A world leader in the
development and manufacturing
of Blow-Fill-Seal technology (BFS)
Euroject®
An innovative BFS-based
device for single dose
injection of therapeutics
Sol-gel™
A patented technology for
formulating ophthalmic hydrogels
TABLET & CAPSULE
PFMD
BLOW-FILL-SEAL
LIQUID STICK-PACK
Our news
Marinomed Biotech AG: Extraordinary general meeting approves sale of Carragelose division
Launch of our first commercial batches of PFMD
Press Release – Acquisition of the Carragelose Portfolio by Unither Pharmaceuticals
Advanced liquid solutions for better patient outcomes
Ophthalmics at Butantã site, São Paulo
BIOPHTA raises 6.5 million Euros Seed Funding to transition its New Standard of Care for Eye Diseases to the Clinical stage
Scientific Review – Ophthalmology – Age-related Macular Degeneration (AMD)
Join us at Europharm SMC
30 year anniversary
Today, the company is a world leader in the manufacture of sterile unit doses, with a production capacity of...
100
countries
in which our products are sold
500
million doses
Stick-pack specialist
2000
employees
A growing company
5
billion doses
World leader in Blow-Fill-Seal
4
continents
International industrial footprint
30
years of experience
A unique know-how
Our goal is to ensure your success in the marketplace by supporting your growth. As a CDMO, Unither Pharmaceuticals offers strategic outsourcing of healthcare products (from early-stage development to manufacturing) using its technology platforms. In parallel, we offer licensing-out: turnkey products that are already registered: License or transfer of marketing authorization, sale of pharmaceutical pharmaceutical files, medical devices. Our collaboration gives you the opportunity to differentiate and expand your product lines with the primary goal of improving patient comfort.
Early-stage development
Galenic development, analytical development
Strategic outsourcing: development and manufacturing
Tech-transfer, scale-up, commercial batch manufacturing
Turnkey files and products
for licensing-out (white label)
Chine
France
Brésil
Etats-Unis
Nanjing
Unither Nanjing Pharmaceuticals
169 Jiangjun Ave, Jiangning District, Nanjing, Jiangsu
Ophthalmology & Asthma
Amiens
Laboratoire Unither Amiens
151, Rue André Durouchez Espace Industriel Nord CS 28028 80084 Amiens Cedex 2
Asthma
Paris
Unither Pharmaceuticals
Gannat
Unither Industries
Coutances
Laboratoire Unither
Colomiers
Unither Liquid Manufacturing
Bordeaux
Unither Développement Bordeaux
Barretos
Unither Pharma Brasil
Av. Mário de Oliveira, 605
Blisters, bottles, tubes, sachet, stick-packs
São Paulo
Unither Pharma Butantã
Rochester
Unither Manufacturing LLC
755 Jefferson Road Rochester, NY
Nanjing Unither Nanjing Pharmaceuticals ( Headquarter )
Unither Nanjing Pharmaceuticals specializes in the development and production of solid and liquid form pharmaceutical products, with an annual revenue around EUR 10 million. It is based in Nanjing, Jiangsu Province, and has 130 employees.
Blow-Fill-Seal (BFS)
0.4 to 3ml
Liquid stick-packs
Know-how
Physicochemical Methods – Appearance – Viscosity – Particle size – Refractometry, osmometry – Conductivity, pH-metry – Melting point (subcontracted)
Identification – TLC – HPLC – UV-Vis spectro – IR spectro
Limit Tests (all) – Biological Tests – Sterility – Bacterial Endotoxins – Bioburden
Pharmaceutical Technical Procedures – HPLC (UV, DAD, ELSD,RI) – Potentiometric Autotitrator – Autotitrator for semi-micro determination of water by Karl Fisher – UV-Vis spectrophotometry – GC/Headspace GC (subcontracted) – Dissolution – Friability
Cleaning Verification Testing – Analytical – Microbiological
Packaging
– 100% Leakage testing (High Voltage Discharge Leak Detection) – 100% Fill volume visual checking – Ink / Laser beam marking – Ampule labelling – Pouching in aluminium foil – Serialisation & Aggregation – Carton boxes packaging – Carton labelling
Standards & Regulations
GMP (China)
With a current staff of 360 employees, Amiens was the first site to specialize in the Blow-Fill-Seal (BFS) technology and now has over 30 years of experience in the technology.
Huge manufacturing capacity is provided by many, and increasing numbers of high-speed BFS lines. The plant produces 1.5 billion unit-doses per year. The analytical team validates methods and performs ICH stability studies.
The Coutances, Gannat (France), and Rochester (USA) sites, also dedicated to BFS technology, offer an alternative production option to meet the needs and constraints.
1,5 billion-unit doses/year
0.25 mL to 10 mL
The teams in Amiens are responsible for tech-transfer or the development of new products. They have the expertise to manage product development from the earliest stages (phases II and III). They also undertake full development of generics or medical devices.
Site specialty
– Compounding and filling with end-filtration sterilization, aseptic compounding and filling (suspensions), gel compounding, autoclaving and filling – Non-injectable and injectable sterile, unit-dose vials Blow-Fill-Seal technology (BFS) – Drug Products and Medical Devices
Standards & regulations
– European cGMP – ISO 13485
Services
– Development of manufacturing processes for new chemical entities or OTC – Formulation and implementation of processes for generic drugs or medical devices – Analytical services (development, validation and quality control) – Phase II and III cGMP clinical batches (variable batch size) – Packaging in sachet of clinical batches – ICH stability (pre-stability, development, clinical batches) – Scale up and validation of manufacturing processes – cGMP batches (pre-industrial and industrial scale)
Authorizations & Certifications
This site is regularly inspected by the ANSM (French National Drug Safety Agency), and other authorities worldwide.
Established over 30 years ago in France, we have grown into an international business that now boasts production facilities in Europe, North America, China and Brazil. We are thus ideally equipped to provide contract pharmaceutical packaging technology services on an international scale, closer to your markets. Moreover, we offer flexible collaboration models, whether you require services incorporating the development to the manufacturing of an entirely new product or are interested in new dosage forms for existing medication.
Our teams
We welcome all enquiries and look forward to developing a successful partnership with you. We will be delighted to welcome you to our Paris-based office, located in the center of Paris near Opera Garnier.
Furthermore, if you wish to join our teams, go to the Career section.
The Gannat site was acquired from the Créapharm Group in 2005 and already had facilities to produce hormone-based egg cells. Its capacities were increased by adding the Blow-Fill-Seal (BFS) technology, offering both innovative and over-the-counter products. The site currently has over 140 employees.
650 million single doses / year
Capacity : 5mL
Suppositories and Ovules
160 million single doses / year
A dedicated R&D team
The Gannat site has a dedicated team to manage the transfer and/or development of new products. They have the skills to manufacture clinical batches for phase III, as well as to develop generics or medical devices.
Site Specialty
– Hormone-based eggs – Rhinology
– ANSM’s European Current Good Manufacturing Practices (cGMP) – Certification ISO 13485 version 2016 (LNE)
– Formulation and implementation of processes for drugs – Analytical services (development and/or validation, quality control) – Phase II and III cGMP clinical batches (medium and large scale) – Packaging of clinical batches – ICH stability (pre-stability, development, clinical batches) – Scale-up and validation of manufacturing processes – cGMP batches (pre-industrial and industrial scale) – ICH Stability (registration and tracking of clinical batches)
This site is regularly inspected by the ANSM (National Agency for the Safety of Medicines) and the Russian Ministry of Health, as well as other authorities around the world.
Laboratoire Unither Coutances is a key player in the ophthalmology market, and the second site to specialize in Blow-Fill-Seal technology. The site manufactures more than 1.5 billion sterile doses each year and has more than 300 employees.
A unique back-up system exists between the Coutances (France) and Rochester (USA) sites, both also dedicated to BFS tehnology, to offer an alternative production response for certain requirements and challenges.
0.25 mL to 4 mL
Preservative-free multidose
25 million bottles/year
5 mL, 10 mL, 11 mL, 15 mL
The Coutances site has a dedicated team to manage the transfer and/or development of new products. They have the skills to manufacture clinical batches from pilot to industrial scale, including mixers for solutions, suspensions, emulsions and gels, as well as to develop generics or medical devices.
This site is regularly inspected by the ANSM (French National Drug Safety Agency), the FDA (Food Drug and Administration), ANVISA (the Brazilian agency), the Turkish Ministry of Health, the Iranian health authorities, the KFDA (Korean Food Drug and Administration), and the Ministry of Industry and Trade of the Russian Federation.
The Colomiers site was acquired from Sanofi in 2009, with state-of-the-art non-sterile bottled liquids, and semi-solids operations in place. Capabilities were enhanced by adding liquid stick-pack technology. The site currently has more than 190 employees.
The site has a high production capacity with several high-speed stick-pack machines delivering 340 million sticks per year, bottle lines delivering 40 million bottles per year, and suppository and pessary lines, as well as tubes. The liquid products can be manufactured in Europe, Brazil and the United States at the same time, which guarantees adaptability to meet demand on all three continents.
Liquid Stick-Packs: Unistick®
340 millions de sticks / an
5 mL to 15 mL
Pharmaceutical Bottles
40 million bottles/year
10 mL to 300 mL
Suppositories and Pessaries
80 million unit doses/year
Sprays
Tubes
Semi-Solid Topical in Tubes
The Colomiers site has a dedicated team to manage the transfer and/or development of new products. They have the skills to manufacture clinical batches for phases II and III, as well as to develop generics or medical devices. Unither Liquid Manufacturing can provide you with regulatory support for your marketing projects.
This site is regularly inspected by the ANSM (French National Drug Safety Agency)) and by ANVISA (Brazilian agency) and the Russian Federation amongst others.
The Bordeaux site was Créapharm Group’s R&D center until it was sold to Unither. It enabled us to meet the demand from pharmaceutical companies wishing to outsource product development and provides a platform for the in-house development of newly patented or non-patented technologies and formulations, which our customers can market under license. With more than 40 employees, the site’s teams master the development of all conventional galenic forms of new chemical entities from the earliest stages (phases I and II) and can rapidly manufacture clinical batches for initial trials. They develop several generic products each year and carry out technology transfers to Unither’s industrial sites or to sites selected by customers.
Sterile and non-sterile liquids
Solids and semi-solids
– Recommendations and pharmaceutical development strategy consulting – Pharmaceutical innovation and development (galenic formulation and analytical services) – Clinical (phase I to IV) and commercial (orphan drugs) manufacturing
Galenic expertise
– Solid forms: tablets, capsules, suppository, ovule… – Liquid forms: solution, suspension… – Semi-solid forms: cream, ointment… – Primary packaging: blister pack, tube, pillbox, bottles, stick-pack,…
Analytical expertise
– Development and validation of analytical methods – Quality control – ICH stability study
This site is regularly inspected by the ANSM (French National Drug Safety Agency) and the ANSES (French Agency for Food, Environmental and Occupational Health & Safety). It benefitted from a French tax credit from 2020 to 2024.
This facility was acquired from Mariol Industrial in December 2015 to establish a Brazilian manufacturing footprint. Extensive expertise in the development and manufacture of oral solids, liquids, vitamins supplements
50 million sticks/year
5 ml to 15 ml
Bottles
55 million bottles/year
10 to 300 ml
Tablets
900 million tablets/year
This site is regularly inspected by ANVISA cGMP.
This facility was acquired from Novartis/Alcon in October 2022 to establish a Brazilian manufacturing footprint within sterile liquids. The Site offers substantial available capacity around 73m multidose bottles on a 24/7 shift model and valuable aseptic capabilities (people, licenses, and equipment) to grow in the ophthalmology area along with respiratory and any other sterile project.
Multidose with preservatives
70 million bottles/year
Capacity: 1.5 to 15mL
Low shear impellers for gel phases
– 200L
– 400L
– 600L
2 Milling stations
3 Sterilization stations for product phases
Blender for API dispersion
Sterile containers with APIs
Low shear impellers
– 500L
– 1000L
Stability studies following ICH and WHO recommendations
Scale-up and Manufacturing Process Validation
Capacity for installation
Available techniques
Main equipment
Regulatory approvals
ANVISA (Brazil), INVIMA (Colombia), DIGEMID (Peru) and DRAP (Pakistan)
This facility was acquired from UCB Pharma in October 2013 to expand our international presence. The site now has more than 320 employees. Our U.S. pharmaceutical laboratory at the Rochester site is responsible for the development of Phase I-III products, generics, over-the-counter medicines, branded products, Class 2, 3 and 5 controlled substances and medical devices, in the following dosage forms :
Filling: 0.25 mL to 3.0 mL
Solution, suspension, gel, emulsion
Liquid Stick-Packs
Filling: 2.5 mL to 10 mL
Solution, suspension, gel
Pharmaceutical bottles
Filling: 10 mL to 150 mL
Solutions and suspensions
Our pharmaceutical company in the USA boasts a dedicated 6,000 sq. ft. cGMP pilot workshop, enabling various non-sterile oral solid and liquid formulations to be manufactured for development, process scale-up, and clinical trials. For oral liquids, batch sizes range from 0.5 to 560 L.
– Formulation, Development & transfer (BFS (Eye drops & Inhaled medication) / – Liquid stick-Pack / liquid bottles) – Analytical Services (Development and/or Validation, Quality control) – cGMP Clinical Batches Phase II and III (Medium and Large Scale) – Primary Packaging of Clinical Batches – ICH Stability (Pre-stability, Development, Clinical Batches) – Scale-up and Manufacturing Process Validation – Analytical Services (Quality Control) – cGMP Clinical Batches (Pilot and Industrial Scale) – ICH Stability (Clinical Batches Registration and On-going) – Full service manufacturing (BFS / Liquid stick-Pack / liquid bottles)
The Rochester site is inspected by the FDA (Food Drug and Administration), DEA certificate, as well as: Turkish Ministry of Health, MHA (Mexico City), ANVISA (Brazilian agency) EMA (European agency), MHRA (UK) and Health Canada, etc.
Global reach
in over 100 countries
Headquarter
Avenue Toussaint Catros, 33185 Le Haillan
Innovation & Development
1-3, Allée de la Neste, 31773 Colomiers
Laboratoire
1, Rue de l’Arquerie, 50200 Coutances
Ophtalmology
17 av Portes Occitanes, 03800 Gannat
Saline solution
3-5 rue Saint Georges, 75009 Paris
Commercial office
Bresil
Av. Nossa Sra. da Assunção, 736 Vila Butantã, São Paulo – SP, CEP: 05359-001
Ophthalmology
États-Unis
Unither Pharmaceuticals is a French CDMO with plants on four continents (United States, France, Brazil and China). As the world leader in the production of sterile unit-doses using Blow-Fill-Seal technology, and a specialist in non-sterile liquids (stick-packs, pharmaceutical bottles, sprays, etc.), our CDMO manufactures and develops innovative, sustainable and competitive solutions for our customers.
means participating in an ambitious business project – that of offering innovative health products which simplify the lives of patients around the world.
Founded in 1993 in Amiens (France), Unither Pharmaceuticals is a French CDMO specializing in the development and manufacture of single-dose liquid formulations (including eye drops, saline solutions, asthma medications in BFS unit doses and prescription or family medication products in stick packs) for pharmaceutical laboratories and generic manufacturers. Our CDMO currently employs around 2000 people in 8 manufacturing plants in France, the United States, Brazil and China.
Unither CDMO offers a wide range of pharmaceutical manufacturing and packaging technologies: Blow-Fill-Seal (BFS) technology, preservative-free multidose, liquid stick-packs, vials and sprays, tablets and capsules, and suppositories and ovules. Ophthalmic medications (glaucoma, dry eye, etc.), asthma treatments, analgesics, vitamins and dietary supplements, products for headaches, colds, coughs or digestive disorders… our single-dose or multi-dose technologies can be adapted to numerous applications to facilitate patient compliance.
We offer our customers several types of collaboration: the development and manufacturing of new products based on their specifications, a catalog of turnkey products but also early-stage development services based on our technology platforms. At Unither Pharmaceuticals, innovation and development are the key words: we offer our customers and their patients appropriate technologies.
Among other services:
Our regulatory team will support you in: drafting IMPDs/INDs, MA files (module 2.3 and 3) and technical files for medical devices (manufacturing part), pharmaceutical variations and answers to pharmaceutical questions from the authorities.
At Unither Pharmaceuticals, we understand that navigating the world of pharmaceutical development and manufacturing can raise numerous questions. To provide clarity and insight into our services, we’ve compiled a comprehensive FAQ guide addressing the most common queries about what we do and how we can support your pharmaceutical needs.
A pharmaceutical CDMO (Contract Development and Manufacturing Organization) is a specialized company that provides a range of services to the pharmaceutical and biotechnology industries. CDMOs play a crucial role in the drug development and manufacturing process by offering services such as drug formulation development, analytical testing, clinical trial manufacturing, and commercial-scale production.
By outsourcing these services to CDMOs, pharmaceutical companies can benefit from specialized expertise, reduce costs, and accelerate the development and manufacturing timelines for their drug products. This allows pharmaceutical companies to focus on their core competencies, such as research and marketing, while leveraging the specialized capabilities of CDMOs for other aspects of the drug development and manufacturing process.
Unither is a global Contract Development and Manufacturing Organization (CDMO) with nearly 30 years of experience. Unither envisions making healthcare products that improve and simplify patients’ lives. Our commitment to constant innovation, cutting-edge technologies, and a global presence (France, Brazil, US, China) positions us as a leader in the industry. We specialize in liquid formulations, including liquid stick-pack and Blow-Fill-Seal (BFS) technology, catering to both originator and generic pharmaceutical companies.
Unither’s commitment to innovation, specialization in key pharmaceutical forms, turnkey solutions, and a global presence make us an ideal partner for pharmaceutical laboratories and start-ups seeking a reliable and experienced CDMO.
Unither offers a spectrum of collaborations, including early-stage development encompassing galenic and analytical development. Additionally, we provide strategic outsourcing opportunities for tech-transfer, scale-up, and commercial batch manufacturing, along with turnkey solutions for licensing-out (white label) products. We also offer a co-development innovative approach, not only reduces R&D costs, granting access to new markets but also minimizes risks by ensuring market-driven and patient-centric products, all facilitated through our extensive international footprint and sustainable, open innovation practices.
Our expertise extends to a wide range of pharmaceutical products, including eye drops, saline solutions, asthma medications in BFS single doses, liquid stick-packs, tablets, sprays, suppositories, and pessaries.
Recognizing the limited market at its inception, Unither pursued a strategy of introducing new unit dose products proactively. By sharing the benefits of economies of scale and industrial competitiveness with our clients, we rapidly expanded the unit dose market. Today, Unither stands as the global leader in BFS technology with a global capacity of 5 billion doses.
BFS technology is a cornerstone of our unit dose manufacturing. It offers numerous advantages, such as aseptic production, reduced contamination risks, and efficient packaging of liquid formulations.
All sites are regularly inspected by European authorities in order to be able to supply products to European markets. One European site and the US site are inspected and accredited by the FDA (USA) in order to supply the US market. These sites are also inspected by ANVISA (Brazil), SKFDA (South Korean FDA), EMA (Europe) and other health authorities around the world.
With manufacturing plants in France, the USA, Brazil, and China, Unither combines global expertise with an understanding of local regulations. This allows us to tailor our services to meet the specific needs and requirements of clients in different regions.
Unither Pharmaceuticals prioritizes sustainability through a comprehensive Corporate Social Responsibility strategy focused on improving treatment access, ensuring the well-being of our collaborators, and actively reducing our environmental impact. Our initiatives include calculating and targeting reductions in carbon emissions, implementing recycling measures like Low-density Polyethylene recycling, and obtaining Ecovadis certification for our French sites. Additionally, we are advancing patient-centric innovations, such as the development of Euroject® injection devices, while fostering employee engagement through shareholding initiatives.
From clinical batches to large-scale commercial production, our global sites in France, the USA, Brazil, and China offer comprehensive innovation and development services, assisting customers in selecting appropriate dosage forms for their specific needs. Specializing in sterile and non-sterile unit doses and multidoses, Unither provides solutions for diverse applications, such as buccal health, cold and flu remedies, gastroenterology, and more. For detailed information on our pharmaceutical dosage forms and collaboration opportunities, please feel free to contact us directly. In addition to our manufacturing capabilities, we also offer a range of services to support the development and commercialization of orphan drugs.
To collaborate with Unither for your pharmaceutical development needs, you can benefit from our full-service development offering, covering development, validation, transfer, and stability, guided by a Quality by Design (QbD) approach.
Our collaborative approach involves the various stages of pharmaceutical development. Our engagement includes Research and Development (R&D), formulation expertise, pre-clinical and clinical development support, small batches manufacture for clinical and commercial purposes, and consumer/market tests. We provide promise and analytical services, aligning with our commitment to regulatory support, development strategy, and the compilation of Investigational Medicinal Product Dossiers (IMPD).
Unither stands out as an innovative company by seamlessly combining technical expertise with a commitment to improving patients’ lives through creative health solutions. We focus on continuous innovation, offering improvements and new solutions. Our diverse range of services, including pharmaceutical development, co-development, patented technological platforms, and regulatory support, reflects our dedication to providing comprehensive and forward-thinking solutions that exceed the traditional boundaries of healthcare product development.
We hope this FAQ guide provides valuable insights into Unither’s pharmaceutical services. If you have additional questions or require further information, feel free to reach out to us. Unither is dedicated to being your trusted partner in pharmaceutical development and manufacturing.
