FARMAK, a. s. CZECH REPUBLIC
INTRODUCTION FARMAK, a. s. is: Ø Czech, privately owned, family based, independent middle-sized company with the tradition of industrial chemical production dates back to the year 1934. Ø Globally active Ø Flexible, reliable and customer oriented partner Ø Focused on R&D and manufacturing of: Ø niche API´s Ø advanced intermediates Ø fine chemicals Ø Supportive in dossier development
LOCATION FARMAK is easily accesible: Olomouc - Vienna = 190 km Olomouc - Prague = 280 km Olomouc - Brno = 80 km
HISTORY Ø 1934 - start of industrial chemical production Ø 1952 - establishment of state-owned company Farmakon (member of Spofa) Ø 1992 - registration of joint-stock company FARMAK Ø 1996 - Farmakon acquired by FARMAK (privatisation) Ø 2004 - new R&D and QA/QC centre construction Ø 2008 - installation of new c. GMP kilolab Ø 2014 - new Hall of final operations (HAFO) Ø 2015 – new multipurpose production line installed
SALES AND MARKET 25. 0 SALES BY TERRITORIES (2015) sales in mil EUR 20. 0 Asia 18. 4% 15. 0 Australia Africa 0. 1% Czech Republic 16. 8% Europe 40. 5% 10. 0 5. 0 0. 0 Latin America 7. 9% 2010 2011 2012 2013 2014 2015 Ø More than 120 business partners across the world Ø Export level in sales around 90% North America 16. 2%
HUMAN RESOURCES approx. 240 employees Structure of the employees Administration 12% Structure by education Sale 3% Production 33% University degree 21% Ph. D. 3% R&D 12% QA/QC 12% Maint. /Services 26% Secondary education 76%
QUALITY ASSURANCE Ø highest level of c. GMP requirements. Ø regular inspection by authorities: • State Institute for Drug Control • FDA Ø Other approvals all manufactured products regulatory documentation available: Ø DMF’s in USA, Canada, EC Ø Dossiers for European Certificate of Suitability (CEP) Certified integrated system of the QC and environmental protection according to ISO 9001 and ISO 14001 standards.
CHEMICAL EXPERTISE Ø Chemistry of heterocyclic compounds (incl. thioaromates) Ø Grignard reactions (incl. sulphur) Ø Various condensations Ø Friedel - Crafts reactions Ø Halogenations Ø Oxidations Ø Catalytic hydrogenations Ø Esterifications Ø Racemic mixture separations Ø Phase transfer catalyzed reactions Ø Reductions (Zn, catalytic hydrogenations)
PRODUCTION FACILITIES Ø Facilities area: approx. 36, 000 m 2 Ø 2 GMP production halls (one is FDA approved) Ø Hall of Final Operations Ø milling Ø micronizing Ø sieving Ø packaging Ø Supporting facilities Ø warehousing Ø waste water treatment Potential Ø water purification expansion of the facility is possible
PRODUCTION HALLS highest level of c. GMP requirements Ø Glass-lined, stainless steel jacketed reactors (250 - 6, 300 litres; typical volume is 1, 600 litres) Ø Total reactor capacity: 100 m 3 Ø Batch size: 5 - 250 kg Ø Reaction temperatures: between -20 and +300 °C reactors Pfaudler Ø Reaction pressure: between -80 and +300 k. Pa Ø Product separation - centrifuges, filters, filter/driers (some of them of Hastelloy C 22) Ø Drying equipment (some of them of Hastelloy C 22) bag filters MAAP
KILOLAB highest level of c. GMP requirements Ø Büchi Chem. Reactor CR: 2 x 60 L, 1 x 15 L Ø cryogenic technology (down to -90°C) Ø glove box Ø mobile pressure filter Ø HVAC system Ø utility systems: non-water heating/cooling medium process nitrogen, process vacuum, hot water Ø protected area for raw material dispensing Ø from 0. 2 – 5 kg batches
HALL OF FINAL OPERATIONS (HAFO) Ø Ø milling/micronization sieving custom packaging HVAC system
R&D and QA/QC CENTRE NMR 400 MHz Ø Analytical Centre – QC Department: Ø production sample service – raw materials, intermediates, final samples Ø documentation – SOP’s, analytical instructions, Co. A’s Ø standards, stability studies, validation of methods, water and air monitoring Ø R&D Analytical Department Ø structural analyses Ø purity analyses/impurity profile Ø development of analytical methods Ø Instrumentation Ø LCMS, GC, HPLC/TLC Ø Capillary Electrophoresis Ø NMR, UV/VIS a IR Spectrometry, XRay Ø DSC Ø Laser Particle Size Analyses (Cilas+Malvern) Ø Microbiological testing
ECOLOGY AND SAFETY Environmental policy in line with FARMAK’s strategy FARMAK: Ø fulfills demands of the national legislation for prevention of serious accidents Ø is involved in the national System of Assistance in Accidents Related to Transportation of Dangerous Materials Ø prepares reports on pollution Ø has got certified integrated system (ISO 9001 and ISO 14001) Ø 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 www. farmak. cz or at: Phone: Fax: e-mail: +420 587 430 111, +420 585 547 111 +420 585 231 424, +420 585 232 368, +420 585 230 540 ceo@farmak. cz Address: FARMAK, a. s. Na vlčinci 16/3, Klášterní Hradisko 779 00 OLOMOUC, CZECH REPUBLIC You can also follow us on Linked. In - FARMAK, a. s.
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