Regensburg

Tablet press Regensburg Aenova
Location Regensburg, Germany Competence Center high potent solids (oncology) – conventional solids - specialty semisolids & liquids

The Aenova Group site in Regensburg with its special environment is one of the leading HPAPI development, production and packaging facilities for high potent solids:

  • Capsules, tablets and film coated tablets
  • From small to large scale (0,5 to 500kg)
  • Covering complete lifecyle from development to commercial supply for Capsules, Tablets & Film Coated Tablets

The Aenova site in Regensburg is a state-of-the-art facility paired with high flexibility.

Strategic expansions will enable the site´s production capacity to double within the next years. This strategic expansion took place in 2023 to enable the site‘s production capacity for HPAPI to double within the next years and to offer tailor-made/ plant-in-plant solutions for customers.

363
employees
10
certifications & approvals
12,000
square meter
Facts
Technologies
Products

The Production PlantThe Production Plant

  • Size of the site: 15,500 m² (total floor area)
  • Production: 3,506 m²
  • Packaging: 3,966 m²
  • Goods receipt and storage: 4,200 m²
  • Analytics: 877 m²
  • Formulation development/ clinical trials: 200 m²
  • FTE: 363
  • Shifts: 15/5

Manufacturing ServicesManufacturing Services

  • Production of Solids
    • Tablets
    • Powder and granules
    • Hardcapsules
    • Film coated tablets
  • Semisolids
    • Gels
    • Creams
    • Pastes
    • Ointments
  • Non sterile Liquids
    • Solutions
    • Suspensions
  • OEB 1-5, incl. narcotics and hormones
  • Quality service

Development ServicesDevelopment Services

  • Handling of cytotoxic / cytostatic and high potent solid dosage forms
  • Fully cGMP compliant analytical and pharmaceutical development
  • Manufacture of clinical trial material and small-scale commercial production
  • Project management and corporate activities (e.g. RFQ, R&D sales, IP & portfolio management)
  • Technolgy transfer
  • Lifecycle management

Packaging ServicesPackaging Services

  • Tablets (blister)
  • Tablets (bottles)
  • Liquids in bottles
  • Semisolids in bottles
  • Tubes
  • Dispensers
  • Integrated serialization & aggregation

Certifications & ApprovalsCertifications & Approvals

  • Manufacturing licenses
    • EU GMP
  • Non EU-GMP certificates
    • US FDA
    • ANVISA
    • Belarusian Health Authority
    • Japanese FDA
    • Kenyan Health Authority
    • MFDS (Korea)
    • Russian MoH
    • FDA Saudi Arabia
    • Turkish MoH
    • Uganda MoH

Product TypesProduct Types

  • Rx
  • OTC
  • Food Supplements
  • COSM