptic manufacturing capabilities from development through commercial supply, with a focus on efficiency and value in the pharma supply chain.

Atlas Life Sciences Private Limited

India

Atlas Life Sciences Private Limited, a division of Atlas Dyechem (India), is an Indian API manufacturer established in 2009. They specialize in small molecule APIs including Pregabalin (anticonvulsant), Phenylephrine HCl (decongestant), Levosulpiride and Amisulpride (antipsychotics), Gliclazide (antidiabetic), and upcoming APIs including Azilsartan, Ticagrelor, and Chlorthalidone. Their WHO GMP-accredited manufacturing unit is in India.

August Bioservices

United States

August Bioservices is a US-based CDMO headquartered in Nashville, Tennessee, specializing in sterile injectable drug product development and manufacturing. They offer end-to-end services from lab-scale process development through commercial manufacturing, including formulation, analytical method development and validation, sterile filling for vials, syringes, and IV bags using both stainless steel and single-use technology (1L to 4000L), lyophilization, automated visual inspection, assembly, labeling, packaging, and serialization. The company operates fully isolated filling lines and drug-device combination product capabilities.

Avanti Polar Lipids (Croda Pharma)

United States

Avanti Polar Lipids, now a Croda Pharma brand (Avanti Research), is a US-based manufacturer and CDMO specializing in high-purity lipids for pharmaceutical and diagnostic applications. Through Croda Alabaster, their FDA-inspected cGMP manufacturing division, they provide contract manufacturing of lipid APIs, excipients, and adjuvants for vaccines and immunotherapies. Services span from custom lipid synthesis at 25mg scale through clinical trial materials to commercial-scale bulk production (1L to 55L batches), including liposome and nanoparticle formulation in cGMP manufacturing suites. They offer lipid-based drug delivery system development, method development and validation, ICH-compliant stability testing, and full regulatory support for IND/NDA submissions.

Avivia BV

Netherlands

Avivia BV is a Netherlands-based pharmaceutical development services company specializing in formulation development, analytical services, dissolution method development, and excipient analysis. Based at Novio Tech Campus in Nijmegen, Avivia bridges the gap from API to pharmaceutical formulations, offering reverse engineering, product characterization, competitor analysis, troubleshooting, and small-scale GMP batch manufacturing. Avivia was acquired by Ofichem Group (a CMO) in 2025 to expand formulation development capabilities. They operate as a CMO-independent development partner, selecting the best manufacturing facility for each product's commercial scale-up.

Bachem AG

Switzerland

Bachem AG is a leading global CDMO specializing in the development and manufacture of peptides and oligonucleotides, with over 50 years of experience. Headquartered in Bubendorf, Switzerland, Bachem provides end-to-end services from research-grade synthesis and CMC development through GMP-scale commercial API manufacturing for pharmaceutical and biotechnology companies worldwide. The company leverages innovative technologies including Multi-Column Solvent Gradient Purification (MCSGP) for higher throughput and purity. Bachem holds a strong regulatory track record and a partnership with Eli Lilly for oligonucleotide-based drug substance development and manufacturing (since April 2022). They serve the peptide therapeutics market including GLP-1 receptor agonists and other complex peptide APIs.

Basic Pharma

Netherlands

Basic Pharma is a full-service CDMO based in the Netherlands specializing in regulated pharmaceutical product development, manufacturing, and commercialization. They offer GMP-compliant manufacturing of medicinal products and formulations, active pharmaceutical ingredients, and analytical testing from lab scale to early clinical phase and beyond. Their state-of-the-art facility includes GMP-compliant clean rooms.

BCN Peptides

Spain

BCN Peptides (BCNpeptides) is a European leader in peptide API manufacturing with over 30 years of experience. As a GMP-certified CDMO approved by USFDA and EDQM, they specialize in solid phase synthesis of peptides from milligrams to multi-kilogram batches. They offer custom synthesis of new chemical entities for preclinical through commercial stages, generic peptide APIs, and GMP neoantigen peptides for personalized medicine.

BDD Pharma

United Kingdom

BDD Pharma is a UK-based combined CDMO and CRO specializing in lean early-stage drug development. With over 25 years of experience, they provide formulation development, GMP manufacturing, and clinical testing under one roof. Their new GMP manufacturing facility in Glasgow has been approved by MHRA for investigational medicinal products (IMP) and placebo manufacturing.

Benta Lyon SAS

France

Benta Lyon SAS is a French pharmaceutical company and CDMO established nearly 50 years ago in Saint-Genis-Laval near Lyon. They specialize in the development and manufacturing of generic pharmaceutical products with GMP/BPF-certified production facilities. Their site covers 16 hectares and focuses on dry, paste, and non-sterile liquid dosage forms, with plans to add sterile injectable capabilities. Their sister company Strategie Sante provides regulatory affairs, product development, and market access support.

BioCina

Australia

BioCina is a global end-to-end biologics CDMO and the only biologics CDMO in Australia approved by the US FDA. Following the merger with NovaCina, the company provides comprehensive biologics CDMO services spanning cell line development, process development, analytical development, GMP manufacturing of biologics drug substance and drug product, and mRNA manufacturing. Operates facilities in Adelaide, Australia with GMP manufacturing capacity up to 1,000L bioreactors.

BioConnection

Netherlands

BioConnection is a contract manufacturing organization (CMO) based in Oss, The Netherlands, specializing in aseptic fill and finish services for sterile drug products. The company offers flexible development and GMP-compliant manufacturing for both innovative and generic biopharmaceutical companies, with capabilities in vials, syringes, and lyophilized products. Partnered with AGC Biologics for drug product services. FDA-registered with 17 inspections (6 NAI, 11 VAI), demonstrating extensive regulatory history.

Biofarma S.p.A. (Biofarma Group)

Italy

Biofarma Group is an Italian CDMO partner specializing in the third-party development and manufacturing of dietary supplements (integratori alimentari), nutraceuticals, probiotics, medical devices, and cosmetics. The company provides contract manufacturing, R&D, formulation development, and packaging services. FDA-registered. This is primarily a health and beauty care CDMO, not a pharmaceutical drug manufacturer; their focus is on supplements, probiotics, and cosmetics rather than prescription drugs or biologics.

Biofortuna

United Kingdom

Biofortuna is a specialist contract development and manufacturing organization (CDMO) focused on diagnostic and life science applications. Based in the UK, the company provides assay development, lyophilization (particularly lyophilized reagent beads), dispensing, kitting, labeling, packaging, stability storage, and DNA extraction services. Biofortuna serves life science innovators with end-to-end outsourcing for diagnostics manufacturing. FDA-inspected (1 VAI). Recently tripled lyo bead output with bespoke robotic manufacturing.

Biologics Manufacturing Centre (BMC) Inc.

Canada

Biologics Manufacturing Centre (BMC) Inc. is a Canadian end-to-end GMP biomanufacturing facility with a public good mandate, established to secure domestic biologics supply. Licensed by Health Canada (DEL 3-002766-A and 3-002818-A) to manufacture and test biological products and vaccines. The facility is BSL-2 accredited and supports orphan drug development for rare and genetic diseases. Subsidiary of the National Research Council Canada.

Biopharma Group CDMO

United Kingdom

Biopharma Group is a UK-headquartered CDMO specializing in lyophilized (freeze-dried) and liquid pharmaceutical formulations for clinical manufacturing. They offer services from R&D through technical transfer, engineering batches, and clinical manufacturing to Annex 1 GMP standards. The company can handle substances classified up to OEB 6 and also manufactures non-sterile diagnostic formulations. They operate three Category D cleanrooms and a dedicated lyophilization center.

Bioprox SA (Bioprox Cultures / Bioprox Healthcare)

France

Bioprox SA operates two divisions: Bioprox Cultures (lactic acid starter culture production -- lyophilized ferments for dairy industry) and Bioprox Healthcare (probiotics and postbiotics toll manufacturing). With 50+ years of experience, 800+ clients, 120+ employees, and exports to 40+ countries. They offer custom culture development, toll manufacturing of proprietary probiotics/postbiotics, and R&D services. ISO 9001 and FSSC 22000 certified, with Halal and Kosher certifications. They are NOT a pharmaceutical manufacturer -- they produce live microbial cultures and probiotics.

Birgi Mefar Group (BMG)

Turkey

Birgi Mefar Group (BMG) is one of Turkey's leading producers of sterile injectable products, recently acquired by Abu Dhabi-based ADQ. The company provides contract manufacturing services for sterile injectables with manufacturing sites in Turkey. BMG is listed on pharmaceutical CDMO directories and provides fill-finish and sterile manufacturing services.

Bliss GVS Pharma Ltd.

India

Bliss GVS Pharma Ltd. is an Indian pharmaceutical company and the world's largest manufacturer of suppositories and pessaries, operating in 60+ international markets. The company operates six manufacturing units in Maharashtra and Daman with WHO-GMP and EU-GMP (PIC/S) approvals, producing suppositories, pessaries, tablets, dry syrups, dry powder injectables, ointments, creams, and gels. Bliss GVS offers contract manufacturing (CMO/CDMO) services alongside its own product portfolio.

Bluepharma

Portugal

Bluepharma is a Portuguese CRDMO with over 55 years of experience, offering an integrated approach from R&D through to commercial manufacturing of medicines. The company produces 2 billion units of oral solid pharmaceutical forms and has an industrial plant for high potency products. Bluepharma's facilities are EMA/Infarmed and FDA approved, and the company has expanded into advanced therapies beyond small molecules.

Caregen Co., Ltd.

South Korea

Caregen Co., Ltd. is a South Korean biotechnology company and global leader in biomimetic peptide synthesis. The company manufactures peptide-based APIs and health/cosmetic ingredients, with FDA inspection history and drug pipeline activities in dermatology and ophthalmology applications.

CD Formulation

United States

CD Formulation provides formulation development, analytical services, drug packaging, and pharmaceutical excipient solutions for pharmaceutical and biotechnology companies. The company offers contract manufacturing and contract research services including liposome cGMP manufacturing, accelerated stability studies, and a wide range of formulation types including oral solid, injectable, and topical formulations. They also supply pharmaceutical excipients and active pharmaceutical ingredients.

Celonic

Germany

Celonic is a Swiss-based 'Pure Play' biologics CDMO offering end-to-end drug substance development and manufacturing solutions for monoclonal antibodies, bispecifics, and other complex molecules. The company is a pioneer in next-generation bioprocessing technologies including process intensification and full perfusion. Celonic operates facilities in Basel, Switzerland and Heidelberg, Germany, and has a strategic alliance with CARBOGEN AMCIS for integrated ADC development and manufacturing.

Cenexi

Belgium

Cenexi is a Belgian/French CDMO specializing in sterile products, biological and injectable pharmaceutical manufacturing. The company operates four manufacturing sites in Europe, including sites in Fontenay-sous-Bois and Herouville-Saint-Clair (France), Osny (France, for highly active solid pharmaceutical forms), and Belgium. Cenexi offers services from development to commercial production for pre-filled syringes, vials, lyophilized products, tablets, capsules, and syrups, with FDA-registered manufacturing operations.

Centre c3i

Canada

C3i Center Inc is the first CDMO in Canada to receive approval for a Drug Establishment License to commercially produce cell therapy drug products. Based in Montreal, the company provides tailored cell and gene therapy CDMO services from development through commercial manufacturing.

Cerbios‑Pharma SA

Switzerland

Cerbios-Pharma SA is a privately held Swiss CDMO based in Barbengo-Lugano with over 40 years in the pharmaceutical industry, now part of the HAS Group. The company specializes in the development and manufacture of chemical and biotechnological APIs, with particular expertise in HPAPIs (high-potency APIs), ADC payloads and conjugation, and recombinant proteins and antibodies. Cerbios offers both chemical synthesis and biological manufacturing capabilities, including living microorganism-based products.

Coating Place Inc

United States

Coating Place Inc is a Wisconsin-based pharmaceutical CDMO founded in 1976, specializing in Wurster fluid bed coating technology for oral solid dosage forms. The company operates FDA- and EMA-approved GMP facilities in Verona and Sauk City, Wisconsin, with 24 proprietary Wurster fluid bed coaters handling batches from 0.010 kg to 800 kg, and is DEA-licensed for Schedule I-V controlled substances. The company celebrated its 50th anniversary in 2026.

Codis

United States

Codis is a global CDMO specializing in commercial-scale spray drying, amorphous solid dispersions (ASD), and particle engineering technologies. Formed through the integration of Particle Dynamics in the US and the Haverhill, UK facility previously operated by EUROAPI, the company operates over 400,000 sq ft of cGMP manufacturing space across three sites with a 30-year regulatory track record, and is the world's leading manufacturer of Sevelamer API producing hundreds of metric tons annually.

Confab Laboratories

Canada

Confab Laboratories is a well-established CDMO located on Montreal's South Shore, Canada, specializing in non-sterile pharmaceutical manufacturing of liquid, solid, and semi-solid dosage forms. The company provides end-to-end services including formulation development, technology transfer, analytical services, and commercial manufacturing for prescription, OTC, generic, controlled drugs, and veterinary products. Confab operates a 100,200 square-foot GMP facility with 32 manufacturing suites and 17 packaging suites, approved by both the FDA and Health Canada.

CorePharma LLC

United States

CorePharma LLC, founded in 1998 and headquartered in Middlesex, NJ, is a CDMO specializing in oral solid dosage forms including IR and ER tablets and capsules. The company offers end-to-end services from product development and contract manufacturing to packaging and analytical testing, with cGMP-compliant FDA & DEA registered facilities producing over 2 billion units annually.

CRAMSN Research Park

India

CRAMSN Research Park is an India-based contract research, development, and manufacturing organization offering end-to-end CRO, CDMO, and CMO solutions. The company provides drug substance (API) and drug product manufacturing with multiple facilities in India and a facility in New Jersey, USA, committed to sustainable practices including green chemistry and solar-powered operations.

Crystal Pharmatech

Canada

Crystal Pharmatech is a global pharmaceutical CRO/CDMO headquartered in Canada specializing in solid-state research, advanced formulation development, and GMP manufacturing for small molecule drugs. The company offers a First-Time-Right 3-STEP approach from API form selection through crystallization development to clinical and commercial manufacturing, with sites in Canada, the US, and China.

Custom Pharma Services

United Kingdom

Custom Pharma Services is a UK-based CDMO founded in 1979 in Brighton, specializing in oral solid dose manufacturing and packaging for clinical and commercial use. The company is MHRA-approved and FDA-inspected, with capacity exceeding 1.5 billion tablets and 250 million capsules annually. Custom Pharma handles controlled drugs, hormonal products, and has launched Centrix Pharma Solutions for early-stage development.

Dalton Pharma Services

Canada

Dalton Pharma Services is a Canadian CDMO and subsidiary of Seikagaku Corporation Japan, providing integrated drug discovery, development, and manufacturing services. The company is FDA-inspected and Health Canada-approved with over 35 years of experience, specializing in custom chemical synthesis, cGMP API manufacturing, sterile vial filling, and formulation development including liposomal formulations. Dalton recently announced major expansion of its commercial sterile manufacturing capacity.

Danhson

Bulgaria

Danhson is a Bulgaria-based pharmaceutical holding company established in 2015, with group companies including Vetprom AD (65+ years of manufacturing history) and Danapha Pharmaceutical in Vietnam. The company develops, produces, and markets pharmaceutical products (Rx and OTC), food supplements, and cosmetics, with CMO/CDMO services. Danhson has invested BGN 50 million in a new production site with separate workshops for ampoule forms, liquid forms, semisolid, and biological products.

Davipharm

Vietnam

Davipharm (Dat Vi Phu Pharmaceutical JSC) is a Vietnamese pharmaceutical manufacturer and member of the Adamed group, holding EU GMP certification. The company manufactures over 300 generic drug products at its facility in Binh Duong, Vietnam, and offers CMO/CDMO services including high-potency drug manufacturing. Davipharm recently expanded its capacity and capabilities in high-potency manufacturing.

Deccan Nutraceuticals Pvt. Ltd. (DNPL)

India

Deccan Nutraceuticals Pvt. Ltd. (DNPL) is an Indian API manufacturer and group company of Alkaloids Corporation, primarily producing active pharmaceutical ingredients, intermediates, and botanical/phytopharmaceutical extracts. Operating from a 22,000 sqm FDA-authorized, USFDA and EDQM inspected facility, DNPL has a portfolio of over 100 products including plant-based, semi-synthetic, and synthetic APIs. The company exports to major markets including USA, EU, Australia, and Canada.

Delpharm

Canada

Delpharm is one of the world's top five CDMOs, specializing in the development and manufacture of medicines across solid, sterile, semi-solid, and liquid dosage forms with particular expertise in nasal sprays and injectables. The company operates 18 manufacturing sites and 3 development centers across Europe and North America, with 6,500 employees and over 1.1 billion EUR in turnover. Delpharm produces over 650 million units annually and recently received a $60 million Canadian government investment to modernize its Boucherville injectable facility.

DifGen Pharmaceuticals

United States

DifGen Pharmaceuticals is a US-based CDMO specializing in complex generics and advanced drug delivery systems, providing end-to-end solutions from product development through commercial manufacturing. Through its 2023 acquisition of Aveva Drug Delivery Systems Inc., DifGen gained a 455,000 sq. ft. US manufacturing footprint producing over 300 million transdermal patches annually, including controlled substances like buprenorphine transdermal systems.