APIs commercially produced and marketed

  • Piritramide
  • Alfentanil Hydrochloride(CEP)
  • Sufentanil Base(CEP)
  • Remifentanil Hydrochloride (CEP)
  • Propentofylline
  • Moxastini Theoclas

APIs under development

  • Dexmedetomidine
  • Noradrenaline Tartrate
  • Sufentanil Citrate

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 high potent APIs per year in the 1st facility
  • Production capacity 500 kg of high potent APIs and Intermediates per year in the 2nd facility

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)