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Manufacturing Footprint

Capsugel Dosage Form Solutions uses an integrated development program to advance compounds from feasibility and design to commercial manufacture of finished dosage forms. This integrated process - combined with our breadth of technologies - provides our customers with a single partner throughout the development process, thereby reducing project time, cost, complexity and risk. Co-located product development sites in the US, UK and France further enable rapid and optimized product design and development.

A global network of eight world class manufacturing facilities, approved by international regulatory agencies, provides clinical and commercial scale manufacturing for global pharmaceutical and health & nutrition clients around the world. Dedicated non-GMP development suites are in place for pre-clinical feasibility assessments. Dedicated high containment suites are also in place to handle highly potent active ingredients to OEB 4-5 and controlled substances from pre-clinical and clinical studies through commercial manufacture. 

Capsugel's flexible manufacturing footprint support product supply throughout the development cycle across our technology platforms, inclusive of:

Primary and secondary packaging is available for clinical trial material and small-scale commercial manufacturing. Global clinical supplies distribution and logistics is also available, inclusive of cold chain capabilities, through our Xcelience Division.

Infrastructure Overview

Worldwide Locations

Ploërmel, France

  • Pharmaceutical market-segment focus
  • Leading global manufacturer of hormone soft-gel production
  • Center of excellence for steroid hormones and pharmaceutical-grade oils
  • FDA and EMA inspected
  • 3 best-in-class manufacturing units
    • 2 production lines for liquid-fill hard capsules (Licaps®)
    • 11 production lines for soft-gel capsules (SGcaps®)
  • Versatile capability
    • Simple to complex formulations
    • High-containment processing capability for OEB-4 and -5 compounds
  • Pilot and commercial manufacturing
    • cGMP and non-GMP
    • Feasibility, stability and clinical batches
 

Edinburgh, UK (Scotland)

  • Pharmaceutical market-segment focus
  • Global leading site in liquid-fill hard-capsule production for pharmaceutical segment
  • FDA and MHRA accredited
  • Co-located product development with pilot- and commercial-scale manufacturing
    • cGMP and non-GMP
    • Feasibility, stability and clinical batches
  • Versatile capability
    • Simple and complex liquid and semi-solid formulations
    • Controlled substances (UK Home Office Schedule 2,3,4/III)
    • High containment processing capability for OEB-4 and -5 compounds
    • Cytoxics, antibiotics, peptides and antibodies
  • Specialty capsule coating for targeted delivery
  • Primary and secondary packaging
 

Bend, USA (OR)

  • Pharmaceutical market-segment focus
    • Drug-product intermediates - SDDs, HME extrudates and nanocrystals
    • Multiparticulate range: extruded / spheronized beads, spray-layered multiparticulates, mini-tablets, and lipid multiparticulates (LMP technology)
    • Tablets, including osmotic and bi-/tri-layered matrices
  • Co-located product development with pilot and commercial manufacturing
    • Dedicated cGMP facility for preparation of kilogram through metric ton (Phase 3) clinical supplies for all technologies
    • Commercial-scale production line for SDD drug-product intermediates
  • Versatile capability
    • Solvent processing
    • High-containment processing capability to OEB-4 and -5 compounds
    • Biologics processing suite
 

Greenwood, USA (SC)

  • Health and nutrition market-segment focus
  • Select pharmaceutical applications
  • Liquid-fill hard capsule (Licaps®) focus with annual capacity of > 800M units
  • Production line for lipid multiparticulate (LMP) technology
  • Co-located product development site
  • cGMP sample manufacture
  • Bottling and blister packaging
  • JIT (just-in-time) warehousing
 

Quakertown, USA (PA)

  • Particle size reduction for pharmaceutical market
    • High potency APIs
    • Controlled substances
    • APIs & excipients
  • High potency milling / micronization
  • 2 locations in Quakertown
    • Headquarters (40,000 ft.2)- 1 non GMP suite for R&D; 2 pilot scale GMP suites; 6 commercial scale GMP suites; 2 labs
    • 65,000 ft.2 - houses a customer-dedicated suite, 1 commercial-scale GMP suite and 1 lab

Tampa, USA (FL)

  • Pharmaceutical and Biotech market-segment focus (Small molecule)
    • Preformulation- Polymorph identification, salt screen/selection
    • Analytical Development Services- API characterization, analytical method development and qualification, method transfer, release and stability testing
    • Formulation Development- Tablets, capsules, oral liquid dosage forms
  • Clinical and small-scale commercial manufacturing
  • 4 locations in Tampa for dedicated service areas
    • Headquarters (71,000 ft.2)- 2 preformulation suites; 14 formulation development suites (4 suites dedicated to potent compounds); analytical lab
    • Dedicated cGMP and small-scale commercial CTM facility
    • Dedicated global clinical supplies and packaging facility- 2 suites dedicated to primary packaging; 7 suites dedicated to secondary packaging
    • Dedicated distribution and logistics facility
 

Colmar, France

  • Health and Nutrition market-segment focus
  • 3 production lines for liquid-fill hard capsule (Licaps®)
  • Manufactures to European and FDA food regulations
  • Co-located product development site
 

Sagamihara, Japan

  • Health and Nutrition market-segment focus
  • Liquid-fill hard capsule (Licaps®) focus
  • Licaps® capacity of annual capacity > 400M units
  • Co-located product development site
 
Manufacturing footprint

Related Links

Dosage Forms Solutions overview

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