CDMO

End-to-end development of small molecule solutions for human and veterinary use

PRODUCTION AND DEVELOPMENT ON A SINGLE SITE

Our EU-GMP production plant gathers its activities on one single production site based in Courcelles in Belgium. Its geographical position was judiciously chosen for its central location in Europe and particularly for its closeness to the airports of Brussels and the industrial port of Antwerp.

CONTRACT MANUFACTURING

Our facilities span over 6,000 m² and are organized into 2 production areas : sterile and non sterile.

Our clients range from small to large laboratories commercializing pharmaceutical products for human or veterinary use. They come from various regions : Japan, Canada, Europe.

STERILE EXPERTISE

BePharBel Manufacturing has strong expertise in sterile drug manufacturing. Our aseptic area is a controlled atmosphere zone (A class) in compliance with the EN/ISO14644-1 standard.

Our sterile dosage forms:

Ophthalmic ointments

  • Annual production : 1,5 million aluminum tubes
  • Bulk batch size : 200 kg

Liquids and powders for injectables

  • Annual production : 3 million glass vials
  • Bulk batch size : 450 L (liquid) or 28 kg (powder)
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NON-STERILE SOLID AND MISCELLANEOUS FORMS

Tablets

  • Annual production : 50 million tablets in blisters or bottles
  • Bulk batch size : 210 kg

 

Capsules

  • Annual production : 10 million capsules in blisters or bottles
  • Bulk batch size : 210 kg

Nasal sprays – Syrups – Liquid ointments

  • Annual production :  8  million vials
  • Packaging : bottles with cap, dropper, dosing spray (in glass or plastic)
  • Bulk batch size : 1 000 L

Ointments – Creams – Gels

  • Annual production : 7 million tubes (aluminium or plastic)
  • Bulk batch size : 850 kg

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    INTEGRATED SUPPORT SERVICES

    To ensure smooth and continuous management of your projects, we also support you in the following areas:

    • Formulation development
    • Process development and scale-up
    • Stability studies
    • Validation and transfer of analytical methods
    • Logistic supply
    • Packaging
    • Serialization
    • Batch release
    • Regulatory support

    CLINICAL AND COMMERCIAL BATCHES

    BePharBel Manufacturing offers comprehensive services for the production of your GMP-compliant clinical batches, covering bioequivalence studies, phase II and phase III.

    With our flexibility, we ensure fast and reliable production to support your clinical trials.

    By integrating all development and manufacturing phases within a single facility, we facilitate your transition to large-scale production, with dedicated resources and equipment.

    OUR CERTIFICATIONS

    • EU-GMP Manufacturing
    • Manufacturing and Distribution Authorization for Medicinal Products and Medical Devices for Human and Veterinary Use
    • Authorised IMP Manufacturer
    • Manufacturing Authorization for Sterile Products, including Injectables

    Our site is regularly inspected by Belgian authorities (FAMHP) as well as by our partners.

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