Livron, France
With over 110 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 production lines including 2equipped with RABS technology
Aseptic filling or terminal sterilisation process by heat
Capacity
145 million units
Formulation 30 to 1,500 L
From 1 mL to 10 mL
Inspection
3 fully automatic visual inspection lines (optical-cosmetic-pinhole detection-labelling)
2 semi-automatic inspection lines
Manual inspection workshop
Packaging
3 blister packaging lines
Packaging of 1, 5, 6, 10, 20, 25 or 50 ampoules
Pre-cutted blisters possible
Suppositories
Technology
2 filling machines and packaging line PVC-PE and PVC/PVDC/PE.
1 filling machine and packaging line PVC-PE ALU-ALU
Capacity
90 million units
Batches from 100 to 2,000 kg
1 automated workshop
1 standard workshop
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
Manual packaging for 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 optimisation, and analytical validation and implementation.
Quality Assurance
- The main central of our approach on quality standards are:
- Quality Manual.
- Quality Organisation.
- 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
Mike Stradling
Mike Stradling is the new Head of the Sterile Cluster, formed by our Jura and Livron facilities. With extensive experience in sterile production and operational leadership, he is committed to driving our Swiss facility toward continued success and excellence. His many years of expertise ensure a promising future for our operations in Jura.
For a more comprehensive look into Mike’s professional profile, connect with him on LinkedIn.
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