Stability Studies CDMOs

Novartis Contract Manufacturing

Austria

Novartis Contract Manufacturing is the CDMO arm of Novartis, offering fully integrated end-to-end manufacturing solutions across biologics (mammalian up to 15,000L, microbial up to 13,000L), small molecules (API to fill & finish), cell & gene therapy (CAR-T, AAV, LV), xRNA/LNP/pDNA, and comprehensive fill & finish services. The operation spans multiple state-of-the-art facilities across Austria, Switzerland, Slovenia, Belgium, France, Singapore, and the United States, with 107 FDA inspections and 27 FEI registrations.

Novocol Pharma

Canada

Novocol Pharma is a CDMO headquartered in Cambridge, Ontario, Canada, specializing in sterile injectable fill-finish and combination drug product assembly. With over 40 years of experience, the company offers aseptic and terminally sterilized manufacturing from development through commercialization. Novocol Pharma is a Septodont company and has a fill-finish partnership with Moderna for mRNA vaccines.

Novugen Pharma

Malaysia

Novugen Pharma is a Malaysian pharmaceutical company and CDMO subsidiary of UAE-based SciTech International, providing vertically integrated API and finished dosage form development and manufacturing. The company has USFDA-approved facilities including a dedicated oncology manufacturing plant. Novugen achieved zero Form 483 citations from USFDA and holds Halal pharmaceutical certification.

Nuvisan

France

Nuvisan is a full-service CRO and CDMO headquartered in France with state-of-the-art laboratories in Germany and France. The company provides integrated drug discovery and development services spanning omics and biomarkers, compound screening, pharmacology, chemistry, preclinical safety, bioanalysis, clinical services (Phase 1 and 2), and CMC services including drug substance and drug product manufacturing, pharmaceutical analytical services, and clinical trial supply management.

OFD Life Sciences

India

OFD Life Sciences is a division of Oregon Freeze Dry, one of the largest and most experienced lyophilization companies, with over 60 years of freeze-drying expertise. The company provides comprehensive lyophilization services for biopharma, medtech, and consumer health sectors, from development through commercialization. Its proprietary LyoVantage platform supports cycle development and clinical trial and commercial-scale lyophilization.

Pace® Life Sciences

United States

DUPLICATE ENTRY -- This is the same company as 'Pace Analytical Services LLC (Pace Life Sciences)' (company index 10). Pace Life Sciences is the CDMO/CRO division of Pace Analytical. Same website content, same capabilities. See company index 10 for full profile.

PCI Pharma Services

Australia

PCI Pharma Services is a global CDMO providing fully integrated drug development, manufacturing, clinical trial services, and commercial packaging solutions. With over 8,000 employees in 38 GMP facilities worldwide, PCI offers services spanning sterile fill-finish, lyophilization, oral solid dose manufacturing, complex formulations, and advanced drug delivery including drug-device combination products.

Pell Tech Healthcare Pvt. Ltd.

India

Pelltech Healthcare is a privately owned WHO-GMP approved Indian pharmaceutical company specializing in the manufacture of conventional and modified-release pellets and finished formulations in capsules and tablets. The company has a dedicated state-of-the-art manufacturing facility focused on pellet-based oral solid dosage forms, taking APIs through formulation development to commercial production.

Pen Tsao Chemical Industry Ltd

China

Pen Tsao Chemical Industry Ltd is a back-integrated manufacturer of APIs, advanced pharma intermediates, and oral solid dosage formulations based in Shanghai, China with over 25 years of experience. The company produces 30+ APIs and formulations from two facilities: a multipurpose plant in Baoshan (56 m3 reactor volume, 218 m3 at Jinshan) and a new site in Pinghu with 270 tons API capacity and 70 tons OSD capacity. Pen Tsao was the first WHO pre-qualified supplier of MDR-tuberculosis drugs.

Pfizer CentreOne

Belgium

Pfizer CentreOne is a global CDMO embedded within Pfizer, specializing in commercial manufacturing of oral solid doses, sterile injectables, biologics including monoclonal antibodies, and antibody-drug conjugates. It leverages Pfizer's global manufacturing network across six continents with cGMP-compliant sites and over 170 years of pharmaceutical manufacturing expertise, backed by $1B+ annual manufacturing investments.

Pharmaron

China

Pharmaron is a premier life science CRO/CDMO providing comprehensive R&D and manufacturing services across the entire drug discovery to commercialization process. The company serves small molecules, biologics, ADCs, cell & gene therapies, and protein degraders. It offers laboratory services, chemistry/manufacturing/controls (CMC), clinical development, and biologics/CGT manufacturing. Pharmaron acquired a commercial API manufacturing facility in the UK and operates a gene therapy CDMO in Liverpool with a 20-year track record. The company has over 20 years of experience across 7+ facilities in the UK, US, and China.

Pharmathen

Greece

Pharmathen is a Greek research-centred CDMO specializing in complex drug delivery and formulation development. Founded in 1969 and acquired by Partners Group for $1.89 billion, the company operates two state-of-the-art manufacturing facilities: Rodopi (FDA-approved, 15,300 m2, capacity 3.3 billion tablets, 1.2 billion capsules, 175 million blisters, 4 million sterile syringes/vials) and Pallini/Attica (4,000 m2, 800 million tablets/capsules, 1.5 million sterile vials, 6 million ampoules). Pharmathen has also acquired CBL Patras. Key technology platforms include Long Acting Injectables (biodegradable microparticles, nanosuspensions, self-assembled nanogel systems), modified release oral formulations, preservative-free ophthalmic formulations, and solubility/permeability enhancement technologies.

Porton Pharma Solutions

China

Porton Pharma Solutions is a global CDMO headquartered in China with over 4,300 employees and operations in the US, Europe (Slovenia), and China. They offer end-to-end services across small molecules, tides (peptides/oligonucleotides), biologics and conjugates (ADCs), and advanced therapy medicinal products. Technical solutions include crystallization, bio catalysis, metal catalysis, flow chemistry, preparative chromatography, milling, and chemical engineering. FDA-registered with 4 FEI numbers for API manufacture, they have 3 FDA inspections with clean outcomes (1 NAI, 2 VAI).

ProBioGen AG

Germany

ProBioGen AG is a fully integrated CDMO headquartered in Berlin, Germany, specializing in the development and GMP manufacturing of biopharmaceuticals, viral vectors, and vaccines. The company offers cell line development, process development, GMP manufacturing up to 1000L bioreactors, and comprehensive analytical services. ProBioGen leverages proprietary technologies including GlymaxX (ADCC enhancement), DirectedLuck (transposase system), and CHO.RiGHT production systems.

Pyramid Laboratories

United States

Pyramid Laboratories (now Pyramid Pharma Services) is a California-based CDMO established in 1988, specializing in aseptic manufacturing, development, and analytical services for parenteral drugs. The company supports biologics, peptide, and small molecule drugs from pre-clinical development through commercial supply. Pyramid operates a 90,000 sq ft GMP-compliant facility in Costa Mesa, California, and has received investment from Audax Private Equity.

Renaissance Lakewood, LLC

United States

Renaissance Lakewood is a US-based pure-play CDMO specializing in nasal spray and sterile injectable dosage forms. Founded in 1979 (originally Paco Packaging Labs), they have nearly 20 years of nasal spray experience and offer bench-to-shelf services including formulation development, spray characterization, clinical through commercial manufacturing. Recently acquired by LTS Lohmann Therapie-Systeme AG to expand LTS's CDMO capabilities. FDA-registered with manufacturing, analysis, labeling, and packaging operations in Lakewood, NJ. They have invested over $100M in facility improvements over the past five years.

Rentschler Biopharma

Germany

Rentschler Biopharma is a leading global CDMO focused exclusively on biopharmaceuticals, with over 50 years of industry experience. The company contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023, has supported 180+ biotherapeutics, and serves 180+ clients worldwide. It is an independent family-owned company employing approximately 1,400 people.

ScinoPharm (scinopharm.com)

China

ScinoPharm Taiwan is a CDMO headquartered in Tainan Science Park, Taiwan, specializing in high-tech oncology APIs, peptide synthesis, and sterile injectable drug products. With FDA-approved facilities and 18 flexible manufacturing lines, ScinoPharm provides end-to-end services from API development through sterile injectable fill/finish, with a strong focus on complex generics and oncology therapeutics.

Senores Group

India

Senores Group (Senores Pharmaceuticals Limited) is an India-based CDMO specializing in complex generic oral solid dosage forms and API manufacturing. The company operates 5 manufacturing facilities including 2 USFDA-approved formulation plants (Atlanta, USA and Gujarat, India) and 2 API/intermediates plants. Senores serves 300+ customers in 49 countries, with particular strength in controlled substances (C2-C5), extended-release, and orally disintegrating tablet formulations.

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.

Sever Pharma Solutions

France

Sever Pharma Solutions is a specialized CDMO focused on high-potent and cytotoxic drug products (up to OEB6), polymer-based controlled-release delivery systems (implants, vaginal rings), hot melt extrusion for bioavailability enhancement, and prefilled syringe/autoinjector aseptic fill-finish. With sites in Malmö (Sweden) and Putnam (Connecticut, USA), they offer end-to-end services from formulation development through commercial manufacturing.

Simtra BioPharma Solutions

Germany

Simtra BioPharma Solutions is a global CDMO focused exclusively on sterile injectable drug products. With over 65 years of expertise, Simtra offers formulation development, lyophilization cycle optimization, technology transfer, analytical services, fill/finish operations, specialized containment, and global regulatory support. They handle cytotoxics, highly potent compounds, biologics, vaccines, small molecules, ADCs, and diluents. They have a strategic alliance with MilliporeSigma for ADC manufacturing. The company has transferred 60+ ADC candidates including six commercial products to their German site.

Stira Pharmaceuticals (Sterile Injectable CDMO)

United States

Stira Pharmaceuticals is a U.S.-based CDMO specializing in the development and cGMP manufacture of complex sterile injectable products, with integrated analytical capabilities. Founded in 2019, the company serves the U.S. market with services spanning small molecules, peptides, oligonucleotides, and biosimilars in formats including vials, syringes, IV bags, and cartridges with batch sizes up to 2,000L.

Symbiosis Pharmaceutical Services

United Kingdom

Symbiosis Pharmaceutical Services is a world-class sterile fill-finish CDMO based in Stirling, UK, specializing in the GMP manufacture of liquid and lyophilized biological and small molecule drug products. The company serves clinical trial and commercial scale with FDA-inspected and MHRA-licensed facilities. Symbiosis has manufactured its first 10,000-vial commercial batch for a cancer immunotherapy currently in Phase III trials. The company handles a full range of biologics including ATMPs, viral vectors, mAbs, ADCs, RNA/peptide therapies, and vaccines.

Symeres

Netherlands

Symeres is a leading mid-sized transatlantic Contract Research, Development and Manufacturing Organization (CRDMO) providing integrated drug discovery and development services from idea to IND. With 600+ scientists across 9 global sites in Europe and North America, the company combines medicinal chemistry, ADME-tox, biology, formulation development, analytical services, and GMP manufacturing up to 1,000 L scale. The company recently acquired DGr Pharma and Exemplify BioPharma to expand its CMC capabilities.

Syngene International

India

Syngene International is a leading Indian Contract Research, Development and Manufacturing Organization (CRDMO) that provides integrated services spanning drug discovery through commercial manufacturing for both small and large molecules. The company has long-term research collaborations with Bristol Myers Squibb (extended until 2035) and Amgen. Syngene recently opened its first US manufacturing facility in Rockville, Maryland, and added a bioconjugation suite in Bengaluru for end-to-end ADC development. The company has 20 kL single-use drug substance capacity for biologics.

ten23 health

Switzerland

Swiss CDMO specializing in formulation, analytical and process development, sterile manufacturing (fill and finish), and testing of injectable medicines. First CDMO in the pharmaceutical industry for injectables to be B Corp certified. Operates from Basel and Visp, Switzerland. Opened new VIVA2 facility with expanded sterile manufacturing lines. QC laboratories approved by both Swissmedic/RHI and FDA. Partners with BD on Libertas wearable injector commercialization. Supports biologics, small molecules, and RNA therapeutics.

The Ritedose Corporation

United States

The largest US CDMO specializing in sterile Blow-Fill-Seal (BFS) technology for aseptic manufacturing of unit-dose medications. Based in Columbia, South Carolina with a 500,000+ sq ft facility and production capacity of over 2.6 billion units annually. Delivered more than 12 billion doses since 2012 with no patient interruptions. Provides both CDMO services and has a generics division. Offers the largest nebulized drug portfolio in the US. Key products include ophthalmic, respiratory, and inhalation medications. Has co-developed 80%+ of new BFS products over the past decade. 100% customer retention for 25 years. Recent investments include $17M cGMP lab expansion and seventh Syntegon packaging line. 16 FDA-approved products.

Thermo Fisher Scientific Inc.

China

One of the world's largest pharmaceutical CDMOs through its Patheon pharma services division. Provides end-to-end pharmaceutical development and manufacturing services for both small molecules and biologics, from API manufacturing through drug product, sterile fill/finish, packaging, and commercial supply. Operates 31+ FDA-registered facilities globally. 158 FDA inspections on record (52 NAI, 104 VAI, 2 OAI). Also provides cell therapy manufacturing solutions (CTS Rotea cell processing system), laboratory informatics, bioprocessing equipment, and reagents. 4 FDA-approved drug products. Revenue >$40B (full company).

Tiefenbacher Group

Cyprus

Purpose-driven, family-owned healthcare company pioneering healthcare since 1963, headquartered in Cyprus. Delivers best-in-class solutions across the entire pharmaceutical value chain from API distribution through development, manufacturing, and registration of affordable medicines. 900+ employees, 400+ customers, 180+ finished dosage form products, serving patients in 80+ countries. Production capacity up to 3 billion units per year. Manufacturing sites in Cyprus (large-scale oral solid dose, SPC waiver site) and Hyderabad, India (specialized high-potent manufacturing block for oncology, FDA-inspected). Includes Tiefenbacher Laboratories (TBD Pharmatech) as API CDMO division. Offers ICH stability studies, technology transfer, analytical laboratory services, and EU batch testing/release.

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.

UI Pharmaceuticals

United States

UI Pharmaceuticals (UIP) is the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the United States, operated by the University of Iowa. They offer comprehensive drug product CDMO services from formulation development through commercialization. In 2023, they launched a new 16,000 sq ft sterile processing facility with fill lines. They serve pharmaceutical, biotech, pediatrics, oncology, and research organizations worldwide.

Unolab Manufacturing

Spain

Unolab Manufacturing is a Spanish CDMO founded in 2008, specialized in development and manufacturing of sterile unit-dose liquid formulations using Blow-Fill-Seal (BFS Bottelpack) technology. Focused primarily on ophthalmic and respiratory products including saline solutions, hyaluronic acid formulations, and inhalation products. Operates an 18,000 m2 facility in Getafe, Spain with capacity exceeding 600 million doses per year. Products exported to 25+ countries. Also offers tech transfer, out-licensing, and product development services across the full product lifecycle.

Upperton Pharma Solutions

United Kingdom

Upperton Pharma Solutions is a UK-based CDMO with an award-winning 60,000 sq ft development and manufacturing facility (Trent Gateway) in Nottingham. They provide integrated services from pre-clinical through late-phase manufacture for oral solids, nasal, pulmonary, and parenteral dosage forms. They recently built a new 7 million GBP sterile fill/finish manufacturing facility with MHRA submission. Services include formulation development, clinical supply manufacturing (Phase I-III), process scale-up and optimization, quality control, and analytical development and validation.

Viralgen

Spain

Viralgen is a premier CDMO specializing exclusively in AAV-based gene therapy manufacturing, founded in 2017 as a subsidiary of AskBio within the Bayer AG group. Claims the world's largest manufacturing capacity dedicated to AAV. Operates from a cGMP facility in San Sebastian, Spain with bioreactors up to 2,000L. Offers end-to-end services from early construct optimization to commercial campaigns. 50+ clients across US, Europe, Asia, and Australia. 10+ years of lentiviral/AAV experience. 200+ batches in bioreactor. 130+ employees. 7 dedicated cleanrooms. Proprietary TESSA technology platform (from AskBio).

Wacker Biotech

Germany

Wacker Biotech is the CDMO division of Wacker Chemie AG, specializing in advanced biologics manufacturing including proteins, plasmid DNA, mRNA, LNP formulations, live microbial products, and vaccines. With over 30 years of experience and five GMP-compliant facilities in Germany, the Netherlands, and the United States, Wacker Biotech offers process development through commercial-scale manufacturing with E. coli-based technology platforms.

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.

WuXi Biologics

China

WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) for biologics, with over 12,000 employees across the US, Ireland, Germany, China, and Singapore. The company provides end-to-end solutions from discovery through commercial manufacturing for biologics including monoclonal antibodies, bispecifics, ADCs, vaccines, and mRNA products using both mammalian and microbial expression systems.

Xellia Pharmaceuticals

China

Xellia Pharmaceuticals is the global leader in fermentation-based non-beta-lactam anti-infective APIs and finished dosage forms (FDFs). With over 120 years of pharmaceutical manufacturing heritage, they supply APIs and sterile injectables to over 500 pharmaceutical companies across 80 countries. Also operates as a CMO for third-party sterile injectable production.

Adare Pharma Solutions

Italy

Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end integrated services from product development through commercial manufacturing, focused on oral dosage forms. They specialize in taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. They have developed and manufactured more than 65 products sold in over 100 countries globally.

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.

Adragos Pharma

Germany

Adragos Pharma is a globally operating CDMO headquartered in Munich, Germany, specializing in small molecule finished dosage forms. They operate six manufacturing sites across Europe and Japan: Athens (Greece, HPAPI capabilities), Halden (Norway, BFS sterile production), Jura (Switzerland, small-batch clinical/commercial), Kawagoe (Japan, ampoules and tablets), Livron (France, sterile liquids and suppositories), and Leipzig (Germany, semi-solid and non-sterile liquids).

Afton Scientific

United States

Afton Scientific is a pharmaceutical CDMO with over 20 years of expertise in aseptic manufacturing for biologics and small molecules. The company operates FDA-inspected facilities with a 99.9% on-time delivery rate and is investing in multi-year expansion of sterile fill-finish capabilities, including new technologies for improved efficiency and increased production capacity.

Akron Biotech

United States

Akron Biotech is a leading contract manufacturing organization (CMO/CDMO) providing cGMP-compliant solutions for cell and gene therapy. The company manufactures cytokines, growth factors, media, buffers, and transfection/transduction reagents, and recently expanded to a second 60,000 sq ft biologics manufacturing facility in Sarasota, Florida, to support growing demand for ancillary materials in cell and gene therapy.

Alcami

United States

Alcami is a US-based CDMO with 45+ years of experience providing integrated drug product manufacturing, laboratory services, and cGMP pharmaceutical storage. The company specializes in sterile fill-finish manufacturing (liquid and lyophilized injectables, prefilled syringes) and oral solid dose, with DEA licensing for controlled substances and EU/Annex 1 compliance.

Altasciences

Canada

Altasciences is a North American CRO/CDMO offering integrated early-phase drug development services. The company provides preclinical safety testing, clinical pharmacology (Phase I-II), bioanalysis, and manufacturing/analytical services including formulation development, drug product manufacturing (tablets, capsules, suspensions, creams, terminally sterilized injectables), and ICH stability testing, with DEA licensing for Schedule I-V substances.

AmbioPharm

China

AmbioPharm is a global peptide CDMO founded in 2005 and headquartered in North Augusta, South Carolina, USA. The company specializes in developing and manufacturing custom peptide APIs for pharmaceutical and biotech companies, with FDA-inspected facilities in the US and China and one of the largest peptide manufacturing capacities in the world.

American Injectables

United States

American Injectables is a privately held, FDA-approved CDMO specializing in sterile injectable drug products. Based in Florida, the company provides end-to-end services from formulation development through commercial manufacturing, with capabilities in aseptic fill/finish for vials and syringes, analytical testing, packaging, and serialization.