Your Global CDMO

A world leader in the

development and manufacturing

of Blow-Fill-Seal technology (BFS)

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30 years

of innovation and expertise

for our customers and the patients

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Unither Développement Bordeaux

Explore the exciting

developments that are

shaping the future of

pharmaceuticals

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Our technologies of pharmaceutical manufacturing

STERILE LIQUIDS (BFS, PFMD)

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NON-STERILE LIQUIDS (stick-pack, bottle, nasal spray)

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TABLET & CAPSULE

PFMD

BLOW-FILL-SEAL

LIQUID STICK-PACK

Key figures Unither Pharmaceuticals

0

countries

in which our products are sold

0

million doses

Stick-pack specialist

0

employees

A growing company

0

billion doses

World leader in Blow-Fill-Seal

0

continents

International industrial footprint

0

years of experience

A unique know-how

Collaborate with us: from pre-formulation to commercial batches

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

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Strategic outsourcing: development and manufacturing

Tech-transfer, scale-up, commercial batch manufacturing

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Turnkey files and products

for licensing-out (white label)

Our products

Global reach in over 100 countries

Unither Pharmaceuticals
CHINA +
FRANCE +
BRAZIL +
UNITED STATES +

Chine

France

Brésil

Etats-Unis

Nanjing

Unither Nanjing Pharmaceuticals

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.
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Nanjing

Unither Nanjing Pharmaceuticals

Amiens

Laboratoire Unither

The first site to specialise in BFS technology, Unither Laboratoire benefits from over 30 years' experience in unit-dose manufacturing and produces more than 2.5 billion unit-doses each year. The site currently has 360 employees.
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Amiens

Laboratoire Unither

Paris

Unither Pharmaceuticals

Gannat

Unither Industries

Coutances

Laboratoire Unither

Colomiers

Unither Liquid Manufacturing

Bordeaux

Unither Développement Bordeaux

Barretos

Unither Pharma Brasil

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.
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Barretos

Unither Pharma Brasil

São Paulo

Unither Pharma Butantã

Rochester

Unither Manufacturing LLC

This facility was acquired from UCB Pharma in October 2013 to expand our international presence. The site now has more than 320 employees.
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Rochester

Unither Manufacturing LLC

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Nanjing
Unither Nanjing Pharmaceuticals
169 Jiangjun Ave, Jiangning District, Nanjing, Jiangsu
Ophthalmology & Asthma
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.
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Amiens
Laboratoire Unither
151 rue Andre Durouchez, 80084 Amiens
Asthma
The first site to specialise in BFS technology, Unither Laboratoire benefits from over 30 years' experience in unit-dose manufacturing and produces more than 2.5 billion unit-doses each year. The site currently has 360 employees.
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Paris
Unither Pharmaceuticals
3-5 rue Saint Georges, 75009 Paris
Commercial office
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.
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Gannat
Unither Industries
17 av Portes Occitanes, 03800 Gannat
Saline solution
The Gannat site was acquired from the Créapharm Group in 2005 and already had facilities to produce hormone-based egg cells.
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Coutances
Laboratoire Unither
1, Rue de l’Arquerie, 50200 Coutances
Ophtalmology
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 1.2 billion sterile doses each year and has more than 290 employees.
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Colomiers
Unither Liquid Manufacturing
1-3, Allée de la Neste, 31773 Colomiers
Laboratoire
This facility was acquired from UCB Pharma in October 2013 to expand our international presence. The site now has more than 320 employees
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Bordeaux
Unither Développement Bordeaux
Avenue Toussaint Catros, 33185 Le Haillan
Innovation & Development
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
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Barretos
Unither Pharma Brasil
Av. Mário de Oliveira, 605
Blisters, bottles, tubes, sachet, stick-packs
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.
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São Paulo
Unither Pharma Butantã
Av. Nossa Sra. da Assunção, 736 Vila Butantã, São Paulo – SP, CEP: 05359-001
Ophthalmology
This facility was acquired from Novartis/Alcon in October 2022 to establish a Brazilian manufacturing footprint within sterile liquids.
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Rochester
Unither Manufacturing LLC
755 Jefferson Road Rochester, NY
Ophthalmology & Asthma
This facility was acquired from UCB Pharma in October 2013 to expand our international presence. The site now has more than 320 employees.

Global reach

in over 100 countries

France

Amiens

Laboratoire Unither

Headquarter

151 rue Andre Durouchez, 80084 Amiens

Asthma

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.

Blow-Fill-Seal (BFS)

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.

Bordeaux

Unither Développement Bordeaux

Avenue Toussaint Catros, 33185 Le Haillan

Innovation & Development

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

Site Specialty

– 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

Authorizations & Certifications

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.

Colomiers

Unither Liquid Manufacturing

1-3, Allée de la Neste, 31773 Colomiers

Laboratoire

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

A dedicated R&D team

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.

Site specialty

  • Compounding and filling of liquids and semi-solids in stick-packs, bottles and blisters (suppositories and pessaries), sprays, and nasal drops
  • Solutions, suspensions, gels, emulsions, pasty dosage forms
  • Drug Products and Medical Devices

Standards & Regulations

  • European ANSM cGMP and cosmetics production and packaging
  • ISO 13485 (LNE) Certification

Services

  • Formulation and implementation of processes for drugs and medical devices
  • Analytical Services (Development, Validation, and 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 Batches (Pilot and Industrial Scale)
  • ICH Stability (Clinical Batches Registration and On-going)
  • Liquids: Solutions and Suspensions for Oral and Topical Use in Bottles

Authorizations & Certifications

This site is regularly inspected by the ANSM (French National Drug Safety Agency)) and by ANVISA (Brazilian agency) and the Russian Federation amongst others.

Coutances

Laboratoire Unither

1, Rue de l’Arquerie, 50200 Coutances

Ophtalmology

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.

Blow-Fill-Seal (BFS)

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

A dedicated R&D team

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.

Site specialty

  • Preparation, sterilization by sterilizing filtration and/or heat and aseptic filling in Blow Fill Seal and Preservative-free multidose
  • Aseptic filling with final sterilizing filtration or specifically without sterilizing filtration (gels, emulsions)

Standards & Regulations

  • European and USFDA Current Good Manufacturing Practices (cGMP)
  • ISO 13485

Services

  • Process formulation and implementation for drugs and 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)
  • ICH stability (registration and tracking of clinical batches)

Authorizations & Certifications

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.

Gannat

Unither Industries

17 av Portes Occitanes, 03800 Gannat

Saline solution

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.

Blow-Fill-Seal (BFS)

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

– Dry forms manufactured under low humidity conditions
– Hormone-based eggs
– Rhinology

Standards & Regulations

– ANSM’s European Current Good Manufacturing Practices (cGMP)
– Certification ISO 13485 version 2016 (LNE)

Services

– 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)

Authorizations & Certifications

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.

Paris

Unither Pharmaceuticals

3-5 rue Saint Georges, 75009 Paris

Commercial office

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.

Bresil

Barretos

Unither Pharma Brasil

Av. Mário de Oliveira, 605

Blisters, bottles, tubes, sachet, stick-packs

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.

São Paulo

Unither Pharma Butantã

Av. Nossa Sra. da Assunção, 736 Vila Butantã, São Paulo – SP, CEP: 05359-001

Ophthalmology

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.

Chine

Nanjing

Unither Nanjing Pharmaceuticals

Headquarter

169 Jiangjun Ave, Jiangning District, Nanjing, Jiangsu

Ophthalmology & Asthma

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.

États-Unis

Rochester

Unither Manufacturing LLC

755 Jefferson Road Rochester, NY

Ophthalmology & Asthma

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.

Our news

All news

30 year anniversary

Today, the company is a world leader in the manufacture of sterile unit doses, with a production capacity of...

Manufacturing of registration batches of PXT3003 in single unit doses

Nanjing’s R&D cell inauguration

Innovation is at the core of our identity, as we believe it opens up new pathways for patient well-being, en...

What makes us proud?

Unither Pharmaceuticals, a major player in drug development and manufacturing serving major laboratories for...

Anticipating Customer Growth

A massive investment plan to increase our capacity and respond to CSR challenges. Author: Eric Chesnel, Chie...

World Sight Day

At Unither Pharmaceuticals, we are committed to eye health, developing innovative solutions to simplify and ...

LDPE study

Amidst increasing interest in sustainable practices, there’s a compelling need to evaluate the environ...

Investing in production capacity

Creating a predictable framework that will allow pharmaceutical manufacturers to invest in production capaci...

Unither Développement Bordeaux new Landing Page

Unither Développement Bordeaux is a GMP-compliant, state-of-the-art facility that features our R&D plat...

Laboratoire Kôl Olisens® eye drops, manufactured by Unither Pharmaceuticals

Foundation stone laid for Laboratoire Unither Amiens new building

Pharnext moves production of its pending drug PXT303 to the United States

Unither Pharmaceuticals has completed the purchase of the Novartis site located at Butantã, in São Paulo, Brazil.  

Jean-François Hilaire: newly appointed CEO of Unither Pharmaceuticals

The Management led by Eric Goupil gathers a consortium to acquire Unither Pharmaceuticals from Ardian

Mouthwash stick-packs

Laboratoire Unither Coutances inaugurates its new premises and production facilities

Official launch of the CURECALL solution to ophthalmologists in France!

New in corneal transplant rejection: the ANSM issues an authorisation for the first industrial eye drop based on ciclosporin 2%.

Physiological serum, Rhinovirus and Sars-COV2

Unither Satisfaction Survey – 2021

Therapeutic and environmental benefits of the nebulized form in inhaled therapy for respiratory diseases

A BUSINESS DEVELOPER’S MISSION AT UNITHER – TO PROVIDE CUSTOMER SATISFACTION

UNITHER invests 68 million euros in the innovative project: Euroject®

Ophthalmic Development

Innovative Ophthalmic products

Blow-Fill-Seal (BFS) advanced aseptic process

Self-medication: towards a new age of responsible health

Synergism between oral paracetamol and nefopam in a murine model of postoperative pain

Team captain of Unither Industries in Gannat

2020 Satisfaction Survey Results

Diluent or Immuno-Reagent solutions for your diagnostic testing kits (Covid, Flu, etc.)

Preservative-free multidose: a disruptive technology that guarantees the absence of preservatives

The Liquid Stick-Pack by Unither Pharmaceuticals

Pharmaceutical Post Publication on our Sol-Gel innovation

Pain: opioids, acetaminophen... new forms to improve their use

Acquisition in China

CDMO’s Challenges for Developing Oral Suspensions for Children

Using Differentiated Drug-Delivery Technologies to Deliver Competitive Advantages

Sol-Gel technology

A new safer, more practical and trendy packaging: the liquid stick-pack

Sterile single doses: Blow-Fill-Seal (BFS), an ophthalmic  technology

Sterile single dose and limitation of contamination risks

Galenic innovations and roads of the future

Galenic innovations to meet the challenges of the future (Part 2)

Hiding taste: a treatment compliance asset

Paediatric medication ideal for avoiding false passages

How Unither Pharmaceuticals fights the current COVID-19 outbreak

Adaptability: a vital condition

D I S C O V E R T H E V I D É O

A global CDMO

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.

Read more

Working at Unither,

means participating in an ambitious business project – that of offering innovative health products which simplify the lives of patients around the world.

Join us

INTERPHEX

16-18 april

New York

Infarma

19-21 march

Madrid

Europharm SMC

16-17 april

Lisbon, Europe

CPhI North America

7-9 May

Philadelphia, North America

CPhI Milan

8-10 october

Milan, Europe

China Beauty Expo

22-24

Shanghai, China

BioEurope Spring

18-20 March

Barcelona

ARVO

5-9 May

Seattle, North America

AAPS

20-23 October

Salt Lake City, Utah, USA, North America

AAO

18-21 November

Chicago MI, North America

Infarma

19-21 march

Madrid, Spain

OIS seco

28 feb - 3 march

Atlanta, North America

ABRADILAN

12-14 Mars

São Paulo

OIS XIII

1-2 December

San Diego, North America

AAO

18-21 Novembre

Chicago MI, North America

MEDICA

13-16 November

Dusseldorf, Germany

AAPS

20-23 October

Salt Lake City, Utah, USA, North America

CPhI Milan

8-10 October

Milan, Europe

PharmaSynergy OTC

11-12 September

Paris, Europe

ESCRS

6-10 September

Barcelona, Spain

CBME China

17-19 July

Shanghai, China

Insights in Ophthalmology

20-21 June

Dublin, Ireland

Octane

20-21 June

Newport Beach, North America

CPhI China

19-21 June

Shanghai, China

FCE PHARMA 2024

4-6 June

São Paulo, Brazil

euroPLX 85 Dublin

3-4 June

Dublin, Europe

China Beauty Expo

22-24 May

Shanghai, China

CPhI North America

7-9 May

Philadelphia, North America

Arvo

5-9 May

Seattle, North America

Pharmaceutical Manufacturing & Packaging Congress PHARMAP

22-23 April

Amsterdam, Europe

Cosmofarma

19-21 april

Bologna, Italy

INTERPHEX

16-18 april

New York

Europharm SMC

16-17 april

Lisbon

ASCRS

5-8 april

Boston MA

Eyecelerator

4 april

Boston

World Vaccine Congress

1-4 april

washington

Infarma

19-21 march

madrid

BioEurope Spring

18-20 March

Barcelona

ABRADILAN

12-14 march

São Paulo

EuroPLX 84

26-27 february

Lisbon

World Vaccine Congress

April 1-4

Washington

OIS seco

17-20 July

Stockholm, Sweden

Connect in Pharma

5-6 June

Geneva, Switzerland

Orphan drug congress

23-25 april

Washington

BioAsia

26-28 February

Hyderabad, India

DCAT Week

18-21 March

New York, NY

BioFIT

3-4 december

Lille, France

BIO-Europe 2024

6-8 november

Munich, Germany

Pharmasynergy

8-9 february

London

EuroPLX 84

26-27 february

Lisbon, Portugal

FCE Pharma

4-6 June

São Paulo, Brazil

CRS 2024

8-12 July

Bologna, Italy

PharmaChina

2 mai

Shanghai, China

Pharmavenue

23-24 May

Madrid, Spain

Pharma Meeting

2 mai

São Paulo, Brasil

NLS Days

17-19 November

Malmo, Sweden

Our events

All events

A CDMO with an international dimension

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:

  • Production of commercial batches: process formulation and implementation for drugs and medical devices
  • Industrial transfer: Scale up and validation of manufacturing processes / cGMP batches (pre-industrial and industrial scale)
  • Analytical development: ICH stability (pre-stability, development, clinical batches) / Analytical services: development, validation and quality control
  • Clinical batches: ICH stability (registration and tracking of clinical batches) / Phase II and III cGMP clinical batches (variable batch size)

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.

Answering your questions: a comprehensive FAQ guide to Unither's pharmaceutical services

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.

What is a CDMO ?

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.

What is the benefit of working with a CDMO ?

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.

What are the key services of a CDMO ?
  • Drug Development Services: CDMOs assist in the development of new pharmaceutical products, including formulation development, pre-formulation studies, and analytical method development.
  • Clinical Trial Manufacturing: CDMOs manufacture small batches of pharmaceutical products for use in clinical trials, ensuring that the drug is produced according to regulatory standards for testing in humans.
  • Commercial-Scale Manufacturing: Once a drug successfully completes clinical trials and receives regulatory approval, CDMOs can scale up production to meet commercial demand.
  • Analytical and Quality Control Services: CDMOs conduct rigorous testing and quality control to ensure that pharmaceutical products meet regulatory standards for safety, efficacy, and quality.
  • Regulatory Support: CDMOs provide expertise in navigating regulatory requirements and help clients comply with various regulations governing the pharmaceutical industry.
  • Technology Transfer: CDMOs assist in transferring technologies from the client or another manufacturing site to ensure a smooth transition between different phases of drug development and manufacturing.
Who is Unither Pharmaceuticals CDMO ?

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.

What kind of collaborations Unither offers ?

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.

What types of pharmaceutical products does Unither manufacture?

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.

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