INTRODUCTION FARMAK as Czech privately owned independent middlesized company with the tradition of industrial chemical production dates back to the year 1934 Globally active Flexible reliable and customer oriented partner ID: 805907
Download The PPT/PDF document "FARMAK, a.s . CZECH REPUBLIC" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
FARMAK,
a.s.CZECH REPUBLIC
Slide2INTRODUCTIONFARMAK,
a.s.Czech, privately owned, independent middle-sized company with the tradition of industrial chemical production dates back to the year 1934. Globally activeFlexible, reliable and customer oriented partnerFocused on R&D and manufacturing of:
niche
API´sadvanced intermediatesSupportive in dossier developmentCustomer and employees oriented – The Essential is Inside
Farmak, a.s.
2
Slide3LOCATION
Farmak, a.s.3
FARMAK
is
easily
accesible
!
Olomouc -
Vienna
= 190 km
Olomouc - Prague = 280 km
Olomouc - Brno = 80 km
Slide4HISTORY
1934 - start of industrial chemical production1952 - 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 kilolab2014 - new Hall of Final Operations (HAFO) construction2015 - new multipurpose production line
installed2016 - c
limatic chambers with water cooling system
- particle size distribution
measurement
on
Malvern
instrument
2017 -
c
omprehensive
Drying and Homogenization Technology Line
Farmak
,
a.s
.
4
Slide5SALES AND MARKET
Farmak, a.s.5
More than 1
30
business partners across the worldExport level in sales around 90%
Slide6HUMAN RESOURCES
Farmak, a.s.6
S
TRUCTURE
EDUCATIONApprox. 250 employees
Slide7QUALITY MANAGEMENT SYSTEMCompliance with international
cGMP standards: EU GMP Eudralex Volume 4, Part 2; ICH Q7; US FDA CFR’s and customer’s Quality Assurance AgreementsInspected by authorities on regular basis Czech State Institute for
Drug
Control US Food and Drug AdministrationApproved byISO 9 001 & ISO 14 001 International StandartsCertified Integrated System of QC and Environmental
Protection
DMF & CEP Regulatory Documentation available
Farmak
,
a.s
.
7
Slide8CHEMICAL EXPERTISEC
hemistry of heterocyclic compoundsGrignard reactionsVarious condensationsFriedel - Crafts reactionsHalogenationsOxidationsCatalytic hydrogenationsEsterifications
Racemic mixture separations
Reductions (Zn, catalytic hydrogenations)
Farmak, a.s.8
Slide9PRODUCTION FACILITIES
Facilities area: approx. 36,000 m2 2 GMP production halls (one is FDA approved)Hall of Final
Operations
:
millingmicronizing sieving packagingSupporting facilities:warehousingwaste water treatmentwater purification
Farmak, a.s.
9
Facility
is
ready
to
expand
!
Slide10PRODUCTION HALLS
Farmak, a.s.10
Glass-lined, stainless steel jacketed reactors
(t
ypical volume is 1,600 litres)Total reactor capacity: 100 m
3Batch 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
reactors
Pfaudler
bag
filters
MAAP
Slide11KILOLAB
Büchi ChemReactor CR: 2 x 60 L, 1 x 15 LCryogenic technology (down to -90°C)Glove boxMobile pressure filter
HVAC system
U
tility systems: non-water heating/cooling mediumprocess nitrogen, process vacuum, hot waterProtected area for raw material dispensing 0.2 – 5 kg batchesFarmak, a.s.11
highest level of cGMP requirements
Slide12HALL OF FINAL OPERATIONS
Farmak, a.s.12
M
illing
/
micronization
S
ieving
C
ustom
packaging
HVAC system
Slide13R&D AND QA/QC CENTRE
Analytical Centre – QC Departmentproduction sample service – raw materials, intermediates, final samplesdocumentation – SOP’s, analytical instructions, CoA’s standards, stability studies, validation of methods, water and air monitoringR&D Analytical Departmentstructural analyses
purity analyses
/
impurity profiledevelopment of analytical methodsInstrumentation LCMS, GCMS, GC, HPLC/TLCCapillary Electrophoresis NMR, UV/VIS a IR Spectrometry, XRay
DSC Laser Particle Size Analyses (
Cilas+Malvern)
Farmak
,
a.s
.
13
Slide14ECOLOGY AND SAFETY
Environmental policy in line with FARMAK’s strategyInvolvement in the national System of Assistance in Accidents Related to Transportation of Dangerous MaterialsCertified
integrated system ISO9001 and ISO14001
O
wn waste water treatment plantRESPONSIBLE CARE certificate holder for 20 yearsApproved by SEDEX – Ethical and Responsible Supply Chain since 2015,
site reference ZS1073996
Farmak
,
a.s
.
14
Slide15CONTACTS
Feel free to contact us through our websites www.farmak.czPhone: +420 587 430 111, +420 585 547 111Fax: +420 585 231 424, +420 585 231 735E-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