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Bourgoin, France

Bourgoin, France

Our Bourgoin facility is an FDA approved center of excellence for early and late-stage development and commercial manufacturing of Oral Solid Dose (OSD) products with a specialization in high potency API.

Early development hub
This new, 430-square-meter, dedicated research and development hub offers state-of-the art equipment and technologies to support formulation development and mature product characterization of oral solid dose form.
This enables our customers to get to market faster by making smarter decisions, minimizing experimental efforts and reducing risk.

Benefits include:

  • Integrated API, solid state analysis, drug product development, clinical services and regulatory support, accelerating time to market
  • Simplified supply chain to help customers avoid costly delays
  • Optimized manufacturing and scale-up to accelerate milestones
  • Fewer tech transfers and improved site communication to optimize timelines

Working in close collaboration with our Milton Park, UK site, Bourgoin provides fast, flexible small-scale manufacturing combined with robust full-scale processes. Bourgoin is our leading EU site for commercial manufacturing of oral solid dose products.

Specialized capabilities

Areas of expertise include:

  • Early development oral solid dose
  • Specialized in handling highly potent APIs up to 3B category, including cytostatic
  • Packaging (bottles, blisters, speed line)
  • Successful transfer and commercialization of development projects worldwide
  • Manufacturing: Tablets, capsules, powders & granules
  • Orphan/niche indication product
  • Non-sexual hormones
  • Small scale production

This site features a strong regulatory inspection history from all major international regulatory agencies. Additionally, we are also making continued investments in the site both in capital and scientific resources.

Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.

 

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