In the news
$106 million investment to modernize
350,000 square-foot facility
Unither Manufacturing LLC
Global CDMO
Blow-Fill-Seal (BFS) worldwide leader
Liquid stick-pack pioneer
A world leader in the
development and manufacturing
of Blow-Fill-Seal technology (BFS)
BLOW-FILL-SEAL
BOTTLES
LIQUID STICK-PACKS
MULTIDOSE
Our news
$106 Million to Modernize Rochester Facility
Manufacturing of registration batches of PXT3003 in single unit doses
Unither Manufacturing LLC 10th anniversary
Unither Manufacturing LLC celebrates this year its 10-year anniversary. Acquired in October 2013 to expand U...
Pharnext moves production of its pending drug PXT303 to the United States
Pharnext, a biotech company developing new treatments for neurodegenerative diseases without satisfactory th...
Liquid stick-pack technology
Unither Pharmaceuticals is a reference for liquid stick-pack technology. The liquid stick-pack offers the po...
12
countries
in which our products are sold
250
million doses
Stick-pack specialist
300
employees
A growing company
5
billion doses (globally)
World leader in Blow-Fill-Seal
23
current product families
Diversity of products to answer your needs
10
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
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 Amiens (France) and Rochester (USA) sites, also dedicated to BFS technology, offer an alternative production option to meet the needs and constraints.
2,5 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 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), the Turkish Ministry of Health, the KFDA (Korean Food Drug and Administration), the GCCDR (Gulf Central Committee for Drug Registration) and the Taiwanese authorities, among others.
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.
1,5 billion-unit doses/year
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 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.
As we strive to hire highly motivated, quality individuals who want to be a part of our team, we offer competitive salaries! Over benefits include: Free healthcare, 401k and Retirement Savings Plan, Profit-Sharing Bonus, …
MEDICA
13-16 November
Dusseldorf, Germany
AAO
18-21 Novembre
Chicago MI, North America
OIS XIII
1-2 December
San Diego, North America
Our events
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:
Blow-Fill-Seal (BFS) – Filling: 0.25 mL to 3.0 mL – Solution, suspension, gel, emulsion for preservative free eye drop and inhaled medication
Liquid stick-packs – Filling: 2.5 mL à 10 mL – Solution, suspension, gel for oral and topical application Pharmaceutical bottles – Solutions and suspensions for oral use (sustained and controlled release formulations)
Tablets & capsules – Hard shell capsules filled with immediate release and prolonged release mixtures
Our services include: Services Formulation and 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 cGMP Clinical Batches (Pilot and Industrial Scale), ICH Stability (Clinical Batches Registration and On-going)
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.
For controlled release bead processes, GPCG-3 and GPCG-5 processors with Wurster inserts are available. Batch sizes in these units range from approximately 1 to 25 kg. For process scale-up and commercial manufacture, two GPCG-60 units are available with 18 and 32-inch Wurster inserts for batch sizes ranging from approximately 30 to 225 kg.
Our pharmaceutical company in the USA undertakes tableting and liquid stick-pack filling operations under industrial conditions. Tablet batch sizes can range from 1.5 to 75 kg with additional equipment available in commercial manufacturing for scale-up.
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.
