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Unither Manufacturing Coutances

Coutances, France
Acquired from Sanofi in 2002 in response to growing demand, Coutances was the second site to specialize in Blow-Fill-Seal (BFS) technology.

The Coutances site has a large manufacturing capacity with several high-speed BFS lines, and is constantly increasing capacity by adding lines. With a current staff of 200, it produces one- billion unit-doses per year.

A unique back-up system exists between the Amiens (France), and Rochester (US) sites, both also dedicated to BFS technology, ensuring continuous production in case of sales spikes.

Sterile Blow-Fill-Seal (BFS)
  • Delivering 1 billion unit-does per year
  • Unit-dose contents from 0.25 mL to 20 mL

Dedicated Team

Highly-trained PhD, MSc and scientific operators perform tech-transfers and process optimization of BFS drug products and medical devices, with pilot equipment including mixers for solutions, suspensions, emulsions and gels.

The analytical team validates methods and performs ICH stability studies.

Site Specialty

  • Compounding and filling with end-filtration sterilization, aseptic gel and emulsions
  • Compounding, autoclaving and filling

Standards & Regulations

  • Europe and FDA cGMP
  • ISO 13485

Technologies & Products

  • Formulation and Process Development for Drug Products
  • Formulation and Process Development for Medical Devices
  • Analytical Services (Development, 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 Batches (Pilot and Industrial Scale)
  • ICH Stability (Clinical Batches Registration and On-going)
  • Sterile Unit Dose, non-injectable Blow-Fill-Seal (BFS)

Authorizations & Certifications

This site is inspected by ANSM (French Health Authorities), US FDA, ANVISA (Brazilian Health Authorities), Turkish Ministry of Health, Iranian Health authorities and KFDA (Korean FDA).

Contact Coutances - How to get there

Laboratoire Unither
ZI de la Guérie,
Rue de l’Arquerie
50200 Coutances FRANCE
Phone: 00 33 (0)2 33 76 70 00
Fax: 00 33 (0)2 33 76 70 05
How to Get There
  • road: see the map
  • rail: Granville (33 km) or Carentan, Manche rail station (37 km)
  • air: Rennes (140 km) or Caen airport (100 km)