API development projects wirkstoffversorgung
(runnig/recently finalised)

  • Aminopiperidine derivatives (Piritramide)
  • Purine derivatives
    • Propentofylline
    • Moxastini Theoclas
  • Beta receptor blockers
    • Carvedilol
    • Betaxolol
  • Allylamine antifungal derivative (Terbinafine)
  • Agonist of α2-adrenergic receptors (Dexmedetomidine)
  • Thienopyridne antiplatelet drug (Clopidogrel)

Capability of API production plant

  • Established GMP certificate since December 2012
  • Production focused on manufacture of API class OEB 3 to OEB 5
  • Production capacity 100 kg of API per year

Department of API production is equipped to provide:

  • Production of API and intermediates fully compliant with GMP rule
  • Batch size of produced batches in range 100 g – 5 000 g
  • Rooms for safety production of HP API with thorough filtration of air input and exhaust
  • Full protection of staff and products
  • Monitoring of water waste with unit for decomposition of dangerous pollutant

Operations:

  • Reaction in temperature range 20°C to +140°C
  • Reaction (hydrogenation) under higher pressure (12 bar)
  • Extraction
  • Filtration
  • Evaporation
  • Crystallisation and Isolation
  • Drying with raking in process filter or on trays in drying oven
    Sieving

Main Equipment:

  • 2 glass reactors double jacketed 30 – 50 L, connected with thermostat
    temperature range: 20°C to +140°C
  • 1 glass 50 L reactor for crystallisation connected to process filter
    temperature range: 20°C to +140°C
  • process filter with capacity maximally 5.000 g
  • sieving and milling device
  • 50 L hydrogenator for work pressure up to 12 bar (in construction)

Gallery

hameln-lab-3

hameln-lab-2

hameln-lab-4

hameln-lab-1

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QC and Laboratory Services (Stabilities, Batch Release, Biologics)

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Development and GMP production of APIs

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Preclinical studies

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