Livron, France
With over 100 years of experience, our facility focuses on sterile liquids and suppositories manufacturing. We handle more than 100 molecules and provide stability studies, narcotics handling and analytical testing services.
Ampoules – Imprinted or Labelled
Technology
4 Integrated filling lines
2 filling lines equipped with RABS technology
Aseptic filling or terminal sterilization process by heat
Capacity
Batch sizes from 30 to 1500 litres
120 million units
Packaging
Ampoules from 1 to 20 ml
3 blister packaging lines
Packaging of 1,2,5,6,10 or 50 ampoules
Pre-cutted blisters possible
Inspection
3 fully automated visual inspection lines (optical-cosmetic-pinhole detection-labeling)
2 semi-automated visual inspection lines
Manual inspection workshop
Suppositories
Technology
2 filling machines and packaging line PVC-PE
1 filling machine and packaging line PVC-PE ALU-ALU
Capacity
Batches from 100 to 2,000 kg
90 million units
Packaging
Suppositories or ovules from 0,9 g to 4,6 g
2 blisters packaging lines
Platelets to 4,5,6 suppositories
Boxes to 5,8,10,12,30 suppositories
Hand-packed suppositories in packs of 100
Our Services
Special Capabilities
- Controlled Drugs capabilities
- Cold chain services
- High viscous liquid product
Product and Tech Transfer
- At Adragos Livron we have spearheaded numerous development and product transfer projects, totaling approximately 220 since 2011.
- 50% dedicated to transfers.
- 50% encompassing various initiatives such as sourcing new API, development of novel formulations, batch size optimization, and analytical validation and implementation.
Quality Assurance
- The main central of our approach on quality standards are:
- Quality Manual.
- Quality Organization.
- Quality Circles.
- Including audits and regulatory assessments, to identify areas for improvement and maintain compliance with industry regulations.
GMP Certifications
- ANSM – EU GMP (National Agency for Medicines and Health Products Safety), GMP certifications for Human Drug.
- ANSES (Agency for Food, Environmental and Occupational Health & Safety), Frenche GMP certification for veterinary drugs.
- KFDA (Korean Food and Drug Administration)
Complementary Services
Microbiological Laboratory
- Microbiological controls
- Microbiological identifications
- Sterility controls (2 rooms)
- Environment controls
- Bacteriological endotoxins
- Methods validations
Physio-Chemical Laboratory
- Raw materials, bulk products, finished products controls, waters (Infrared and NIR for identifications; Titrimetric method, Total Organic Carbon Method; UV / visible Spectrophotometers; HPLC)
- Stability programs (ICH stability chambers)
- Methods validations
- Contract analysis
Commercial Services:
- Stability (ICH chambers on site)
- PQR
- Release to market
- Packaging item creation
- Variation file
- Contract analysis (7 HPLC, Spectrophotometer UV/IR)
- Logistic transportation
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Key Information
Location: Livron, France
SQM: 7,627m2
Foundation Year: 1,918
FTE (Employees): 230
Expertise
Sterile liquids – Ampoules
Suppositories
Narcotics
Viscous products
Cold chain
Certifications
ANSM – EU GMP (National France Agency for Medicines and Health Products Safety)
ANSES (Agency for Food, Environmental and Occupational Health & Safety)
KFDA (Korea Food and Drug Administration)
Meet our team in Livron
Highly skilled and experienced in their field.
Meet our Site Head
Gaël Le Saux
With a career spanning over two decades in the pharmaceutical industry, Gael is the site Head at Adragos, Livron. He is a dedicated and results-driven professional with a proven track record of success in leadership roles. Gael’s prior roles as Directeur Général, Industrial Director, and Sites Director have each played a pivotal role in honing his expertise in operational leadership. His journey also encompasses noteworthy positions like Site Head of Production, Production Manager, and Packaging Manager, reflecting a rich and diverse experience that underscores his strategic impact on various facets of pharmaceutical manufacturing.
Gael attended The University of Lille for DESS Industrial galenic pharmacy, as well as Paris- Sud University for Pharmacy.
To learn more about Ian’s career path, view his LinkedIn profile
