Unither Manufacturing LLC

Global CDMO


Blow-Fill-Seal (BFS) worldwide leader

Liquid stick-pack pioneer

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World-leading CDMO

A world leader in the

development and manufacturing

of Blow-Fill-Seal technology (BFS)

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Our technologies of pharmaceutical manufacturing

STERILE LIQUIDS (Blow-Fill-Seal)

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NON-STERILE LIQUIDS (stick-pack, bottle)

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BLOW-FILL-SEAL

BOTTLES

LIQUID STICK-PACKS

MULTIDOSE

Key figures Unither Manufacturing LLC

0

countries

in which our products are sold

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million doses

Stick-pack specialist

0

employees

A growing company

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billion doses (globally)

World leader in Blow-Fill-Seal

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current product families

Diversity of products to answer your needs

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
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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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

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...

Jean-François Hilaire: newly appointed CEO of Unither Pharmaceuticals

Unither Pharmaceuticals’ Supervisory Board appoints Jean-François Hilaire as Chief Executive Officer. As ...

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...

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,

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, …

Apply now

Pharmasynergy

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

China Beauty Expo

22-24 May

Shanghai, China

CPhI North America

7-9 May

Philadelphia, North America

Arvo

5-9 May

Seattle, North America

INTERPHEX

16-18 april

New York

Europharm SMC

16-17 april

Lisbon

World Vaccine Congress

1-4 april

washington

Infarma

19-21 march

madrid

BioEurope Spring

18-20 March

Barcelona

World Vaccine Congress

April 1-4

Washington

OIS seco

February 28 - March 3

Atlanta

DCAT Week

March 18-21

Atlanta

Connect in Pharma

5-6 juin

Geneva, Switzerland

Orphan drug congress

23-25 april

Washington

Bio Asia 2024

26-28 Février

Hyderabad, Inde

EuroPLX 84

26-27 february

Lisbon, Portugal

BioFIT

3-4 decembre

Lille, France

FCE Pharma

4-6 June

São Paulo, Brazil

CRS 2024

8-12 July

Bologna, Italy

BIO-Europe 2024

4-6 novembre

Stockholm, Suisse

PharmaChina

2 mai

Shanghai, China

Pharmavenue

23-24 May

Madrid, Spain

Pharma Meeting

21 mai

São Paulo, Brasil

NLS Days

17-19 November

Malmo, Sweden

Our events

All events

A CDMO with an international dimension

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.