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FARMAK, a.s. CZECH REPUBLIC FARMAK, a.s. CZECH REPUBLIC
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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 1934. 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
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LOCATION FARMAK is easily accesible: Olomouc - Vienna = 190 km Olomouc - Prague = 280 km Olomouc - Brno = 80 km
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HISTORY 1934 - start of industrial chemical production 1952 - establishment of state-owned company Farmakon (member of Spofa) 1992 - registration of joint-stock company FARMAK 1996 - Farmakon acquired by FARMAK (privatisation) 2004 - new R&D and QA/QC centre construction 2008 - installation of new cGMP kilolab 2014 - new Hall of final operations (HAFO) 2015 – new multipurpose production line installed
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SALES AND MARKET SALES BY TERRITORIES (2015) More than 120 business partners across the world Export level in sales around 90%
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HUMAN RESOURCES approx. 240 employees Structure of the employees Structure by education
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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)
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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)
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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
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PRODUCTION HALLS highest level of cGMP requirements reactors Pfaudler bag filters MAAP Glass-lined, stainless steel jacketed reactors (250 - 6,300 litres; typical volume is 1,600 litres) Total reactor capacity: 100 m 3 Batch size: 5 - 250 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)
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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
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HALL OF FINAL OPERATIONS (HAFO) milling/micronization sieving custom packaging HVAC system
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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
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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
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CONTACT DETAILS Please feel free to contact us through our websites www.farmak.cz or at: Phone: +420 587 430 111, +420 585 547 111 Fax: +420 585 231 424, +420 585 232 368, +420 585 230 540 e-mail: ceo@farmak.cz Address: FARMAK, a. s. Na vlčinci 16/3, Klášterní Hradisko 779 00 OLOMOUC, CZECH REPUBLIC You can also follow us on LinkedIn - FARMAK, a.s.
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