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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 1934. Globally active Flexible, reliable and customer oriented partner

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FARMAK, a.s. CZECH REPUBLIC

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  1. FARMAK, a.s. CZECH REPUBLIC

  2. 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: • nicheAPI´s • advanced intermediates • fine chemicals • Supportive in dossierdevelopment

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

  4. 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 – newmultipurposeproduction line installed HISTORY

  5. SALES AND MARKET SALES BY TERRITORIES (2015) • More than 120 business partners across the world • Export level in salesaround90%

  6. Structureoftheemployees Structure by education HUMAN RESOURCES approx. 240 employees

  7. 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) QUALITY ASSURANCE Certified integrated system of the QC and environmental protection according to ISO9001 and ISO14001 standards.

  8. 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)

  9. PRODUCTION FACILITIES • Facilities area: approx. 36,000 m2 • 2 GMP production halls (one is FDA approved) • HallofFinalOperations • milling • micronizing • sieving • packaging • Supporting facilities • warehousing • waste water treatment • water purification Potential expansion of the facility is possible

  10. highest level of cGMP requirements • Glass-lined, stainless steel jacketed reactors (250 - 6,300 litres; typical volume is 1,600 litres) • Total reactor capacity: 100 m3 • Batch size: 5 - 250 kg • Reaction temperatures: between -20 and +300 °C PRODUCTION HALLS reactors Pfaudler • Reaction pressure: between -80 and +300 kPa • Product separation - centrifuges, filters, filter/driers (some of them ofHastelloy C22) • Drying equipment (some of them ofHastelloy C22) bag filters MAAP

  11. highest level of cGMP requirements • BüchiChemReactor 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 mediumprocess nitrogen, process vacuum, hot water • protected area for raw material dispensing  • from 0.2 – 5 kg batches KILOLAB

  12. milling/micronization • sieving • custom packaging • HVAC system HALL OF FINAL OPERATIONS (HAFO)

  13. NMR 400 MHz R&D and QA/QC CENTRE • 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

  14. Environmental policy in linewith 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. isholderof • RESPONSIBLE CARE ECOLOGYAND SAFETY

  15. 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, KlášterníHradisko 779 00 OLOMOUC, CZECH REPUBLIC You can also follow us on LinkedIn - FARMAK, a.s.

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