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Vertically integrated pharmaceutical
company in the Baltic States

Active Pharmaceutical Ingredients Analytical Scale-up Laboratory


«Grindeks» offers to perform a complicated multi-stage (5-10 stage) API synthesis, mainly focusing on the niche pharmaceutical products:

  • Technological  transfer from laboratory-scale volumes (flasks) to industrial volumes (reactors)
  • Analytical research and specification of the substance before commencing the production cycle
  • commercial production in smaller volumes in glass reactors (to 6 kg) and enamelled reactor (to 30 kg)
  • Production is in compliance with the Good Manufacturing Practice standards
  • Entire analytical support of the process (including methods validation) is ensured by:

    • high effective liquid chromatography (ultraviolet, mass spectrometric, air diffusion or refractometric detector)
    • nuclear-magnetic resonance
    • differential scanning calorimetery
    • x-ray diffractio
    • infrared spectroscopy
    • ultraviolet spectrophotometery
    • elementanalysis
    • atomabsorption

 

Capabilities 

We are capable to perform multi-stage organic synthesis in gram to multi-kilogram quantities:

  • synthesis of GMP API intermediates and active pharmaceutical ingredients (APIs)
  • APIs for pre-clinical and clinical R&D under cGMP requirements
  • specific technologies: freeze drying, electro dialysis, Grignard reactions, catalytic hydrogenation, etc.

Services
 
  • Complete analytical support:

         ο HPLC (including UV, MS, LSD, refractometrical detection)
         ο UPLC
         ο GC
         ο particle size analysis
         ο NMR
         ο DSC
         ο XRPD
         ο IR
         ο UV
         ο CHN
         ο AAS
         ο etc. incl. method validation in GMP or GLP certified laboratories

  • Scientific research in Riga Technical University, University of Latvia and Latvian Institute of Organic Synthesis
  • Development and optimization
  • Process scale-up and optimization in pilot plant
  • Process and product validation
  • Equipment cleaning validation
  • Analytical method validation
  • Manufacturing from gram quantities up to ~30 kg scale per batch
  • Custom manufacturing under cGMP
  • Stability studies under ICH guidelines
  • Development of active substance master files (ASMFs) and Dossiers  in CTD and e-CTD formats




CONTACTS

R&D of API

Eriks Ivanovskis
Deputy Head of R&D Department

E-mail: eriks.ivanovskis@grindeks.lv

 

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Small batch GMP synthesis

«Grindeks» offers production of small batches (0.1 – 3 kg inlaboratory and 1 – 20 kg batches in a brand new pilot plant) forclinical trials and other needs under cGMP conditions.