FARMAK, a.s. CZECH REPUBLIC FARMAK, a.s. CZECH REPUBLIC

INTRODUCTION FARMAK, a.s. is:  Czech, privately owned, family based, independent middle-sized company with the tradition of industrial chemical production dates back to the year  Globally active  Flexible, reliable and customer oriented partner  Focused on R&D and manufacturing of:  niche API´s  advanced intermediates  fine chemicals  Supportive in dossier development

LOCATION FARMAK is easily accesible: Olomouc - Vienna = 190 km Olomouc - Prague = 280 km Olomouc - Brno = 80 km

HISTORY  start of industrial chemical production  establishment of state-owned company Farmakon (member of Spofa)  registration of joint-stock company FARMAK  Farmakon acquired by FARMAK (privatisation)  new R&D and QA/QC centre construction  installation of new cGMP kilolab  new Hall of final operations (HAFO)  2015 – new multipurpose production line installed

SALES AND MARKET SALES BY TERRITORIES (2015)  More than 120 business partners across the world  Export level in sales around 90%

HUMAN RESOURCES approx. 240 employees Structure of the employees Structure by education

QUALITY ASSURANCE Certified integrated system of the QC and environmental protection according to ISO9001 and ISO14001 standards.  highest level of cGMP requirements.  regular inspection by authorities: State Institute for Drug Control FDA  Other approvals all manufactured products regulatory documentation available:  DMF’s in USA, Canada, EC  Dossiers for European Certificate of Suitability (CEP)

CHEMICAL EXPERTISE CHEMICAL EXPERTISE  Chemistry of heterocyclic compounds (incl. thioaromates)  Grignard reactions (incl. sulphur)  Various condensations  Friedel - Crafts reactions  Halogenations  Oxidations  Catalytic hydrogenations  Esterifications  Racemic mixture separations  Phase transfer catalyzed reactions  Reductions (Zn, catalytic hydrogenations)

PRODUCTION FACILITIES  Facilities area: approx. 36,000 m 2  2 GMP production halls (one is FDA approved)  Hall of Final Operations  milling  micronizing  sieving  packaging  Supporting facilities  warehousing  waste water treatment  water purification Potential expansion of the facility is possible

PRODUCTION HALLS highest level of cGMP requirements reactors Pfaudler bag filters MAAP  Glass-lined, stainless steel jacketed reactors ( ,300 litres; typical volume is 1,600 litres)  Total reactor capacity: 100 m 3  Batch size: kg  Reaction temperatures: between -20 and +300 °C  Reaction pressure: between -80 and +300 kPa  Product separation - centrifuges, filters, filter/driers (some of them of Hastelloy C22)  Drying equipment (some of them of Hastelloy C22)

KILOLAB KILOLAB  Büchi ChemReactor CR: 2 x 60 L, 1 x 15 L  cryogenic technology (down to -90°C)  glove box  mobile pressure filter  HVAC system  utility systems: non-water heating/cooling medium process nitrogen, process vacuum, hot water  protected area for raw material dispensing  from 0.2 – 5 kg batches highest level of cGMP requirements

HALL OF FINAL OPERATIONS (HAFO)  milling/micronization  sieving  custom packaging  HVAC system

R&D and QA/QC CENTRE NMR 400 MHz  Analytical Centre – QC Department:  production sample service – raw materials, intermediates, final samples  documentation – SOP’s, analytical instructions, CoA’s  standards, stability studies, validation of methods, water and air monitoring  R&D Analytical Department  structural analyses  purity analyses/impurity profile  development of analytical methods  Instrumentation  LCMS, GCMS, GC, HPLC/TLC  Capillary Electrophoresis  NMR, UV/VIS a IR Spectrometry, XRay  DSC  Laser Particle Size Analyses (Cilas+Malvern)  Microbiological testing

ECOLOGY AND SAFETY Environmental policy in line with FARMAK’s strategy FARMAK:  fulfills demands of the national legislation for prevention of serious accidents  is involved in the national System of Assistance in Accidents Related to Transportation of Dangerous Materials  prepares reports on pollution  has got certified integrated system (ISO9001 and ISO14001)  operates own waste water treatment plant FARMAK, a.s. is holder of RESPONSIBLE CARE

CONTACT DETAILS Please feel free to contact us through our websites or at: Phone: , Fax: , , Address: FARMAK, a. s. Na vlčinci 16/3, Klášterní Hradisko OLOMOUC, CZECH REPUBLIC You can also follow us on LinkedIn - FARMAK, a.s.